FDA Aluminum-Containing Antiperspirant Renal Warning
Aluminum-Containing Antiperspirant Renal Warning
Mandated by FDA
Antiperspirants contain aluminum will be required to carry a renal dysfunction warning due to risks associated with possible increased absorption of the ingredient, according to the OTC Antiperspirant Drug Products Final Monograph.
FDA "is concerned that people with renal dysfunction may not be aware that the daily use of antiperspirant drug products containing aluminum may put them at a higher risk because of exposure to aluminum in the products," the monograph notes. The rule is scheduled to appear in the June 9 Federal Register.
Assuming a person has normal renal function, "accumulation of aluminum resulting from unusual exposures to antiperspirant drug products (application to the underarms once or twice daily) and subsequent absorption is considered minimal", FDA points out.
However, those with renal dysfunction "have an impairment in normal renal excretion of aluminum." Thus, FDA "considers it prudent to alert these people to consult a doctor before using or continuing to use these products on a regular basis." The monograph requires the statement, "Ask your doctor before use if you have kidney disease."
Based on the concern that young children and those with immature renal function are "at a higher risk resulting from any exposure to aluminum", the agency is also requiring all products containing the ingredient "to inform parents and others to keep these products away from children and to seek professional assistance if accidental ingestion occurs."
The warnings respond in part to citizen petitions to FDA raising concerns about the amount of aluminum absorbed from antiperspirants. Two petitions submitted in 1992 asked the agency to reclassify all aluminum compounds used in antiperspirants from Category I to Category III.
The petitions were filed by Glen Scott, MD of Cincinnati and Patricia Sanders, a microbiologist with the agency. Both argued aluminum-containing antiperspirants may be linked to neurotoxicity, especially Alzheimer's disease.
However, FDA "does not find date from topical and inhalation chronic exposure animal and human studies submitted to date sufficient to change the monograph status of aluminum containing antiperspirants," the rule states.
The agency "will continue to monitor the scientific literature on aluminum and if new information appears, will reassess the status of aluminum-containing antiperspirants at such time."
The final rule includes 18 of the 19 active ingredients proposed by FDA in 1982 tentative final monograph on antiperspirants. All are aluminum based. The final rule specifies concentration limits of 20%-25% for each ingredient.
Aluminum sulfate buffered has been removed from Category I because it is not currently the subject of a U.S. Pharmacopeia - National Formulary compendial monograph. "While aluminum sulfate does have a compendial monograph", FDA points out, "the buffer component, sodium aluminum lactate, does not."
Should a compendial monograph eventually be developed, the agency will move this ingredient into Category I, FDA adds.
The agency also denies a request that aluminum sesquichlorohydrate be granted monograph status when it is prepared by neutralizing aluminum chloride with magnesium hydroxide.
Analytical data submitted are not "sufficient to support the claim that the ingredient prepared by this neutralization method is chemically equivalent in composition to aluminum sesquichlorohydrate" and "an appropriate USP-NF monograph amendment [is needed] before the ingredient prepared by the new method can be...recognized as safe and effective and included in the final monograph," FDA says.
The monograph includes a revised definition for antiperspirant that omits reference to the underarm. The agency explains "it is not necessary to specify the area of use on the body in the definition of an antiperspirant because that information is included in the product's labeling."
The effective date of the monograph and the compliance deadline for products with annual sales of over $25,000 is 18 months after the rule appears in the Federal Register. Products with less than $25,000 in annual sales will be given 24 months to comply.
62 Leuning Street