Food And Drug Administration The Law In General

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 recodified as follows:

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.”