On August 7, we submitted detailed comments to the FDA in response to the Administrative Order reclassifying ultraviolet lamps for tanning to a Class II Medical Device. Lawyers at the firm of Covington and Burling were charged with drafting our comments, and the industry should take comfort in the fact that this firm is widely viewed as the best in Washington, D.C. regarding regulatory issues at the Food and Drug Administration.
In our submission, we raised a number of issues where we see the flaws in the process, and asked questions about the quality of the science on which the proposed reclassification is based. Our lawyers tell us the real problem is not that there are so many flaws in the proposed order but that there are so many unanswered questions. It is what the order leaves for regulators to fill in later that is most troubling for our industry.
As I reflect on what the FDA is using for the basis of this order and all the questions left unanswered by the proposal, it seems very clear that the Agency was in a hurry to get this order published because of the political pressure exerted by outside groups and some elected officials on Capitol Hill.
There is no specific time by which the FDA must make a final decision on this order. In fact, one of the best outcomes possible from this process may be that the FDA decides to do nothing. While that is not likely, remember that the process under which this reclassification was undertaken is brand new, and ours is one of the first out of the gate. Our goal is to make the FDA recognize its missteps, sit down with our industry, garner a better understanding of the businesses they are regulating, and then go back to the drawing board and start over.
I understand that the end of the year is about as soon as we can expect the FDA to act. Until then, we will continue to reach out to elected officials who care about small business–officials who understand the contribution all of our businesses make to local economies and ask each of them to make the FDA act fairly and responsibly in the oversight of our industry.
Thanks,
Rob Quinn
