NPR featured a brief segment on energy drinks this week, discussing the dichotomy of labeling such drinks as either foods or dietary supplements. In 1997, Red Bull came on the market with a bang. Since then, there has been a rapid increase in new brands of energy drinks, to include Amp, a new energy juice. Some drinks are marketed as food, while others maintain the label of dietary supplements. The result of this labeling split? The Food and Drug Administration regulates them differently. Food is regulated under the Federal Food, Drug and Cosmetic Act, while dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Products labeled and regulated as "food," must contain a nutrition facts label which lists all additives. These additives must be formally approved by the FDA. On the other hand, under the DSHEA, dietary supplements do not require the same degree of regulation. Instead of the FDA being responsible for ensuring that ingredients are safe, the manufacturer of the product must ensure that the supplement or ingredient is safe. The FDA steps in to take action against those unsafe products categorized as dietary supplements, only after they have hit the market. Moreover, manufacturers of dietary supplements are not required to register their products with the FDA or get FDA approval prior to producing or selling their products.
What's the big deal you ask? The big deal is this. Energy drinks marketed as dietary supplements are not so different from those labeled as food; at least not different enough to deserve separate and distinct labels. Take 5-Hour Energy. This is labeled as a dietary supplement, not a food. Monster's Loca Moca? Also a dietary supplement. Starbucks' mocha-flavored drink? Food. When you put the two next to one another, the differences are not evident. Add insult to injury, the label of "dietary supplement" or "food" is not overly obvious, nor is the amount of caffeine contained within.
What we are faced with is an industry that is not uniformly regulated. To avoid safety reviews, energy drink manufacturers have the ability to label their products as dietary supplements, place them on the market with unapproved ingredients and only if they get caught and are categorized as "unsafe," do they have to worry about the FDA stepping in. The lines are all too blurred and the consequences are potentially deadly. These drinks, when left unregulated, result in overuse, abuse and hazardous consumption, especially when mixed with little or no sleep and overuse of alcohol.
If the FDA is not going to come down hard on the manufacturers of energy drinks, forcing them to label their products only as "food," then the least they can do is present a greater screening mechanism for those energy drinks being labeled as "dietary supplements." Cries for clarification and greater regulation were heard when the FDA presented the dietary supplement industry with the new dietary ingredient (NDI) draft guidance. Any dietary ingredient that was not marketed in the United States in a dietary supplement prior to October 1994 (the date DSHEA was enacted) qualifies as an NDI. As a result, there is no authoritative list of dietary ingredients. The draft guidance may not be the answer for the energy drinks industry. However, in the absence of a mandate for all energy drinks to be labeled as food, the FDA is at least making an effort towards greater consumer protection for those drinks labeled dietary supplements.
In a world where kids and adults alike are consuming energy drinks that send a confusing, mixed message due to unrefined and varying labels, shouldn't there be regulations in place? A consumer has the right to know whether the product they are purchasing is a "food" or a "dietary supplement." They have the right to know whether the ingredients have been approved by the FDA. More importantly, they have a right to know whether the ingredient had to meet the inadequate standard for dietary supplements of, "reasonably expected to be safe," or the far more stringent standards applied to food, food additives, or GRAS ingredients of "reasonable certainty of no harm" or "generally recognized as safe." Manufacturers should not be able to pick and choose how to label their energy drinks in an effort to circumvent the safety standards required for conventional foods. So long as the determination of how to label these products lies with the manufacturer, additional safety measures are needed to protect consumers.