Chapter 3

Chapters
1 - 2 - 3 - 4 - 5 - 6 - 7 - 8 - 9
2007-08 Lamp Application Guide

Regulation Issues
Food And Drug Administration— The Law In General
FDA Amendment 21 CFR Part 1040, Effective September 1986
FDA District Office Addresses
FDA Notices To Manufacturers
FDA Amendment 21 CFR Part 1040, Effective May 1980 
FDA Amendment 21 CFR Part 352
Possible Tanning Rule Amendments
State And Local Regulations
Sample State Regulations
Regulatory Roundup
State Radiation Control Offices
Legislative Hotline Numbers
Draft Of CRCPD Model Regulations
Underwriters Laboratories
UL 482 Standard For Portable Sun/Heat Lamps
Protective Eyewear 
Protective Eyewear Care
Educating Customers About Eyewear

CHAPTER THREE

Regulation Issues 

The goal of regulatory agencies is to protect the consumer. As the indoor tanning industry continues to grow, these agencies are stretched to the limit in carrying out that primary objective. Because of this, it is ultimately the responsibility of indoor tanning facilities to assure that mandatory regulations as well as sound facility practices are being followed in day-to-day operations—with the health and safety of the tanning consumer utmost in mind.

Local, state and federal regulations are in place to protect the industry as a whole. For those salon owners interested in providing secure, useful products and the longevity of the indoor tanning industry, regulations are a welcomed development. However, it cannot be emphasized enough that self-regulation and adhering to proper business conduct is in the industry’s best interest.

Last year the indoor tanning industry was besieged with anti-tanning propaganda from the media and medical communities, as well as an increase in legislative efforts to ban or restrict indoor tanning. The two biggest issues in 2006 were underage tanning and salon’s making health claims. It looks like 2007 is shaping up to be the same.

Locating rules and regulations, especially those from federal agencies, can be a time-consuming and difficult task, and for this reason we have designed this section to help salon owners understand what the FDA requires and its role in our industry. It contains all FDA regulations that apply to indoor tanning.

This chapter also contains a draft of a model set of state regulations written by the Conference of Radiation Control Program Directors (CRCPD). This draft gives an idea of what typical state rules might include. In addition to these rules and regulations, salon owners and equipment manufacturers also should pay attention to the electrical testing laboratories. UL and ETL are non-profit testing laboratories whose goals are to protect the consumer.

This chapter also includes regulations concerning protective eyewear and provides you with the tools to educate your customers about the importance of protecting their eyes during the tanning process.

Food And Drug Administration
The Law In General

The mission of the Food and Drug Administration is to enforce laws enacted by the U.S. Congress and regulations promulgated by the Agency to protect the consumer’s health, safety and pocketbook.

1. The Federal Food, Drug and Cosmetic Act (21 U.S.C. 301-392), and the Fair Packaging and Labeling Act (15 U.S.C. 1451-1461), which apply to food and drugs for man or animals, cosmetics and medical devices.

2. Sections of the Public Health Service Act relating to biological products for human use (42 U.S.C. 262-263) and control of communicable diseases (42 U.S.C. 264).

3. The Radiation Control for Health and Safety Act, relating to electronic products which emit radiation, such as X-rays, lasers, microwave ovens and TV sets (42 U.S.C. 263b-263n).

The Federal Food, Drug and Cosmetic Act is the basic food and drug law of the United States. With numerous amendments, it is the most extensive law of its kind in the world. Many of the states in the United States have laws similar to the Federal Law, and some have provisions to automatically add any new Federal requirements.

The law is intended to assure the consumer that foods are pure and wholesome, safe to eat and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative and not deceptive. Another law, the Fair Packaging and Labeling Act, affects the contents and placement of information required on the package.

On Nov. 28, 1990, President George Bush signed the Safe Medical Devices Act of 1990 (P.L. 101-629). This law was intended by Congress to strengthen the Federal Food, Drug and Cosmetic Act (FFDCA). One of the consequences of the Safe Medical Devices Act is that the provisions of the Radiation Control for Health and Safety Act of 1968 (RCHSA) have now been transferred to Chapter V of the FFDCA.

The requirements for electronic product radiation control will remain unchanged. The responsibilities of the Food and Drug Administration’s Center for Devices and Radiological Health also will remain the same. The RCHSA, however, has been renamed and re-codified as follows:

RCHSA (old) Chapter V, FDDCA (new) 
Sec. 354, Purpose Sec. 530 
Sec. 355, Definitions Sec. 531 
Sec. 356, Control Program Sec. 532 
Sec. 357, Studies Sec. 533 
Sec. 358, Standards 
Sec. 534 Sec. 359, Defects Correction Sec. 535 
Sec. 360, Imports Sec. 536 
Sec. 360A, Inspections, Records, Reports Sec. 537 
Sec. 360B, Prohibited Acts Sec. 538 
Sec. 360C, Enforcement Sec. 539 
Sec. 360D, Report to Congress Sec. 540 
Sec. 360E, Federal/State Relations Sec. 541 
Sec. 360F, State Standards Sec. 542 

The regulations pertaining to radiation control have not been changed or renumbered. They are still contained in Title 21, Code of Federal Regulations (CFR), Parts 1000 through 1050.

Because indoor tanning can be dangerous when performed improperly, the FDA has stringent rules and regulations that govern the manufacturing and use of devices for indoor tanning.

The FDA has become aware of the rapid development of the tanning industry and has completed an investigation on the use of these devices. As a result of this investigation, the FDA has become concerned with the potential for injury. Use of these products has resulted in several injuries such as “severe sunburn” from overexposure to the ultraviolet radiation and cuts from broken lamps.

A performance standard for sunlamp products (including tanning units) has been published in the Federal Register and is effective for all tanning devices manufactured since May 7, 1980. This regulation was designed primarily to promote the safety of home sunlamps. It was developed after a long period of both public and industry comment.

However, during the FDA’s investigation of commercial tanning it became apparent that other safety precautions were needed in addition to those that are required by the standard. Therefore, the standard was amended in 1985; the new version to be applicable for all tanning devices manufactured on or after Sept. 8, 1986. (Copies of both standards are included in this chapter).

The following document, titled “Equipment Recommendations for Tanning Booths,” was written by the FDA for use until the original standard was amended. This document identifies certain potential safety problems associated with commercial tanning units that weren’t adequately addressed by the earlier regulation and suggests possible approaches that manufacturers may take to eliminate them.

If any products pose a risk to the health of users, the FDA is prepared and authorized to take regulatory action. Safety may be enforced through mandatory or voluntary recalls, injunctions, imposition of fines or seizure of the products. However, in this specific case, the FDA requested that manufacturers of tanning units which did not meet the standard and recommendations voluntarily discontinue production until modifications could be made. In addition, modification of previously manufactured products was recommended as soon as was feasible.

Although these rules and regulations were written specifically for manufacturers, salon owners and operators should be familiar with the rules and regulations that will help them run a safer and more comfortable salon. It also will prove beneficial when educating salon employees and customers.

The following safety problems are identified and possible solutions in the form of equipment recommendations are provided for manufacturers of tanning booths or other similar equipment that provides whole body exposure for tanning purposes. Some of these recommendations may be in addition to the requirements of the Sunlamp Product Performance Standards, reproduced later in this chapter.

User Positioning In The Booth 
The intensity of the radiation to which a user is exposed usually depends upon the distance the user is from the lamp. The intensity of the radiation at contact can be as much as five times higher than that at a distance of 12 inches. Serious burns can occur if the proper exposure distance is not maintained. Installing hand rails, markings on the floor or other suitable physical aids are possible solutions.

Timer Error 
The ultraviolet radiation intensity usually found inside a tanning booth is relatively high when compared to the sun or the intensities associated with smaller home portable sunlamps.

Because of this, allowable exposure times are shorter. Therefore, more accurate control of exposure duration is necessary to decrease the risk of overexposure and injury. A timer having an accuracy of + or - 10 percent of any selected timer interval is sufficiently accurate.

Protective Eyewear 
Exposure of a person’s eyes to ultraviolet radiation may result in eye damage; however, persons being exposed need to see well enough to maintain their balance and to locate the door and the exit quickly and safely should it be necessary. It is important that protective eyewear be provided that protects from ultraviolet radiation and allows adequate vision.

Temperature Control Operation of sunlamps can increase the temperature in an enclosed area. A large increase in temperature might cause fainting and subsequent injury. Units which keep the temperature below 100 degrees F (38 degrees C) would not be cause for concern.

Electrical Safety 
If potential electrical hazards in the unit are not controlled, users, operators and service personnel could be seriously injured. Elevated temperatures cause perspiration which enhances the possibility or severity of an electric shock. Even without perspiration, the skin may come into contact with the interior surfaces which house lamps and ballasts that carry large amount of current. There is a potential for electric shock without proper circuit design and insulation.

In addition, there are potential hazards to operators and service personnel. Changing lamps, turning on the device, etc., can be a hazard if the device is not grounded properly and if ground fault protectors are not included. There also is the possibility of a fire due to circuit overloads, wire shorting and flammable material being used. Electrical hazards will be minimized in booths that conform to currently recognized electrical standards for such equipment. (See UL Standards later in this chapter.) 

Mechanical Construction 
The collapse of a booth might cause electrical shock, fire or direct physical injury. This can be prevented by designing the booth to have had enough strength and rigidity to resist the stress of use and to withstand the impact of a falling person.

Protection From Lamps 
A person can be cut and seriously injured by falling into or bumping against bare sunlamps. This could be prevented by use of physical barriers around the lamps, such as heavy grid wires or ultraviolet transmitting plastics, which are sturdy enough to withstand the impact of a falling person.

Access And Support 
Rapid entrance into or exit from the booth is essential in emergencies. This can be assured by use of doors which open outwardly and are opened easily from both inside and outside of the booth. The potential for injuries from falls can be reduced by use of hand rails and floors which provide adequate traction for wet or dry bare feet.

The Tanning Process 
Skin tanning results from exposure of the skin to ultraviolet radiation in the wavelength region between 260 and 400 nanometers. This region is conventionally subdivided into UVB short wavelength radiation (260 nm to 320 nm) and the longer wavelength UVA radiation (320 nm to 400 nm). Tanning results when melanin pigment is formed in the skin following exposure to ultraviolet radiation. There are two processes for tanning that occur.

Immediate pigment darkening results from photo-oxidation of melanin already present in the melanocyte cells of the skin basal cell layer and is caused primarily by long wavelength ultraviolet radiation.

Delayed tanning results from production of new “packages” of melanin pigment called melanosomes. UVB radiation is much more efficient than UVA in this process. The FDA considers sunlamp products (defined in 21 CFR 1040.20 (b)(9) and ultraviolet lamps (defined in 21 CFR 1040.20 (b)(11) to be both electronic products and medical devices. Therefore, these products and their manufacturers are subject to both the Radiation Control for Health and Safety Act of 1968 (transferred to Chapter V of the Federal Food, Drug and Cosmetic Act in 1991) and the Medical Device Amendments of 1976 (which amended the Food, Drug and Cosmetic Act).

Ultraviolet lamps and accessory equipment have been proposed for classification into Class II. Instructions for preparation of a premarket notification to the Food and Drug Administration and registering a firm as a medical device manufacturer may be found in 21 CFR 801 (Labeling), 21 CFR 803 (Medical Device Reporting), 21 CFR 807 (Establishment Registration and Device Listing for Manufacturers of Devices) and 21 CFR 808 (Exemptions from Federal Preemption of State and Local Medical Device Requirements).

A manufacturer of a sunlamp or sunlamp product is any person engaged in the business of manufacturing, assembling or importing a sunlamp or sunlamp product designated to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the living body, by ultraviolet radiation with wavelengths in air between 200 nm and 400 nm, to induce skin tanning.

Manufacturers are required, under Part 1002 of the regulations for the enforcement of the Radiation Control for Health and Safety Act of 1968, to submit an initial report and model change reports for new or modified product models. These reports must be submitted prior to the introduction of a product into commerce and must be prepared in accordance with the “Reporting Guide for Initial Reports and Model Change Reports on Sunlamps and Sunlamp Products.”

