The U.S. Food and Drug Administration (FDA) has issued five warning
letters to the distributors of pure powdered caffeine, citing two fatalities
linked to caffeine toxicity as evidence that the products “are dangerous
and present a significant or unreasonable risk of illness or injury to
consumers.” Equating 1 teaspoon of pure caffeine to 25 cups of coffee,
FDA also warns consumers not to purchase or use powdered caffeine as
“it is nearly impossible to accurately measure pure powdered caffeine
with common kitchen measuring tools and you can easily consume a
lethal amount.”

In particular, the agency plans to “aggressively monitor the marketplace”
for pure powered caffeine being sold as a dietary supplement. The
warning letters not only find the products adulterated under the Federal
Food, Drug, and Cosmetic Act, but argue that labeling directs consumers
to use difficult measurements such as one-sixteenth of a teaspoon.
“Consumers are unlikely to have a one-sixteenth teaspoon measuring
tool, as this tool is not generally available in standard consumer
measuring spoon sets,” FDA tells one company. “Even if such a tool
were available, it would be difficult to use it to measure a 50 milligram
serving of your product, as 50 milligrams is approximately one-quarter
of a one-sixteenth teaspoon measuring tool based on the numbers on the
chart you provided.”

As the agency’s letters conclude, “In light of the potential toxicity of your
product; the fact that your product is packaged to contain an amount that
would be lethal to many consumers; the fact that the packaging requires
the consumer to separate out a safe serving from this potentially lethal
amount; and the fact that the product labeling incorrectly implies that
this process of separating out a safe serving from a potentially lethal
amount can be done with certain common household measuring tools,
when in fact it would require a precise scale; we have determined that
your product presents a significant or unreasonable risk of illness or
injury under the conditions of use recommended or suggested in the


Issue 577

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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