|02-19-2016, 12:25 PM||#1 (permalink)|
Join Date: Aug 27 2002
Location: East Coast
Rep Power: 15
We are four weeks away from 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 21st 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. The restricted device rule is straight forward. The powers at the FDA dont 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 number 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.
In our comments to the FDA, we will argue that sunlamp products should not be regulated under FDAs device authority, the science doesnt back any age restrictions and the government doesnt have the right to usurp this basic parental right.
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. We also know from experience that state regulatory bodies have tried to enforce the letter of the recommended exposure schedule and that in itself makes the recommendations dangerous.
In our comments, we will argue that once again that the science doesnt back any of these recommendations and, absent that, the government should not make such recommendations.
Another equally worrisome aspect of the performance standard amendments is the status of existing equipment. All the FDA says is 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 depending on what the FDA finally does. We will argue forcefully that existing equipment must be grandfathered.
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 renewing your membership today and by encouraging your suppliers and friends in the industry to do the same. We cannot wage a successful fight unless everyone pulls together.
Superior UV Technologies
(888) 526-7712 x77
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