The Food and Drug Administration (FDA) will take no general regulatory action against energy drinks based upon safety concerns about their caffeine content. In an August 10, 2012 response to concerns raised in April 2012 by Senator Richard Durbin (D-IL), Assistant FDA Commissioner for Legislation Jeanne Ireland stated that caffeine levels in energy drinks are comparable to caffeine levels in other caffeine-containing products and that FDA is not aware at present of any new information that would indicate an immediate health issue. She stated that when violations of the Food, Drug, and Cosmetic Act (FDCA) or its regulations are found, the agency will pursue Federal regulatory action, as appropriate, and is not precluded from changing its regulations if new safety information becomes available.
FDA noted that caffeine intake up to 400 milligrams (mg) per day by healthy adults is not associated with general toxicity, cardiovascular effects, effects on bone status and calcium balance, changes in adult behavior, incidence of cancer, or effects on male fertility.
FDA’s Generally Recognized As Safe (GRAS) regulation for caffeine in cola soft drinks (21 C.F.R. § 182.1180) is set at 0.02 percent or less of the product (reportedly about 75 mg in a 21 oz. soda), but as explained in FDA’s response, this does not automatically preclude other uses of caffeine in other kinds of beverages from being considered GRAS. FDA states that in response to the emergence of energy drinks as a new class of caffeinated products, it reassessed the amount of caffeine ingested by U.S. consumers. That updated assessment shows that even considering the caffeine from energy drinks, most of the caffeine consumed comes from what is naturally present in coffee and tea.
FDA stated that caffeine levels in energy drinks range in general from 160 to 500 mg per serving. This is comparable to other beverages containing caffeine, such as soft drinks and brewed coffee. Brewed coffee contains about 135 mg per 8 ounce (oz.) serving; coffeehouse brewed coffee contains about 330 mg per 16 oz. serving; and soda pop contains about 35 mg per 12 oz. serving.
In addition, FDA confirmed that it is conducting a review of recently published safety studies on caffeine and the available studies do not indicate any new, previously unknown risks associated with caffeine consumption. Senator Durbin’s inquiry to FDA was in part based upon reports of increased emergency room visits apparently due to energy drink consumption reported by the Substance Abuse and Mental Health Services Administration (SAMHSA) and the reported cardiac arrest suffered by a teenaged girl after drinking two 24 ounce energy drinks within 24 hours. FDA is following up with SAMHSA to review individual reports and any associated adverse event reports; attempts to obtain further information about the reported teen’s death to date have been unsuccessful.
In regard to the difference between a conventional beverage and a liquid marketed as a dietary supplement, FDA referenced its December 2009 “Draft Guidance for Industry on Distinguishing Liquid Dietary Supplements from Beverages, Considerations regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods” (the draft Drinks Guidance) (click here to access). FDA is currently preparing a final guidance on this topic.
The distinction between a conventional food or beverage and a dietary supplement is important because any substance added intentionally to a conventional beverage/food must be: 1) an authorized food additive, 2) a substance generally recognized as safe (GRAS) for food use, or 3) be otherwise exempt from the food additive definition. Ingredients that meet the statutory definition of a “dietary ingredient” are exempt from the food additive definition, need not be GRAS, and, unless deemed to be “new,” may be used in dietary supplements without FDA approval or premarket notification to FDA.
Nevertheless, if FDA determines that a product’s labeling, packaging, or appearance causes the product to be “represented” as a conventional food, it will not meet the dietary supplement definition in the FDCA regardless of its ingredients. Further, as stated in FDA’s response to Sen. Durbin, merely labeling the product as an “energy supplement” and using the Supplement Facts, rather than the Nutritional Facts, panel on the label does not make such a product a dietary supplement.
In the draft Drink Guidance, FDA expressed its concern that some of the “novel” ingredients added to beverages and other conventional foods may cause the food to be adulterated because they are not used in accordance with an approved food additive regulation and may not be GRAS for their intended use. In addition, the agency expressed concern about the safety of ingredients present in the food supply for many years that are added to beverages and other conventional foods at levels in excess of their traditional use levels or added to new beverages. The draft guidance also addressed the labeling and representations permitted for conventional foods and dietary supplements, including the use of health claims and structure/function claims and the need to distinguish claims permitted for each regulatory classification.
The final Drink Guidance, when issued, will be useful in helping companies determine the line between a conventional food and a dietary supplement and what is required and permitted, although it is almost certain such a clarification will probably not satisfy all parties. In the meantime, energy drink producers and other dietary supplement companies may take joy from FDA’s measured response to Sen. Durbin’s concerns.