FDA takes action against dietary supplements containing very high levels of extremely concentrated or pure caffeine

FDA on Friday issued a new <a href="https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatory…; target="_blank">guidance</a> 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 on Friday issued a new <a href="https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatory…; target="_blank">guidance</a> 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. According to the agency, "These products present a significant public health threat because of the high risk that they will be erroneously used at excessive, potentially dangerous doses." FDA noted that one-half of a cup of a highly concentrated liquid caffeine can contain about 2,000 mg of caffeine and one teaspoon of a powdered pure caffeine product can contain about 3,200 mg of caffeine&#8212;equivalent to 20&#8211;28 cups of coffee. The recommended safe serving of highly concentrated or pure caffeine products is much lower, often at 200 mg of caffeine&#8212;equal to 1/16th of a teaspoon of pure powder or about 2.5 teaspoons of a liquid. However, powdered forms of caffeine are often sold in large bags and liquid forms are sold in bottles that may contain a gallon or more, and consumers may not have the correct tools to properly measure such a small amount. Even when they do, using a "heaping scoop" instead of a "level scoop," for example, can make a big difference in the amount used. FDA said the guidance does not affect other types of products that might also contain caffeine, such as prescription or OTC drugs or conventional foods. FDA Commissioner Scott Gottlieb, MD, stated: "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."

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