- On August 5, 2026, FDA posted a Citizen Petition from The Food Foundations Project requesting that the Agency initiate rulemaking to require caffeine disclosures on caffeine-containing dietary supplements. The Petition defines “caffeine-containing dietary supplement” as “a product labeled as a dietary supplement in which caffeine is present in the finished product, whether added directly or contributed by caffeine anhydrous, a botanical, a botanical extract, a proprietary blend, or another ingredient.”
- The Petition proposes a new section in FDA’s dietary supplement labeling regulations at 21 CFR 101.36 to require:
- Disclosure of the total caffeine per serving, reflecting the aggregate caffeine in the finished product from every source, including directly added caffeine, caffeine anhydrous, botanicals, botanical extracts, proprietary blends, and other caffeine-contributing ingredients;
- Disclosure of the total caffeine per container for a single-use container when the unrounded caffeine amount meets or exceeds the final reportable threshold. This requirement is intended to cover single serving units, packages with directions that contemplate consuming the entire contents at one time, small-format shots, and comparable one-dose products, rather than every large multi-use bottle or tub; and
- Supporting records to substantiate the caffeine declaration.
- The Petition includes a fallback request for FDA to adopt a narrower rule requiring declaration of caffeine from non-proprietary sources if the Agency determines it does not have the authority to require an aggregate declaration including proprietary sources. In addition, the Petition requests that FDA publish a request for information concerning caffeine amounts and sources and conduct or commission research related to caffeine testing, formulation, consumer understanding, reportable thresholds, and labeling.
- Finally, the Petition asks FDA to issue guidance recommending caffeine disclosures if the Agency does not initiate rulemaking. According to the Petition, the guidance should include an explanation of approaches for calculations and sampling and announce an enforcement policy “concerning materially misleading voluntary caffeine representations.”
- The Petition explains that supplement labels currently do not always state the total caffeine dose or explain caffeine sources, which may increase the risk profile of caffeine-containing dietary supplements. The proposed caffeine disclosure is intended to provide consumers with information to help judge the amount of caffeine they consume in a day.
- Keller and Heckman will continue to monitor updates related to food and dietary supplement labeling.
