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FDA Again Targets Bulk Quantities of Pure or Highly Concentrated Caffeine Sold to Consumers as Dietary Supplements

  • As previously reported on this blog, FDA sent Warning Letters to five companies that distributed pure powdered caffeine in 2015 and advised that it intended to “aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate.”  FDA stated in the letters 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.

  • FDA has recently made public two additional Warning Letters involving bulk forms of dietary supplements with pure or highly concentrated caffeine.  FDA’s May 29, 2018 Warning Letters, to the sellers of Caffeine Anhydrous Powder, a pure caffeine powder sold in bulk to consumers, and the sellers of Liquid Caffeine, a highly concentrated liquid form of caffeine sold in bulk to consumers, note potential difficulties for consumers in accurately measuring a safe dose of these products.  Liquid Caffeine is the first liquid caffeine dietary supplement to be targeted by FDA.  FDA’s letter on Liquid Caffeine states:

In light of the potential toxicity of your product; the fact that your product is packaged to contain an amount that would be toxic several times over, and potentially lethal to certain consumers; the fact that the packaging requires the consumer to separate out a safe serving from this potentially toxic amount; the fact that the product labeling incorrectly implies that this process of separating out a safe serving from a potentially toxic amount can be done with a pump, which is not in fact sold with the product; and the fact that the product is instead co-packaged with a measuring device that holds 6 “one-pump” servings of your product, but is labeled with a different unit of measurement from the directions, such that consumers might not understand how many servings it contains and assume that it contains one serving; we have determined that your product presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling.

  • FDA’s continuing actions against bulk quantities of dietary supplements with pure or highly concentrated caffeine show that the Agency considers potential overdosing with caffeine to be a very serious risk for these products.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...