The Sunlamp Product Performance Standard, 21 CFR 1040.20, located in the regulations for the enforcement of the Act, initially became effective on May 7, 1980. All sunlamps and sunlamp products manufactured or offered for entry into the United States on or after May 7, 1980, are subject to the code. For products such as suntanning booths, couches or beds, the Center also issued equipment recommendations. In addition to the standard, these recommendations also had to be met prior to introducing a product into commerce.

The standard was amended to include many of the equipment recommendations and better address certain safety issues in September 1985. The amended version took effect on Sept. 8, 1986; all sunlamps and sunlamp products made or submitted for entry into the United States on or after this effective date must comply with the amended standard.

Failure to certify products as required in the code or to provide the required reports or to maintain the required records are violations of Section 538, Chapter V, FDDCA (Section 360B, RCHSA) and may result in the imposition of the penalties, specified in Section 539 (Section 360C, RCHSA).

The reporting and recordkeeping requirements are set forth in Part 1002. In brief, manufacturers, importers and assemblers are required to submit:

1. An initial report (see 1002.10) for each product family which:
a. Identifies models within the reported model family and their intended uses.
b. Describes the nature of radiation emissions associated with those products and the performance and safety characteristics affecting such emissions.
c. Details manufacturer design, quality control, and testing standards and procedures with respect to product radiation and safety.

2. Model change reports (see 1002.12) for each new or different model family.

3. Annual reports which summarize the contents of records maintained by the manufacturer (see 1002.30(a).

Initial and model change reports must be filed prior to the introduction of sunlamps and sunlamp products into commerce. They are to include sufficient information to enable the determination of whether a manufacturer has correctly certified his products as being in compliance with the performance standard.

Annual reports should be submitted by Sept. 1 of each year and should cover the 12-month period beginning on July 1 of the previous year and ending on June 30 of that year.

For aid in submitting the information required in the initial and model change reports, consult the Guide for Preparing Annual Reports. The use of these reporting guidelines is mandatory.

Since the product is also a medical device, manufacturers should be aware of the provisions of the Medical Device Amendments of 1976. Among these provisions are requirements for establishment registration and pre-market notification. Also, section 807.87, paragraph (f) of the regulations requests information on substantial equivalence of the device to similar devices already in commercial distribution.

Cosmetic Standards
In addition, those companies which produce sunscreens, lotions and moisturizers, etc., are subject to 21 CFR part 352, titled “Sunscreen Drug Products for Over-the-Counter Human Use.”

FDA Amendment 21 CFR Part 1040
EFFECTIVE SEPT. 1986

Department of Health and Human Services 
Food and Drug Administration 
21 CFR Part 1040 
[Docket No. 82N-0188] 
Sunlamp Products; Performance Standard 

Agency: Food and Drug Administration.
Action: Final rule.

Summary: The Food and Drug Administration is amending the performance standard for sunlamp products and ultraviolet (UV) lamps intended for use in these products to accommodate new products employing design concepts significantly different from those for which the current standard was developed. Also, FDA’s experience in applying the current standard, which went into effect on May 7, 1980, indicates that some requirements are either inappropriate or inapplicable to some products.

The amendments are intended to establish a standard that is appropriate for the present technology of suntanning and new sunlamp product designs.

Dates: Effective Sept. 8, 1986, for sunlamp products and ultraviolet lamps that are manufactured on or after this date. For additional information concerning the applicability of this amended performance standard, see the “EFFECTIVE DATE” paragraph in the preamble of this document. The Director of the Office of the Federal Register approves the incorporation by reference of certain publications in 21 CFR 1040.20 effective Sept. 8, 1986.

For Further Information Contact: Manuel Karos, FDA Office of Compliance, 2098 Gaither Road, Rockville, MD 20850, (301) 594-4654.

Supplementary Information:

In the Federal Register of May 20, 1983 (48 FR 22886) (corrected Oct. 21, 1983; 48 FR 48837), FDA issued a proposed rule to amend the performance standard for sunlamp products and ultraviolet lamps intended for use in sunlamp products (21 CFR 1040.20). In the preamble to the May 20, 1983, proposal, FDA discussed the history of 1040.20 and the issues that led to the agency’s decision to propose to revise the standard. The preamble also described the changes in the standard that FDA proposed to make based on the agency’s experience in administering the standard. Interested persons were given until July 19, 1983, to provide written data, views or comments concerning the amendments and any associated information on their potential environmental or economic impact.

Comments

Comments were received from an interested member of the public, a medical academy, two manufacturers, an individual who described himself as an association representing suntanning professionals, and a Canadian government agency. A summary of the comments and FDA’s responses to them follows:

1. One comment agreed with the proposed amendments as they would apply to the use of sunlamp products for skin-tanning purposes but questioned whether the regulations also were intended to apply to sunlamp products used for medical purposes. The comment stated that most of the safety provisions of the proposed rule should be adhered to regardless of the purpose of the sunlamp use. The comment suggested, however, that the warning statement in 1040.20(d)(1)(i) not be required to be included on medical therapy units because the statement would establish a negative environment for the treatment regimen and would be counterproductive. In addition, the warning statement could cause patients to resist the use of an effective form of therapy for diseases such as psoriasis. Section 1840.20 applies only to sunlamp products as defined in 1040.20(b)(9): “Sunlamp product means any electronic product designed to incorporate one or more ultraviolet lamps intended for irradiation of any part of the living human body, by ultraviolet radiation with wavelengths between 200 nm and 400 nm, to induce skin tanning” (emphasis added). Accordingly, the warning statement of 1040.20 (d)(1)(i) applies only to sunlamp products intended for skin tanning.

2. One comment suggested that the proposed amendments should be modeled after the draft German Industrial Standard DIN 50-50, “Non-Therapeutical UV Irradiation Apparatus for the Human Body.” In this standard, a sunburn effect is defined by the erythema-threshold time and by the tanning effect (pigmentation-threshold time). Each manufacturer is required to declare on its sunlamp product label the erythema and pigmentation threshold times for the product. In addition, the product is required to be classified and labeled according to the magnitude of the erythema-threshold time.

FDA believes that the current standard, which requires manufacturers to provide adequate directions for use, including recommended exposure schedules and exposure positions, achieves the same goals that the German standard achieves. FDA’s Evaluation indicates that little safety advantage is to be gained by rating sunlamp products according to an estimated erythema potential. To establish a system of erythema potential ratings that would be appropriate under all use conditions and for all product designs or configurations would be burdensome and excessively complicated. A sunlamp product may have almost any spectral distribution and irradiance depending upon varying factors; for example, product design, lamp design and lamp age. Also, human skin varies greatly from individual to individual in sensitivity to burning induced by sunlamp products. For all these reasons, FDA declines to adopt the suggestion.

3. One comment on 1040.20(c)(2)(ii) objected to FDA’s proposal to remove the current 10-minute limit on a sunlamp product timer. The comment also objected to the proposal to revise 1040.20(c)(4) to proscribe only automatic resumption of emission from a product. The comment argued that such changes inappropriately allow the manufacturer, seller, or user of the product to decide what conditions of sunlamp use are safe.

FDA believes that irradiation of the skin with ultraviolet radiation to induce skin tanning is hazardous. The performance standard for sunlamp products was established to protect the consumer from acute burns (as evidenced by erythema) and from exposure to hazardous radiation that is unnecessary for skin tanning (in this case, UV radiation of wavelengths in air of less than 280 nm and to warn the consumer of the known adverse effects to the body after exposure to ultraviolet radiation. FDA believes that the user of a sunlamp product can take appropriate action when informed of the possible adverse effects to the body from exposure to ultraviolet radiation, if the product is equipped with necessary safety performance features.

The current 10-minute maximum timer interval and the requirement concerning resumption of radiation emission, however, are inappropriate for newer sunlamp products now on the market. The agency’s position on these two requirements remains as expressed in the discussion in the preamble to the proposed rule (48 FR 22888).

FDA notes that the timer is defined in 1040.20(b)(10) as any device incorporated into a sunlamp product that terminates radiation emission after a preset time interval. A sunlamp product may, however, be designed to use more than one source of ultraviolet radiation with differing spectral distributions. Such a product may need to incorporate more than one timer and more than one maximum exposure time to minimize potential injury to the user. The manufacturer is required to provide a recommended exposure schedule that would not result in acute injuries when followed and to provide the means to enable the user to follow these instructions regardless of the complexity of the spectral distribution of the radiation. The standard is modified in the final rule to make this requirement clear.

4. A comment stated that the language of 1040.20 (c)(2)(iv) of the proposed amendments may be misleading because the proposed language may be interpreted to exclude timers that automatically will resume radiation at the point when power is interrupted. Because the intent of the amendment has been perceived to allow this usage, the comment suggested that this requirement be revised to state, “The timer may not automatically reset and cause radiation emission to resume for a period greater than the unused portion of the timer cycle, when emission from the sunlamp product has been terminated.”

The agency accepts the suggested change.

5.A comment suggested that the warning statement required by 1040.20(d)(1)(i) should utilize the signal word “CAUTION” rather than “DANGER.” The comment contended that the word “DANGER” implies an immediate and serious threat to life, a hazard not associated with UVA sunlamp products, i.e., sunlamp products that operate in the wavelength region of 320 nm to 400 nm. The comment stated that there is a need for an appropriate warning label cautioning the user that certain safeguards need to be observed to avoid injury and that prolonged use has longterm risk.

The agency believes that the word “DANGER” as used on the warning statement is appropriate. Exposure to ultraviolet radiation can be an immediate threat to life for people using photosensitizing medications or cosmetics and for people with a medical condition that causes them to be sensitive to ultraviolet radiation, for example, photoallergies.

6. One comment urged that UVA lamps should be exempt from the provisions of 1040.20(d) that require the warning: “As with natural sunlight, overexposure can cause eye and skin injury and allergic reactions. Repeated exposure may cause premature aging of the skin and skin cancer.” The comment argued that radiation at wavelengths in air longer than 320 nm cannot induce skin cancer and that only radiation at wavelengths in air shorter than 320 nm is responsible for premature skin aging. The comment argued further that UVA radiation that does not contain measurable UVB radiation (280 nm to 320 nm) has positive effects, for example, a UVA tan can protect a person against the harmful UVB radiation of the sun (photoprotection), and UVA radiation that does not contain UVB radiation can monomerize pyrimidine dimers in the deoxyribonucleic acid (DNA).

FDA disagrees that it has been proven that UVA does not cause skin cancer or premature skin aging, or that UVA radiation can protect humans against UVB radiation. Relatively few studies have been carried out on the long-term biological effects of UVA radiation in humans or in animals. Further studies are needed to establish clearly the long-term biological effects of UVA radiation. There are, however, reports that, under long-term continuous exposure, UVA radiation can induce skin cancer in test animals (Refs. 1 and 2). Also, there is evidence that the incidence of skin tumors induced in animals by irradiation with a combination of UVB and UVA radiation can be increased by subsequent irradiation with UVA alone (Ref. 3).

There is evidence (Ref. 4) that UVA radiation can enhance the photoreactivation of pyrimidine dimers in the DNA of human leukocytes. However, this effect has not been shown to provide humans protection against UVB radiation (Ref. 5). The Task Force on photobiology of the American Academy of Dermatology has expressed concerns about potential risks of tanning with UVA radiation (Ref. 8).

Based on available evidence, FDA concludes that to exempt UVA lamps from the warning statement required by the standard would not promote the public health and safety.

7. One comment disagreed with the language of the warning statement set forth in 1040.20(d)(1) of the proposed amendments and argued that the statement, “If you do not tan in the sun, you are unlikely to tan from the use of this product,” would be inappropriate because it may confuse the sunlamp user. The comment argued that the action of direct exposure to the sun cannot be compared to that of exposure to either UVA or UVB suntanning equipment: that the current warnings already clearly and accurately provide the same information in more detail; and that the quoted statement would be redundant to the statement “Consult a physician before using lamp if taking any medication or if you believe yourself sensitive to sunlight.”

