In a petition sent on Dec. 9 to the Food and Drug Administration (FDA) and the Depart of Health and Human Services, CSPI asked the agencies to ban the sale of the widely available powdered caffeine products. In addition, the petition urges the federal agencies to specify limits on the form in which caffeine is sold, including its labeling, serving sizes, and potency.
Highly concentrated, unfamiliar source
“The level of concentration in these products poses a severe health risk,” Laura MacCleery, CSPI’s chief regulatory affairs attorney told NutraIngredients-USA. “You would need a microgram scale to measure an appropriate dose. Consumers expect that something that is sold to them in a manner that is familiar to them will be like other products. For these other things that are sold in bulk, (such as protein powders or pre workout products) the consumer is used to taking a big scoop or two of them. The serving size for the powdered caffeine products is typically 1/16 of a teaspoon.”
The caffeine powders are available from a number of sources. Bulksupplements.com, for example, offers powdered caffeine in containers ranging from 100 grams up to 1 kilogram. In the information on its website, the web portal says, “the suggested serving size of Caffeine powder is anywhere from 50mg (1/64 teaspoon) to 200mg (1/16th teaspoon) per day, adding up to a total of no more than 600mg per day depending on intended effect.”
Familiar sources, familiar doses
“Most consumers know how a cup of coffee will affect them,” MacCleery said. “The powdered caffeine is a big difference from a form that is familiar and is easier to use and hard to overuse. NoDoz, for example, is an over the counter drug. I’m not familiar with any unintentional overdoses with NoDoz,” she said.
NoDoz is sold in caplets that provide 200 mg of caffeine each. According to the Mayo Clinic, an 8 oz. cup of brewed coffee can contain from 80 mg up to 200 mg of caffeine. The generally recognized safe limit for caffeine consumption is set at 400 mg/day for a typical adult. According to the petition, “just one teaspoon of powder caffeine, which amounts to approximately 3 grams, is equivalent to drinking 25 cups of coffee.”
“The two deaths that we know about happened from unintentional overdoses. It’s a combination of the extreme concentration that makes it hard to measure and the lethality of high doses of caffeine. I have a 250 gram container of caffeine on my desk. The label says it has 1,250 servings. There is enough caffeine inside to kill 50 people,” she said.
The petition concludes with this statement: “Because pure or highly concentrated caffeine has only recently become widely available to consumers, the full extent of its dangers have yet to be discovered. FDA has the opportunity to get in front of a problem that has the potential to grow exponentially, and to address its risks before they can be fully realized. FDA should act now to ban direct sales of caffeine powder because even when used as directed, it presents an unreasonable risk to consumers, and the benefits it provides are easily obtained from other, safer sources.”
MacCleery said that it is possible that FDA could move quickly on the petition. "FDA has a history of taking quick action on things that pose an imminent health risk. An analogy would be how quickly the agency moved on the combination of caffeine and alcohol," she said.
Controlling the dose
Anthony Almada, MSc managing director of Fein Innovations, LLC, concurred with CSPI’s take on the risk posed by the caffeine powders. His company markets a product called Fein (pronounced “feen”) that is packaged in individual stick packs that combine a 75 mg dose of caffeine with vitamin C and other ingredients that are intended to mask caffeine’s typical intensely bitter flavor. The choice of stick packs was driven both by marketing and safety considerations, Almada said.
“It’s important to have a controlled dose for anything that is potentially hazardous or lethal,” Almada said. “The understanding of caffeine pharmacology on the part of the consumer is anemic or sophomoric at best.
“And where would you find a scoop that would accurately measure 1/16 of a teaspoon? Even if you could find one, these products usually don’t contain scoops because they are offered in ultra-cheap packaging,” he said.
Almada also said that aligning a product’s concentration and form with consumer expectations is an important safety consideration. He drew an analogy from the world of alcoholic beverages.
“Why do you think everclear is usually not for sale? That is 95% alcohol—almost pure ethanol. The alcohol that consumers are familiar with, even ‘hard’ liquor, is highly diluted. With pure ethanol the potential for a lethal overdose is significant,” he said.
Read the full text of the petition here.