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Guidance Issued for OTC Botanical Drug ProductsGuidance Issued for OTC Botanical Drug Products

August 11, 2000

1 Min Read
Guidance Issued for OTC Botanical Drug Products

WASHINGTON--The Food and Drug Administration (FDA) has finally published guidance for obtaining marketing approval of botanical drugs in the Aug. 11 Federal Register. It was originally scheduled to be published in July of 1997.

The guidance pertains to obtaining approval through and OTC monograph or new drug application (NDA). It also describes the process for submitting an investigational new drug application (IND) for a botanical drug and touches on several areas in which botanicals differ from conventional drugs.

According to FDA, the guidance is intended to encourage the marketing of botanicals with drug indications. According to attorney Marc Ullman, that may truly be its intent. However, he noted, "it may provide an excuse for FDA to clamp down on dietary supplement claims-especially for herbal products."

According to the new guidance, a company wishing to sell a botanical under an existing OTC monograph must file a citizen's petition. The product must have already been on the market [for an unspecified amount of time] and there must be published clinical studies to verify its safety and efficacy. The facility that manufactures the product must meet good manufacturing processes for OTC drugs, as well.

FDA also determined that botanicals not generally recognized as safe (GRAS) must be approved using an NDA that includes clinical studies, safety data and chemistry information as well as manufacturing and controls information. If the data does not exist, then the company must submit an IND.

For specifics about the guidance, visit www.fda.gov/cder/guidance/1221dft.pdf. The docket can also be found through the search engine at www.fda.gov by entering "marketing botanical drugs."

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