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:
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.
The FDA and Indoor Tanning
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.
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.
