FDA Has “Ample Regulatory Authority” To Oversee Cosmetics – McNeil
This article was originally published in The Rose Sheet
Executive Summary
FDA has "ample regulatory authority" to take action against cosmetic manufacturers who cross the line into making illegal drug claims, and should not resort to changing the regulatory status of certain categories of products, McNeil Personal Products Company states in comments to the agency
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FDA has "ample regulatory authority" to take action against cosmetic manufacturers who cross the line into making illegal drug claims, and should not resort to changing the regulatory status of certain categories of products, McNeil Personal Products Company states in comments to the agency. Submitted June 24, the comments respond to FDA's call for data last year on six categories of products under consideration for OTC drug review eligibility (1 (Also see "Are Wrinkle Treatments With AHAs, BHAs OTCs? FDA Issues Call For Data" - HBW Insight, 5 Jan, 2004.), p. 9). Among those categories are wrinkle removers, nasal sprays and vaginal moisturizers, all currently regulated as cosmetics. McNeil, the maker of K-Y lubricants, says claims for these products that relate to "moisturization," "eliminating vaginal dryness that can cause discomfort" and "enhances intimate activity" are clearly cosmetic claims. "Products intended as vaginal moisturizers are cosmetics and do not meet the statutory definition of a drug, because they do not affect the structure or function of the body or mitigate disease," McNeil states. Claims for these products are separate from those of patient lubricants, which are regulated as medical devices by the Center for Devices & Radiological Health, the firm adds. McNeil's comments were echoed by other marketers, including those filed by the law firm Sonnenschein, Nath & Rosenthal on behalf of drug and cosmetic distributor C.B. Fleet. "A product is deemed to be a cosmetic, and not a drug, if the claims made for the product demonstrate that the product is intended to be used for cleansing, beautifying, promoting attractiveness or altering the appearance without affecting the body's structure or functions," the company says. B.F Ascher, manufacturers of Ayr nasal sprays, mists and drops also commented, arguing a similar position for nasal moisturizers. The Cosmetic, Toiletry and Fragrance Association already submitted comments to FDA urging the agency not to reclassify certain categories of products and claiming regulatory status must be based on "intended use" of the product based on legal precedent (2 (Also see "AHA, BHA Products Are Cosmetics Based On Legal Precedent – CTFA" - HBW Insight, 31 May, 2004.), p. 3). |