INSIDER Law
FDA Issues Warning Letters on Powdered Caffeine

FDA Issues Warning Letters on Powdered Caffeine

Laura MacCleery, regulatory affairs director with the Center for Science in the Public Interest (CSPI), said the warning letters fell short of an outright ban on powdered caffeine.

FDA on Tuesday announced issuing warning letters to five marketers of powdered bulk caffeine, citing the nominal difference between a safe amount and toxic dose. It is virtually impossible to accurately measure a safe amount of powdered bulk caffeine with common kitchen measuring tools, such as a teaspoon, FDA cautioned in its constituent update.

Just 1 teaspoon of pure powdered caffeine roughly corresponds to 28 cups of coffee, according to the agency’s Aug. 27 warning letters. Erratic heartbeat, a seizure and death are among the serious health effects of powdered caffeine, FDA noted in the constituent update.

The agency previously advised consumers to avoid pure powdered caffeine after two young men who consumed the substance died.

Reaction to FDA Action

Laura MacCleery, regulatory affairs director with the Center for Science in the Public Interest (CSPI), said the warning letters fell short of an outright ban on powdered caffeine. Her employer petitioned FDA to ban pure powdered caffeine.

“Pure caffeine never should have been sold to consumers," MacCleery said in a statement. “A teaspoon is a fatal dose for a child, and two teaspoons would kill most adults. FDA has clear authority to ban such a hazardous product and should do so."

Daniel Fabricant, Ph.D., executive director and CEO of the Natural Products Association (NPA), said pure powdered caffeine is a legal dietary ingredient.

“I am unfamiliar with empirical evidence at FDA or elsewhere that would suggest that people would substitute directed conditions of use (i.e., greater than 1/16th of a teaspoon) due to measuring devices that weren’t consistent with the labeling," Fabricant advised FDA officials Tuesday in an email. “Furthermore, the ability to weigh out 1/16th and 1/32nd of a teaspoon is commonplace in conventional culinary arts as explained by" online references that Fabricant provided the officials.

In a phone interview Tuesday, Fabricant expressed concerns that FDA’s reasoning in the warning letters could have broader implications.

“They are saying people can’t be trusted to measure things out" without the studies or data to support that idea, said Fabricant, who previously led FDA’s Division of Dietary Supplement Programs. “If they can use that argument here, they can certainly use that on other products that contain caffeine and are used safely by millions of Americans every day."

If a person takes one-sixteenth of a teaspoon of powdered caffeine, the amount is “well under anything that any scientific body has said is harmful," Fabricant added.

Others in the industry—including the American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN) and United Natural Products Alliance (UNPA)—have adopted policies and guidelines that discouraged the sales of powdered caffeine to consumers by their members.

“Our guidelines do not limit marketing or sales of pure powdered caffeine in bulk form as part of a business-to-business transaction, but we have advised that our companies—and we hope the industry will follow suit—should not sell or market pure powdered caffeine in bulk form directly to consumers," said Rend Al-Mondhiry, regulatory counsel for CRN, in a statement Tuesday. “We hope the companies receiving the warning letters will take these concerns seriously, and if not, we look to FDA to take the next steps under the law."

Some legal experts told Natural Products INSIDER that a ban on powdered caffeine would face regulatory hurdles but is still possible.

“UNPA is in full support of the action taken today by FDA to remove bulk powdered caffeine (BPC) products from retail sales to protect consumer health," said Loren Israelsen, president of UNPA, in a statement Tuesday. “As indicated by the action taken by the agency, UNPA believes that FDA has the authority to remove BPC from the market under the Dietary Supplement Health and Education Act of 1994 (DSHEA), per the ‘significant or unreasonable risk of illness or injury' provision, which was exercised in 2004 by FDA to remove ephedra from the market."

Powdered caffeine also has garnered attention on Capitol Hill where Sens. Richard Blumenthal (D-Connecticut) and Sherrod Brown (D-Ohio) pressed FDA last year to ban the substance.

“I continue to urge FDA to move forward with a ban on its retail sale to once and for all stop this product from killing consumers," Blumenthal said Tuesday in a statement. “Powdered caffeine is a threat to public health—putting users in extreme peril—and we cannot afford to lose any more lives as the result of deceptive labeling and marketing of the dangerous product. I am glad the FDA heeded our call and has begun the process of protecting consumers against the significant risk posed by powdered caffeine."

Marianna Naum, an FDA spokeswoman, said the agency will “continue to aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate."

“If violations exist, the FDA can pursue enforcement action, such as seizure of the product or an injunction to prevent the firm from continuing to manufacture or market the product," Naum said in a statement.

Warning Letters

In the warning letters, FDA declared the products posed a “significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling." The quoted language comes from DSHEA.

FDA issued the letters to SPN LLC (dba Smartpowders), Purebulk Inc., Kreativ Health Inc. (dba Natural Food Supplements), Hard Eight Nutrition LLC and Bridge City LLC.

A representative of Pure Bulk said in an email that the company was preparing a response.

Bridge City's Jeffrey Stratton said the company is "taking this matter very seriously." He also noted Bridge City responded to FDA's warning letter and has stopped selling the caffeine powder.

"We have received no adverse event reports and no product complaints at anytime, ever," he said in an emailed statement.

None of other three companies immediately responded to requests for comment.

FDA described labels that it said could be interpreted differently. For instance, while Smartpowders’ label recommends a serving size of 200 mg, the label also notes that a quarter of a teaspoon is 574 mg, far in excess of the recommended serving size, according to the warning letter. Smartpowders’ Caffeine Anhydrous 400 Grams product contains 2,000 recommended servings of the product, or approximately 49 teaspoons of powdered caffeine, the letter noted. 

“Although your product’s serving size is listed as 200 milligrams, it is possible that a consumer would understand your label as a whole as suggesting a serving size of one-quarter teaspoon," FDA said.

“Furthermore, to the extent that your label suggests a serving size of 200 milligrams and the information regarding a one-quarter teaspoon is meant to help the consumer accurately administer a serving of 200 milligrams, these suggested conditions of use present a significant or unreasonable risk of illness or injury," FDA continued in the letter. “Your product label appears to suggest that consumers can use a one-quarter teaspoon to measure a serving of 200 milligrams. While consumers are likely to have a one-quarter teaspoon measuring tool, a 200-milligram dose would be 34.8% of a one-quarter teaspoon, based on the information on your label. This amount cannot be accurately measured using a one-quarter teaspoon measuring tool."

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