The Office of Dietary Supplement Programs within CFSAN at FDA has prepared and published guidance for industry, warning that powdered and liquid dietary supplements containing pure or highly concentrated caffeine may be deemed to be adulterated under section 402(f)(1)(A) of the FD&C Act: Highly Concentrated Caffeine in Dietary Supplements: Guidance for Industry (Apr. 2018).
Caffeine is generally recognized as safe (GRAS) by FDA’s regulations solely in cola-type beverages up to 0.02% (200 ppm). 21 C.F.R. § 182.1180. Nonetheless, it is present in a substantial number of other conventional foods and dietary supplements. In fact, caffeine is one of the most commonly consumed stimulants world-wide.
FDA’s guidance makes note of the following consumption levels for caffeine:
FD&C Act § 402(f)(1)(A) provides:
A food shall be deemed to be adulterated—
* * *
(1) If it is a dietary supplement or contains a dietary ingredient that—
(A) presents a significant or unreasonable risk of illness or injury under—
(i) conditions of use recommended or suggested in labeling, or
(ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use…
21 U.S.C. § 342(f)(1)(A).
FDA’s guidance notes that bulk containers of powdered and liquid dietary supplements comprised of pure or highly concentrated caffeine reasonably contain many potentially lethal doses of caffeine, and that this danger is not offset adequately by serving size declarations and/or warning statements on labels. This being the case, the guidance advises that such dietary supplements may be deemed to be adulterated under FD&C Act § 402(f)(1)(A). The guidance’s advice includes caffeine from all sources, including coffee beans, cocoa beans, kola nuts, tea leaves, yerba mate, guarana, and artificial/synthetic sources. A number of Warning Letters already have been issued, including:
Nevertheless, FDA’s guidance acknowledges that when formulated and marketed appropriately, caffeine may be an ingredient in a dietary supplement that does not present a significant or unreasonable risk of illness or injury:
Assuming that the product otherwise complies with all applicable legal requirements, we do not expect to consider the following types of dietary supplements to be adulterated:
A. Dietary supplements sold in solid dosage forms, such as tablets or capsules that do not provide an excessive amount of caffeine per item. Products in these forms eliminate the need for a consumer to accurately measure the appropriate serving.
B. Dietary supplements containing powdered or liquid caffeine (either diluted or undiluted) that are sold in premeasured packets or containers, with each premeasured unit containing an amount of caffeine that is not excessive. Products that are sold in pre-measured quantities eliminate the need for a consumer to measure the appropriate amount.
C. Bulk powdered or liquid caffeine dietary supplement products that have been significantly diluted to low enough concentrations of caffeine, such that a reasonably foreseeable measurement error, misreading of the directions, or misunderstanding about the nature of the product would not normally be expected to lead to toxic or life-threatening symptoms.