Industry Applauds FDA’s Action Against Highly Concentrated Caffeine

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Washington, D.C. – Industry leaders are reacting positively to the Food and Drug Administration’s (FDA) recently published guidance about the dangers of selling bulk powdered caffeine (BPC) products.  This comes after at least two confirmed deaths and an unknown number of medical events have been attributed to the consumption of BPC sold through retail venues, according to the FDA.

In a statement issued Friday, the FDA said some dietary supplements that consist of only caffeine, or primarily pure or highly concentrated caffeine, could be adulterated. The guidance is directed to firms that manufacture, market, or distribute dietary supplement products that contain pure or highly concentrated caffeine, or are considering doing so.

The agency fears that these products – which continue to be sold to consumers in bulk quantities –  are being used in potentially dangerous ways.  Says Scott Gottlieb, M.D., FDA commissioner, in a press release issued by the agency:  “For example, teenagers, for a perceived energy kick, sometimes mix dangerously high amounts of super-concentrated caffeine into workout cocktails. The amounts used can too easily become deceptively high because of the super-concentrated forms and bulk packaging in which the caffeine is being sold.

“We’re making clear for [the] industry that these highly concentrated forms of caffeine that are being sold in bulk packages are generally illegal under current law,” Gottlieb adds. “We’ll act to remove these dangerous bulk products from the market.”

The United Natural Products Alliance (UNPA) commended the FDA’s announcement as an important step for public health and safety, and will seek to expand its current no-sale policy of BPC to include liquid, high-dose caffeine products.  The association first announced a ‘no-sale’ policy for bulk-powdered caffeine as a condition of membership in 2015.  At that time, UNPA encouraged all other members of the dietary supplement industry to take similar steps to remove bulk-powdered caffeine from the retail marketplace and recommended that BPC not be advertised, sold or marketed as a dietary supplement for retail sale or exhibited at trade shows until a final determination is reached by FDA as to the safety and suitable labeling of such products.

According to Loren Israelsen, president, UNPA, “This new guidance is a logical next step to FDA’s prior efforts to inform consumers about the health risks associated with the consumption of high-dose caffeine products.

“Therefore, in response to [Friday’s] guidance, UNPA will present to its executive committee early next week a proposal seeking to expand our current no-sale policy of BPC to include liquid, high-dose caffeine products and to include an endorsement of FDA’s April 2018 guidance on this issue,” Israelsen concluded.

The CRN also applauded the FDA’s announcement.  Steve Mister, president & CEO of CRN, said in a press release: “Extremely concentrated or pure caffeine has no place in the consumer marketplace, and CRN fully supports FDA’s commitment to taking immediate steps to remove products from the marketplace that present public health concerns. 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. 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.”

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