Does the FDA regulate energy drinks?

Not as much as it should. Incredibly, it is not the FDA but the energy drink companies themselves that decide whether to label their products as beverages or dietary supplements. Manufacturers that designate their energy drinks as beverages must comply with the Nutrition Labeling and Education Act of 1990 (NLEA) and label the drinks with conventional Nutrition Facts panels. Manufacturers of energy drinks designated as dietary supplements must comply with the labeling requirements of the Dietary Supplement Health and Education Act of 1994, which are significantly laxer. Instead of the Nutrition Facts panels, these products are labeled with Supplement Facts panels, on which manufacturers can list ingredients that aren’t permitted on beverage labels under the NLEA. Thus, labeling is inconsistent across companies.

Most energy drinks were originally classified as “dietary supplements” in order to sidestep the U.S. Food and Drug Administration (FDA)’s caffeine ceilings for beverages. When energy drinks first came under fire a few years ago—with doctors and lawmakers pushing for more transparency and regulation in response to the deaths of 19-year-old Alex Morris and 14-year-old Anais Fournier, among others—most manufacturers agreed to disclose their ingredients and add labels displaying the quantity of caffeine, sugar, and other stimulants.

Around the same time, because dietary supplements have to inform the FDA when their products are linked to injury or death (i.e., Serious Adverse Events), companies like Monster reclassified their products as “beverages.” To do so, all they had to do was self-affirm that all of their individual ingredients are “generally regarded as safe” (GRAS). These companies had and have the option of filing a GRAS petition to get the official approval of the FDA, but none have done so, which means the FDA has not thoroughly researched or explicitly approved these beverages—only their individual ingredients. Closer scrutiny, of course, might lead to the type of energy drink ban that exists in places like Uruguay, or a caffeine cap akin to Canada’s.

In January 2014, in response to the rising popularity and threat of energy drinks, the FDA issued a series of industry guidances “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.” Though the FDA’s heart was in the right place, these were guidances—not regulations. By its own admission (emphasis ours), “This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.”

Compared to the way the FDA regulates sodas and soda consumption in the U.S., the energy drink industry is the Wild West.