Products consisting of or containing only pure or highly concentrated caffeine have been linked to at least two deaths in the United States in the last few years, and continue to present a significant public health threat. Many products that consist of only or primarily pure or highly concentrated caffeine are sold as dietary supplements. FDA considers some such products to be adulterated under section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(f)(1)(A)], because they are dietary supplements that present a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling or, if no conditions for use are suggested or recommended, under ordinary conditions of use.

This document is intended to provide guidance to firms that manufacture, market, or distribute dietary supplement products that contain pure or highly concentrated caffeine, or are considering doing so. This guidance should help such parties determine whether their products are or would be adulterated under section 402(f)(1)(A) of the FD&C Act.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

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Related Information

• Pure and Highly Concentrated Caffeine
• Dietary Supplements Guidance Documents & Regulatory Information