PROGESTERONE, PREGNENOLONE ACETATE AT LOW LEVELS ALLOWED IN COSMETICS

PROGESTERONE, PREGNENOLONE ACETATE AT LOW LEVELS ALLOWED IN COSMETICS under an FDA proposed rule published in the Sept. 9 Federal Register. Also, in a separate, same-day notice, FDA issued its final rule on OTC topically applied hormone-containing products, which found no ingredients acceptable as OTC drug ingredients. FDA noted that it received only one comment on OTC products containing topical hormones in response to the agency's Oct. 2, 1989 tentative final monograph; that comment related to a consumer's right to know the source of hormones contained in OTC products. The TFM did not list any Category I (safe and effective) ingredients. The OTC topical hormones final rule, FDA said, affects products that contain estrogens, progestins, androgens, anabolic steroids, and adrenal corticosteroids and synthetic analogs -- none of which FDA said are generally recognized as safe and effective. The rule also covers pregnenolone and pregnenolone acetate, "which are closely related to progesterone in chemical structure and that exert an estrogen-like action on the skin when applied topically," FDA noted. However, the rule does not affect products containing hydrocortisone and hydrocortisone acetate. The rule goes into effect on March 9, 1994. FDA pointed out that "there are only a limited number of these types of products currently being marketed." The agency noted that "these products would be able to remain on the market with some relabeling in accord with the notice of proposed rulemaking for cosmetic products" containing low levels of progesterone and pregnenolone. The agency said it has decided to allow use of the two hormones in cosmetics at levels that have been found to be safe but "lack effectiveness for drug use." The limits on progesterone are 5 mg/ounce, when labeled for use not to exceed 2 ounces per month. The agency is restricting pregnenolone to no more than .5%, with use not to exceed two ounces per month. However, cosmetic products may not bear therapeutic claims for the hormones or mention the word "hormone" on labels, FDA said. The agency said it has "determined that use of the word 'hormone' in the text of the labeling or in the ingredient statement is an implied drug claim. The claim implied by the use of this term is that the product will have some therapeutic or some other physiological effect on the body." The proposal continues: "Therefore, reference to a product as a 'hormone cream' or any statement in the labeling that 'hormones' are present . . . will be considered to be a therapeutic claim for the product, or a claim that the product will affect the structure or any function of the body." Such statements will be considered unapproved new drug claims. FDA said that progesterone and pregnenolone acetate should be the names used to designate those ingredients in cosmetics labeling in order to be readily recognizable to consumers. "The agency is aware that some consumers may wish to avoid using a cosmetic product containing a hormone ingredient for medical or other reasons," the proposal states. "The establishment of uniform names tobe used in all cosmetic product labeling should aid consumers in identifying those ingredients." The proposal lists only progesterone and pregnenolone acetate as cleared foruse in cosmetics. FDA said it has not evaluated any safety data on pregnenolons hemisuccinate and pregnenolone succinate but "invites comments an data to support the safe use of these ingredients in cosmetic products." Theagency will announce in the final rule whether the ingredients will be allowed in cosmetics. Comments on the proposal are due by Nov. 8. FDA also solicited comments on the "qualitative and quantitative composition of natural estrogens that would allow the setting of safe levels for use in cosmetic products." Noting that estrogens and estrogen-containing substances have been used in cosmetics in the past, FDA urged manufacturers of such products "to submit data on the safety and exact chemical identity of such . . . substances. The submission should also contain product labeling (current and historical) and provide information showing how long the cosmetic product containing this ingredient has been marketed." If adequate information is not received to establish the chemical identity and composition of natural estrogens used in cosmetic hormone products, the final rule will state that natural estrogens will not be permitted in cosmetics, the proposal states. Hormones such as anabolic steroids and adrenal corticosteroids are not allowed in cosmetics at any level, FDA noted.