FDA to ban pure, highly concentrated bulk caffeine supplements

Modesto Morganelli
Aprile 17, 2018

"Despite multiple actions against these products in the past, we've seen a continued trend of products containing highly concentrated or pure caffeine being marketed directly to consumers as dietary supplements and sold in bulk quantities, with up to thousands of recommended servings per container", FDA Commissioner Dr. Scott Gottlieb said in a statement. Risk of overuse and misuse is high when highly concentrated caffeine is sold in bulk quantities, and therefore present a significant and unreasonable risk of illness or injury to the consumer. Highly concentrated and pure caffeine has been linked to at least two deaths in otherwise healthy individuals, the FDA reported. At that time, UNPA encouraged all other members of the dietary supplement industry to take similar steps to remove bulk-powdered caffeine from the retail marketplace and recommended that BPC not be advertised, sold or marketed as a dietary supplement for retail sale or exhibited at trade shows until a final determination is reached by FDA as to the safety and suitable labeling of such products. The guidance is directed to firms that manufacture, market, or distribute dietary supplement products that contain pure or highly concentrated caffeine, or are considering doing so.

"We know these products are sometimes being used in potentially unsafe ways. For example, teenagers, for a perceived energy kick, sometimes mix dangerously high amounts of super-concentrated caffeine into workout cocktails". The amounts used can too easily become deceptively high because of the super-concentrated forms and bulk packaging in which the caffeine is being sold.

A half cup of a highly concentrated liquid caffeine can contain approximately 2,000 milligrams (mg) of caffeine. "The FDA's decision to ban the direct sale of pure, lethal powdered caffeine will finally bring about the consumer protections we have been demanding for years", Brown said. "This is equivalent to about 20 to 28 cups of coffee, a potentially toxic dose of caffeine", the agency said. Ingesting just a few tablespoons of some formulations of powdered, pure caffeine can be deadly to most adults, and even smaller amounts can be life-threatening to children.

A safe serving size of highly concentrated or pure caffeine is around 200 mg of caffeine, which equals one-sixteenth of a teaspoon of pure powder or approximately 2.5 teaspoons of a liquid. "When sold in bulk, it is almost impossible for consumers to tell the difference between a safe dose of pure powdered caffeine and a lethal one", said Durbin.

According to Loren Israelsen, president, UNPA, "This new guidance is a logical next step to FDA's prior efforts to inform consumers about the health risks associated with the consumption of high-dose caffeine products".

"Because consumers are unlikely to have the correct tools to accurately measure these amounts, even a consumer who reads the warning statement and attempts to measure a safe serving might inadvertently consume an unsafe amount".

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