The FDA’s concern over the sale of pure or highly concentrated bulk caffeine products recently resulted in warning letters to Liquidcaffeine.com (“Liquidcaffeine”) and Dual Health Body and Mind (“Dual Health”) related to their Liquid Caffeine and Caffeine Anhydrous Powder products, respectively.
The letters set forth the FDA’s position that the products are adulterated under 21 U.S.C. §342(f)(1)(A)(i), stating that each dietary supplement “presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling.”
The warning reflects the FDA’s longstanding concern over the powerful nature of caffeine and its health risks and side effects. The agency has historically sought to take action on ensuring consumer safety as it relates to over-consumption or the potential for over-consumption.
In the warning letters, the FDA takes issue among other things with the large size of the products being offered by the companies, the lack of adequate measuring tools and, accordingly, the difficulty consumers would have in measuring a safe serving size. For example, the letter to LiquidCaffeine cites its liquid caffeine product, which provides directions for one pump (83 mg or one teaspoon); two pumps (166 mg or two teaspoons); and three pumps (250 mg or three teaspoons) but provides consumers with only a one-fluid-ounce measuring cup (approximately 500 mg of caffeine).
The FDA further notes that while the serving size describes pumps, the product does not come with a pump and is available only as an add-on purchase. The FDA cites a concern that consumers will believe that the measuring cup (i.e. one fluid ounce) is the accurate serving size and will be unable to perform the conversion between milligrams and teaspoons and fluid ounces.
The concern over a consumer’s inability to measure out a safe serving of pure or highly concentrated caffeine dietary supplement products is not a new concern, as the FDA previously issued warning letters to several companies in 2015 related to similar practices.
The FDA recently issued a guidance document clarifying the type of bulk caffeine products which the FDA deems adulterated as well as providing tips on how to produce safer caffeine dietary supplements products. One of those tips was diluting the concentrations of caffeine in such products significantly, or selling the products in premeasured packets, as the FDA stated that even with proper measuring tools, bulk products can still present a significant or unreasonable risk of illness or injury.
The FDA’s most recent warning letters against pure or highly concentrated bulk caffeine products confirm that this issue remains a serious concern of the FDA.
You can download and read the Guidance Document from the FDA.
