Dietary Supplements Containing Pure or Highly Concentrated Caffeine – Potential Adulteration
In response to the increase in caffeinated dietary supplements in the marketplace and public health risks associated with oral intakes of caffeine, the Food and Drug Administration (FDA) released guidance to industry regarding products containing pure or highly concentrated caffeine. The caffeine guidance document describes multiple circumstances under which FDA may deem pure or highly concentrated caffeine-containing dietary supplements to be adulterated under Section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).1,2 These circumstances include, but are not limited to package size, product form, and even the expiration date. The guidance is critical for manufacturers, marketers and distributors of caffeinated dietary supplements to understand to avoid introducing what FDA might consider adulterated dietary supplements into commerce.
FDA Guidance on Caffeinated Liquid & Powder Dietary Supplements
The guidance document focuses on liquid and powder forms of dietary supplements which contain pure or highly concentrated caffeine, especially those sold in bulk containers. Due to the size of bulk containers, FDA is concerned that a consumer may not be able to “accurately and precisely measure” a serving size that is safe versus a “potentially lethal amount” on their own, even if a measuring device is provided. Concern was raised for consumers potentially losing the measuring device, filling the measuring device too full with a powder, over-pouring a liquid, inaccurately diluting a liquid product, or assuming their tolerance for caffeine is greater than others and exceeding the recommended serving size — for these and other reasons, the product would be considered adulterated by FDA under the FD&C Act. Recognizing that many caffeinated products contain a warning label to address potential risks associated with the use and misuse of dietary supplements, FDA stated that a warning label could/does not “remedy the adulteration” associated with such products as the perceived risks are too great.
The FDA indicated many bulk products are shared among groups, which introduces an increased risk for misuse of products as well. If a powder or liquid dietary supplement containing pure or highly concentrated caffeine were to be shared, FDA is concerned that the measuring device (if provided by the manufacturer) and warning label (if included on the product label) may be separated from the actual product being consumed, preventing consumers from accurately measuring the product and being informed of the associated risks.
Interestingly, expiration dates on packages were also mentioned as they are thought to contribute to the potential for adulteration. The guidance suggests an individual may be inclined to share a bulk product amongst a group, because a single person could not safely consume all of the product, according to the use instructions, prior to the expiration date. Again, this introduces the potential for the product to be separated from the original container, which may bear a warning label and contain a measuring device. Alternatively, FDA expressed that the expiration date and volume of a bulk product may imply that a consumer could safely consume the entire bulk product prior to the expiration date, encouraging the consumer to disregard the use instructions and warning labels.
Conclusion
Ultimately, the guidance indicates that liquid or powder dietary supplements containing pure or highly concentrated caffeine “present a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling,” if the consumer is expected to differentiate between a safe and potentially lethal serving size of the product. In such cases, the inclusion of safe-use instructions, warning labels and measuring devices are not sufficient and FDA, under the FD&C Act, would deem the product adulterated. Should you have any questions or needs related to regulatory compliance, Burdock Group is always eager to assist.
References:
21 U.S.C. 32(f)(1)(A)
U.S. Food and Drug Administration. 2018. Center for Food Safety and Applied Nutrition. Guidance for Industry: Highly Concentrated Caffeine in Dietary Supplements. Site last visited Sept. 5, 2018.