Everyone has heard the old saying, “Just because you’re paranoid doesn’t mean they’re not out to get you.” Just look at what our friends in Washington have brought us in the past three years.
First, in 2010 with Obama Care we get the Tan Tax. Also thanks to Obama Care, in 2013 the manufacturers get saddled with the medical device tax. Most recently, we have the FDA’s proposed order to reclassify sunlamp products to Class II medical devices.
And if all of this were not enough, the pending proposed reclassification order puts us on notice that we can expect another gift from our government. In the proposed order, the FDA tells us to expect amendments to the performance standard [§ 1040.20], maybe later this year. Who knows what these amendments will entail; but I can tell you that we probably won’t like it. And to make this even more bewildering, the proposed order on which we just submitted comments and is currently under review by the FDA includes an additional special control that will require compliance with the performance standard in 1040.20. But because the FDA has yet to update the performance standard, they couldn’t even tell us what we are commenting on!
I believe everything the FDA is doing is flawed and unfair. I spoke at FDA’s March, 2010 advisory panel meeting and of the 17 panelists, six identified themselves as dermatologists and two were past presidents of the American Academy of Dermatology (AAD). Without question, the AAD is a stakeholder in this process. They have a financial stake in the outcome and for decades lobbied the FDA to either ban or place unjustified restrictions on this industry. Of course this panel recommended additional restrictions on indoor tanning.
When the FDA released the proposed order in May, Mary Maloney, M.D., F.A.A.D., Regulatory Policy Committee Chair of the AAD, jointly hosted FDA’s public announcement of the pending proposed reclassification order. Again, the AAD has publicly and privately lobbied the FDA and Congress to get the FDA to reclassify sunlamp products to Class II. Is this a fair process?
Well, it is hard to believe that the government is not out to get us – but we’re not going to let them. The ITA has been dealing with these issues for over 12 years and tests such as this are the reason we are here.
Here’s a summary of some of the items we’re presently working on:
- We’re continuing the fight to overturn the Tan Tax by working with Congress to gain additional sponsors for our “Tan Tax Repeal Legislation”.
- On behalf of salons, we are working with two extremely capable law firms (Akin Gump and Covington and Burling) to oppose and formulate a more acceptable solution to the recent FDA reclassification order. (Visit theITA.com to see our recent submissions.)
- On behalf of both lamp and equipment manufacturers, we are working with those same two firms to oppose and formulate a more acceptable and transparent solution to the expected changes in performance standards that could potentially turn our industry upside down overnight. (Visit theITA.com to see these recent comments and submissions.)
- On behalf of the entire industry, we’re working with key lawmakers on Capitol Hill to send a strong message to the FDA and request very specific answers to a number of questions regarding deviations from the law in the process utilized in issuing the proposed order.
In many ways, what we are now facing defines the need for a strong association… and working together, we will rise to meet the challenges brought upon our industry by the Federal Government.
Thanks,
Rob Quinn
