FDA released Guidance for Industry on highly concentrated caffeine in dietary supplements. FDA considers products which only or primarily consist of pure or highly concentrated caffeine and are sold as dietary supplements to be adulterated under section 402(f)(1)(A) of the FD&C Act [21 U.S.C. § 342(f)(1)(A)] due to the 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. These products which have been linked to at least two deaths in recent years are considered to present a significant public health threat.
Posted in FDA Update.