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Regulation of Probiotic and Other Live Biologic Products

USA

Oct 05, 2020

This chapter discusses the regulation of probiotic products in the United States. In the U.S, the intended use determines how a product is regulated. Products marketed to treat or prevent disease are regulated as drug or biologic products. Ingestible products, other than conventional foods, marketed to supplement the diet are regulated as dietary supplements while topical products that are designed to cleanse or beautify the body are regulated as cosmetics. The Federal Food and Drug Administration (FDA) is the primary agency responsible for regulating drugs, foods (including dietary supplements), and cosmetics. The Federal Trade Commission (FTC) shares jurisdiction with FDA and is the agency charged with ensuring that products are marketed truthfully and claims are properly substantiated. The myriad of U.S. regulations pursuant to which these agencies exercise their regulatory oversight of probiotic products is discussed below.

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