I want to update you on very important recent developments at the FDA that require your attention. Three days before Christmas, the FDA published two proposed rules in the Federal Register that could have a significant impact on our industry for years to come. The first, a proposal that would make sunlamp products (which includes both sunbeds and sunlamps) “restricted devices,” is clearly aimed at implementing a ban on use for anyone under the age of 18.
The second proposal encompasses amendments to the performance standard which we have known the FDA has been considering for years. This is the far more complicated and far-reaching of the two proposed rules. These amendments address a host of specific issues such as UV output of the equipment, replacement lamps, eyewear, the warning label, and recommended exposure schedules, among other things.
First it is important to understand the process. Unlike the last mandate from the FDA, which was promulgated in 2014 and went into effect last September, wherein the FDA reclassified sunlamp products to Class II medical devices, the procedures the FDA has to follow in a formal rulemaking are more drawn-out and complicated.
For both proposed rules, we have 90 days to provide the FDA with the industry’s detailed responses called “comments.” At the close of the comment period, the FDA is required to weigh all submissions and respond in writing to each one justifying everything they propose to do. There is no way to know how long this phase of the process will take, but certainly months – possibly six months to a year or even longer.
After considering and responding to the arguments we and others submit, the FDA can publish a final rule. The final rule may be different from the original proposal, or not. There is no set timeline for publication of a final rule. It could take months, it could be years, or it could be never. While “never” is unlikely, it will almost certainly be months or a year.
Finally, there is an implementation period. For the restricted device proposal, there is a 90-day period; for the amendments to the performance standard, there is a one-year phase-in. The bottom line is that this will drag out over the next 12-18 months, or even longer.
It is also important that everyone in the industry understands that this is very serious and we are approaching it that way. The process will not only be long, but also costly. We have a law firm – arguably the best FDA law firm in Washington – advising us on the strategy and they will be drafting the industry’s comments. We will challenge the FDA on the science they use to justify any restrictions they are proposing. The FDA will also have to justify the potential costs to the industry in implementing any new regulations.
Because of the potential impact these proposed rules will have on both the manufacturers and the salons, we are partnering with the American Suntanning Association to present a unified industry response.
It is a fact that the FDA’s decisions on these two proposed rules will affect your business for years to come, so please don’t sit on the sidelines. Support this effort financially through membership or contributions. We are setting up a segregated fund which will only be used to pay for this fight. If you want more information, email admin@theita.com.
Thanks,