The agency disagrees with the comment. The scientific literature clearly demonstrates that some people do not tan or that they tan only with great difficulty using either the sun or sunlamps (Ref. 7). People who, when exposed to the sun, do not tan or tan only with great difficulty should be informed about the futility of exposures to potentially hazardous ultraviolet radiation.

8. A comment disagreed with the requirements of 1040.20(d)(l)(vi) and (2) of the proposed amendments, arguing that there are not any lamps that are “uniquely designed” for a particular sunlamp product. According to the comment, only a few manufacturers of lamps manufacture replacement lamps for other manufacturers’ sunlamp products. The comment stated that FDA is providing an unfair competitive advantage to certain manufacturers and a great disadvantage to others because the additional labeling would be extremely expensive, in monetary as well as person-hour terms. The comment said that the requirement would have a significant impact on a substantial number of small entities, as this term is used in the Regulatory Flexibility Act. The comment stated further that it would be impossible for some manufacturers to maintain and service their own products because their products are distributed throughout the country and urged the agency not to exempt any sunlamp products or ultraviolet lamps from the proposed labeling requirements. According to the comment, there would be no way for FDA to monitor whether a particular unit was being maintained and serviced by the manufacturer or its agent.

After having reviewed reports submitted to the agency under Part 1002 (21 CFR Part 1002), FDA agrees that there are few ultraviolet lamps that are unique to a sunlamp product. The agency concludes that a substitute lamp could be made by other manufacturers. Also, FDA agrees that monitoring the maintenance and servicing of sunlamp products would be difficult and would not be warranted. For these reasons, FDA has concluded not to exempt any sunlamp products or ultraviolet lamps from the labeling requirements and has revised final 1040.20(d) (l)(vi) and (2) accordingly.

The comment does, however, illustrate that manufacturers use lamps produced by other firms. It also is apparent that many of these lamps are equivalent and can be used safely in a number of different models of sunlamp products. The current standard is not clear on how a person or manufacturer would be able to determine that a replacement lamp is equivalent to that designated on the sunlamp product to be used in the product.

FDA advises that replacement lamps must comply with each applicable requirement of the performance standard and be certified under 1010.2 of the regulations (21 CFR 1010.2). Section 1040.20(e) requires that any ultraviolet lamp not accompanying a sunlamp product contain instructions for its safe use. Thus, the manufacturer of a replacement ultraviolet lamp is required to state in the user instructions any specific model of ultraviolet lamps for which the manufacturer is promoting its lamp as a replacement. FDA has revised 1040.20(e)(2) in the final rule to make this concept clear. FDA advises that the promotion of incompatible lamps will be considered as marketing a falsely certified product.

Effective Date

The final rule became effective Sept. 8, 1986, for sunlamp products and ultraviolet lamps that are manufactured on or after this date. Sunlamp products and ultraviolet lamps manufactured on or after May 7, 1980, but before Sept. 8, 1986, are subject to the provisions of 21 CFR 1040.20 as published in the Federal Register of Nov. 9, 1979 (44 FR 65357). The agency, however, does not object to any manufacturer of a sunlamp product or ultraviolet lamp complying with the final rule after it is published and prior to its effective date, provided the manufacturer specifies on the certification label for the product that it complies with the amended standard and provided the manufacturer complies with the recordkeeping and reporting requirements of Part 1002.

References

The following references are on file in the Dockets Management Branch (HFA305), Food and Drug Administration, Rm. 4-62, 5600 Fishers Lane, Rockville, MD 20857, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Forbes, P.D., R.E. Davies, and C.A. Cole, “Photocarcinogenesis by UVA Alone,” Abstract MAM-D6, Tenth Annual Meeting, American Society for Photobiology, Vancouver, BC, Canada. June 27-July 1, 1982.

2. Van Weelden, H., F.R. de Gruijl, and J.C. van der Leun, “Tumors induced by UVA in Mice,” Abstract WAM-F4, Photochemistry and Photobiology, 7S:79, 1983.

3. Staberg B. et al. “The Carcinogenic Effect of UVA Irradiation,” Journal of Investigative Dermatology, 81:6:517-519, 1983.

4. Sutherland. B.M., P. Runge, and J.C. Sutherland, “DNA Photoreactivating Enzyme from Placental Mammals. Origin and Characteristics,” Biochemistry 23:4710-4715, 1974.

5. Mutzhas. M.F., et al., “A New Apparatus with High Radiation Between 328-480 nm: Physical Description and Dermatological Applications.” Journal of Investigative Dermatology, 76:42-47, 1981.

6. Jeffry, Jr., T.E., “Danger of Tanning Booths Bared. New Release,” American Academy of Dermatology. Evanston, IL, May 1, 1983.

7. Pathak, M.A., “Sunscreens: Topical and Systemic Approaches for Protection of Human Skin Against Harmful Effects of Solar Radiation.” Journal of the American Academy of Dermatology, 7:285-311, 1982.

Economic Impact

The FDA has evaluated the economic consequences of this action in accordance with Executive Order 12291 and the Regulatory Flexibility Act (Pub. L. 98-354). This action has been determined not to be a major rule as defined in Executive Order 12291. Further, the agency certifies that the final rule will not have a significant impact on a substantial number of small entities, as defined in the Regulatory Flexibility Act. A threshold assessment supporting this conclusion is on file with the Dockets Management Branch (address above).

Section 1040.20 (d) and (e) of this final rule contains information collection requirements that were submitted for review and approval to the Director of the Office of Management and Budget (OMB), as required by Section 3507 of the Paperwork Reduction Act of 1980. The requirements were approved and assigned OMB control number 09100195.

Electronic products, HID lamps, Incorporation by reference, Lasers, Medical devices, Radiation protection, Standards, Sunlamps. Therefore, under the Public Health Service Act, as amended by the Radiation Control for Health and Safety Act of 1968. Part 1040 is amended to read as follows:

PART 1040—PERFORMANCE STANDARDS FOR LIGHTEMITTING PRODUCTS 

1. The authority citation for Part 1040 continues to read as follows: Authority: Secs. 358, 360A, 82 Stat. 11771179, 1182 (42 U.S.C. 263f, 263i); 21 CFR 5.10.

2. By revising 1040.20. to read as follows: 
§1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
(a)Applicability.

(1) The provisions of this section, as amended, are applicable as specified herein to the following products manufactured on or after Sept. 8, 1986.

(i) Any sunlamp product.

(ii) Any ultraviolet lamp intended for use in any sunlamp product.

(2) Sunlamp products and ultraviolet lamps manufactured on or after May 7, 1980, but before Sept. 8, 1986, are subject to the provisions of this section as published in the FEDERAL REGISTER of Nov. 9, 1979 (44 FR 65357).

(b) Definitions. As used in this section the following definitions apply:

(1) “Exposure position” means any position, distance, orientation, or location relative to the radiating surfaces of the sunlamp product at which the user is intended to be exposed to ultraviolet radiation from the product, as recommended by the manufacturer.

(2) “Intended” means the same as “intended uses” in 801.4.

(3) “Irradiance” means the radiant power incident on a surface at a specified location and orientation relative to the radiating surface divided by the area of the surface, as the area becomes vanishingly small, expressed in units of watts per square centimeter (W/cm2).

(4) “Maximum exposure time” means the greatest continuous exposure time interval recommended by the manufacturer of the product.

(5) “Maximum timer interval” means the greatest time interval setting on the timer of a product.

(6) “Protective eyewear” means any device designed to be worn by users of a product to reduce exposure of the eyes to radiation emitted by the product.

(7) “Spectral irradiance” means the irradiance resulting from radiation within a wavelength range divided by the wavelength range as the range becomes vanishingly small, expressed in units of watts per square centimeter per nanometer (W/(cm/ nm).

(8) “Spectral transmittance” means the spectral irradiance transmitted through protective eyewear divided by the spectral irradiance incident on the protective eyewear.

(9) “Sunlamp product” means any electronic product designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the living human body, by ultraviolet radiation with wavelengths in air between 200 nm and 400 nm, to induce skin tanning.

(10) “Timer” means any device incorporated into a product that terminates radiation emission after a pre-set time interval.

(11) “Ultraviolet lamp” means any lamp that produces ultraviolet radiation in the wavelength interval of 200 nm to 400 nm in air and that is intended for use in any sunlamp product.

(c) Performance requirements (1) Irradiance ratio limits. For each sunlamp product and ultraviolet lamp, the ratio of the irradiance within the wavelength range of greater than 200 nm through 260 nm to the irradiance within the wavelength range of greater than 260 nm through 320 nm may not exceed 0.003 at any distance and direction from the product or lamp.

(2) Timer system.

(i) Each sunlamp product shall incorporate a timer system with multiple timer settings adequate for the recommended exposure time intervals for different exposure positions and expected results of the products as specified in the label required by paragraph (d) of this section.

(ii) The maximum timer interval(s) may not exceed the manufacturer’s recommended maximum exposure time(s) that is indicated on the label required by paragraph (d)(l)(iv) of this section.

(iii) No timer interval may have an error greater than 10 percent of the maximum timer interval of the product.

(iv) The timer may not automatically reset and cause radiation emission to resume for a period greater than the unused portion of the timer cycle, when emission from the sunlamp product has been terminated.

(v) The timer requirements do not preclude a product from allowing a user to reset the timer before the end of the preset time interval.

(3) Control for termination of radiation emission.

Each sunlamp product shall incorporate a control on the product to enable the person being exposed to terminate manually/radiation emission from the product at any time without disconnecting the electrical plug or removing the ultraviolet lamp.

(4) Protective eyewear.

(i) Each sunlamp product shall be accompanied by the number of sets of protective eyewear that is equal to the maximum number of persons that the instructions provided under paragraph (e)(1)(ii) of this section recommend to be exposed simultaneously to radiation from such product.

(ii) The spectral transmittance to the eye of the protective eyewear required by paragraph (c)(4)(i) of this section shall not exceed a value of 0.001 over the wavelength range of greater than 200 nm 320 nm and a value of 0.01 over the wavelength range of greater than 320 nm through 400 nm, and shall be sufficient over the wavelength greater than 400 nm to enable the user to see clearly enough to reset the timer.

(5) Compatibility of lamps. An ultraviolet lamp may not be capable of insertion and operation in either the “singlecontact medium screw” or the “double-contact medium screw” lampholders described in American National Standard C81.10-1976, Specifications for Electric Lamp Bases and Holders—Screw-Shell Types, which is incorporated by reference. Copies are available from the American National Standards Institute, 1430 Broadway, New York, NY 10018, or available for inspection at the Office of the Federal Register, 1100 L St. NW., Washington, D.C. 20408.

(d) Label requirements. In addition to the labeling requirements in Part 801 and the certification and identification requirements of 1010.2 and 1010.3, each sunlamp product and ultraviolet lamp shall be subject to the labeling requirements prescribed in this paragraph and paragraph (e) of this section.

(1) Labels for sunlamp products. Each sunlamp product shall have a label(s) which contains:

(i) A warning statement with the words “DANGER—Ultraviolet radiation. Follow instructions. Avoid overexposure. As with natural sunlight, over exposure can cause eye and skin injury and allergic reactions. Repeated exposure may cause premature aging of the skin and skin cancer. WEAR PROTECTIVE EYEWEAR: FAILURE TO MAY RESULT IN SEVERE BURNS OR LONG-TERM INJURY TO THE EYES. Medications or cosmetics may increase your sensitivity to the ultraviolet radiation. Consult physician before using sunlamp if you are using medications or have a history of skin problems or believe yourself especially sensitive to sunlight.

If you do not tan in the sun, you are unlikely to tan from the use of this product.”

(ii) Recommended exposure position(s). Any exposure position may be expressed either in terms of a distance specified both in meters and feet (or in inches) or through the use of markings or other means to indicate clearly the recommended exposure position.

(iii) Directions for achieving the recommended exposure position(s) and a warning that the use of other positions may result in overexposure.

(iv) A recommended exposure schedule including duration and spacing of sequential exposures and maximum exposure time(s) in minutes.

(v) A statement of the time it may take before the expected results appear.

