OTC "HAIR GROWTH" AND "HAIR LOSS PREVENTION" CLAIMS MUST BE REMOVED

OTC "HAIR GROWTH" AND "HAIR LOSS PREVENTION" CLAIMS MUST BE REMOVED from product labeling by Jan. 8, 1990, following publication of the final monograph for OTC hair growth products in the July 7 Federal Register. The final rule establishes that "any OTC hair grower or hair loss prevention drug product for external use is not generally recognized as safe and effective and is misbranded." Like the tentative final monograph published on Jan. 15, 1985, the final rule found no OTC ingredient to be effective against hair loss. * A same day FDA Talk Paper states that the regulation targets products "usually sold by mail or through barbers or beauticians." The rule does not apply to cosmetics and toiletries that make general hair health claims such as "thickens hair" or "nourishes hair." Consequently, "shampoos and scalp cleaners used to cleanse the hair (and not labeled with any claims relating to hair loss prevention or hair growth) are cosmetics and are not covered by this rulemaking proceeding," the agency noted. Although the agency stated in its tentative final monograph fours years ago that OTC antibaldness treatments were not considered to be safe and effective, continued marketing of the products has attracted the attention of both Congress and the Federal Trade Commission. Such marketing triggered expressions of concern by Rep. Dingell (D-Mich.) last year over delays in the OTC Drug Review process ("The Pink Sheet" July 11, 1988, p. 6). Two antibaldness products, Pantron I's Helsinki Formula and California Pacific Research's New Generation were the subject of FTC actions for misrepresentation ("The Pink Sheet" Nov. 28, T&G-10). Publication of the final rule on hair loss prevention products also has been sought by Upjohn to prevent ineffective products from piggybacking on its Rogaine (minoxidil) launch. In a same-day release, Upjohn announced that it "will extend its hair loss information campaign to hair salons and barbershops in Chicago and, over the next two weeks, to three other U.S. cities: Atlanta, New York and Los Angeles." The FDA Talk Paper mentions minoxidil as the only approved product for stimulating hair growth in the treatment of male pattern baldness. Active ingredients cited as safe but not generally recognized as effective by the agency are ascorbic acid, benzoic acid, estradiol (not to exceed 5.5 micrograms per day), lanolin, tetracaine hydrochloride, and wheat germ oil. Other hair grower and hair loss prevention product ingredients which are considered neither safe nor effective and are banned from such claims by the regulation are amino acids, aminobenzoic acid biotin, B-vitamins, dexpanthenol, topical hormones, jojoba oil, nucleic acids, polysorbate 20 and 60, sulfanilamide, sulfer 1% on carbon in a fraction of paraffinic hydrocarbons, and urea. FDA said it received comments from four manufacturers and 218 consumers on the proposed rule. One manufacturer's comments included two studies, one double-blind, on its product which contains estradiol as the active ingredient. The estradiol product was considered at length by FDA in the final rule. Although "there was a slight indication in the [double-blind] study that estradiol, with the cleansing agents, could be more helpful," the agency concluded that "the statistical significance of estradiol over placebo has not been demonstrated." Although the final rule covers only external products, FDA emphasized that "orally ingested products [including vitamins and food supplements] marketed for the same or similar hair grower or hair loss prevention indications are also subject to regulatory action." Oral products making such claims, since they are not covered by OTC rulemaking, "will be handled on a case-by-case basis," the agency said.