FDA Issues New Guidance On Mega-Dose Caffeine Products

On Friday morning, the U.S. Food and Drug Administration, or FDA, announced the release of new guidance for “supplements” that are made with either very high levels of caffeine or with pure caffeine. In recent years, such products have been blamed for the deaths of at least two otherwise healthy people.

The new guidelines will go into effect immediately and cover 2 types of supplements:

  • Powdered Dietary Supplements Containing Highly Concentrated Caffeine
  • Liquid Dietary Supplements Containing Highly Concentrated Caffeine

The liquid products are the newest on the market and the agency’s fear seems mainly to focus preventing on accidental overdoses–as might happen if a child were to swallow a mouthful or if a user were to use too much at a time. Given how concentrated these liquids are, either of those scenarios seems likely to happen if the products are allowed to remain on the market. (Lisa’s Note: no bottled liquid caffeine product we looked at for this article had a child-resistant cap.)

FDA innues guidance for concentrated caffeine supplements.

An example of a liquid concentrated caffeine product. This one comes in a 16-ounce bottle and holds the caffeine equivalent of around 100 cups of coffee.

Instead, the agency is recommending that manufacturers package liquid caffeine in individual packets or sell products in such high dilutions that accidental overdoses are unlikely.

Powdered  caffeine products have a bit more history behind them and FDA already has a growing library of official warning letters it has sent to companies that offer them. In August of 2015 the agency went on a letter sending spree and formally warned 5 sellers:

  • SPN, LLC dba Smartpowders
  • Purebulk, Inc.
  • Kreativ Health Inc. dba Natural Food Supplements
  • Hard Eight Nutrition, LLC
  • Bridge City Bulk
Official warnings sent to powdered caffeine websites.

Formal warning letters sent to sellers of “adulterated” powdered caffeine products in 2015.

In each case, the caffeine powders in questioned were deemed by FDA to be “adulterated” and to “present a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling”. In some cases, the correct “doses” were so small the average consumer simply could not accurately measure them out.

In Friday’s announcement, FDA recommends that powdered caffeine be packaged in capsules or single-serve packets in doses that contain safer levels of caffeine. Bulk powders should be “cut” with ingredients to a point at which the chances of an accidental overdose is reduced.



Photo by Arshad Pooloo on Unsplash

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