"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.

The Council for Responsible Nutrition and the American Herbal Products Association amend guidelines and requirements for labeling and marketing caffeine-containing products, going beyond the law in response to congressional and public health complaints about the ingredient’s safety.

The nine drug manufacturers with products selected for Medicare drug price negotiations have agreed to participate in the program. Seven of them now have pending suits challenging the Inflation Reduction Act program with Novo’s recent complaint, which objects to the aggregation of its insulin products.