With our filing on March 21 of over 300 hundred pages of comments on the two proposed rules issued by the FDA last December, the waiting game began. While the ball is clearly in the FDA’s court right now, it is important to remember that there is no set timetable for any action on the part of the Administration.
However, there is a prescribed set of steps the FDA must follow, the first being publication of written responses to all the comments that were received regarding the two proposed rules. It will be with those responses that we will see our first inkling of the manner in which the FDA will handle the important issues we raised.
Regarding the proposed Amendment to the Electronic Products Performance Standard for Sunlamp Products and Ultraviolet (UV) Lamps intended for use in these products.
Of all the arguments, the science submissions are by far the most comprehensive and complex. Drafted by Allen Miller, Palm Beach Tan’s general counsel, and spanning hundreds of pages, Miller detailed how the scientific support provided by the FDA for the proposed rules fails to reflect the totality of the current scientific evidence and therefore, they must go back and start over.
To read the ITA/ASA comments, visit theita.com, look under “Government Relations” and you can find all 300+ pages linked. I think you will be impressed by the comprehensive nature and professionalism of the submissions.
And, if you’re not a current ITA member, join us now and help fund our fight for YOUR livelihood!
is the Executive Director of the Indoor Tanning Association.
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