ALUMINUM ANTIPERSPIRANT SAFETY DATA SUFFICIENT FOR CATEGORY I, CTFA

ALUMINUM ANTIPERSPIRANT SAFETY DATA SUFFICIENT FOR CATEGORY I, CTFA asserted in Sept. 23 comments to FDA. Responding to a March 24 request for information on whether additional study on the products is needed, the Cosmetic, Toiletry and Fragrance Association maintained that "there is currently in existence sufficient safety data demonstrating that aluminum-containing and aluminum zirconium-containing OTC antiperspirants are safe, and that they should remain in Category I. No new testing and no additional data are needed to demonstrate the safety of the ingredients." FDA requested comments on the safety of the ingredients on March 24, noting that it will consider responses, as it develops a final monograph for OTC antiperspirants ("The Tan Sheet" March 29, p. 13). FDA also said it would take any comments into consideration when it responds to two citizen petitions on aluminum-containing antiperspirants. Submitted by Glen Scott, MD, of Cincinnati and Patricia Saunders, a microbiologist in the agency's analgesic, antiperspirant and antimicrobials section of the OTC Drug Monograph Staff, the two petitions asked FDA to reclassify aluminum-containing antiperspirants as Category III (data insufficient to permit classification), pending further studies, due in part to concerns over a link to Alzheimer's disease. Concurring with an OTC advisory panel's recommendations, FDA classified aluminum and aluminum zirconium as Category I in its August 1982 tentative final monograph on antiperspirants. CTFA argued that "despite the allegations" in the petitions, "there have been no new data that call into question the determinations of safety made by the FDA panel and by FDA itself in the TFM." CTFA pointed out that other regulatory bodies have since reviewed the data on the antiperspirant ingredients and concluded that they are safe. The association cited a decision by the European Community's Scientific Committee on Cosmetology (SCC), which the association said "provides additional support of the earlier regulatory conclusions by FDA." The estimated daily systemic exposure to aluminum from antiperspirants is approximately 19.5 mg for non-aerosols via the dermal route and approximately 20 mg (19.5 mg via the dermal route and 0.6 mg via inhalation) for aerosols, CTFA said. "However," CTFA asserted, "due to the nature of aluminum salts in antiperspirant aerosols (a significant fraction are less than or equal to 10 mu m in diameter and therefore not respirable), and to the low potential of aluminum for dermal absorption (aluminum salts penetrate minimally, bind to keratin and are lost through desquamation), actual systemic exposure to aluminum following use of either aerosol or non-aerosol antiperspirants is negligible." Regarding the possible link between aluminum exposure from antiperspirants and Alzheimer's disease, CTFA argued that "the weight of the evidence linking aluminum with Alzheimer's disease is unconvincing, and for this reason the current majority scientific opinion is that aluminum plays no cause in the etiology of AD. Indeed, aluminum is no longer a major focus of research on AD." The association also argued that "other neurotoxic effects that may be linked to aluminum are extremely rare and are not related to use of antiperspirants." CTFA noted that "aluminum neurotoxication has occurred only rarely as an industrial disease or as a result of high concentrations of aluminum in fluids used in kidney dialysis" and that "the number of cases has dwindled worldwide as aluminum has been excluded from dialyzing fluids." No new labeling requirements for aluminum-containing antiperspirants are needed, CTFA stated. "The current label warning requirement -- 'Avoid excessive inhalation' -- has been more than adequate during 20 years of safe market history," the association contended. The "excessive inhalation" warning was proposed in the TFM. The Nonprescription Drug Manufacturers Association concurred with the CTFA comments in separate, Sept. 20 remarks to FDA, explaining that it "participated in the development of the CTFA submission . . . and supports CTFA's conclusions."