FDA issued guidance titled, "Highly Concentrated Caffeine in Dietary Supplements: Guidance for Industry," to explain that it generally considers pure or highly concentrated caffeine dietary supplements, sold in bulk directly to consumers, to be adulterated because they present a significant or unreasonable risk of illness or injury.
FDA stated "We are issuing this guidance without prior public comment because we have determined that prior public participation is not feasible or appropriate in light of the threat to the public health that is posed by pure and highly concentrated caffeine products, which have been linked to several deaths in recent years.
The principle in this guidance is consistent with a policy adopted by AHPA members in 2015.
AHPA President Michael McGuffin expressed support for FDA's efforts to prevent consumers from purchasing pure caffeine in bulk.
"Consumer safety is a top concern for AHPA members and that's why the association adopted a policy in 2015 that prohibits the sale of pure caffeine to consumers," said AHPA President Michael McGuffin. "The regulated supplement industry appreciates the FDA's recent action on this issue which AHPA believes is very much in the public interest."
AHPA members have also adopted a comprehensive labeling policy to help the industry promote the responsible use of products that contain caffeine.
"Caffeine can be an ingredient in a dietary supplement that does not present a significant or unreasonable risk of illness or injury," FDA's guidance states.
The guidance outlines ways to formulate and market dietary supplements containing caffeine in a manner that make it unlikely for FDA to consider the product adulterated, including:
- Dietary supplements sold in solid dosage forms, such as tablets or capsules that do not provide an excessive amount of caffeine per item eliminate the need for a consumer to accurately measure the appropriate serving.
- Dietary supplements containing powdered or liquid caffeine (either diluted or undiluted) that are sold in premeasured packets or containers, with each premeasured unit containing an amount of caffeine that is not excessive eliminate the need for a consumer to measure the appropriate amount.
- Bulk powdered or liquid caffeine dietary supplement products that have been significantly diluted to low enough concentrations of caffeine, such that a reasonably foreseeable measurement error, misreading of the directions, or misunderstanding about the nature of the product would not normally be expected to lead to toxic or life-threatening symptoms.
"All dietary supplements are required to comply with the adulteration provisions of the FD&C Act, and we intend to carefully review any dietary supplement products that contain potentially dangerous amounts of caffeine in any form," the FDA guidance states.
FDA's announcement notes that a half cup of a highly concentrated liquid caffeine can contain approximately 2,000 mg of caffeine and just a single teaspoon of a powdered pure caffeine product can contain approximately 3,200 mg of caffeine.
The recommended safe serving of highly concentrated or pure caffeine products is often 200 mg of caffeine, which equates to 1/16 of a teaspoon of pure powder or approximately 2.5 teaspoons of a liquid and makes it difficult for consumers to limit consumption to safe limits.