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Posted June 5, 2018

Product Packaging Could Lead to Consuming Dangerous Amounts of Caffeine

On May 29, 2018, the FDA issued a warning letter to following a review of the company's website which found its Liquid Caffeine product to be adulterated because it "presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling". 

The product's label states that one pump equals 83 mg of caffeine, or one tsp; that two pumps equals 166 mg of caffeine, or two tsp; and that three pumps equals 250 mg of caffeine, or three tsp. However, the product does not come with a "pump," which is sold separately, but with a measuring cup which is labeled as being 1 fluid oz. The FDA noted that "there is a significant danger that consumers may consider this cup to be one serving of your product, since it is included as a measuring device and they may not be able to determine the conversion between the milligram and teaspoon serving sizes listed on your label and the fluid ounce measurement provided on your measuring cup."  

The agency warned that a one-cup serving of the product would provide 500 mg of caffeine and that if a consumer were to consume slightly more than two one-cup servings of the product, they would be ingesting levels of caffeine known to have toxic effects, such as chest pain, hypokalemia, elevated blood glucose, tachycardia, bigeminy, agitation, respiratory alkalosis, and irregular heartbeat.

In April 2018, the FDA issued a new industry guidance to clarify that that dietary supplements containing pure or highly concentrated caffeine in powder or liquid forms are considered unlawful when sold in bulk quantities directly to consumers, and can be dangerous.

See Related Warnings:

Highly Concentrated, Bulk Caffeine Products Dangerous and Illegal, Says FDA

Powdered Caffeine Risky, FDA Warns

Powdered Caffeine Can Be Lethal, FDA Warns

To read the complete warning letter, use the link below.