The Indoor Tanning Association has a plan to fight the biggest battle this industry has ever faced. The only question is, are you ready to help?
The ITA is preparing its response to the Food and Drug Administration regarding proposed tanning equipment reclassification – 510(k) – announced May 6. If passed, this would have far-reaching impact upon the industry, which is why the ITA is urging everyone to get involved. “The FDA’s proposal is open for public comment for 90 days,” said John Overstreet, ITA Executive Director. “After that, the agency will review all comments before final recommendations are issued. We know that the number of comments matters because the FDA has said as much, so we encourage everyone to get involved. Business owners needing assistance are urged to contact us and we will walk them through the process.”
Among the concerns raised in the ITA’s response is the cost that 510(k) will pose to tanning equipment manufacturers. “The FDA would require a substantial amount of pre-market testing, and it would be very expensive for manufacturers to comply with the testing and submission requirements,” Overstreet said. “These costs would also likely be pushed down to the tanning salons, which are small businesses located throughout the country. In addition, the requirement for FDA review of a 510(k) would be especially 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.”
The ITA is concerned about the length of time for approval involved in the 510(k) process. “The proposed order gives manufacturers just one year to get products approved, and there is great concern that this is insufficient,” Overstreet said. “We’re also concerned about replacement lamps, as the proposed order is not clear regarding how sunlamps will be approved for replacement. Also, who is responsible for approval and labeling of equipment already in service, and discontinued equipment and sunlamps? These are questions that need to be addressed by the FDA.”
On May 6, the FDA announced its intention to reclassify tanning equipment and sunlamps to Class II medical devices. If the order is finalized, manufacturers would have to submit to the FDA a pre-market notification (510(k)) for these products, which are currently exempt from any pre-market review. Manufacturers would have to show that their products have met certain performance-testing requirements, address certain product-design characteristics and provide comprehensive labeling that presents consumers with clear information on the risks of use.
As the ITA continues to prepare its response to the FDA, the organization encourages members of every tanning industry sector to register their concerns to the FDA. To help prepare for the biggest battle this industry has ever faced, contact the organization – your industry organization – and ask how you can help.
