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Executive Summary

OTC TOPICAL HORMONE-CONTAINING PRODUCTS: COSMETIC CLAIMS ONLY are permitted, FDA said in its proposed rule for the product class. The rulemaking, published in the Oct. 2 Federal Register, proposes that "topically applied hormone-containing drug products for OTC human use are not generally recognized as safe and effective and are misbranded." Although the proposed rule does not include any Category I ingredients, FDA noted that manufacturers of skin cream products could continue marketing products that contain hormones if the products do not make drug claims. A key labeling issue is reference to the term "hormone," which FDA said would render a product a drug. "The agency considers the use of the word 'hormone' in the text of the labeling (e.g., 'This cream (or oil) is scientifically formulated to contain a hormone') or in the ingredient statement to be an implied drug claim," FDA said. "The claim implied by the use of this term is that the product will have a therapeutic or some other physiological effect on the body. Therefore, reference to a product as a 'hormone cream' or any statement in labeling that 'hormones' are present in the product will be considered to be a therapeutic claim for the product, or a claim that the product will affect the structure or function of the body, and will consequently cause the product to be a drug," the proposed rule states. * FDA noted that manufacturers may "denominate" the hormone ingredient "in the labeling by any appropriate name." However, FDA said the "use of the chemical name is preferable." As an example, the agency cited progesterone, for which the chemical name is pregn-4-ene-3,20-dione. The agency also cautioned that "any statement on the label of a cosmetic product of the presence of a hormone ingredient, e.g., 'contains natural estrogen and progesterone' . . . must not be given undue prominence." The proposed rule does not affect the hormone product hydrocortisone, which is Category I for itching under the external analgesic OTC rulemaking. FDA is accepting comments on the hormone proposed rule through Dec. 1 and new data through Oct. 2, 1990.

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