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Old 06-21-2013, 07:49 PM   #1 (permalink)
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Exclamation ITA Update 6/21/13 - IMPORTANT


Indoor Tanning Association, Inc., 2025 M St, NW Suite 800 Washington, DC 20036 Phone: 888-377-0477 Fax: 202-367-2142



Member Update 06/21/2013:



Member Alert

ITAs 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 orders 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 FDAs 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 has 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 FDAs 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: click here.

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 Click Here
Click here to access filing instructions Click Here

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 dont delay! Remember, FDAs 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 admin@theita.com or call 202 367 1142.
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Old 06-24-2013, 10:08 AM   #2 (permalink)
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Re: ITA Update 6/21/13 - IMPORTANT

The AAD is pushing this:

Quote:
The science is clear. Research indicates that the risk for developing melanoma increases by 75 percent in individuals who have been exposed to UV radiation from indoor tanning devices, and the risks increase with each subsequent use. Approximately 12,000 people will die each year from skin cancer. More than 9,000 skin cancer deaths are due to melanoma. Sadly, melanoma is no longer a cancer reserved for older individuals. Instead, melanoma is the most common form of cancer for young adults 25-29 years old and the second most common form of cancer for adolescents and young adults 15-29 years old.
The ITA needs to show that that study is bogus.
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Old 06-24-2013, 11:25 AM   #3 (permalink)
 
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Re: ITA Update 6/21/13 - IMPORTANT

I have found the data to refute the 75% (i.e., 75% of WHAT? - over WHAT time period?). More later.....
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Old 06-24-2013, 03:28 PM   #4 (permalink)
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Re: ITA Update 6/21/13 - IMPORTANT

Don, that's great.
I think this is the way to go. Instead we will say poor us, we are so poor, quit picking on us. (Which doesn't work & won't work)

We need science & math to fight the science & math of the these bogus reports.

We then need the FDA to do their job & review all that is put on the table.

Crying about taxes & economy doesn't help us at all.
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Old 06-24-2013, 04:01 PM   #5 (permalink)
 
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Re: ITA Update 6/21/13 - IMPORTANT

Coming from a science background, I hate when a "study" ends up being nothing more than a journal review of the literature. Calling that a study is an insult and misleads the public. Original work would constitute a study not combining multiple works that are incongruous to one another to come up with a statistic is despicable. It's all anecdotal too. Don is right, we have to refute this "study" for what it is: manipulation.
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Old 06-27-2013, 10:27 AM   #6 (permalink)
 
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Re: ITA Update 6/21/13 - IMPORTANT

How do you fight a group who is being given preferential treatment by government agencies and whom presents and accepts lies as the truth? This is exactly the same thing as the climate debate. There is no place to with this.
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