Dietary supplements that present a significant or unreasonable risk (21 CFR 119.1).

Part 119 of Title 21 of the Federal Code of Regulations provides for rules and provisions concerning the labelling of dietary supplements that present a significant or unreasonable risk to the human health.
This Regulation defines that all dietary supplements containing ephedrine alkaloids are to be considered as unreasonably/risky for human health (if not properly labelled and marked).