FDA Shines a Light on Tanning Bed Safety, Proposes Device Reclassification and Warnings to Users Under 18
After issuing a public warning regarding the dangers of tanning nearly three years ago (see our previous blog here), this week the U.S. Food and Drug Administration (“FDA”) issued a proposed order to reclassify sunlamp devices and require labeling changes to include a warning discouraging young people (those under 18) from using them.
If finalized, this proposed order would reclassify sunlamp devices from a class I (low risk) device to a class II (moderate risk) device requiring premarket notification and stricter controls. FDA’s authority to reclassify a device is based on section 513(e) of the Food, Drug, and Cosmetic Act (“FDCA”) which allows FDA to reclassify a device based upon “new information” through an administrative order. As the proposed order explains, “new information” includes information developed as a result of reevaluation of the data before FDA when the device was originally classified. If finalized, this order will heighten the regulatory requirements for tanning bed manufacturers and distributors doing business in the United States.
I. Regulatory History of Sunlamps
The proposed order takes us through the regulatory history of sunlamps. In 1977, the review panels evaluating sunlamp devices recommended that dermatologic UV lamps (intended for use in treatment of dermatologic disorders or for tanning) be deemed class II devices. The reason for this classification being that the panels perceived there to be risks that could not be mitigated with general controls. The identified risks included burns to skin and eyes, aging of skin, skin cancer, and photosensitivity. FDA agreed with the panels’ recommendation. However, in FDA’s final rule, published June 24, 1988 (53 Fed Reg 23856), FDA separated UV lamps for dermatological disorders and UV lamps for tanning. At that time, FDA classified the lamps for dermatological disorders as class II and postponed classification of tanning lamps to consider issuing a proposal classifying them as class I. FDA eventually finalized that classification in November of 1990 (55 Fed Reg 48436). In 1994, FDA amended that classification and published a final rule exempting 148 class I devices from premarket notifications with some limitations, including UV lamps for tanning (59 Fed Reg 63005).
Classifying sunlamp products for tanning as class I devices meant FDA determined that manufacturer premarket notifications for these devices were necessary to protect the public health at that time. In its new proposed order, FDA notes that “[p]rior to the issuance of the 1994 exempting UV lamps for tanning from premarket notification submission, some manufacturers of UV lamps for tanning had already submitted 510(k)s and received clearance for their devices.” Should this proposed order be finalized, device manufacturers may use those devices as predicate devices for future 510(k) submissions.
II. Stricter Classification – 510(k) Process
FDA requires a premarket notification submission (a “510(k)”) for class II medical devices, i.e. devices that are moderate risk and require special controls. Class I, or low risk devices, only require general controls and are not required to submit anything to FDA to begin marketing. During the 510(k) process, FDA reviews technological characteristics, performance, intended use, and labeling of medical devices to ensure the devices are “substantially equivalent” to legally marketed predicate devices before they enter the market. The 510(k) process can be described as a “piggybacking” system with one device piggybacking on the FDA clearance of another, similar device. As FDA explains in the proposed order:
Substantial equivalence requires that a new device must have (1) the same intended use as legally marketed predicates, and (2) either the same technological characteristics as a legally marketed predicate, or if there are significant differences, the differences must not raise new questions of safety and effectiveness and the performance data must demonstrate that the new device is at least as safe and effective as the legally marketed predicate device. (See section 513(i) of the [FDCA].) This assures that new devices that differ significantly in terms of safety and effectiveness from devices already legally on the market will be subject to the more rigorous premarket approval requirement.
In its proposed order, FDA is proposing this heightened classification because it has identified several risks related to UV lamps for tanning. These risks are similar to those identified in 1977 and include increased skin cancer risk, ocular risk, burns to the skin, skin damage, transmission of infectious disease due to improper cleaning, and others. FDA cites a growing body of literature on the association of skin cancer with use of sunlamp devices.
III. Proposed Reclassification and Special Controls, Including Labeling Requirements
FDA is proposing that sunlamp products be reclassified from class I (general controls) to class II (special controls). FDA reasons that general controls alone are insufficient to provide reasonable assurance of safety and effectiveness. FDA has identified special controls it believes will be sufficient to ensure safety and effectiveness for these devices. These special controls include, among others, performance testing, demonstration of mechanical safety, demonstration of electrical safety and electromagnetic compatibility, and specific product labeling.
The proposed labeling requirement includes several warnings. First, it would discourage use of sunlamp devices to those under the age of 18 and those with a personal history or family history of skin cancer. Additionally, the labeling would include a warning that regular users of these types of devices be regulatory evaluated for skin cancer. FDA’s proposed order also suggests that labeling requirements include warnings related to transmission of infectious disease through improper cleaning would mitigate that risk. Furthermore, FDA proposes that a warning be included that these devices should not be used by those with skin lesions or open wounds. Should this proposed order take affect and these warnings be required on tanning beds, it will be interesting to see if there is actually a decrease in tanning bed use by young people. With these warnings, FDA is merely discouraging sunlamp use by young people and not prohibiting their use by anyone under the age of 18. The efficacy of these warnings is called into question even by the proposed order. The FDA cites a study in its proposed order that reported “47 percent of college student had reported using a sunlamp product during the last year because it improved their appearance, despite 92 percent being aware of potential health risk.” (Emphasis added.) That study alone indicates that young people will likely continue the use of tanning beds despite warnings regarding health risks.
IV. Potential Effects on Industry
FDA will take comments on this proposed order for the next 90 days. Any member of the industry or general public may comment on it. Should FDA move forward with finalization of this order, there will be major changes to the regulatory framework governing the tanning bed industry. Upon finalization of this order, FDA has expressed that it expects sunlamp manufacturers to submit a 510(k) and comply with the special controls within one year of the date of the final order or cease marketing their devices. This expectation will apply to sunlamp devices already on the market, meaning that manufacturers of sunlamp devices currently sold in the United States without 510(k) clearance would be expected to obtain 510(k) clearance before continuing sales. Due to the protracted time periods the 510(k) process can take, tanning bed manufacturers should be prepared to move forward with a 510(k) submission if finalization of this rule occurs in order to avoid delays in distribution.
Fuerst, Ittleman, David & Joseph, PL will continue to track and report on FDA’s position related to these types of devices. For more information, please contact us via e-mail at firstname.lastname@example.org or via telephone at (305) 350-5690.