In a move to crack down on the sale of pure powdered caffeine online, the US Food and Drug Administration (FDA) has issued warning letters to five companies selling the product, giving them 15 days to come up with a response or run the risk of having their caffeine products seized.
Pure caffeine, which is sold as a white powder, is extremely potent — just one teaspoon is equivalent to roughly 28 cups of coffee. A 100-gram package costs about $10, and contains as much caffeine as 1,250 Red Bulls or 3,000 cans of Coca-Cola.
The substance is widely available online. It is marketed as a dietary supplement, used as a weight loss aid, and enjoyed by bodybuilders and ravers alike, who use it to enhance their physical stamina.
The recommended dosage of pure caffeine is around 200 milligrams — about one-fourteenth of a teaspoon, which is equivalent to the amount of caffeine in two cups of coffee. But according to the FDA, the line between a safe and lethal dose of the substance is dangerously thin. Safe usage of the product requires a kind of precision that can't be achieved by basic household measurement tools like teaspoons, and going just a little over the recommended dose can push a user into the danger zone.
"These products are dangerous and present a significant or unreasonable risk of illness or injury to consumers," the FDA wrote in a statement on Tuesday. "The difference between a safe amount and a toxic dose of caffeine in these pure powdered products is very small."
For years, the product flew under the federal radar and remained relatively unregulated by the FDA until two healthy young men died from overdosing on it in 2014.
Logan Stiner, 18, from Ohio, died in May 2014 from a cardiac arrhythmia and seizure as a result of acute caffeine toxicity. His parents discovered bags of pure caffeine in his room, and filed a wrongful death suit earlier this year against the manufacturers of the substance for failing to adequately warn consumers about the health risks.
James Wade Sweatt, 24, from Georgia, had been taking the powder because he wanted to avoid the sugar and sodium contained in sodas and energy drinks. A month after Stiner died, Sweatt fell into a coma. His cause of death was ruled an overdose of caffeine.
The deaths of Stiner and Sweatt prompted consumer advocates to push for tighter oversight, and reignited the conversation around the toxicity of caffeine.
This isn't the first time that a caffeine product has fallen under close scrutiny. The Monster Beverage Corporation, which makes Monster Energy drinks, previously classified its products as "dietary supplements" and enjoyed the same exemptions from the FDA's caffeine limits in food products until it was hit with a wrongful death lawsuit in 2012.
The US imports approximately 15 million pounds of caffeine annually, mainly from China, India, and Germany, most of which is funneled into the soft drink industry. But a portion of it is packaged as a dietary supplement, in the form of pills, pure powder, or the energy shots that often sit next to cashiers in mini marts. It is also a chemical component used by pharmaceutical companies to make anti-migraine medication.
Laura MacCleery, who directs regulatory affairs at the Center for Science in the Public Interest, a Washington-based nonprofit, told VICE News that she "would prefer an outright formal ban" of pure caffeine, but that the letters sent by the FDA are a step in that direction. MacCleery described powdered caffeine as "unreasonably dangerous" and "uniquely hazardous" — more so than energy drinks and other products that contain caffeine.
Kevin Baronowsky, the CEO of Hard Eight Nutrition which does business under the name BulkSupplements.com — one of the five companies that received a warning from the FDA — said in a statement that, "In light of our recent warning letter from the FDA, Bulksupplements.com has chosen to stop selling pure caffeine powder to consumers." Baronowsky said they will, however, continue to sell caffeine powder to energy drink manufacturers.
Similarly, Jeff Stratton from Bridge City told VICE News in an email that the company is "taking this matter very seriously," and that it has "immediately stopped selling the material and on a permanent basis." Stratton also said Bridge City sold a "very minimum amount" of powdered caffeine, and "received no adverse event reports and no product complaints."
The Associated Press reported that Kreativ Health also plans to take their powdered caffeine off the market.
Pure Bulk and Smartpowders did not return requests for comment from VICE News.
Follow Tess Owen on Twitter: @misstessowen
Photo via Nina Jean/Flickr