A couple of years ago, after reports surfaced about deaths that might be attributable to popular energy drinks, U.S. Sen. Dick Durbin (D-IL) demanded that the U.S. Food and Drug Administration (FDA) investigate the potentially dangerous levels of caffeine that may be involved.
Instead of an investigation, FDA is now sharing the agency's "current thinking" about whether a beverage might not be a food or a drug but a liquid dietary supplement. FDA calls it "guidance" for the largely unregulated dietary supplements industry.
Writing on her popular Food Politics blog, nutrition expert Marion Nestle speculates that FDA likely published the new guidance documents because "weird ingredients" and excessive caffeine are showing up in popular energy drinks that largely escape regulation.
In addition to a handful of deaths occurring shortly after taking so-called energy shots, the government's own Drug Abuse Warning Network has logged thousands of hospital visits going back several years from their consumption. More than half of the hospital visits have involved young people aged 18 to 25.
"Energy drinks are flavored beverages containing high amounts of caffeine and typically other additives, such as vitamins, taurine, herbal supplements, creatine, sugars, and guarana, a plant product containing concentrated caffeine, " according to the Warning Network. "These drinks are sold in cans and bottles and are readily available in grocery stores, vending machines, convenience stores, and bars and other venues where alcohol is sold. These beverages provide high doses of caffeine that act as a stimulant upon the central nervous system and cardiovascular system. The total amount of caffeine in a can or bottle of an energy drink varies from about 80 to more than 500 milligrams (mg) of caffeine, compared with about 100 mg in a 5-ounce cup of coffee or 50 mg in a 12-ounce cola."
The FDA guidance comes in two parts, and both have been published as drafts for public comment. The purpose is to help dietary supplement and beverage manufacturers determine whether a liquid food product is properly classified as a dietary supplement or as a beverage and to remind the industry of legal requirements regarding the substances that may be added to either type of product.?Together, FDA says the two guidances finalize a previously published draft guidance and take into account public comments submitted on that draft.
The first of the guidances – Distinguishing Liquid Dietary Supplements from Beverages – describes the factors that characterize liquid products that are dietary supplements and those that characterize beverages that are conventional foods.?Such factors include product claims, names, packaging, serving size, recommended daily intake, conditions of use and product composition, as well as statements or graphic representations in labeling and advertising.
The second guidance – Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements – reminds the industry of requirements in the Federal Food, Drug, and Cosmetic Act that apply to substances added both to conventional foods such as beverages and to dietary supplements.?These statutory requirements are intended to assure safety for consumers of both types of products.
In a statement, the agency said it is issuing these guidances "to clarify legal requirements in the face of growth in the marketplace of beverages and liquid dietary supplements that contain novel substances such as botanical extracts or other botanical ingredients."
