Thread: ITA Update
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Old 08-24-2016, 04:50 PM   #1 (permalink)
Robert K
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Executive Director's Report - FDA Update
While it is impossible to know the FDA's timeline for publication of the final versions of the two proposed rules, the ITA and ASA continued our efforts through the summer to provide the Agency with information and data that we hope will lead to a workable set of final rules.
At our June meeting at the FDA, questions regarding the soundness of the scientific justification supporting the two proposed rules were purposefully left out of the discussion. Instead we provided the agency with the most recent data on the indoor tanning industry, particularly the small business category, the commercial relationship between tanning salons and manufacturers of sunlamps and sunlamp products, and the interactions of tanning salons and clients in providing services. We also focused the regulators' attention on the actual number of beds already in the field and the impracticality of recertifying that equipment to any new standards.
The issues surrounding the science on which most of the proposed regulations are based only came up at the end of the June meeting when we asked the FDA to meet with us again to review those concerns. The officials with whom we met seemed open to such a meeting and suggested we submit a "Pre-Sub" or a detailed meeting request outlining the specific issues and studies we would like to discuss.
The goal of the science meeting will be to talk over a number of issues regarding UV radiation and tanning, including misinformation underlying the two December, 2015 proposed rulemakings. We want to call to the FDA's attention several relevant studies that have been published since the March, 2010 FDA Advisory Panel meeting which are contrary to what the FDA is using to justify the two proposed rules.
We are hopeful that a thoughtful reexamination of the science will make the FDA realize there is no consensus on the science the FDA is using to justify either the under 18 ban in the restricted device proposal or for the new recommended exposure schedule in the proposed rule amending the performance standard.
We are planning to meet with the FDA again in September.
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Robert Klem
Superior UV Technologies
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robertk@superioruv.com
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