FDA declares bulk sale of caffeine supplements unlawful

BY Michael Johnsen

The Food and Drug Administration on Friday cracked down on the bulk sale of caffeine supplements direct to consumers. The agency issued new guidance that clarifies 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.

The guidance, supported by industry, takes effect immediately given the significant public health concern, the agency stated.

“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,” Scott Gottlieb, FDA commissioner, said. “These products are sometimes being used in potentially dangerous 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.

The Council for Responsible Nutrition commended the agency for cracking down on the bulk sale of caffeine supplements. “Extremely concentrated or pure caffeine has no place in the consumer marketplace, and CRN fully supports FDA’s commitment to taking immediate steps to remove products from the marketplace that present public health concerns,” Steve Mister, president and CEO of CRN, said. “Consumers have access to a whole host of dietary supplements and other over-the-counter products that are manufactured with safe amounts of caffeine.

CRN began addressing this issue as many as five years ago when it released its recommended guidelines for caffeine supplements. The association suggested caffeine content from both added caffeine and naturally occurring caffeine combined should be declared in milligrams per serving either in the Supplement Facts Box or in a separate statement elsewhere on the label. In addition, any supplement with total caffeine content of more than 100 mg per serving should provide disclaimer statements alerting consumers that the product is not recommended for use in children, pregnant or nursing women, those with a medical condition, those taking medication or those sensitive to caffeine.

In 2015, CRN updated its guidelines on caffeine supplements to include restraints against the sale and marketing of pure powdered caffeine directly to consumers.

A half cup of a highly concentrated liquid caffeine can contain approximately 2,000 mg of caffeine and just a single teaspoon of a powdered pure caffeine product can contain approximately 3,200 mg of caffeine. This is equivalent to about 20 to 28 cups of coffee, a potentially toxic dose of caffeine, FDA noted. In fact, less than two tablespoons of some formulations of powdered, pure caffeine can be deadly to most adults, while even smaller amounts can be life threatening to children.

Risk of overuse and misuse is high when highly concentrated caffeine is sold in bulk quantities, and consumers are expected to measure a very small, precise recommended serving. Regardless of whether the product contains a warning label, such products present a significant and unreasonable risk of illness or injury to the consumer.

The recommended safe serving of highly concentrated or pure caffeine products is often 200 mg of caffeine, which equates to 1/16 of a teaspoon of pure powder or approximately 2.5 teaspoons of a liquid. Yet, despite these small serving sizes, powdered forms of caffeine are sold in large bags and liquid forms are sold online in bottles that can contain a gallon or more, the agency reported.

This guidance does not affect other types of products that might also contain caffeine, such as prescription or over-the-counter drugs or conventional foods, like traditionally caffeinated beverages.

In 2015 and 2016, the FDA issued warning letters to seven distributors of pure powdered caffeine, with several of the letters citing that the products were dangerous and presented a significant or unreasonable risk of illness or injury to consumers. Since that time, the FDA has continued to see a proliferation of similar products being sold online. The FDA intends to carefully review any dietary supplement products that contain potentially dangerous amounts of caffeine in any form, and the agency will continue to take action when products put consumers at risk.


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