We are approaching our first major milestone in what we expect to be a protracted process with the FDA regarding the additional restrictions the agency is seeking to place on sunlamp products.
On March 21, the three-month comment period ends and all comments on the two proposed rules are due. Our team of experts has looked closely at the two proposals and, unfortunately, there is not a great deal to like about either of them.
The restricted device rule is straightforward. The powers at the FDA don’t want teens to suntan indoors and if approved, no one under the age of 18 will be allowed to do so. In spite of the fact that the tide of states restricting teen tanning has spread across the U.S. in the past couple of years, and a majority of states have banned the practice, we still have to oppose this ban on the Federal level. In addition to the fact that there is no scientific basis for this age demarcation, there are other facets to the “restricted device” label, all of which can lead to the government placing more restrictions on indoor tanning and the operation of the business.
The amendments to the performance standard are not so straightforward. The most obviously troubling part of the proposal is in regard to the recommended exposure schedule. The FDA is prepared to recommend a limited number of tanning sessions, a maximum number of courses and an annual exposure limit. While these are only recommendations and there is absolutely no way to enforce them, once again, we have to oppose what can only be described as another overreach of government.
Another equally worrisome aspect of the performance standard amendments is the status of existing equipment. All the FDA says is that by a certain date, all new equipment has to meet the new standards. The status of equipment already in the field is not addressed. This may be a problem or it may not be; until we know, we will hope for the best and prepare for the worst.
We are working in close partnership with the American Suntanning Association to make sure your interests are protected. This process will take many months, possibly years and will be very expensive. Please support us by joining the ITA or contributing to a segregated legal fund we have established. Visit theita.com for more information.
We cannot wage a successful fight unless everyone pulls together.
