The U.S. Food and Drug Administration (FDA) recently took an important step to better protect consumers from the dangers of highly concentrated and pure caffeine products. These products present a significant public health threat because of the high risk that they will be erroneously used at excessive, potentially dangerous doses. Highly concentrated and pure caffeine, often sold in bulk packages, have been linked to at least two deaths in otherwise healthy individuals.

The agency 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. Given the significant public health concern, this guidance is immediately in effect. The FDA is prepared to take steps right away to begin removing illegal products from the market.

“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 know these products are sometimes being used in potentially dangerous ways. For example, teenagers, for a perceived energy kick, sometimes mix dangerously high amounts of super-concentrated caffeine into workout cocktails. The amounts used can too easily become deceptively high because of the super-concentrated forms and bulk packaging in which the caffeine is being sold,” said FDA Commissioner Scott Gottlieb, MD. “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.”

In response, the American Herbal Products Association (AHPA), NSF International and The Council for Responsible Nutrition (CRN) offered statements of support.

“Consumer safety is a top concern for AHPA members and that’s why the association adopted a policy in 2015 that prohibits the sale of pure caffeine to consumers,” said AHPA President Michael McGuffin. “The regulated supplement industry appreciates the FDA’s recent action on this issue which AHPA believes is very much in the public interest.”

“NSF International recognizes caffeine as a legitimate public health concern, which is why NSF/ANSI 173: the American National Standard for Dietary Supplements, includes strict labeling requirements and limits on the amount of caffeine that NSF certified supplements can contain,” added Lori Bestervelt, executive vice president and chief technical officer at NSF International.

“Extremely concentrated or pure caffeine has no place in the consumer marketplace, and CRN fully supports FDA’s commitment to taking immediate steps to remove products from the marketplace that present public health concerns. [The] announcement from FDA puts all dietary supplement stakeholders, including online retailers, on notice that highly concentrated caffeine sold in bulk to consumers is dangerous and illegal,” stated Steve Mister, president and CEO of CRN. “Caffeine is one of the most studied dietary ingredients and well-established science demonstrates safe use of caffeine. Consumers have access to a whole host of dietary supplements and other over-the-counter products that are manufactured with safe amounts of caffeine.”

For more information, visit www.fda.gov.