Please join us and contact the FDA to oppose the proposed order!

Please join Heartland Tanning and the ITA by contacting the FDA to oppose the proposed order!

ITA’s Response to the FDA Administrative Order

As everyone is certainly aware, in early May the FDA issued an Administrative Order reclassifying ultraviolet lamps for tanning to a class II medical device. If this order is approved, it could have a significant negative impact on your business.

The ITA is planning a comprehensive response. We will address a number of major issues including the following:

The Economic Impact will be harmful to small business:

• The 510(k) requirement proposed by FDA would have a severe negative economic impact on thousands of small businesses nationwide. FDA is proposing to impose 510(k) notification requirements on sunlamp product manufacturers that are very detailed and would require a substantial amount of premarket testing. It would be very expensive for manufacturers to comply with these testing and submission requirements, and these costs would also likely be passed onto the tanning salons that are small businesses located around 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 premarket review process, and would likely lead to substantial delays in introducing new products to the market.”

• FDA already faces a significant backlog of 510(k) applications. The proposed order would require manufacturers to secure 510(k) premarket notifications for all products within one year of the proposed order’s effective date. The industry is very concerned about delays by the agency to clear 510(k) submissions and the impact this would have on the industry and small businesses nationwide.

• The FDA’s proposed order calls into question the viability of products already in the marketplace and the substantial investments in those products. The proposed order provides that products already in the marketplace must cease being marketed if the manufacturer does not submit a 510(k) within one year of the effective date of the final order. The industry is very concerned about the future status of products that are already in the market for which the manufacturer is no longer in business or for which it is not economically viable for the manufacturer to incur the costs associated with filing a 510(k) notice.

The Entire Industry MUST to weigh In and oppose this order!

We know from recent statements made by the FDA that the number of comments filed has an impact on the FDA’s final decision. We also know that the American Academy of Dermatology and other anti-tanning lobbying groups are mounting an aggressive campaign to get their members to generate comments to the FDA in support of the order. This is a link to the AAD campaign website: http://test.neton-line.com/EMAIL/broadcastemails/memberalert052913.html

Please join us and contact the FDA to oppose the proposed order!

•Click here to access a template that you can use to customize your comments:

http://www.regulations.gov/#!submitComment;D=FDA-2013-N-0461-0001

Please focus your remarks on the negative economic impact that reclassification would have on you personally and talk about how this change could affect your business and livelihood.

Please use the issues outlined above and apply them to your business. For example:

• The order is vague regarding equipment already in the field, potentially making it illegal and requiring you to replace much or all of your equipment.

• The order adds great expense for companies bringing new products to market adding additional costs for you and your customers.

• The vagueness of the order related to lamp replacement could make lamp replacement cost prohibitive.

• The industry is already struggling in the recession and as a result of the 10% excise tax being imposed on tanning services. This change will push many small businesses over the edge.

Comments are due by August 7. Please don’t delay! Remember, FDA’s final decision likely will be influenced by the number of comments filed by members of our association and within our industry.

Please send the ITA a copy of the comments you submit to the FDA. If you have any question or need assistance, please contact the ITA .(JavaScript must be enabled to view this email address) or call 202 367 1142.

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Heartland Tanning, Inc. is a wholesale distributor and does not sell direct to the public.