As previously reported on this blog in 2015, FDA warned that it intended to “aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate.” The Agency made this announcement shortly after sending Warning Letters to five companies that distributed pure powdered caffeine. In the letters, FDA stated that it concluded that pure powdered caffeine is adulterated under Section 402(f)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) based on the potential toxicity of the product.

On April 13, 2018, FDA issued a new guidance to clarify that dietary supplements containing pure or highly concentrated caffeine in powder or liquid forms are considered unlawful when sold in bulk quantities directly to consumers. In a press release concerning the guidance, FDA Commissioner Scott Gottlieb, M.D., explained:

• “Despite multiple actions against these products in the past, we’ve seen a continued trend of products containing highly concentrated or pure caffeine being marketed directly to consumers as dietary supplements and sold in bulk quantities, with up to thousands of recommended servings per container. … We’re making clear for industry that these highly concentrated forms of caffeine that are being sold in bulk packages are generally illegal under current law. We’ll act to remove these dangerous bulk products from the market.”

The guidance is intended to assist firms that manufacture, market or distribute dietary supplements products that contain pure or highly concentrated caffeine in determining whether their products are adulterated under Section 402(f)(1)(A) of the FD&C Act. It also includes a list of the types dietary supplements containing caffeine that the FDA does not consider to be adulterated.