FDA Guidance Stirs In Caffeine Restrictions For Supplements

"An inherent feature of the conditions of use for such products is that the consumer must separate out a very small, precise serving from a potentially lethal amount of product – a task that poses a significant or unreasonable risk of illness or injury," says FDA's Office of Dietary Supplement Programs. Only products containing pure caffeine that packaged in the ingredient in premeasured doses and bulk caffeine that is sufficiently diluted will be considered compliant.

Bulk caffeine marketed as dietary supplements is so dangerous that no label warning on dosing will make the products compliant with FDA regulations, the agency says in a guidance.

"An inherent feature of the conditions of use for such products is that the consumer must separate out a very...

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