(vi) Designation of the ultraviolet lamp type to be used in the product.

(2) Labels for ultraviolet lamps. Each ultraviolet lamp shall have a label which contains:

(i) The words “Sunlamp—DANGER—Ultraviolet radiation.

Follow instructions.”

(ii) The model identification.

(iii) The words “Use ONLY in fixture equipped with a timer.”

(3) Label specifications.

(i) Any label prescribed in this paragraph for sunlamp products shall be permanently affixed or inscribed on an exterior surface of the product when fully assembled for use so as to be legible and readily accessible to view by the person being exposed immediately before the use of the product.

(ii) Any label prescribed in this paragraph for ultraviolet lamps shall be permanently affixed or inscribed on the product so as to be legible and readily accessible to view.

(iii) If the size, configuration, design or function of the sunlamp product or ultraviolet lamp would preclude compliance with the requirements for any required label or would render the required wording of such label inappropriate or ineffective, or would render the required label unnecessary, the Director, Office of Compliance (HFZ-300), Center for Devices and Radiological Health, on the Center’s own initiative or upon written application by the manufacturer, may approve alternate means of providing such label(s), alternate wording for such label(s), or deletion, as applicable.

(iv) In lieu of permanently affixing or inscribing tags or labels on the ultraviolet lamp as required by 1010.2(b) and 1010.3(a), the manufacturer of the ultraviolet lamp may permanently affix or inscribe such required tags or labels on the lamp packaging uniquely associated with the lamp, if the name of the manufacturer and month and year of manufacture are permanently affixed or inscribed on the exterior surface of the ultraviolet lamp so as to be legible and readily accessible to view. The name of the manufacturer and month and year of manufacture affixed or inscribed on the exterior surface of the lamp may be expressed in code or symbols, if the manufacturer has previously supplied the Director, Office of Compliance (HFZ-300), Center for Devices and Radiological Health, with the key to such code or symbols and the location of the coded information or symbols on the ultraviolet lamp. The label or tag affixed or inscribed on the lamp packaging may provide either the month and year of manufacture without abbreviation, or information to allow the date to be readily decoded.

(v) A label may contain statements or illustrations in addition to those required by this paragraph if the additional statements are not false or misleading in any particular; e.g., if they do not diminish the impact of the required statements; and are not prohibited by this chapter.

(e) Instructions to be provided to users. Each manufacturer of a sunlamp product and ultraviolet lamp shall provide or cause to be provided to purchasers and, upon request, to others at a cost not to exceed the cost of publication and distribution, adequate instructions for use to avoid or to minimize potential injury to the user, including the following technical and safety information as applicable:

(1) Sunlamp products. The users’ instructions for a sunlamp product shall contain:

(i) A reproduction of the label(s) required in paragraph (d)(l) of this section prominently displayed at the beginning of the instructions.

(ii) A statement of the maximum number of people who may be exposed to the product at the same time and a warning that only that number of protective eyewear has been provided.

(iii) Instructions for the proper operation of the product including the function, use, and setting of the timer and other controls, and the use of protective eyewear.

(iv) Instructions for determining the correct exposure time and schedule for persons according to skin type.

(v) Instructions for obtaining repairs and recommended replacement components and accessories which are compatible with the product, including compatible protective eyewear, ultraviolet lamps, timers, reflectors, and filters, and which will, if installed or used as instructed, result in continued compliance with the standard.

(2) Ultraviolet lamps. The users’ instructions for an ultraviolet lamp not accompanying a sunlamp product shall contain:

(i) A reproduction of the label(s) required in paragraph (d) (1) (i) and (2) of this section, prominently displayed at the beginning of the instructions.

(ii) A warning that the instructions accompanying the sunlamp product should always be followed to avoid or to minimize potential injury.

(iii) A clear identification by brand and model designation of all lamp models for which replacement lamps are promoted, if applicable.

(f) Test for determination of compliance. Tests on which certification pursuant to 1010.2 is based shall account for all errors and statistical uncertainties in the process and, wherever applicable, for changes in radiation emission or degradation in radiation safety with age of the product. Measurements for certification purposes shall be made under those operational conditions, lamp voltage, current, and position as recommended by the manufacturer. For these measurements, the measuring instrument shall be positioned at the recommended exposure position and so oriented as to result in the maximum detection of the radiation by the instrument.

Dated: Aug. 12, 1985.

FDA District Office Addresses

The following is a regional breakdown of U.S. Food and Drug Administration District Offices. All requests for additional forms to the Registration Monitor can be obtained at these offices. If you have any questions regarding the FDA and indoor tanning you can contact the office within your state. This information also is available online at www.tanningtraining.com. 

Click here to view List

FDA Notices To Manufacturers

In addition to the code published in the Federal Register, the FDA periodically distributes notices to all manufacturers, importers and potential manufacturers of sunlamp products, clarifying general policy guidelines. These notices may serve the purpose of rectifying widespread instances of noncompliance by ensuring that the standard is understood, or of informing all interested parties that changes in the standard itself are imminent.

In the months before the amended version of 21 CFR 1040 took effect in 1986, two notices were sent to inform all manufacturers, importers and potential manufacturers of sunlamp products of the impending changes in timer intervals and lamp compatibility. In June 1985, the FDA had sent a notice to encourage manufacturers and importers to be sure their product labeling was in compliance with the standard.

Although these notices are written principally for manufacturers and importers, salon operators also may find them useful as a “plain-English” description of certain aspects of the code with which their equipment must comply. The notices are as follows:

Date:
June 25, 1985 

To:
All Manufacturers, Importers and Potential Manufacturers of Sunlamp Products.

Subject:
Policy on Warning Label Required on Sunlamp Products.

Background:
The Center for Devices and Radiological Health has found numerous imported and domestic sunlamp products labeled in such a way as to render the label illegible and/or inaccessible to view by the consumer under normal conditions of purchase and use.

Sunlamp products are electronic products as defined by Section 355(2) [42 U.S.C. 263c(2)] of the Radiation Control for Health and Safety Act of 1968 (RCHSA) and medical devices as defined by Section 201(h)(3) of the Federal Food, Drug and Cosmetic Act (FD&C) [21 U.S.C. 321(h)(3)]. The performance standard for sunlamp products (21 CFR 1040.20), promulgated under authority of Section 358 of the RCHSA, requires that labels containing specific information be permanently affixed or inscribed on an exterior surface of the product so as to be legible and readily accessible to view when the product is fully assembled for use. The general labeling provisions for medical devices under 21 CFR 801.5 require adequate directions for use be provided to the user and 21 CFR 801.15 defines the prominence of the required label statements for devices.

Policy:
The intended purpose of the warning label required on sunlamp products is to provide that information necessary for the consumer to make an informed decision regarding the risks of using sunlamp products and to provide adequate directions for skin tanning.

Therefore, the label must be legible and conspicuously placed on the product so as to render it likely to be read by the user under normal conditions of purchase and use. The Agency will consider sunlamp products to be non-compliant with the performance standard under Section 358(a)(1) of the RCHSA and misbranded under Section 502(c) of the FD&C Act if the required product label is not legible and accessible to view for the following reasons:

1) The label required under 21 CFR 1040.20(d)(1) does not appear on a prominent part or panel which is presented or displayed under normal conditions of purchase and/or use.

2) Adequate space is not provided for the required label or the label is not prominently displayed on the device.

3) The normal individual cannot read the label from a distance of 1 meter because of inadequate lettering size and background contrast. Lettering of 10 millimeters (height) for the word “DANGER” and 5 millimeters for the rest of the label information is recommended to meet the visibility requirements.

Date:
Aug. 21, 1986 

To:
All Manufacturers, Importers and Potential Manufacturers of Sunlamp Products.

Subject:
Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products.

Background:
The amended performance standard for sunlamp products (21 CFR 1040.20) was published in the Sept. 6, 1985, issue of the Federal Register and became effective Sept. 8, 1986. Any sunlamp product manufactured on or after that date must comply with the amended standard.

The 10-minute maximum timer interval requirement was removed from the original performance standard since there are newer sunlamp products on the market for which 10 minutes is not appropriate. The maximum timer interval now depends on the intensity and spectral distribution of ultraviolet (UV) radiation emission of each individual model of sunlamp product and must not exceed the maximum recommended exposure time provided on the required product warning label. Therefore, sunlamp product manufacturers must develop an exposure schedule and establish the maximum recommended exposure time (and therefore the maximum timer interval) based on the characteristics of their particular products.

The intended purposes of a sunlamp product timer are to provide for reliable control of exposures and to limit acute (and delayed) damage from unintentionally long exposures. However, the maximum timer setting also should allow for selection of exposure times needed to build up and maintain a tan. The maximum timer interval is in no way to be considered a safe limit; all ultraviolet radiation is potentially hazardous.

The standard requires the manufacturer to provide an exposure schedule in the product warning label. The purpose of the exposure schedule is to allow a person to build up skin pigmentation gradually and to maintain a tan while controlling the risk of acute injury and delayed adverse effects. Since the UV radiation dose that causes a barely discernible pink coloration (minimum erythemal dose or MED) is not the same for different skin types, the exposure schedule for first-time users will depend on the skin type of the user. Furthermore, suberythemogenic doses of UV radiation received at 24-hour intervals initially lead to lowering of the erythema and tanning thresholds. Therefore, the exposure schedule and maximum recommended exposure time should be constrained by the potential for erythema as well as the quantity of radiation necessary to achieve and maintain a tan.

Policy:
The Center for Devices and Radiological Health (CDRH) will use the following criteria to evaluate the adequacy of the exposure schedule and the recommended maximum exposure time (and therefore the maximum timer interval):

1). The maximum recommended exposure time (and maximum timer interval) must not exceed a value which will result in an exposure of four times the minimum erythema dose (MED) for untanned Type II skin (always burns, then tans slightly). This is based on the CDRH Erythema Action Spectrum [proposed action spectrum of the Commission Internationale de L’Eclairage (CIE) modified by CDRH].

2). The recommended maximum exposure time must not exceed a value which will result in an exposure of four times the minimal melanogenic dose (MMD) for untanned Type II skin. This is based on the melanogenic action spectrum developed by Parrish et al (1982).

3). The recommended exposure schedule should provide for exposures of no more than 0.75 MED three times the first week, gradually increasing the exposure time the following weeks until maximum tanning has occurred (approximately four weeks total) and then provide for maintenance of a tan by biweekly or weekly exposures of up to four MEDs or four MMDs, whichever is less.

CDRH believes that the above criteria balances the need to limit acute (and delayed) damages from unintentionally long exposure and the need to provide for single exposure durations adequate to achieve and maintain a tan.

Date:
Sept. 2, 1986 

To:
All Manufacturers, Importers and Potential Manufacturers of Sunlamps.

Subject:
Policy on Lamp Compatibility 

Background:
The amended performance standard for sunlamp products (21 CFR 1040.20) was published in the Sept. 6, 1985, issue of the Federal Register and became effective Sept. 8, 1986. Any ultraviolet lamp (intended to be used in sunlamp products) and sunlamp products manufactured on or after that date must comply with the amended standard.

The amended standard requires the user instructions of an ultraviolet lamp not accompanying a sunlamp product to contain a clear identification by brand name and model designation of all lamp models for which the replacement lamps are promoted, if applicable [21 CFR 1040.20(f)(2)(iii)]. As stated in the preamble of the amendment to the standard (Federal Register issue of Sept. 6, 1985), the promotion of incompatible lamps will be considered as marketing a falsely certified product.

The Center for Devices and Radiological Health (CDRH) has been asked what criteria will be used to evaluate lamp compatibility.

Policy:
A replacement lamp will be considered compatible with (or equivalent to) another (original) lamp if:

1). The replacement lamp will not cause any sunlamp product intended to use the original lamp to fail to comply with the standard or to become defective as defined by 21 CFR 1003.2 and;

2). The lamp is as effective, within + or - 10 percent, as the original lamp, in causing erythema and melanogenesis. 

