Pure Caffeine Products Adulterated, FDA Warns in Dietary Supplement Guidance

In guidance issued Friday for the dietary supplement industry, FDA said products containing pure or highly concentrated caffeine in powder or liquid forms are considered unlawful when sold in bulk amounts to consumers, due to the significant health risks they pose.

Citing public health concerns, FDA said the guidance takes effect immediately, and the agency disclosed it is prepared to take actions to begin removing such products from the market.

“Symptoms of caffeine overdose can include rapid or dangerously erratic heartbeat, seizures and death,” FDA stated in a consumer advisory. “Vomiting, diarrhea, stupor and disorientation are also symptoms of caffeine toxicity. These symptoms are likely to be much more severe than those resulting from drinking too much coffee, tea or other caffeinated beverages.”

In recent years, FDA sent warning letters to companies about powdered bulk caffeine, following the deaths of two young Americans. The products, the letters cautioned, posed a “significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling.”

The warnings failed to produce the desired effect. In a statement, FDA Commissioner Scott Gottlieb, M.D. said his agency has observed “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.”

FDA has cautioned it is virtually impossible to accurately measure a safe amount of powdered bulk caffeine with common kitchen measuring tools, such as a teaspoon. In its news release announcing the guidance, FDA said a single teaspoon of powdered pure caffeine is potentially toxic, containing the equivalent of up to 28 cups of coffee.

“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,” Gottlieb explained. “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.”

FDA’s 2018 guidance is intended for marketers, manufacturers and distributors of dietary supplements containing pure or highly concentrated caffeine.

“Products consisting of or containing only pure or highly concentrated caffeine have been linked to at least two deaths in the United States in the last few years, and continue to present a significant public health threat,” the guidance stated.

Such products sold as dietary supplements are “adulterated” under the law, FDA maintained in the guidance, because they “present a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling or, if no conditions for use are suggested or recommended, under ordinary conditions of use.”

FDA said caffeine can be sold in a dietary supplement when formulated and marketed properly. For example, the guidance noted supplements sold in premeasured packets or containers are less likely to present the same safety risks as pure or highly concentrated caffeine.

Several trade organizations representing the dietary supplement industry, including the Council for Responsible Nutrition (CRN), supported FDA’s decision.

“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,” said Steve Mister, president and CEO of the Washington-based trade organization, in a statement. “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.”

In 2015, CRN updated certain caffeine guidelines to include restraints against the sale and marketing of pure powdered caffeine directly to consumers. That was the same year the United Natural Products Alliance (UNPA) adopted a “no-sale” policy for bulk powdered caffeine for retail sales. The policy is a condition of membership for prospective and current UNPA members.

Loren Israelsen, president of UNPA, described FDA’s most recent action “as an important step for public health and safety.”

He said UNPA will present to its executive committee early next week a proposal seeking to expand its no-sale policy of bulk powdered caffeine to include liquid, high-dose caffeine products and an endorsement of FDA’s guidance.

“This new guidance is a logical next step to FDA’s prior efforts to inform consumers about the health risks associated with the consumption of high-dose caffeine products,” Israelsen said in a statement.

The American Herbal Products Association (AHPA) also supported FDA’s move.

"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," AHPA President Michael McGuffin said in a statement. "The regulated supplement industry appreciates the FDA's recent action on this issue, which AHPA believes is very much in the public interest."

FDA’s guidance was met with less fanfare from Daniel Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA). He previously led FDA’s Division (now an Office) of Dietary Supplement Programs.

“FDA feels people are too dumb to measure out amounts,” Fabricant said in an interview. “This is a guidance on spoons and how to use spoons.”

Fabricant said FDA should go through the rulemaking process if it believes consumers are overconsuming caffeine, and there are dangerous products on the market. He questioned FDA’s use of resources to develop the guidance—and he raised concerns that language in it could provide ammunition for plaintiffs’ class action lawyers—at a time when the agency faces other challenges, such as the proliferation of products spiked with Viagra, the prescription drug to treat erectile dysfunction.

The former FDA official described the cases of caffeine overdoses as tragic. But, he added, “[I]f it’s a case of abuse, that’s not FDA’s jurisdiction.”

The guidance is not legally binding and falls short of a formal rule banning retail distribution of pure caffeine sold in powder form as a dietary supplement—the subject of a 2014 petition filed by the Center for Science in the Public Interest (CSPI), a consumer watchdog group.

After the petition was filed, legal experts told Natural Products INSIDER that a ban on bulk powdered caffeine would face hurdles but was nonetheless possible. In 2004, FDA banned ephedra from dietary supplements, although the process took several years and culminated in litigation.

CSPI praised FDA for issuing the 2018 guidance.

“This action will save lives and remove a serious hazard for consumers,” said Laura MacCleery, policy director for CSPI, in a statement.

She added, “Anyone selling these supplements online should now be on notice that the products are illegal if they are highly concentrated.”