FDA issues Warning Letters to five distributors of powdered caffeine alleging safety risks inherent to product use.

  • FDA regulates the marketing of dietary supplements.  Under Section 402(f)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), a supplement is adulterated when it “presents a significant or unreasonable risk of illness or injury under…conditions of use recommended or suggested in labeling.”
  • FDA has issued Warning Letters to five companies distributing pure powdered caffeine and has posted a Constituent Update on its website to warn consumers about the dangers associated with the use of this product.  According to the Warning Letters, FDA has concluded that pure powdered caffeine is adulterated based on the potential toxicity of the product; the fact that the products are “packaged to contain an amount that would be lethal to many consumers”; and the fact that consumers would need to measure the product very precisely to “separate out a safe serving from [the] lethal amount.”  According to FDA’s Constituent Update, one teaspoon of pure powdered caffeine is equivalent to the amount of caffeine in about 28 cups of regular coffee.
  • FDA’s current action highlights the Agency’s authority to take enforcement action against products positioned as dietary supplements where evidence suggests the potential for significant toxicity; future violations carry the risk of product seizures or injunctions to prevent firms from continuing to manufacture or market the product.  FDA has warned the industry of its intent to “aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate.”