Another powdered caffeine warning letter issued, highlighting FDA’s plight in combing through flood of imports

06-Apr-2021 - Last updated on 08-Apr-2021 at 16:03 GMT

©Getty Images - Alena Zharava

A warning letter sent to a Connecticut wholesaler about the sale of pure powdered caffeine points to the difficulty of keeping problematic products off the market in an environment in which hundreds of thousands of tons of cargo arrives in domestic ports every day.

The letter was sent to a company called Trippo International LLC, a wholesaler based in Newington, CT. Trippo offers a quirky blend of products mostly aimed at CBD vaping and the smoking of hemp. But it also carries some goods that have a potential nutritional use, such as powder lactose and powdered forms of mannitol. Both of these can be used as diluents in formulas meant to be inhaled or snorted.

Ingredient identified as a danger years ago

The FDA warning letter alleges that Trippo was selling a 16 oz. package of a product that consisted of one ingredient: caffeine anhydrous. The package allegedly was labeled as containing 2,267 servings at 200 mg per serving.

FDA first raised the alarm about the sale of pure powdered caffeine in 2015, when it sent warning letters to five companies selling the ingredient. In 2018 the Agency issued a guidance for industry on the subject, that said that certain forms of highly concentrated caffeine offered for sale would be considered to be adulterated. That coincided with two more warning letters sent to companies selling the ingredients.

On an informational page on concentrated, powdered caffeine that was updated in light of the Trip letter the Agency notes that the ingredients are associated with two deaths in the US. The page lays out FDA’s concern about the use of these products:

“The difference between a safe amount and a toxic or life-threatening amount of caffeine in these highly concentrated products is very small. Safe quantities of these products can be difficult or nearly impossible to measure accurately with common kitchen measuring tools. For many of these products, volume measures such as teaspoons are not precise enough to calculate how many milligrams of caffeine are in the recommended serving size. These products are also often sold in ways that increase the likelihood of accidental measurement error.

“Just one teaspoon of pure powdered caffeine can contain the same amount of caffeine as 28 cups of coffee, and a half cup of a liquid highly concentrated caffeine product contains the equivalent of more than 20 cups of coffee. These are toxic amounts that can have serious health consequences.”

Can these products be kept out?

If the Agency has determined that such products should not be on the market, why do they continue to show up? From the point of view of Daniel Fabricant, PhD, president and executive director of the Natural Products Association, it’s a matter of focus, or lack thereof.

“The fact that you can still find these things online is a signal that the Agency does these things, such as issuing these warnings about powdered caffeine, and then doesn’t follow up. You need to stay vigilant with a consistent purpose or otherwise you are just playing whack a mole,” Fabricant said.

Nevertheless, the problem FDA faces in identifying illegal products in the massive flood of imports is huge and grows every year.

The alarm about a potentially leaky border was raised more than 15 years ago in a 2004 article in Smithsonian Magazine that noted that 19,000 shipping containers were arriving in United States ports every day at that time. That article was mostly focused on the danger of the import of weapons of mass destruction.

The scope of the issue has expanded greatly since then. In 2020, the Port of Los Angeles alone reported receiving 9.23 million TEUs, or twenty-foot equivalent units, a rough standard measure for cargo capacity based on a 20-foot long unit. That works out to slightly more than 25,000 per day.