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On April 13, 2018 the FDA announced new restrictions on the sale of so-called dietary supplements containing high amount of caffeine. The new guidelines restrict the sale of pure or highly concentrated caffeine products in powder or liquid form directly to consumers in bulk quantities. They were said to pose a significant public health threat because of the high risk they will be used in excessive, potentially dangerous doses. A single teaspoon of powdered caffeine contains approximately 3,200 mg of caffeine—the equivalent to about 20 to 28 cups of coffee—a potentially fatal dose of caffeine. The FDA said it was prepared to take immediate steps to begin removing illegal products from the market.

The recommended serving of highly concentrated or pure caffeine products is 200 mg, equal to 1/16 of a teaspoon of pure powder, or 2.5 teaspoons of liquid. The FDA press release said the risk of overuse and misuse is high when these products are sold in bulk quantities, given the expectation of the buyer making small, precise measurements per recommended serving. Despite the small serving sizes, “powdered forms of caffeine are sold in large bags and liquid forms are sold online in bottles that can contain a gallon or more.” Often consumers don’t have the right tools to correctly measure the small dosage amounts so they are at risk of ingesting too much concentrated or pure caffeine.

Another concern is these products can resemble safe, household items like water, distilled vinegar, flour or powdered sugar. “The consequences of a consumer mistakenly confusing one of these products could be toxic or even lethal.” The new guidance does not apply to products such as prescription or over-the-counter drugs containing caffeine or conventional caffeinated beverages. The FDA commissioner, Scott Gottlieb, was quoted as saying:

 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. . . . 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.

Concern with the public health risk of products containing concentrated, high levels of caffeine is not new. In September of 2015 the FDA issued a warning that “Pure and highly concentrated caffeine products present a significant public health threat and have contributed to at least two deaths in the United States.” The FDA then issued warning letters to five distributors of pure powdered caffeine. In March of 2016 the FDA sent two additional warning letters to manufacturers. See the 2015 FDA announcement for links to the warning letters.

The FDA warnings about dietary supplements with high concentrations of caffeine reported knowledge of at least two confirmed deaths attributed to these products. This was apparently referring to a 2014 FDA article, “Tragic Deaths Highlight the Dangers of Powdered Pure Caffeine.”  The article described the unfortunate deaths of two men, an eighteen-year-old high school senior and a 24-year-old college graduate who died after using pure powdered caffeine products. These aren’t the only two deaths linked to these products. The Washington Post highlighted the case of a South Carolina teen who died in April of 2017 of a “caffeine-induced cardiac event” after drinking a latte and a Mountain Dew, then chugging an energy drink within the span of two hours.

In 2015 a group of US senators sent a letter to the FDA requesting the agency require clearer labeling on powdered caffeine products and a ban on the retail sale and marketing of such products to consumers. They renewed their call to the FDA to take action on the 2015 requested ban on April 26, 2016 as the FDA still had not taken any action. In the 2016 letter, the senators said:

It is disturbing that despite two unintended and untimely deaths associated with powdered caffeine, the FDA has done little to regulate these products or adequately enforce the standards in place to protect Americans from the substantial risk associated with ingesting powdered caffeine in any form. . . . Unfortunately, in the absence of strong regulatory action, companies are continuing to develop new delivery mechanisms and creative advertising ploys to attract new powdered caffeine users and are doing so without relaying the serious health consequences of improper use.

The senators also sent information to the FDA on data from the nonprofit organization, the Center for Science in the Public Interest (CSPI), supporting the requested ban on the retail distribution of pure and highly concentrated caffeine products. In their April 26, 2016 letter to the FDA, CPSI noted while the five dietary supplement companies who received warning letters by the FDA in 2015 voluntarily removed pure caffeine products from their retail sales, “pure caffeine in powdered (PPC), liquid (PLC) and now inhalable (IC) forms is still widely available for purchase online.” A basic internet search found at least fifteen online suppliers. Five of these were domestic suppliers and ten were international suppliers based in Canada, the United Kingdom, India and China.

This compelling evidence demonstrates why a ban is the only step that will protect consumers from the hazards of PPC. Moreover, a ban would prevent legal importation of this dangerous substance into the country from foreign suppliers.Given the evidence, and vocal support from experts, parents, and trade associations, CSPI reiterates the need for a complete ban on the retail distribution of highly concentrated caffeine marketed as a dietary supplement. This includes specifying limits on the form in which caffeine is sold, including its labeling, serving sizes, and potency, to minimize the risk of accidental overdose by all potential users, including young consumers.

Senators Sherrod Brown (D-OH), Richard Blumenthal (D-CT), and Dick Durbin (D-IL) voiced their support to the FDA ban they have been seeking for the past four years. Senator Brown said: The FDA’s decision to ban the direct sale of pure, lethal powdered caffeine will finally bring about the consumer protections we have been demanding for years.” Senator Blumenthal said: “The FDA has rightly heeded our call to take swift action to get highly concentrated bulk caffeine products off the market. Pure caffeine is simply unsafe and has long posed dangerous – even deadly – risks to unsuspecting consumers. Robust enforcement action will go a long way towards stopping senseless and tragic caffeine overdoses.” Senator Durbin concurred with these sentiments, saying he was glad to see the FDA heeded their call to action, adding that when sold in bulk, “it is nearly impossible for consumers to tell the difference between a safe dose of pure powdered caffeine and a lethal one.”

For more information on problems with energy drinks and other products with high caffeine concentrations, see:  “Overdosing On Energy Drinks” and “Killer Caffeine.”