FDA Rules on Aloe, Cascara Sagrada in OTC Laxative Products

WASHINGTON--According to a final ruling by the Food and Drug Administration (FDA), aloe and cascara sagrada in over-the-counter (OTC) drug products are not GRASE (Generally Recognized As Safe or Effective) or are misbranded. Under the final rule, which will be published in the May 9 Federal Register (www.fda.gov/OHRMS/DOCKETS/98fr/78n-036L-nfr0004-vol107.pdf), the ingredients included aloe extract, aloe flower extract, cascara fluidextract aromatic, cascara sagrada extract, casanthranol, cascara sagrada bark and cascara sagrada fluidextract. The agency is reclassifying these ingredients to category II (nonmonograph) and is adding them to the list of stimulant laxative ingredients for which the data are inadequate to establish general recognition of safety and effectiveness.

In June 1998, FDA reclassified aloe, cascara sagrada, bisacodyl and senna--all with laxative effects when taken internally--from category I (monograph) to category III (more data needed). Carcinogenicity data on bisacodyl and senna was requested and ultimately provided from pertaining manufacturers, FDA wrote in the ruling, and this data will be discussed in future issues of the Federal Register. FDA also requested mutagenicity, carcinogenicity and genotoxicity data on aloe and cascara sagrada ingredients from manufacturers, but there were no submissions.

According to FDA, products containing the aloe and cascara sagrada ingredients must be reformulated or discontinued. The stimulant laxatives must therefore be deleted or replaced, FDA said. Reformulated products will also need to be relabeled.

"While the FDA's ruling on aloe and cascara sagrada is only limited to drug products and because the FDA's basis for removal is on the grounds of safety and efficacy, companies that include these ingredients in dietary supplements should carefully re-evaluate their evidence of safety and efficacy," said Steve Shapiro, a partner with Ullman, Shapiro & Ullman.

FDA's Drug Listing System identified approximately 15 OTC laxative products containing the aloe ingredient and 160 laxative products containing cascara sagrada ingredients. An additional six products contained both aloe and cascara sagrada or casanthranol.