FDA Takes Action Against Highly Concentrated Caffeine in Dietary Supplements, Citing Public Health

FDA caffeine supplements

Dietary supplements containing pure caffeine are unlawful when sold in bulk quantities directly to consumers, due to the high risk that they will be erroneously consumed at excessive doses, according to the FDA.

The following is an excerpt from the latest NCA Member Alert

The U.S. Food and Drug Administration (FDA) recently issued a new guidance  to clarify that selling dietary supplements containing pure or highly concentrated caffeine in bulk quantities directly to consumers is  “considered unlawful,” because of the high risk that they will be accidentally consumed at excessive, potentially dangerous doses.

Read the FDA press announcement

With respect to pure or highly concentrated powdered or liquid caffeine, the National Coffee Association (NCA) supports the FDA’s common-sense measure to protect consumers. But it is important to remember that these products have very little relation to coffee: a single teaspoon of powdered caffeine has as much caffeine as 20 to 28 cups (3,200 mg).

In fact, drinking coffee – and the natural caffeine it contains – is perfectly safe for most people. It may even be good for you.

 A recent scientific review on caffeine safety confirms that drinking up to four cups of coffee daily, or about 400 milligrams of caffeine, is “not associated with overt, adverse effects” in healthy adults.* (The average U.S. coffee drinker has 2.1 cups daily, according to the 2018 NCA National Coffee Drinking Trends report.) 

“Products with naturally-occurring caffeine, like tea and coffee, have been safely consumed for hundreds of years,” said Dr. Mark Corey, NCA Director of Scientific Affairs & Project Management. “Nature controls the amount of caffeine in these beverages, and consumers learn to adjust their drinking habits in accordance with their own tolerances to caffeine.”

Yet, despite what we know about coffee’s potential health benefits, concerns about caffeine and health remain a key factor limiting coffee consumption: 46% of US consumers said that a desire to limit caffeine was a major reason for drinking less coffee, according to the NCDT data.

Learn more about the latest scientific research on coffee, caffeine, and your health.

* Please note that this information is not intended to be medical advice, and you should always consult your doctor or a medical professional with any specific questions or concerns.

Read the full NCA Member Alert (login required)

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