It should be noted that the above criteria apply to the sunlamp product exposure and maximum timer interval which must appear on the product’s labeling. The manufacturer should use the following procedure to establish conformance with criterion number 2 above:

1). Calculate the recommended maximum exposure time for a single original lamp (Y) using the CDRH Aug. 21, 1986, guidance (Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products).

2). Calculate the recommended maximum exposure time for a single replacement lamp (X) using the same method.

3). Compare the values. If the value for the replacement lamp (X) is within plus or minus 10 percent of the value of the original lamp (Y), the lamp would be considered compatible [X+Y±10%].

The distance(s) used for this comparison should represent the typical use-distance range in products using the original (Y) lamp.

The CDRH welcomes comments on this policy.

(a) Applicability. The provisions of this section are applicable as specified herein to the following products manufactured on or after May 7, 1980.

(1) Any sunlamp product.

(2) Any ultraviolet lamp intended for use in any sunlamp product.

(b) Definitions. As used in this section the following definitions apply:

(1) “Intended” means the same as “intended uses” in 801.q of this chapter.

(2) “Irradiance” means the radiant power incident on a surface divided by the area of the surface, as the area becomes vanishingly small, expressed in units of watts per square centimeter (W/cm2).

(3) “Maximum exposure time” means the greatest continuous exposure time interval recommended by the manufacturer of the product.

(4) “Maximum timer interval” means the greatest time interval setting on the timer of a product.

(5) “Minimum use distance” means the least distance from the ultraviolet lamp at which the user should be exposed to radiation from the product, as recommended by the manufacturer.

(6) “Protective eyewear” means any device designed to be worn by users of a product to reduce exposure of the eyes to radiation emitted by the product.

(7) “Spectral irradiance” means the irradiance resulting from radiation within a wavelength range divided by the wavelength range as the range becomes vanishingly small, expressed in units of watts per square centimeter per nanometer (W/(cm/nm).

(8) “Spectral transmittance” means the spectral irradiance transmitted through protective eyewear divided by the spectral irradiance incident on the protective eyewear.

(9) “Sunlamp product” means any electronic product designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the living human body, by ultraviolet radiation with wavelengths in air between 180 nm and 320 nm, to induce skin tanning.

(10) “Timer” means any device incorporated into a product that terminates radiation emission after a preset time interval.

(11) “Ultraviolet lamp” means any lamp which produces radiation in the wavelength interval of 180 nm to 320 nm in air and is intended for use in any sunlamp product.

(c) Performance requirements.

(1) Irradiance ratio limits. For each sunlamp product and ultraviolet lamp, the ratio of the irradiance within the wavelength range of greater than 180 nm through 260 nm to the irradiance within the wavelength range of greater than 260 nm through 320 nm shall not exceed 0.003 at any distance and direction from the product or lamp.

(2) Timer. (i) Each sunlamp product shall incorporate a timer with multiple timer settings adequate for the recommended exposure time intervals for different exposure distances and expected results of the product as specified in the label required by paragraph (d) of this section.

(ii) The maximum timer interval shall not exceed the recommended maximum exposure time as indicated on the label required by paragraph (d)(1)(vii) of this section, or 10 minutes, whichever is less. This requirement does not preclude a product from allowing a user to reset the timer before the end of the preset time interval. No timer interval shall have an error greater than 10 percent of the maximum timer interval of the product.

(3) Control for termination of radiation emission. Each sunlamp product shall incorporate a control on the product to enable the user manually to terminate radiation emission from the product at any time with-out disconnecting the electrical plug or removing the ultraviolet lamp.

(4) Resumption of radiation emission. When radiation emission from a sunlamp product has been terminated for any reason, including termination by a timer, resumption of such emission shall not be possible until the product is reactivated manually by the user.

(5) Protective eyewear. (i) Each sunlamp product shall be accompanied by the number of sets of protective eyewear that is equal to the maximum number of persons that the instructions provided under paragraph (f)(1)(iii) of this section recommend to be exposed simultaneously to radiation from such product.

(ii) The spectral transmittance of the protective eyewear required by paragraph (c)(5)(i) of this section shall not exceed a value of 0.001 over the wavelength range of greater than 180 nm through 320 nm and a value of 0.01 over the wavelength range of greater than 320 nm through 360 nm, and shall be sufficient over the wavelengths greater than 360 nm to enable the user to see clearly enough to read the labels and reset the timer.

(6) Compatibility of lamps. An ultraviolet lamp shall not be capable of insertion and operation in any of the following lampholders:

(i) “Single-contact medium screw,” described in American National Standard C81.10-1976.

(ii) “Double-contact medium screw,” described in American National Standard C81.10-1976.

(d) Label requirements. In addition to the labeling requirements in Part 801 of this chapter and the certification and identification requirements of 1010.2 and 1010.3 of this chapter, each sunlamp product and ultraviolet lamp shall be subject to the labeling requirements prescribed in this paragraph and paragraph (f) of this section. All labels prescribed in this paragraph shall be permanently affixed or inscribed on an exterior surface of the product so as to be legible and readily accessible to view when the product is fully assembled for use.

(1) Each sunlamp product shall have a label which contains:

(i) The words “DANGER—Ultraviolet radiation. Follow instructions. As with natural sunlight, overexposure can cause eye injury and sunburn; repeated exposure may cause premature aging of the skin and skin cancer. Medications or cosmetics applied to the skin may increase your sensitivity to ultraviolet light. Consult physician before using lamp if taking any medication or if you believe yourself especially sensitive to sunlight.”

(ii) Designation of the ultraviolet lamp type which is to be used in the product.

(iii) A recommended minimum use distance specified both in meters and in feet (or in inches).

(iv) Directions for measuring the minimum use distance.

(v) A warning that exposure at distances less than the minimum use distance is not recommended.

(vi) A warning to use protective eyewear whenever the product is energized.

(vii) A recommended maximum exposure time in minutes.

(viii) A recommendation for duration, frequency and spacing of sequential exposures.

(ix) A statement of the time it may take before the expected results appear.

(2) Each ultraviolet lamp shall have a label which contains:

(i) The words “Sunlamp-DANGER—Ultraviolet radiation.

Follow instructions.”

(ii) The model identification.

(iii) The words “Use ONLY in fixture equipped with a timer.”

(3) In lieu of permanently affixing or inscribing tags or labels on the ultraviolet lamp as required by 1010.2(b) and 1010.3(a) of this chapter, the manufacturer of the ultraviolet lamp may permanently affix or inscribe such required tags or labels on the lamp packaging uniquely associated with the lamp, if the name of the manufacturer and month and year of manufacture are permanently affixed or inscribed on the exterior surface of the ultraviolet lamp so as to be legible and readily accessible to view. When the tags or labels required by 1010.2(b) and 1010.3(a) of this chapter are affixed or inscribed on the ultraviolet lamp packaging, the name of the manufacturer and month and year of manufacture required to be permanently affixed or inscribed on the exterior surface of the lamp may be expressed in code or symbols, if the manufacturer has previously supplied the Director, Bureau of Radiological Health, with the key to such code or symbols and the location of the coded information or symbols on the ultraviolet lamp.

(e) Test for determination of compliance. Tests on which certification pursuant to 1010.2 of this chapter is based shall account for all measurement errors and statistical uncertainties in the measurement process and, wherever applicable, for changes in radiation emission or degradation in radiation safety with age of the product. The measurements shall be made under those operational conditions and procedures that maximize the emission of radiation and with the measuring instrument so positioned and so oriented as to result in the maximum detection of the radiation by the instrument. However, the measuring instrument shall be no closer to the product than the minimum use distance. Such measurements shall be made at a test voltage up to 130 root-mean-square volts if the sunlamp product or ultraviolet lamp is designed to operate from nominal 100 to 120 root-mean-square volt power sources. If the sunlamp product or ultraviolet lamp is designed to operate from a power source having some voltage other than from nominal 100 to 120 root-mean-square volts, the measurement shall be made at a voltage up to 110 percent of the maximum nominal root-mean-square voltage specified by the manufacturer for the power source.

(f) Instructions to be provided to users. Each manufacturer of a sunlamp product and ultraviolet lamp shall provide or cause to be provided to purchasers and, upon request, to others at a cost not to exceed the cost of publication and distribution, instructions for safe use, including the following technical and safety information as applicable:

(1) Sunlamp products. The users’ instructions for a sunlamp product shall contain:

(i) A reproduction (color optional) of the label required in paragraph (d)(l) of this section prominently displayed at the beginning of the instructions.

(ii) A prominently displayed statement containing the words “DANGER—Ultraviolet radiation. Follow instructions. As with natural sunlight, overexposure can cause eye injury and sunburn; repeated exposure may cause premature aging of the skin and skin cancer. Medications or cosmetics applied to the skin may increase your sensitivity to ultraviolet light. Consult physician before using lamp if taking any medication or if you believe yourself especially sensitive to sunlight.”

(iii) A statement of the maximum number of people who may be exposed to the product at the same time and a warning that only that number of protective eyewear has been provided.

(iv) Instructions for obtaining repairs and recommended replacement components and accessories which are compatible with the product, including compatible protective eyewear, ultraviolet lamps, timers, reflectors and filters, and which will, if installed or used as instructed, result in continued compliance with the standard.

(2) Ultraviolet lamps. The user’s instructions for an ultraviolet lamp not accompanying a sunlamp product shall contain:

(i) A reproduction (color optional) of the label required in paragraph (d)(2) of this section, prominently displayed at the beginning of the instructions.

(ii) A statement prominently displayed containing the words “DANGER—Ultraviolet radiation. Follow instructions. As with natural sunlight, overexposure can cause eye injury and sunburn; repeated exposure may cause premature aging of the skin and skin cancer. Medications or cosmetics applied to the skin may increase your sensitivity to ultraviolet light. Consult physician before using lamp if taking any medication or if you believe yourself especially sensitive to sunlight.”

(iii) A warning that the instructions accompanying the sunlamp product should always be followed to avoid or to minimize potential injury. (Sec. 358, 82 Stat. 1177-1179 (42 U.S.C. 263f).

AGENCY: 
Food and Drug Administration.

ACTION: 
Proposed rule.

SUMMARY: 
This proposed rule would establish conditions for the safety, effectiveness and labeling of over-the-counter (OTC) sunscreen drug products. The proposed rule, based on the recommendations of the Panel on Review of Topical Analgesic including antirheumatic, otic, burn, and sunburn treatment and prevention drugs is part of the Food and Drug Administration’s ongoing review of OTC drug products.

SUPPLEMENTARY INFORMATION: 
Pursuant to part 330 (21 CFR Part 330), the Commissioner of Food and Drugs received on Dec. 14, 1977, a report of the Advisory Review Panel on Over-The-Counter (OTC) Topical Analgesic, Antirheumatic, Otic, Burn and Sunburn Prevention and Treatment Products. In accordance with 330.10(a)(6).

(21 CFR 330.10(a)(6), the Commissioner is issuing (1) a proposed regulation containing the monograph recommended by the Panel, which establishes conditions under which OTC sunscreen drugs are generally recognized as safe and effective and not misbranded; (2) a statement of the conditions excluded from the monograph on the basis of a determination by the Panel that they would result in the drugs generally not being recognized as safe and effective or would result in misbranding: (3) a statement of the conditions excluded from the monograph on the basis of a determination by the Panel that the available data are insufficient to classify such conditions under either (1) or (2) above; and (4) the conclusions and recommendations of the Panel to the Commissioner. The minutes of the Panel meetings are on public display in the office of the hearing Clerk (HFA-305), Food and Drug Administration (address given above).

The purpose of issuing the Panel’s unaltered conclusions and recommendations is to stimulate discussion, evaluation, and comment on the full sweep of the Panel’s deliberations. The Commissioner has not yet fully evaluated the report; the Panel’s findings are being issued as a formal proposal to obtain public comment before the agency reaches any decision on the Panel’s recommendations. The report has been prepared independently of the Food and Drug Administration (FDA). It represents the best scientific judgment of the Panel members but does not necessarily reflect the agency position on any particular matter contained in it.

