Weight control drug product reclassified

Benzocaine would be reclassified from its previously proposed monograph status (category I) for over-the-counter (OTC) weight control use to nonmonograph status in a proposed rule by the FDA. An approved new drug application (NDA) or abbreviated new drug application (ANDA) for the marketing of OTC weight control products containing benzocaine would be required, because agency data could not sufficiently support benzocaine’s safety and effectiveness in OTC weight control use. Although, an advanced notice of proposed rulemaking in 1982 included the recommendation of an advisory panel, consisting of health care providers from outside FDA, and recommended that benzocaine should be generally recognized as safe and effective (GRASE) for weight control, the FDA reviewed the information and data available to the panel as well as information and data that had been developed since 1982 to make its determination that benzocaine was not GRASE when used in OTC weight control products. FDA Proposal, ¶46,164

For more information on this and related topics, consult the CCHFDA Food, Drug and Cosmetic Law Reporter.

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