In late August, FDA sent warning letters to five companies marketing the ingredient saying that powdered caffeine is an inherently dangerous ingredient when packaged and sold for use in a typical household setting.
Measuring danger
“The agency issued warning letters to five distributors of pure powdered caffeine because these products are dangerous and present a significant or unreasonable risk of illness or injury to consumers. The difference between a safe amount and a toxic dose of caffeine in these pure powdered products is very small. Furthermore, safe quantities of these products can be nearly impossible to measure accurately with common kitchen measuring tools,” the agency wrote.
The serving sizes for the product is extremely small, and FDA noted in the warning letters that the advice that the companies gave to consumers was unlikely to help them measure the products accurately. One company, Kreativ Health Inc., advised consumers to use a milligram scale—an unlikely appliance to have in a home kitchen—to measure out the recommended 50 mg to 200 mg daily dose. Another company that does business under the name Smartpowders stated its serving size as 200 mg and provided the additional information that a 1/4 teaspoon of the product contained 574 mg of caffeine.
“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,” FDA wrote in that warning letter.
FDA said that consumers of typical caffeinated products such as coffee and tea are very unlikely to be able to ingest a lethal dose. While they may be familiar with the nervousness and tremors that accompany a slight overdose—say after your sixth cup of coffee for the day—they are mostly unaware of caffeine’s potential lethality at high doses. Following the deaths of two young men in good health in 2014, the FDA issued a Consumer Advice alerting consumers to the dangers of pure powdered caffeine. One teaspoon of pure powdered caffeine is equivalent to the amount of caffeine in about 28 cups of regular coffee. An overdose of this magnitude can cause serious health effects, including rapid or dangerously erratic heartbeat, seizures and death. Vomiting, diarrhea, stupor and disorientation are also symptoms of caffeine toxicity.
Trade organizations concur
As they did when FDA took its first moves on powdered caffeine, most of the trade organizations in the business were supportive of the recent spate of warning letters. The Council for Responsible Nutrition and the United Natural Products Alliance both responded to requests for comment. While the American Herbal Products Association could not be contacted for comment, the organization in the past has joined CRN and UNPA in instituting policies than ban or discourage the retail sale of powdered caffeine among their members.
“We have been, and continue to be, supportive of FDA’s efforts in this area to educate consumers about the potential dangers of pure powdered caffeine. We share the agency’s concerns about the safety of this product being sold directly to consumers. 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,” said Rend Al-Mondhiry, CRN’s regulatory counsel.
“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. "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 (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."
Legal ingredient
The Natural Product Association has, alone among the dietary supplement trade organizations, taken a stance of questioning the assumptions that underlie FDA’s stance on powdered caffeine. Daniel Fabricant, PhD, NPA’s executive director and CEO, said that caffeine is a legal dietary ingredient with a long history of safe use. From his point of view, FDA is trending over into rule making by decree, without basing its decision on a firm underpinning of evidence.
“The issue I take umbrage with is the agency’s assumption that people don’t have access to a 1/16 teaspoon measure or can’t weigh the dosage out accurately. Where is the data to support that assumption? The science has to matter. What they are presenting here is not based even on consumer studies,” Fabricant told NutraIngredients-USA.
“This is supposed to be a science-based agency. They have just assumed that people are incapable of measuring these things out. You can buy a 1/16 teaspoon measure and you can buy a 1/32 teaspoon measure. I don’t think it’s as hard as they are trying to make it out. This is clearly something that is extra statutory and is a bit of a slippery slope,” he said.
While two young men did die after using powdered caffeine, Fabricant said their unfortunate ends came as a result of using more of the product than the labels recommended. This points to another issue he has with the agency, namely its fuzzy position on caffeine in general. In the past in response to being pushed on the question of caffeine by Sen. Dick Durbin, D-IL and others, the agency has made a general statement that a dosage of 400 mg/day for an average adult is generally considered safe. The agency has not issued a more formal policy on the ingredient.
“If there is a level at which FDA feels caffeine is unsafe, they should specify that level. They should do a study and set a level. That’s how policy should be implemented,” he said.
Warning letters
FDA sent warning letters to the following five companies: