The Food and Drug Administration has sent enforcement letters to five dietary supplement companies that sell pure powdered caffeine. Many people use pure powdered caffeine as an alternative to coffee and energy drinks.
In the enforcement letters, the FDA said the dietary supplement companies are in violation of federal law because the way their powdered caffeine is marketed and labeled poses an unnecessary risk of injury to consumers. The suggested serving size of pure powdered caffeine is one-sixteenth of a teaspoon, and the FDA said that is too small of a dose to measure accurately.
The enforcement letters were sent on Aug. 27, and the companies have fifteen business days to respond. They have to stop selling powdered caffeine as it’s currently marketed and labeled and if they don’t the FDA can seize the product.
PureBulk.com was one of the companies the FDA sent an enforcement letter to. The company did not respond to comment for this story. The company currently lists pure powdered caffeine as “out of stock”, but, as of July, the product was available.
Before purchasing the powdered caffeine, customers had to check off a warning box saying they understood the product could be life threatening. Without shipping, the cost for a 50 gram bag of powdered caffeine is $2.75.
Dr. William Lawson, a cardiologist at Stony Brook University Medical Center for more than thirty years, received a warning from the FDA last summer, after two men from Ohio and Alabama fatally overdosed from powdered caffeine.
“Basically saying there were two deaths noted and concerns about it being an available drug that was cheap and increasingly used,” Lawson said.
With a recommended serving size of one-sixteenth of a teaspoon, Lawson said that it can take only three teaspoons to fatally overdose and that people could have a heart attack after just one teaspoon. He said it would be impossible to ingest that amount of caffeine from coffee alone.
“You’re going to have to try 32 cups of coffee…that’s a lot, lot of, lot of coffee,” Lawson said. “Most of us couldn’t get that down if we tried.”
Lawson said to measure pure powdered caffeine appropriately, you need a digital scale that can measure down to the milligram. Those types of scales are sold on Pure Bulk, and they had instructional videos on how to use them.
Lawson said digital scales that can measure that small aren’t typical and drug dealers are likely to be the type of people to own them.
“They do sell them, they’re available online, they’re not very expensive,” Lawson said. “But just wait when your apartment gets searched, they’re going to wonder why you have a digital scale, particularly if there’s a white powder on it.”
A movement has been growing to ban pure powdered caffeine after the two men from Ohio and Alabama overdosed from it. Ohio and Illinois have passed statewide laws limiting the sale of powdered caffeine and Suffolk County on Long Island was the first in the country to ban its sale to minors back in October.
Legislator William Spencer (D-Centerport) co-sponsored the bill that led to the ban.
“I felt that this was something that represented an imminent public health threat and as a public servant we needed to take action,” Spencer said.
After the local bill in Suffolk passed, Spencer was invited to Washington by a group of activists to help petition the FDA for an outright federal ban. Suffolk County Executive Steve Bellone said the fact the county took action can set an example for federal regulators.
“I think Suffolk County has a long history of producing legislation that turns out to be a model either state wide or nationally for important issues,” Bellone said.
Among other things, Suffolk County was the first to limit the sale of energy drinks to kids under eighteen.
In 2003, Suffolk County was also the first in the country to ban the sale of ephedra, the weight loss and energy herbal supplement that was linked to many hearts attacks, strokes and deaths. A year later, ephedra was banned nationwide. It’s the only dietary supplement the FDA has ever banned.
Sen. Chuck Schumer (D-NY) is one of six members of Congress calling on the FDA to ban pure powdered caffeine.
“The FDA can’t ban a substance until they find out [the substance is] dangerous,” Schumer said. “It’s out there creating trouble and then they can ban it. They can’t ban it ahead of time.”
More than 150 deaths were linked to ephedra before it was banned. Those deaths included some famous athletes, including Baltimore Orioles pitcher Steve Bechler. The FDA started warning users to stay away from ephedra in 1997.
Laura MacCleery is an attorney with the Center for Science and the Public Interest, a non-profit that advocates for safer and healthier foods.
“I think the number of deaths was significant. I also think the deaths of some very high profile athletes caused intense public attention to the issue that was sadly what was needed to really get the agency to act,” she said.
MacCleery has been petitioning the FDA to ban pure powdered caffeine for more than a year. She said the enforcement letters the FDA sent are just short of a ban and are very serious.
MaCleery said the companies could respond to the FDA’s letters by reducing the potency of the powdered caffeine, or by packaging it with special measuring spoons. According to the FDA, the smallest common measuring spoons are a quarter of a teaspoon, which is four times bigger than the serving size of powdered caffeine.
MacCleery said two of the five companies have already agreed to stop selling powdered caffeine altogether.
Dr. Daniel Fabricant, CEO of the Natural Products Association, said he doesn’t agree with the FDAs claims against the powdered caffeine companies.
“We certainly respect the FDA’s response and opinions and we understand the concerns surrounding pure powdered caffeine,” Fabricant said. “I think the agency is missing its target claiming the product is dangerous because it can’t be measured. They’re not actually claiming the product is dangerous.”
Fabricant said consumers shouldn’t have a problem measuring out one-sixteenth of a teaspoon, regardless of how small it is. And the fact that two men overdosed isn’t enough evidence that powdered caffeine is unsafe to use.
“It’s a tragic reminder of an iron clad rule when it comes to these issues, which is to always read labels carefully on anything you put in your body and always consult a doctor or your health care provider when using any over-the-counter medicine or dietary supplement,” he said.
Lawson said he wouldn’t recommend powdered caffeine to any of his patients, regardless of why they wanted to use it.
“It’s too easy to abuse and make a mistake,” Lawson said. “Have a cup of coffee. Have a cup of Joe.”
Earlier this year, the FDA sent warnings to consumers about pure powdered caffeine saying they were concerned users couldn’t accurately measure a safe serving size and they should stay away from it.