The Commissioner recognizes that extensive changes will result in the current marketing practices of these products if the Panel recommendations are fully implemented. The Panel’s recommendations include many labeling revisions. One of these labeling recommendations is the statement “Overexposure to the sun may lead to premature aging of the skin and skin cancer. The liberal and regular use over the years of this product may help reduce the chance of premature aging of the skin and skin cancer.” As with other of the Panel’s recommendations, the Commissioner is not at this time making a final decision with regard to this labeling. However, he finds it necessary to comment that the issue is important and requires careful study.

Because of the critical nature of the disease conditions involved, the wording of any claim concerning them must be very carefully considered especially because three of the seven panel members oppose the use of the recommended statement. Special attention must be given to assure that consumers are not misled or confused. The Commissioner recognizes the potential for such a statement to mislead the public, and is concerned about its use.

However, the issue is open and will receive the fullest attention before any claim with regard to skin cancer or aging of the skin is included in any OTC drug monograph. After careful review of all contents submitted in response to this proposal, the Commissioner will issue a tentative final regulation in the FEDERAL REGISTER to establish a monograph/ or OTC sunscreen drug products.

In accordance with 330.10(a)(2) (21 CFR 330.10(a)(2), all data and information concerning OTC sunscreen drug products submitted for consideration by the Panel have been handled as confidential by the Panel and FDA. All such data and information will be put on public display at the office of the Hearing Clerk, Food and Drug Administration, after Sept. 25, 1978, except to the extent that the person submitting it demonstrates that it still falls within the confidentiality provisions of 18 U.S.C. 1905 or section 301(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(j). Requests for confidentiality should be submitted to William E. Gilbertson Bureau of Drugs (HFD-510).

Based on the conclusions and recommendations of the Panel, the Commissioner proposes the following:

1. That the conditions included in the monograph, under which the drug products generally would be recognized as safe and effective and not misbranded (category I), be effective 30 days after the date of publication of the final monograph in the FEDERAL REGISTER.

2. That the conditions excluded from the monograph because they would cause the drug to be not generally recognized as safe and effective or to be misbranded (category II), be eliminated from OTC drug products effective six months after the date of publication of the final monograph in the FEDERAL REGISTER regardless whether further testing is undertaken to justify their future use.

3. That the conditions excluded from the monograph because the available data are insufficient (category III) to classify such conditions either as category I or category II be permitted to remain on the market, or to be introduced into the market after the date of publication of the final monograph in the FEDERAL REGISTER, provided that FDA receives notification of testing in accordance with 330.10(a)(13) (21 CFR 330.10(a)(13). The Panel recommended that a period of two years be permitted for the completion of studies to support the movement of category III conditions to category I. The Commissioner will review that recommendation as well as all comments on this document, and will determine what time period to permit for category III testing after that review is completed.

In the FEDERAL REGISTER for Jan. 5, 1972 (37 FR 85), the Commissioner of Food and Drugs announced a proposed review of the safety, effectiveness and labeling of all OTC drugs by independent advisory review panels. In the FEDERAL REGISTER of May 11, 1972 (37 FR 9464), the Commissioner published the final regulations providing for the OTC drug review under 330.10 which were made effective immediately. Pursuant to these regulations, the Commissioner issued in the FEDERAL REGISTER of Dec. 12, 1972 (37 FR 26456), a request for data and information on all active ingredients utilized in topical analgesic, including antirheumatic, otic, burn, sunburn prevention and treatment drug products.

The Commissioner appointed the following Panel to review the data and information submitted and to prepare a report pursuant to 330.10(a)(1) on the safety, effectiveness and labeling of those products:

Thomas G. Kantor, M.D., Chairman, John Adriani, M.D., Col. William A. Akers, M.D., Maxine Bennett, M.D., Minerva S. Buerk, M.D., Walter L. Dickison, Ph.D., and Jerry Mark Shuck, M.D.

The Panel was charged to review submitted data and information for OTC topical analgesic ingredients, including antirheumatic, otic, burn and sunburn prevention and treatment active ingredients. For purposes of this review, the Panel grouped the active ingredients and labeling into four major pharmacologic groups, i.e., external analgesics, skin protectants, topical otics and sunscreens.

The Panel presents its conclusions and recommendations for sunscreen active ingredients in this document. The Panel’s conclusions for topical otic active ingredients were published in the FEDERAL REGISTER of Dec. 16, 1977 (42 FR 63556), and its conclusions for skin protectant active ingredients were published in the FEDERAL REGISTER of Aug. 4, 1978 (43 FR34628).

The Panel’s conclusions and recommendations for external analgesic ingredients will be presented in a later issue of the FEDERAL REGISTER.

The Panel was first convened on March 6, 1973, in an organizational meeting. Working meetings were held on May 8 and 9, July 12 and 13, Sept. 27 and 28, Nov. 3 and 4, Nov. 26 and 27, 1973: Jan. 30 and 31, March 6 and 7, April 10 and 11, May 8 and 9, June 10 and 11, July 17 and 18, Sept. 24 and 25, Oct. 22 and 23, Nov. 26 and 27, 1974; Jan. 21 and 22, March 13 and 14, April 17 and 18, May 21 and 22, July 15 and 16, Sept. 30 and Oct.

1, Nov. 12 and 13, 1975; March 4 and 5, May 19 and 20, June 22 and 23, Sept. 27 and 28, Nov. 18 and 19, 1976; Feb. 23 and 24, May 25 and 26, Aug. 22, 23 and 24, Oct. 25 and Dec. 13, 14 and 15, 1977.

Seven non-voting liaison representatives served on the Panel: Mrs. Jacqueline Pendleton (at the initial meeting), Mrs. Valerie Howard (from May 8, 1973 to Sept. 28, 1973), Lynn Berry (from Nov. 3, 1973 to April 27, 1976), Kathleen A. Blackburn (from July 6, 1976 to Aug. 24, 1977) and Emily Londos (from Oct. 25, 1977). Each was nominated by an ad hoc group of consumer organizations and served as the consumer liaison; and Joseph L Kanig, Ph.D., nominated by the Proprietary Association, and Ben Marr Lanman, M.D., nominated by the Cosmetic, Toiletry, and Fragrance Association, served as the industry liaisons.

The following FDA employees served: C. Carnot Evans, M.D., served as Executive Secretary. Lee Geismar served as Panel Administrator. Lee Quon, R.Ph., served as Drug information Analyst until July 1975, followed by Timothy T. Clark, R.Ph., until July 1973, followed by Thomas H. Gingrich, R.Ph., until July 1976, followed by Victor H. Lindmark, Pharm.D.

The following individuals were given an opportunity to appear before the Panel to express their views either at their own or the Panel’s request on the issues before the Panel:

Joseph P. Armellino, M.D., Charles Bluestone, M.D., Stuart Ericksen, Ph.D., Alexander A. Fisher, M.D., Thomas Fitzpatrick, M.D., Ph.D., J. M. Glassman, M.D., Peter Hebborn, Ph.D., George E. Heinze, Kenneth R. Johannes, Albert M. Kligman, M.D., Howard Maiback, M.D., Edward Marlowe, Ph.D., Kenneth L. Milstead, Ph.D., John Parrish, M.D., Madhue Pathak, M.D., Robert Sayre, Ph.D., Joseph P. Soyka, M.D., Garrett Swenson, Esq., Stephen M. Truitt, Esq. and Frederick Urbach, M.D.

No person who so requested was denied an opportunity to appear before the Panel.

The Panel thoroughly has reviewed the literature and data submissions, has listened to additional testimony from interested persons and has considered all pertinent data and information submitted through Dec. 14, 1977, in arriving at its conclusions and recommendations for OTC sunscreens.

In accordance with the OTC drug review regulations (21 CFR 330.10), the Panel’s findings with respect to sunscreen active ingredients are set out in three categories:

Category I. Conditions under which sunscreen products are generally recognized as safe and effective and are not misbranded.

Category II. Conditions under which sunscreen products are not generally recognized as safe and effective or are misbranded.

Category III. Conditions for which the available data are insufficient to permit final classification at this time.

I. SUBMISSION OF DATA AND INFORMATION Pursuant to the notice published in the FEDERAL REGISTER of Dec. 12, 1972, (37 FR 26156) requesting the submission of data and information on OTC topical sunscreen drugs, the following firms made submissions related to the indicated products:

A. SUBMISSIONS BY FIRMS 
FIRMS AND MARKETED PRODUCTS AVA Inc., 
Garland, Texas 75040, AVA Suntan Lotion. Bonne Bell, Lakewood, Ohio 44107, Sure Tan Gel and Sure Tan Lotion.

Paul B. Elder Co., 
Bryan, Ohio 43506, 
RVP Wide Range Sunscreen, RVP Ultra-Range Sun Protection, RVPlus, RVPaque UltraViolet Occlusive Agent, RVPABA Lipstick.

Elizabeth Arden Inc., 
New York, N.Y. 10022, 
Sun Gelee and Suncare.

Greiter Corp. Inc., 
Weidling, Austria, 
Piz Buin Exclusiv Suntan Cream, Piz Buin Exclusiv Extrem Suntan Cream, Piz Buin Exclusiv Suntan Liquid Cream.

G. S. Herbert Laboratories, 
Irvine, Calif. 92664, 
Eclipse Sunscreen Lotion.

Lanvin-Charles of the Ritz Inc., 
Holmdel Township, N.J. 07733, 
Alexandra de Markoff Lip Emollient, Alexandra de Markoff Allevia Body Treatment, Alexandra de Markoff Allevia Travel Stick, Bain de Soleil Suntan Creme White, Bain de Soleil Suntan Cream, Bain de Soleil Suntan Lotion, Bain de Soleil Leg Make-up, Bain de Soleil Foam Concentrate, Bain de Soleil Bronzer, Imperial Nutricia Moisture Tint, Revenescence Sun Bronze, Revenescence Protective Cream for the Face, Revenescence Extra Protective Cream for the Face, Revenescence Moisture GlowBronze Shade, Revenescence Moisture Glow Liquid-Bronze Shade.

Menley & James Laboratories, 
Philadelphia, Pa. 19101, 
Sea & Ski Golden Tan, Sea & Ski Block Out.

Miles Laboratories Inc., 
Elkhart, Ind. 46514, 
Sungard Lotion.

Plough Inc., 
Memphis, Tenn. 38101, 
Coppertone Improved Shade Suntan Lotion, Coppertone Lipkote Lip Balm, Coppertone Noskote Sunscreen, Coppertone Suntan Cream, Coppertone Suntan Foam, Coppertone Suntan Lotion, Coppertone Suntan Oil, Coppertone Suntan Oil Aerosol Spray, Q.T. Foam, Q.T. Lotion, Sudden Tan, Sun Protective Foam, Sun Shielding Lotion.

Rowell Laboratories Inc., 
Baudette, Minn. 56623, 
Duoshield One and Duoshield Two.

Texas Pharmacal Co., 
San Antonio, Texas 78296, 
A-Fil Cream, Sundare Creamy Lotion, Sundare Clear Lotion, SunStick Lip Protectant, SunSwept Cream.

Westwood Pharmaceuticals Inc., 
Buffalo, N.Y. 14213, 
Presun Lotion.

In addition, the following firms made related submissions:

Amerchol, 
Edison, N.J. 08817, 
Amerscreen P.

Chattem Laboratories, 
Chattanooga, Tenn. 37409, 
Alpaba.

EM Laboratories Inc., 
Elmsford, N.Y. 10523, 
Eusolex 161, Eusolex 232, Eusolex 4360, Eusolex 6300, Eusolex 3573, Eusolex 5563.

Felton International Inc., 
Brooklyn, N.Y. 11237, 
Sunarome.

GAF Corp., 
New York, N.Y. 10020, 
Sulisobenzone.

Givaudan Corp., 
Clifton, N.J. 07104, 
GivTan-F, Parsol MCX and Parsol Hydro.

Greiter Corp., 
Tulsa, Okla. 74101, 
Exclusiv Creme, Exclusiv Milk, Exclusiv Moisture Creme, Exclusiv Oil Lotion, Exclusiv Stick Extrem Creme, Extrem Glacier Creme, Extrem Junior Creme, Extrem Milk, Piz Buin.

