“Many Unanswered Questions”

If the U.S. Food and Drug Administration decides to reclassify tanning equipment and sunlamps, what will be this industry’s “blueprint” for thriving in a post-reclassification market? No such “game plan” can exist, says the Indoor Tanning Association, until the FDA answers some very important questions.

Members of the ITA say they have discovered several flaws in the FDA’s proposed order to reclassify tanning equipment and sunlamps. The tanning industry organization has listed and submitted its questions regarding these flaws – as well as listed the many negative economic impacts that reclassification could have on tanning salon owners – to the FDA as part of its public comment on the proposal. The FDA allowed public comment on the matter until August 7, and the ITA awaits the results, and hopefully a response. “Reading through the FDA’s reclassification proposal has left us with many unanswered questions that we as an industry need clarification on,” said John Overstreet, ITA Executive Director.

One of the ITA’s biggest issues with the proposed reclassification is that a significant part of it is not a reclassification at all. “The current device classification regulation is entitled ‘Ultraviolet lamps for tanning,’ but the FDA is proposing to expand the definition to also include specific regulatory requirements applicable to tanning beds and tanning booths,” said Overstreet. “Since tanning units are currently regulated under the electronic product standards provisions of the statute and 21 CFR 1040.20, this would be an ‘initial classification’ that’s being labeled as a reclassification. According to the FDA’s own guidelines, they can’t reclassify something that has never been previously classified to begin with.”

In its rush to get its proposal passed, the FDA has taken away many of the safeguards that protect industries from governmental overreach, says the ITA. “Under a new law passed in 2012, the FDA is required to hold a meeting of a device classification panel – outside experts picked to give their opinions – when considering reclassification,” Overstreet said. “The FDA hosted a device classification panel on this matter in March of 2010, and is claiming that meets the requirement three years later, but we disagree. Compounding the problem, the proposed order cites several studies that were published subsequent to the 2010 panel which undermines the evolving science in this field.  The agency is now denying stakeholders a fair opportunity to address the methodology or other concerns related to studies on which the agency is relying to take this action.”

The FDA has not discussed the scientific submissions regarding indoor tanning given to it by the ITA in March 2010. “On behalf of the industry, we submitted detailed comments to the record in connection with the 2010 panel meeting, including a detailed critique of the scientific papers on which FDA is now relying,” Overstreet explained. “Specifically, the FDA consistently references the WHO/IARC study of 2009, despite the fact that this report has been widely discredited by reputable scientists. We would like the opportunity to discuss the findings we submitted with the FDA and ask that they be taken into consideration.”

In addition to the many questions it has regarding the reclassification proposal, the ITA is convinced that the 510(k) process will be expensive and time consuming for tanning equipment and sunlamp manufacturers. “I believe it would be very expensive for manufacturers to comply with the testing and submission requirements, and these costs would also likely be passed down to the tanning salon operators,” Overstreet said. “This would also be burdensome for companies that have no experience with the medical device pre-market review process, and would likely lead to substantial delays in introducing new products to the market. We’re also very concerned about tanning lamps and units that are in the marketplace while the manufacturer is either no longer in business or no longer making that product. The FDA has not provided information on who will be responsible for filing the 510(k) notice for these products, and this is another question we would like answered.”

On May 6, the FDA announced its intention to reclassify tanning equipment and sunlamps to Class II medical devices, and is considering several other safety control measures. If the order is finalized, manufacturers will have to submit a pre-market notification (510(k)) showing that their products have met certain performance testing requirements, address certain product design characteristics and provide comprehensive labeling regarding risks of use. The FDA’s proposal was opened for public comment for a 90-day period ending on August 7. If approved, the tanning industry will have one year to comply with the new requirements.

The ITA firmly believes the proposed FDA regulations issued are the most important challenge facing tanning businesses because this industry’s ability to deliver a cosmetic tan is at stake. If the FDA makes a decision that would make all current tanning equipment obsolete and new equipment unable to produce a tan, the tanning industry as a whole could be finished. This is why Overstreet urges all salon owners to join the ITA to help protects everyone’s right to tan.