CSPI posted a letter it sent yesterday to FDA in which it makes the demand for the immediate ban of retail sales of powdered and liquid caffeine, as well as inhalable forms, which the organization said are also now available. The warning letters that FDA sent in September of 2015 served only to restrain the activities of the five companies specifically addressed, CPSI asserts. This is the second time CSPI has asked for such a ban, the first being in 2014.
“FDA’s actions thus far are sorely inadequate to address consumer safety and prevent future deaths or other serious harm from highly concentrated (and inadequately labeled) forms of caffeine,” the letter says.
Laura MacCleery, director of regulatory affairs for CSPI, said the letter was timed to see what happened after FDA sent the warning letters.
“We initially sent them a letter last fall to say that they had missed a few sellers when they sent the warning letters. Then we waited to see if new sellers came online to take up the business and our investigation found a lot of them had,” MacCleery told NutraIngredients-USA.
No dispute about safety concerns
When FDA sent those five letters, it had this to say: “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 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 that received a warning letter, 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. Neither company still offer powdered caffeine products for sale.
Labeling confusion persists
Those problems still persist, CSPI asserts, and if anything have gotten worse. In general the labeling on the packages of the 15 high potency caffeine products that CSPI was able go find for sale with a basic Internet search do almost nothing to help consumers use the products safely. One product, for example, simply admonished consumers to use it “sparingly.” According to CSPI’s letter another highly concentrated liquid caffeine product from South Korea “has no serving size information on the label whatsoever except to drop some ‘amout’ [sic] and not to ‘overuse it.’ ”
The issue with serving size is that an overdose can be not just unpleasant but lethal. At least three men in the US have died from caffeine overdose attributed to the high potency products. Just a teaspoon of the pure powdered caffeine contains as much caffeine as in 28 cups of coffee, the letter noted.
Pure powdered caffeine and other high potency caffeine products have been for sale for years as food additives for use in beverages and caffeine fortified foods. The sale of these directly to consumers is a relatively recent phenomenon, starting first in about 2006, MacCleery said. Most of the trade organizations representing the dietary supplement industry in the US have banned the sale of powdered caffeine among their members, concurring with CSPI’s and FDA’s position that the ingredient is too difficult for consumers to safely handle. The lone exception was the Natural Products Association which holds high potency caffeine to be a legal ingredient. CEO Dan Fabricant took the position that FDA was making an assumption that consumers were incapable of properly measuring dosages of the pure caffeine products without consumer research to back that up.
In any event, MacCleery has said the time has come for comprehensive action to address a clear public safety concern.
“This is still a niche product, thank goodness, or there would have been more bodies,” MacCleery said. “We think there has been a general ramp up in recent years in dietary supplement ingredients offered for sale directly to consumers, and the caffeine products are part of that. It is unbelievable to us that the agency has not already instituted a ban. It has the authority to do so.”
Loren Israelsen, president of the United Natural Products Alliance, said his organization supports the renewed call to FDA to remove bulk powdered caffeine (BPC) from the marketplace.
"This issue is important enough that UNPA issued a ’no-sale’ trade policy as a condition of membership in February 2015—the first trade association in the natural health products market to do so—as part of its efforts to support safety, science and quality," he said.
“It is important to note that in the form marketed, BPC is clearly a drug mislabeled as a dietary supplement. As such, its sale is both inappropriate and illegal. We join others in seeking the removal of BPC from the market.
“As UNPA said when we issued the no-sale policy, under the Dietary Supplement Health and Education Act of 1994, FDA has the authority to remove from the market BPC, mislabeled as a dietary supplement, per the ‘significant or unreasonable risk of illness or injury’ provision. FDA exercised this same authority in 2004 to remove ephedra (Ephedra sinica) from the market. This fact is noted in a petition from CSPI to FDA dated Dec. 9, 2014, and UNPA agrees that FDA can and should exercise this same authority with respect to BPC.”