Haarmann and Reimer Corp., 
Springfield, N.J. 07081, 
Neo Heliopan AV.

Hill Top Research Inc., 
St. Petersburg, Fla. 33709, Sun Block 253E, Sun Block 256E, Sun Block U-2575.

Ingram Pharmaceutical Co., 
San Francisco, Calif. 94111, 2- Ethylhexyl 2-cyano-3,3-diphenylacrylate.

Van Dyk & Co. Inc., 
Belleville, N.J. 07109, Escalol 106, Escalol 506, Escalol 507.

B. LABELED INGREDIENTS CONTAINED IN MARKETED PRODUCTS AND OTHER INGREDIENTS SUBMITTED TO THE PANEL.

Alcohol 
Allantoin 
Allantoin-p-aminobenzoic acid complex p-Aminobenzoic acid 
Amyl dimethyl PABA 
Amyl para-dimethylaminobenzoate 
Amyl-p-dimethylaminobenzoate 
Beeswax 
Benzophenone-3 
Benzyl alcohol 
BHA BHT 
2-Bromo-2-nitropropane-l,3-diol 
Camphor 
Carbomer 934 
Carboset 
Cellulose gum 
Cetyl alcohol 
Cetyl palmitate 
Cetyl stearyl glycol 
Cinoxate Citric acid 
Clove oil 
Cocoa butter 
Color 
Digalloyl trioleate 
Dihydroxyacetone 
Dimethicone 5-(3,3-Dimethyl-2-norbornyliden)- 
3-penten2-one 3,4-
Dimethylphenyl-g lyoxylic acid sodium salt 
Dimethyl polysiloxane 
Dioxybenzone 
Dipropylene glycol salicylate 
Ethyl alcohol 
2-Ethylhexyl 2-cyano-3,3-diphenylacrylate 
Ethylhexyl-p-methoxycinnamate 
2-Ethylhexyl 
4-phenylbenzophenone-
2-carboxylic acid 
2-Ethylhexyl salicylate 
FD&C yellow No.5 
FD&C red No.4
Fragrances 
Glycerin 
Glyceryl PABA 
Glyceryl stearate 
Homosalate 
Isopropyl myristate 
Isopropyl palmitate 
Lanolin 
Lanolin alcohol 
Lanolin derivatives 
Lanolin oil 
Lawsone (2-hydroxy-1,4-naphthoquinone) 
Menthol 
Menthyl anthranilate 
p-Methoxycinnamic acid diethanolamine 
3-(4-Methylbenzyliden)-camphor 
Methylparaben 
Microcrystalline titanium- coated mica platelets 
Microcrystalline wax 
Mineral oil 
Octyl dimethyl PABA 
Oleth-3-phosphate 
Oxybenzone 
Padimate 
Padimate A 
Padimate O 
Parabens 
Paraffin 
PEG 2 stearate 
Petrolatum 
2-Phenylbenzimidazole 
Polyoxyl-40-stearate 
Polysorbate 60 
Propellant 46 
Propellant 12/114 
Propoxylate of p-aminoethylbenzoate 
Propylparaben 
Propylene glycol 
Propylene glycol stearate 
Quaternium 15 
Red petrolatum 
SD alcohol 40 
Sesame oil 
Silaca 
Sodium carbomer 
Sorbitan oleate 
Sorbitan stearate 
Stabilized aloe vera gel 
Stearyl alcohol 
Sulisobenzone 
Synthetic spermaceti 
Titanium dioxide 
Triethanolamine 
Triethanolamine salicylate 
Triethanolamine stearate 
Water 
Wax 
Zinc oxide

C. CLASSIFICATION OF INGREDIENTS 
1. Active ingredients.

Allantoin combined with aminobenzoic acid (allantoin paminobenzoic acid complex) 
Aminobenzoic acid (p-aminobenzoic acid) 
Cinoxate 
Diethanolamine p-methoxycinnamate (p-methoxycinhamic acid diethanolamine) 
Digalloyl trioleate 5-(3,3-Dimethyl 2 norbornyliden)-3penten-2-one 
Dioxybenzone 
Dipropylene glycol salicylate 
Ethyl 4-[bis(hydroxypropyl)] aminobenzoate (propoxylate of p-aminoethylbenzoate) 
2-Ethylhexyl 2-cyano-3,3-diphenylacrylate 
Ethylhexyl p-methoxycinnamate 
2-Ethylhexyl 4-phenylbenzophenone-2-carboxylic acid 
2-Ethylhexyl salicylate 
Glyceryl aminobenzoate (glyceryl PABA) 
Homosalate 
Lawsone with dihydroxyacetone [dihydroxyacetone; lawsone (2-hydroxy-1,4-naphthoquinone)] 
Menthyl anthranilate 3-(4-Methylbenzylidene)-camphor 
Oxybenzone (benzophenoe-3) 
Padimate A (amyl pdimethylaminobenzoate, amyl paradimethylaminobenzoate, amyl dimethyl PABA, padimate) 
Padimate O (octyl dimethy PABA) 
2.Phenylbenzimidazole-5-sulfonic acid phenylbenzimidazole sulfonic acid) 
Red petrolatum 
Sodium 3,4-dimethylphenyl glyoxylate (3,4-dimethylphenyl-glyoxylic sodium salt) 
Sulisobenzone 
Titanium dioxide 

Possible Tanning Rule Amendments

The Food and Drug Administration requested and was given the go-ahead to develop amendments to the U.S. performance standard for sunlamp products based on certain initiatives of international standards organizations concerning sunlamp products. This came after the FDA’s Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) heard a proposal Oct. 1, 2003, for rule changes associated with indoor tanning products.

Several industry professionals spoke at the TEPRSSC hearing, including representatives from the Indoor Tanning Association, Ultraviolet Research Institute, National Tanning Training Institute, LOOKING FIT magazine and Suntanning Association for Education, as well as a Pennsylvania salon owner.

During the sunlamps session of the meeting, the FDA’s Sharon Miller proposed several regulatory changes regarding indoor tanning on behalf of the FDA. The changes covered warning labels, eyewear, the definition of a manufacturer and more.

Warning Label The proposed revised label must include the following text:

“WARNING— Ultraviolet radiation may cause:

• Injury to the eyes and skin.
• Skin aging.
• Skin cancer.

Read instructions carefully.
Wear protective eyewear provided.
Certain medicines and cosmetics may increase sensitivity to ultraviolet radiation.”

It is recommended that the word “warning” have lettering at least 10 millimeters in height and the rest of the label information be 5 millimeters tall to meet the visibility requirements specified in 21 CFR 1010.3.

Label Placement 

The label must be included in catalogs, specification sheets and descriptive brochures. The FDA proposes: “ ... in all catalogs, specifications sheets, and descriptive brochures and any other purchasing information pertaining to each sunlamp product and ultraviolet lamp, a legible reproduction of the warning statement required by 21 CFR 1040.20 shall be affixed.”

This modification is designed to be used only in promotional material for home tanners.

Definition Of A Manufacturer 

Significant modification of a sunlamp product means recertification as a “manufacturer.” Here are some examples from the FDA: 
“A replacement lamp will be considered compatible with (or equivalent to) another (original) lamp if: 
The replacement lamp will not cause any sunlamp product intended to use the original lamp to fail to comply with the standard or to become defective as defined by 21 CFR 1003.2, and; 
The lamp is as effective, within plus or minus 10 percent, as the original lamp, in causing erythema and melanogenesis.”

However, to harmonize with the international standard for sunlamps, the requirement that the lamps effectiveness be compared on the basis of melanogenesis will be removed and a new requirement based on the CIE nonmelanoma skin cancer action spectrum will be added. (See the section on coding systems for lamps below.) Protective Eyewear UV limits will remain the same as before, but standards for the visible region (> 400 nm) will include a more quantitative definition: “the luminous transmittance shall not be less than 1 percent over the 380 to 780 nm wavelength region and the unweighted transmittance ( 5 nm intervals) over the 400 to 550 nm region shall not exceed 5 percent.” This second requirement is currently part of the international standard for sunlamp products (IEC 6-335-2-27).

New MED Dose The currently used “CIELYTLE” erythema action spectrum will be replaced with the internationally-accepted CIE Reference action spectrum for erythema.

The proposal includes the adoption of a maximum timer setting of 3 minimal erythema doses (MEDs) where an MED is defined as 200 J/m2-effective (wavelength-weighted with the CIE action spectrum). The limit of 3 MEDs provides a biologicallyequivalent dose to what is currently used (4 MEDs), weighted with the CIELYTLE action spectrum and assuming that 1 MED equals 156 J/m2-effective. Limits for the old and new action spectrums are roughly equal to 600 J/m2-effective.

Coding System For Lamps For determining replacement lamps—low pressure, fluorescent types—the following coding scheme shall be used: Wattage - Reflector type code - UV code. Wattage is the nominal lamp wattage, marked “watts” or “W.” The reflector type code is defined as follows:

O—for nonreflector lamps.
B—for lamps with a broad reflector angle.
N—for lamps with a narrow reflector angle.
R—for lamps with a regular reflector.

The following UV code shall be used: UV code = X/Y. X equals the total erythema effective UV irradiance over the range 250-400 nm, and Y equals the ratio of the CIE action spectrum effective UV irradiances

State And Local Regulations

State and local regulations are key elements to keeping the indoor tanning industry running on a level playing field. Since the mid-1980s, a number of states have implemented regulations for businesses that offer indoor tanning services.

With these instances of state level regulation now in place and available to serve as examples for other states, industry experts expect many of the remaining states to be at work on their own regulations. Those already adopted by some states, such as Ohio, California and North Carolina, likely will aid in the development of other local codes. In addition, a model set of rules written by a national organization of state radiation control officers is slated for final approval.

The Conference of Radiation Control Program Directors (CRCPD) is, as its name suggests, a national organization made up of the directors of the radiation control programs of each state. In existence since 1968, its purpose is to share knowledge freely between the states and to set national standards for radiation control.

The purpose of the model regulations is to give governmental agencies at all levels a framework on which to build the codes for their particular state. The CRCPD’s intent is to achieve some national uniformity in this type of regulations. Although the model only addresses radiation control, and skips over some health and cosmetic issues such as sanitation, most local authorities should find it a good starting point, since most of their radiological research is already done for them.

Although some salons owners may view regulation as something to be avoided, industry experts argue that the enforcement of fair and reasonable rules actually will improve the health of the industry by forcing uncommitted and uneducated operators out of the industry and preventing them from causing consumers harm.

Not surprisingly, in Ohio, North Carolina and California, as well as in the handful of counties and cities with regulations in place, the central theme seems to be consumer safety.

Whatever their intent, there are some limits to what local rules can require. States and cities cannot implement any regulation that is substantially different from the FDA regulations, according to FDA representatives. This argument apparently has legal merit, since based on it, an outright ban on tanning equipment in Wakefield, Mass., was challenged a few years back and overturned.

However, Wakefield’s ban is a worst-case example; few local authorities take controls to quite that extreme. More typically, they apply themselves to ensuring that operating procedures are followed to reduce consumer risk. States, counties and cities are fairly consistent in what they address. Most have provisions requiring that all businesses offering tanning be registered, that warning signs be posted, that consumers are adequately notified of the risks of tanning, that protective eyewear is available, that certain minimum cleanliness standards are observed, that minors not be allowed to tan without parental permission and that the state or FDA be notified of any injuries.

The means of enforcement and penalties for violations is not so standardized, but it is typically moderate. Even those local authorities that have such measures at their disposal are slow to use them, usually trying to give salon owners every opportunity to rectify the situation before penalizing them or suspending their licenses.

More states and local agencies than you might think are in the process of developing regulations, and once the CRCPD’s model rules are approved, the process may accelerate further. However, not all local authorities are eager to take on the responsibility of regulating the tanning industry. In South Dakota, the state health, cosmetology and radiation control authorities have had some disagreement over whose job it is and other states have expressed a desire to sidestep the development of regulations altogether and pass the job on to county and city authorities.

