FDA Considers Comments On Proposed Rulemaking
by Michael Caswell, Ph.D.
Recently, the U.S. Food and Drug Administration (FDA) has been unusually active in changing the regulations of the indoor tanning industry. In the past two years, the FDA has reclassified indoor tanning beds from a Class II medical device to a Class I medical device. In addition, it recently asked for comments on the regulations of tanning beds, including recommended exposure schedules.
In an effort to explain just what the FDA's job is, the following is a brief explanation of its role when it comes to the indoor tanning industry.
The FDA is a division of the Department of Health and Human Services of the U.S. government. Located outside Washington D.C. in Rockville, Md., the FDA oversees five main areas: veterinary medicines, food safety and nutrition, drug evaluation and research, biologics evaluation and research, and medical devices and radiological health. The FDA can be accessed via its Web site at www.fda.gov.
- Center for Veterinary Medicine-- Reviews all medicines approved for animal use, including medicines that are used in animals for human consumption.
- Center for Food Safety and Nutrition-- Supervises most foods in the United States together with foods that are imported.
- Center for Drug Evaluation and Research-- Ensures that safe and effective drugs are available to Americans.
- Center for Biologics Evaluation and Research-- Ensures that biological items such as blood, vaccines and biological thera peutics enhance the public health.
- Center for Devices and Radiological Health-- Responsible for ensuring the safety and efficacy of medical devices.
The FDA can ensure the safety and efficacy of products in all these areas through regulations. Regulations are different from statute laws. Statute laws are enacted by a representative legislature; regulations are developed through regulatory agency expertise. Nonetheless, the regulatory agency has all the powers of our legal system to enforce the laws.
Center for Devices and Radiological Health
The Center for Devices and Radiological Health regulates medical devices and devices that emit radiation. The Center can be located on the Web at www.fda.gov/cdrh.
A medical device generally is defined as any healthcare product intended to affect the structure or function of the body that does not achieve its primary purpose through a chemical action. Medical devices are very diverse and include IUDs, pacemakers, wheelchairs, heart valves, toothbrushes and surgical lasers. About 1,700 medical devices are regulated by the FDA. They also include diagnostic devices like those used to determine sugar levels in blood of diabetics.
In addition, the CDRH has established three classes of medical devices and assigns each device to a class. The class distinction is based on an evaluation of the logical risk to the consumer.
Class III medical devices have a high risk to the user's health should the device fail. A heart valve is one example of a Class III medical device. Clearly, failure of a heart valve would create immediate risk to the user's life. Favorable premarket approval must be obtained from the CDRH before a Class III medical device can be sold on the market.
Class II medical devices are under special controls. They require premarket approval from the CDRH and any company that wishes to market a Class II medical device can do so only after the FDA has favorably reviewed the premarket application. Examples of Class II medical devices are ultrasound machines, wheeled stretchers and surgical masks and gowns.
Class I medical devices only are under general controls and present minimal risk to the user in case of failure. Generally, anyone can market these devices if they are made according to regulatory specifications. Premarket notification is not necessary. Examples of Class I medical devices are crutches, medical adhesive tape, dental floss and sunlamps or tanning beds.
Tanning beds are intended to provide ultraviolet radiation to tan skin. Although this is considered a cosmetic effect, a change in the function of the skin occurs. Consequently, tanning beds are Class I medical devices and are subject to regulations common to Class I medical devices including registration, listing and current proper manufacturing practices. These regulations are found in parts 1000 through 1010 and paragraph 1040.20 of the Codes of Federal Regulations, Volume 21.
The CDRH can change the regulations on any medical device. The first step is to announce its intent to propose new regulations. The announcement can be made in response to new scientific information that changes the evaluation of the risk to the user, or it can be made as a result of any other type of new information.
The announcement of the intent to propose new regulations is published in the Federal Register with a request for information from interested parties concerning the medical device. On Feb. 9, 1999, the CDRH published such a request on tanning beds. The CDRH took this step because of concerns about the adequacy of warning labels on tanning beds, the current recommended exposure schedule, the current labeling on replacement lamps and the current health warnings.
Thus, the CDRH searched for information in these areas of concern. It accepted information up until July 9, 1999. The organization now will gather the information it received, review it and eventually publish a set of proposed rules. This effort may take two years or more. Once this set of proposed rules is published, a period of time is set aside for comments to the proposed rules. Any comment received will be considered and the proposed rules may be adjusted accordingly.
A number of industry leaders have communicated concerns to the CDRH on the issues facing our industry. These comments and others will be considered during the deliberation that will occur over the next two years. Once the proposed rules are published, leaders of our industry again will address these issues with the interests of salon owners and the industry in mind.
Tanning bed regulations have not changed in more than 10 years. During that time, many new scientific advances have been made in our understanding of the biological effects of UV radiation on the skin. These new understandings can be used to increase the safety of a tanning bed. You, the salon owners and operators, know the problems encountered in attempting to follow the FDA regulations. Open and honest review, clarification and enforcement of regulations will make your job easier.
Dr. Caswell is a frequent speaker at tanning trade shows and writes for the tanning industry. He recieved his Ph.D. in biochemistry from the University of North Carolina and has made important discoveries in tanning, photoaging and skin immunology.
He is a member of the American Academy of Dermatology, Society of Investigative Dermatology, and Photomedicine Society. He has worked for Yale University, Lever Brothers, Schering-Plough and Body Drench.
Presently he is employed by Stephens & Associates, a Carrollton, Texas-based global research organization with offices in Colorado and Japan.