Caffeinated Dietary Supplements on the FDA High Risk Radar Screen

Dear Colleagues

Forwarding FDA news about caffeine—which can apply to caffeine derived from green tea.  Immediate concern is any bulk sales of caffeinated supplements directly to consumers that are not “pre-measured” to control dosing (including products measured with a “scoop”).

“The FDA intends to carefully review any dietary supplement products that contain potentially dangerous amounts of caffeine in any form, and the agency will continue to take action when products put consumers at risk.”

PDF of guidance is here https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM604319.pdf

Assuming that the product otherwise complies with all applicable legal requirements, we do not expect to consider the following types of dietary supplements to be adulterated:

  1. Dietary supplements sold in solid dosage forms, such as tablets or capsules that do not provide an excessive amount of caffeine per item. Products in these forms eliminate the need for a consumer to accurately measure the appropriate serving.
  2. 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. Products that are sold in pre-measured quantities eliminate the need for a consumer to measure the appropriate amount.
  3. 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.

Thankyou Debra Topham

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