ITA/ASA comments –

Restricted Device, Performance Standard

ITA/ASA comments –
Restricted Device, Performance Standard

The Indoor Tanning Association and American Suntanning Association’s response to the proposed rules published by the Food and Drug Administration.

On March 21, 2016, the ITA and ASA submitted detailed comments on two proposed rules published in December by the FDA.

I. FDA’s Proposed Rule for the Restricted Sale, Distribution, and Use of Sunlamp Products

ITA and ASA raised the following concerns about FDA’s proposed rule:

  1. The scientific support provided for the proposed rule fails to reflect the totality of the current scientific evidence;
  2. 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);
  3. 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;
  4. The risk acknowledgement certification and user manual provisions are duplicative and overly burdensome; and
  5. FDA’s economic analysis fails to adequately measure the proposed rule’s significant economic impact on small entities.

Click here to read the full text of the comments and supporting documents


II. FDA’s Proposed Amendment to the Electronic Products Performance Standard for Sunlamp Products and Ultraviolet (UV) Lamps Intended for Use in These Products

ITA and ASA raise the following issues involving FDA’s proposed amendment of the performance standard:

  1. FDA’s proposal has shown a misunderstanding of the current sunlamp products industry and the potential impact of the proposed amendments;
  2. 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;
  3. ITA and ASA do not support FDA adoption of the IEC International Standard exposure schedule;
  4. The absolute limit on UVC irradiance, the IEC “equivalency code” system, and the protective eyewear transmittance requirements present scientific and practical concerns; and
  5. 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.

Click here to read the full text of the comments and supporting documents