However, regardless of who finally takes responsibility to write the rules, the number of tanning businesses affected by state or local codes is growing. Authorities in the following states and local governments either have rules in place, are in the process of writing legislation or have at least requested information to that end from one of the trade associations, the FDA or LOOKING FIT Magazine.

Getting Involved In Regulation Development 

Whether local tanning codes are initiated by industry members, the involvement of salon owners in their development is imperative. Rules written and passed by those with no intimate knowledge of the tanning industry can have unwelcome effects. The aborted Wakefield ban is one example and a recent attempt by the Weights and Measures division of the Department of Health and Human Services in Columbus, Ohio, to regulate tanning unit timers is another.

If it hadn’t been derailed by objections from local salon owners and even the Ohio Board of Cosmetology, the measure would have required timers to be accurate to within five seconds over the length of a session. FDA and Ohio requirements allow timers in tanning equipment a variance of + or - 10 percent, or three minutes over a 30- minute session.

The Board of Cosmetology opposed the local ordinance because the industry in Columbus was already subject to both state and federal regulations, and contradicting rules at the city level made no sense. If the measure had passed, it would have been possible for a salon to be completely in compliance with both the FDA and state codes and still be cited and fined by a Columbus Weights and Measures inspector.

The main intent of the rule seemed to be that customers get at least as much time as they paid for, but no provision was made for customizing exposure time for skin type, demonstrating a clear lack of knowledge about the tanning process and the risks of overexposure. If someone goes to a car wash or a laundromat, it doesn’t hurt them if the timer runs a little long. However, if they’re tanning, it’s far preferable for them to be shortchanged than overexposed.

Clearly, local authorities can benefit from informed input. However, those who have experience in working with legislators on any level recommend that the most important thing to do is to arrange your support and prepare your strategy before ever meeting with them. Learn as much about ultraviolet radiation and its effects as possible. Don’t hesitate to request information from the FDA, a trade association, magazine or manufacturer.

Once you’re armed with the facts, calmly offer constructive advice, not just complaints. The squeaky wheel gets the grease, but it’s annoying all the same. If you have an argument with something, be sure to have a suggested improvement prepared. Give it to them in writing so they can refer back to it in later planning sessions.

Don’t overlook other local businesses as allies either. The greater the number of local business owners who show interest in the developing regulations, the more seriously most authorities will take the process. If addressing authorities at a public meeting, a coalition of salon owners would be well-advised to compare notes and consider electing one spokesperson, rather than having several consecutive speakers rehash the same points over and over again. The easier it is for the council or board to listen and the more reasonably salon owners come across, the better the chances of success.

If regulations are proposed that you do not find objectionable, plan to attend the public hearings anyway and comment on the proposals. There’s no telling what can be changed or added on at the last minute.

It seems that the days of loose operating requirements for tanning salons are numbered, a change that is welcomed by many in the industry. As time goes on, complying with local regulations will become an unavoidable part of operating a salon. Fortunately, the CRCPD model as well as many of the codes currently in effect should act as benevolent precedents, making it less likely that one-sided rulings unfairly inhibit the profitability of providing indoor tanning services to the public.

SAMPLE STATE REGULATIONS

The following is a sample of state regulations for indoor tanning. These regulations were provided by the state of Tennessee.

68-54-101. Short title.—This chapter shall be known and may be cited as the “Tanning Facility Control Act of 1990.” (Acts 1990, ch.845 sec. 1.) Effective dates. July 1, 1990. Cross-References. Consumer Protection, title 47, ch. 18.

68-54-102. Definitions.—As used in this chapter, unless the context otherwise requires: (1) “Tanning device” means any equipment that emits radiation used for tanning of the skin, such as a sunlamp, tanning booth, or tanning bed, and includes any accompanying equipment, such as protective eyewear, timers and handrails; and (2) “Tanning facility” means any place where a tanning device is used for a fee, membership dues, or any other compensation. (Acts 1990, ch. 845, sec. 1.) 68-54-103. Applicability To Health Care Professionals.—The provisions of this chapter do not apply to a licensed health care professional who uses a tanning device for the treatment of patients, if such use is within the lawful scope of practice of such health care professional. (Acts 1990, ch. 845, sec.1.) 68-54-104. Requirements.—(a) A tanning facility must:

(1) Have a trained attendant on duty whenever the facility is open for business;

(2) Provide each customer with protective eyewear that meets the standards for tanning devices established under this chapter;

(3) Not allow a person to use a tanning device if that person does not use the protective eyewear;

(4) Show each customer how to use suitable physical aides, such as handrails and markings on the floor, to maintain proper exposure distance as recommended by the manufacturer;

(5) Limit each customer to the maximum exposure time as recommended by the manufacturer; and (6) Control the interior temperature of a tanning facility so that it does not exceed 34-degrees C.

(b)(1) Either each time a person uses a tanning facility or each time a person executes or renews a contract to use a tanning facility, the person must sign a written statement that the person:

(A) Has read and understood the warnings before using the device; and (B) Agrees to use the protective eyewear that the tanning facility provides.

(2) When using a tanning device a person must use the protective eyewear that the tanning facility provides.

(3) A person between the ages of 14 and 18 must give the tanning facility a statement signed by the person’s parent or legal guardian consenting to the person’s use of a tanning device.

(4) A person under the age of 14 must be accompanied by a parent when using a tanning device. (Acts 1990, ch. 845, sec. 1.) 68-54-105. Penalty.—A violation of any of the provisions of this chapter constitutes a misdemeanor punishable by a fine of not more than $500. Each day on which a violation occurs constitutes a separate offense. (Acts 1990, ch. 845, sec. 1.)

Regulatory Roundup

Salon owners and operators need to pay close attention to proposed regulation changes at all levels—not only to make sure that compliance is met, but also to ensure a voice in the process. The proposal of additions or changes to regulations at the local, county and state level has become an increasing trend, especially in regard to teen tanning. It is critically important for indoor tanning professionals to be active in working together to keep watch of proposed tanning regulations.

Last year brought an increase in proposed tanning legislation and antitanning campaigns, and it looks like 2007 will be no different. In fact, salons surveyed during LOOKING FIT’s 2007 Top 250 Salon search reported that anti-tanning campaigns affected their 2006 season by 16 percent. This number is up from 10 percent the previous year.

In 2006, the indoor tanning industry was besieged with anti-tanning propaganda from the media and medical communities. The two biggest issues were underage tanning and salon’s making health claims. Add to that the introduction of HR 4767, otherwise known as The Tanning Accountability and Notification Act, which was introduced to Congress by Rep. Carolyn Maloney (DNY) and Rep. Ginny Brown-Waite (R-FL). The bill pushed to require the FDA to conduct consumer testing to determine the appropriateness of the current labeling requirements for indoor tanning beds. It also would have required FDA to hold public hearings, solicit comments from the public and report to Congress the determinations it makes in the study. The bill died in committee; however, many view the federal proposal as a sign of increased aggression toward indoor tanning.

Additionally, the Academy of American Dermatology (AAD) and other medical associations teamed up with cosmetic and beauty companies to wave the antitanning stick in the public’s eye. Just look at Cosmopolitan magazine’s 2006 multimedia anti-tanning crusade. Did you know it was co-sponsored by Neutrogena? It doesn’t take a rocket scientist to realize that Neutrogena sells self-tanners and is taking profits from you—the professional skincare consultant.

The indoor tanning industry has a tough road ahead fighting multimillion-dollar public relations firms touting the so-called evils of tanning. It must band together as an intelligent unified voice and spread the Good News about moderate, sensible and responsible exposure to sunlight. This is the only way to take the ammunition out of the hands of the anti-tanning coalition.

Additionally, the anti-tanning drum is beating earlier and louder each year. The American Academy of Dermatology (AAD) launched a highly calculated anti-tanning consumer campaign Oct. 18, 2006 targeting the indoor tanning industry. The campaign targets teenagers and consists of public service advertisements (PSAs) in which teens warn their peers against indoor tanning. This aggressive campaign had national media distribution including television, radio and print advertisements.

The AAD’s campaign speaks to teens in a language they can understand—instant messaging (IM). Approximately 53 million American computer users exchange IMs, many of whom are teens, and the Academy developed the campaign specifically to target this demographic.

Furthermore, the organization is working with Miss Maryland 2006, Brittany Lietz, to help reach its target group—teenage girls. Lietz is a skin-cancer survivor and faults indoor tanning for causing her disease. She won her state pageant with a skin-cancer awareness/anti-tanning platform.

Spread The Good News 

Tanning critics will continue to beat their drums; however, it can be countered largely by the mounting studies favoring sensible, moderate and responsible exposure to light in a controlled atmosphere.

The ITA and a handful of salon operators are doing their best to fight state tanning legislations, but they need help by salon owners stepping up to the plate and helping at the local level. If you are not a member of the ITA, please join by calling (888) 377-0477 or visiting www.theita.com. ITA’s mission is to protect one’s freedom to acquire a tan, and strengthen and advance our industry through research, education and partnerships with organizations whose efforts further its mission. ITA is a non-profit and every dollar salons spent for ITA services is invested back in the industry.

The UV Foundation also is working on some groundbreaking studies that will lend credibility to the benefits of tanning.

Legislative Activities 

The outcome of the proposed legislation listed below directly affects salon owners, operators and customers in the tanning industry. It is extremely important for those in the industry to stay and informed and oppose legislation that could harm the industry. The legislative process can move very quickly in proposing and approving anti-tanning bills, therefore, response from those in the industry must be equally swift.

Active Bills In 2007 

So far, the 2007 legislative season has been very busy for the tanning industry with the continuing issue of teenage tanning dominating proposed legislation. Currently, there are 12 pieces of active proposed bills with the majority seeking to prohibit tanning of minors under age 18.

Federal. HR 945, otherwise known as The Tanning Accountability and Notification Act of 2007, was introduced Feb. 8 by Rep. Carolyn B. Maloney (D-NY). Co-sponsored by Rep. Ginny Brown-Waite (R-FL), Rep. Steven R. Rothman (D-NJ), Rep. Maurice D. Hinchey (D-NY) and Rep. Henry A. Waxman (D-CA), the bill was referred to the House Committee on Energy and Commerce on the same day where it currently remains. Maloney and Brown-Waite were the sponsors of a similar bill, HR 4767, that was introduced to Congress in 2006 and died in committee.

HR 945 would require the Food and Drug Administration (FDA) to conduct consumer testing to determine the appropriateness of the current labeling requirements for indoor tanning devices and determine whether such requirements provide sufficient information to consumers regarding the risks that the use of such devices pose for the development of irreversible damage to the skin, including skin cancer, and for other purposes.

California. AB 105 was introduced to the California Legislative Assembly on Jan. 3 to amend Sections 22705 and 22706 of the Business and Professions Code relating to tanning facilities, also known as the Filante Tanning Facility Act of 1988.

Assemblyman Ted Lieu introduced the proposed bill that would institute further statewide restrictions for tanning salons and customers. Specifically, AB 105 would prohibit a person less than 16 years of age from using a tanning device, would require the parent or legal guardian of a person between ages 16 and 18 to sign the requisite consent form in the presence of a facility owner or employee, and would require that proof of age be provided.

Furthermore, the proposed bill would require tanning salons to conspicuously post warning signs and would require that a warning sign also be posted in the front or main entrance of the tanning facility. The bill would prohibit a tanning facility from claiming that indoor tanning has any known health benefits, and would require a tanning facility timer to be remotely located so that customers could not set their own exposure time.

Colorado. SB 07-023 was introduced in the General Assembly on Jan 10 by Sen. Bob Hagedorn (D) and Rep. Anne McGihon (D). The bill would amend Section 2. 25-5- 1007 of the Colorado Revised Statutes and prohibit the use of an artificial tanning device by a minor under age 18 unless specifically prescribed by a physician. It also would require an owner, employee or operator of an artificial tanning device or tanning facility to verify the age of any person seeking access to an artificial tanning device.

On Feb. 7 the proposed bill passed unamended from the Senate’s Committee on Health and Human Services to the Senate Committee of the Whole. On Feb. 16 the bill passed the Senate’s second reading amended. It was intro