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 rule for the Restricted Sale, Distribution and Use of Sunlamp Products, ITA and ASA raised the following concerns:
- The scientific support provided for the proposed rule fails to reflect the totality of the current scientific evidence.
- The proposed rule is contrary to law because the restrictions on sale, distribution and use do not meet the statutory criteria articulated in FDCA § 520(e).
- The proposal to prohibit the use of sunlamp products by individuals under the age of 18 is unconstitutional and should be replaced with a parental waiver option.
- The risk acknowledgement certification and user manual provisions are duplicative and overly burdensome.
- FDA’s economic analysis fails to adequately measure the proposed rule’s significant economic impact on small businesses.
Regarding the proposed Amendment to the Electronic Products Performance Standard for Sunlamp Products and Ultraviolet (UV) Lamps intended for use in these products.
ITA and ASA raised the following issues:
- FDA’s proposal has shown a misunderstanding of the current sunlamp products industry and the potential impact of the proposed amendments.
- FDA should clarify that any final rule will not apply to products currently in the marketplace and will not require modification or recertification of products in the
market prior to the effective date of the rule. - ITA and ASA do not support FDA adoption of the IEC International Standard exposure schedule.
- The absolute limit on UVC irradiance, the IEC “equivalency code” system, and the protective eyewear transmittance requirements present scientific and
practical concerns. - FDA should delete proposed § 1040.20(h), which refers to medical device classification under 21 C.F.R. § 878.4635, because it is not a proper subject for inclusion in an
electronic product performance standard issued under 21 C.F.R. Part 1040.
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!
