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Cascara sagrada, aloe rule

This article was originally published in The Tan Sheet

Executive Summary

OTC laxative drug products containing cascara sagrada or aloe that were in interstate commerce as of Nov. 5 can be sold until stock is depleted, FDA says. However, such drugs cannot be introduced into interstate commerce after that date, when FDA's final rule classifying the ingredients as Category II in OTC laxatives took effect. Agency is completing responses to petitions by AHPA and others requesting stay of rule's effective date and enforcement action. Reg does not cover dietary supplements containing the ingredients, FDA notes...

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