G/TBT/N/USA/293/Add.3 Page 1

WORLD TRADE G/TBT/N/USA/293/Add.3 29 June 2011 ORGANIZATION (11-3194)

Committee on Technical Barriers to Trade Original: English

NOTIFICATION

Addendum

The following communication, dated 22 June 2011, is being circulated at the request of the delegation of the United States.

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TITLE: Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use

AGENCY: Food and Drug Administration, Department of Health and Human Services

ACTION: Final Rule

SUMMARY: The Food and Drug Administration (FDA) is issuing this document to address labelling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labelling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of 27 August 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labelling contained in the 1999 Drug Facts final rule (published in the Federal Register of 17 March 1999, by lifting the delay of implementation date for that rule that we published on 3 September 2004).

DATES: Effective Date: This final rule is effective 18 June 2012. For additional information concerning this effective date, see section X in the preamble of this document. The incorporation by reference of a certain publication listed in this rule is approved by the Director of the Federal Register as of 18 June 2012.

Compliance Date: The compliance date for all products subject to this final rule with annual sales less than $25,000 is 17 June 2013.

The compliance date for all other products subject to this final rule is 18 June 2012.

Implementation date: FDA is lifting the delay of implementation date for Sec. 201.66 as published at 69 FR 53801, 3 September 2004.

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URL's: http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/html/2011-14766.htm http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14766.pdf

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