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Hormone-Containing Cosmetics Rule Should Be Pursued – Advocacy Groups

This article was originally published in The Rose Sheet

Executive Summary

Progesterone-containing topical cosmetics should be permitted on the market and FDA should pursue a final rule establishing such a policy, according to several alternative medicine and women's health advocacy groups

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Hormone cosmetics

FDA withdraws advanced notice of proposed rulemaking for cosmetic products containing certain hormone ingredients effective Nov. 26, as it is no longer considered a viable candidate for further action, the agency reports in a 1Federal Register notice published last year and recently posted on dockets. Action is part of a move to reduce FDA's regulatory backlog. Agency received nine comments relating to the withdrawal of the hormone-containing cosmetics ANPR, some of which argued the move could call into question points raised in the proposed rule and change the marketing status of these products. FDA responds the withdrawal neither affirms nor rejects statements in the preamble, and as the proposed rule, published in 1993 permitting progesterone and pregnenolone in cosmetics in certain concentrations, was never finalized, its withdrawal does not change the marketing status of these products. Agency announced its intention to withdraw the proposed ANPR along with 83 other proposed actions in 2003 (2"The Rose Sheet" April 3, 2003, p. 10)...

Hormone cosmetics

FDA withdraws advanced notice of proposed rulemaking for cosmetic products containing certain hormone ingredients effective Nov. 26, as it is no longer considered a viable candidate for further action, the agency reports in a 1Federal Register notice published last year and recently posted on dockets. Action is part of a move to reduce FDA's regulatory backlog. Agency received nine comments relating to the withdrawal of the hormone-containing cosmetics ANPR, some of which argued the move could call into question points raised in the proposed rule and change the marketing status of these products. FDA responds the withdrawal neither affirms nor rejects statements in the preamble, and as the proposed rule, published in 1993 permitting progesterone and pregnenolone in cosmetics in certain concentrations, was never finalized, its withdrawal does not change the marketing status of these products. Agency announced its intention to withdraw the proposed ANPR along with 83 other proposed actions in 2003 (2"The Rose Sheet" April 3, 2003, p. 10)...

Topical Progesterone Cream Yields Prescription-Level Exposure - Study

Topical progesterone cream results in the same level of exposure to progesterone as prescription oral micronized capsules, according to a small study presented by Anne Hermann, MD, at the annual meeting of the American Society for Clinical Pharmacology and Therapeutics in Miami March 25

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