FDA Issues Guidance over Highly Concentrated Caffeine in Dietary Supplements

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FDA today issued published guidance warning the public about the dangers of products marketed as dietary supplements that contain highly concentrated, unsafe amounts of caffeine. The agency says that bulk amounts of both powder and liquid forms of highly concentrated caffeine products have been linked to several deaths in recent years. FDA’s guidance is now in full effect, even as the agency continues to collect public comments on its contents.

The biggest concern lies with highly concentrated caffeine products that are delivered to the user in bulk packaging, FDA says. “Pure or highly concentrated powdered caffeine is often sold in packages containing powder for thousands of recommended servings,” the agency writes, noting that some bulk products are sold in quantities as large as 10 kg, which is equivalent to more than 10,000 recommended servings of product. Consumers are often instructed to measure out dosages themselves, which the agency says poses “significant or unreasonable risk of illness or injury” because users can easily consume an unsafe dose.

“A half cup of a highly concentrated liquid caffeine can contain approximately 2,000 mg of caffeine, and just a single teaspoon of a powdered pure caffeine product can contain approximately 3,200 mg of caffeine,” FDA said in a press release announcing the new guidance. “This is equivalent to about 20 to 28 cups of coffee, a potentially toxic dose of caffeine. In fact, less than two tablespoons of some formulations of powdered, pure caffeine can be deadly to most adults, while even smaller amounts can be life threatening to children.”

FDA says it considers such products to be adulterated and that even if products are packaged with “tiny” measuring scoops with which consumers can measure a single serving, the agency might still consider the product to be adulterated.

The agency stresses that its guidance applies to these types of highly concentrated caffeine products in bulk; when caffeine products are formulated responsibly, they do not present a risk, it says. For instance, capsule and tablet forms of supplements that do not contain excessive amounts of caffeine are not considered adulterated because they eliminate the need for consumers to measure the dosage themselves. Similarly, powdered or liquid caffeine products sold in premeasured packets or unit-dose containers are not considered adulterated. Finally, FDA says, bulk powdered or liquid products would not be considered adulterated if they were “significantly diluted” to lower concentrations of caffeine in order to make using them safe.

Several dietary supplement associations already provide their members with guidelines for marketing caffeine products. For instance, both the Natural Products Association (NPA; Washington, DC) and the Council for Responsible Nutrition (CRN; Washington, DC) have published voluntary guidelines for the labeling of caffeine-containing products. (NPA says its guidelines are adapted from CRN’s guidelines.)

As part of the recommended best practices, NPA and CRN advise companies to disclose caffeine content from both added and naturally occurring sources on a product’s Supplement Facts or Nutrition Facts label. (The associations say that foods or supplements containing no added caffeine or containing less than 25 mg of naturally occurring caffeine per serving do not merit such a requirement.) Product serving sizes and daily intake recommendations should also align with safe levels established by competent and reliable scientific evidence. Both groups also warn against promoting the use of caffeine-containing foods and supplements with alcohol. CRN also updated its guidelines in 2015 specifically to address pure powdered caffeine products.

FDA says that in 2015 and 2016, it issued warning letters to seven distributors of pure powdered caffeine. “Since that time, the FDA has continued to see a proliferation of similar products being sold online,” it says.

“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.” said Scott Gottlieb, MD, FDA commissioner, in an FDA press release. “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. 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 a press release, Steve Mister, president and CEO of CRN, said, “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. Today’s 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.”

“Caffeine is one of the most studied dietary ingredients, and well-established science demonstrates safe use of caffeine,” Mister said. “Consumers have access to a whole host of dietary supplements and other over-the-counter products that are manufactured with safe amounts of caffeine.”

Also read:

CRN Adopts Caffeine Guidelines

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Caffeine Labeling