FDA Issues Warning Letters to Five Distributors of Powdered Caffeine Supplements

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Newman_020915_2The U.S. Food and Drug Administration (FDA) has issued warning letters to five distributors of pure powdered caffeine supplements, notifying them that their products are potentially dangerous. The letters revolve around how these companies label their products, pointing out that the current labels are easy to misunderstand and could lead consumers to take dangerously high doses.

Powdered caffeine is a popular supplement among those who prefer an inexpensive source that lacks the sugars or additives common in most caffeinated drinks. The problem is that powdered caffeine is highly potent. One teaspoon of the powder is equivalent to 28 cups of regular coffee. Too much can lead to erratic or rapid heartbeat, vomiting, seizures, and death.

The warning letters, which were sent to distributors Smartpowders, Purebulk, National Food Supplements, Hard Eight Nutrition, and Bridge City Bulk, point out potentially dangerous flaws in how their powdered caffeine products are labeled. In most of the cases, measurements in excess of the recommended safe dosage were offered that the FDA felt could lead to consumers mistakenly assuming they were the suggested dosage. In other cases, the labels advised consumers to use measurements such as “1/16 teaspoon” to figure out a safe dose. As the FDA noted in its letters, teaspoons of this size are not commonly available to most consumers and are absent in most commercially available measuring spoons.

As one of the letters stated, “the fact that the packaging requires the consumer to separate out a safe serving from [a] potentially lethal amount; and the fact that the product labeling incorrectly implies that this process…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.”

The companies have 15 working days to respond.

Sources for Today’s Article:
“Hard Eight Nutrition LLC 8/27/15,” U.S. Food and Drug Administration web site; http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm460200.htm, last accessed September 2, 2015.

Payne, E., “Food and Drug Administration warns distributors of pure powdered caffeine,” CNN web site, last updated September 2, 2015; http://www.cnn.com/2015/09/02/health/powdered-caffeine-warning/.
“PureBulk 8/27/15,” U.S. Food and Drug Administration web site, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm460204.htm, last accessed September 2, 2015.
“Smartpowders 8/27/15,” U.S. Food and Drug Administration web site, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm460201.htm, last accessed September 2, 2015.