In 2014, the Center for Science in the Public Interest (CSPI) filed a Citizen Petition requesting that FDA ban the retail distribution of highly concentrated caffeine marketed as a dietary supplement and specify limits on the forms in which caffeine may be sold. On April 16, 2018, on the same day that FDA issued guidance regarding highly concentrated caffeine in dietary supplements, FDA denied the petition.
FDA denied the Petition because, as explained in the denial, the Agency does not think that the requested actions (involving rulemaking) are necessary. It points to the guidance and “publication of information directed toward industry and consumers, through which [FDA] communicated about the legal status of” highly concentrated caffeine products.
In the guidance, FDA explained that it generally considers products containing potentially lethal amounts of pure or highly concentrated caffeine in powder or liquid form sold in bulk to be adulterated under FDC Act § 402(f)(1)(A). As discussed in the guidance, FDA’s concern relates to the difficulty of separating out a safe amount (serving) of caffeine. FDA has taken the position that labeling the product with instructions at to a safe serving size and warning statements do not mitigate the risk; notwithstanding the provision of a warning, directions, and dosing cups or other tools, the highly concentrated bulk caffeine product continues to present a significant or unreasonable risk of illness or injury.
The guidance also provides some examples of caffeine products that, according to FDA, do not present a significant or unreasonable risk of illness or injury. Assuming that the product otherwise complies with all applicable legal requirements, FDA likely will not consider caffeine supplement in solid dosage form or premeasured packets or containers that do not provide an excessive amount (not defined) of caffeine per dosage form adulterated. Even though such products may be highly concentrated, the dosage form eliminates the need to measure the serving and thus avoids the risk of inaccurate dosing. To avoid an adulteration charge for bulk powdered or liquid caffeine product, the caffeine concentration must be low so that a serving error or misunderstanding about dosing would not normally be expected to lead to a toxic/life threatening situation.
In the Federal Register notice, FDA justified issuing the guidance as final guidance; according to the Agency, the threat to public health posed by pure and highly concentrated caffeine products made prior public participation not feasible.
It is reasonable to expect that the Guidance will have the effect of discouraging the marketing of highly concentrated caffeine products sold in bulk form. Thus, it appears that even though FDA denied the Petition, CSPI effectively got what it requested and the Agency avoided having to go through notice and comment rulemaking.