The US Food and Drug Administration (FDA) has issued guidance declaring that dietary supplements containing pure or highly concentrated caffeine, in powder or liquid forms, are unlawful when sold in bulk quantities directly to consumers. The agency notes that it is prepared to take immediate steps to begin removing such “dangerous bulk products.”
Products containing highly concentrated or pure caffeine are increasingly being marketed directly to consumers as dietary supplements and sold in bulk quantities, with up to thousands of recommended servings per container, the agency notes.
Linked to at least two deaths in otherwise healthy US individuals, highly concentrated and pure caffeine products “present a significant public health threat because of the high risk that they will be erroneously used at excessive, potentially dangerous doses,” adds the agency.
Importantly, the bulk quantities and concentrated forms of these products make it far too easy for consumers to ingest “deceptively high” amounts of caffeine, as they may not have the correct measuring tools or knowledge to ensure the use of safe amounts.
The FDA's announcement notes that a half cup of a highly concentrated liquid caffeine can contain approximately 2,000mg of caffeine and just a single teaspoon of a powdered pure caffeine product can contain approximately 3,200mg of caffeine.
In light of these figures, the recommended safe serving of highly concentrated or pure caffeine products is often 200mg of caffeine, which equates to 1/16 of a teaspoon of pure powder or approximately 2.5 teaspoons of a liquid. These differing amounts can make it difficult for consumers to limit consumption to safe limits.
Caffeine can be utilized in dietary supplements when formulated and marketed appropriately. In the FDA guidance, the agency outlines ways to formulate and market dietary supplements containing caffeine in a manner that make it unlikely for the FDA to consider the product adulterated. These steps include:
Dietary supplements sold in solid dosage forms, such as tablets or capsules, should not have an excessive amount of caffeine, and therefore will 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, should have each premeasured unit containing an adequate amount of caffeine, therefore eliminating 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 must be at levels so that, in the event of a measurement error, a misreading of the directions, or misunderstanding about the nature of the product, would not lead to toxic or life-threatening symptoms.
Moreover, this guidance does not affect other types of products that might also contain caffeine, such as prescription or over-the-counter drugs or conventional foods, like traditionally caffeinated beverages.
Innova Market Insights has noted that caffeine is the leading ingredient among 2017 product launches featuring energy claims. Its use is especially prevalent in sport nutrition products.
A number of US trade and lobby groups have voiced their support for the curbing of high caffeine products.
The American Herbal Products Association (AHPA) expressed support for the FDA's efforts to prevent consumers from purchasing pure caffeine in bulk, with AHPA President Michael McGuffin noting that the association’s members have also adopted a comprehensive labeling policy to help the industry promote the responsible use of products that contain caffeine.
Meanwhile, the Council for Responsible Nutrition applauded the FDA’s guidance, “Today’s announcement from FDA puts all dietary supplement stakeholders, including online retailers, on notice that highly concentrated caffeine sold in bulk to consumers is dangerous and illegal,” notes Steve Mister, President & CEO, CRN.
“Caffeine is one of the most studied dietary ingredients and well-established science demonstrates safe use of caffeine. Consumers have access to a whole host of dietary supplements and other over-the-counter products that are manufactured with safe amounts of caffeine,” he adds.
“This action will save lives and remove a serious hazard for consumers. The policy follows the tragic deaths in 2014 of two young men — Logan Stiner and James Wade Sweatt — who died in separate incidents one month apart following unintentional overdoses of highly concentrated caffeine products,” notes Laura MacCleery, Policy Director at the Center for Science in the Public Interest. “Anyone selling these supplements online should now be on notice that the products are illegal if they are highly concentrated.”