JAMA Backtracks on Claim That FDA Does Not Regulate Energy Drinks

The Journal of the American Medical Association (JAMA) has reversed a published claim that energy drinks are not regulated by the U.S. Food and Drug Administration (FDA).

The change came shortly after BevNET contacted the organization to inquire about the validity of the claim.

Last month, JAMA published a series of reports on energy drinks, including a one-page informational sheet about the category. JAMA’s “Patient Page,” which the organization encourages its readers to “copy for your patients,” featured a brief synopsis about energy drinks, a list of common ingredients found in the products, and the caffeine content in top energy brands. The report also included the statement “Energy drinks are not regulated by the US Food and Drug Administration.”

Following a series of phone calls and e-mails between BevNET and JAMA’s media department, in which BevNET asked for clarification on the claim, the medical organization yesterday reversed itself and changed the line to read, “Energy drinks are regulated by the US Food and Drug Administration.” The journal did not include a specific acknowledgment about the correction.

The FDA’s role in the regulation of energy drinks has been widely discussed in political and media circles in recent months following requests by members of the U.S. Congress for closer scrutiny of the products.

Justin Prochnow

While JAMA did not comment on why it initially made the claim, Justin Prochnow, an attorney with Greenberg Traurig LLP who specializes in government regulation affecting the beverage industry, attributed JAMA’s statement to “the real lack of understanding of how such products are regulated and [how] this lack of understanding runs from consumers to media to politicians.”

Prochnow stated that although the FDA does not have a specific recognized category for energy drinks, the products “fall into two separate categories of regulated products: energy drinks, sold as beverages, and energy supplements, sold as dietary supplements.”

“Dietary supplements are actually a sub-category of foods and beverages, all of which are unquestionably regulated by the FDA,” Prochnow said. “This existence of two categories of products that resemble each other in almost every way has elicited concern from the FDA and is the cause for the existence of the FDA’s Draft Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages.”

Moreover, Prochnow noted that beverages and supplements are required to comply with requirements established under the Federal Food Drug and Cosmetic Act.

“The labeling of products is governed by regulations issued pursuant to the FFDCA and found in the Code of Federal Regulations at 21 CFR Part 101,” he stated. “Beverages are considered foods and must be labeled with Nutrition Facts panels and carry a statement of identity labeling it as a beverage, drink or an established name like tea, juice, water, etc.  The FDA has issued a Food Labeling Guide [for food and beverage suppliers].”

Additionally, Prochnow stated that “supplements must be labeled with Supplement Facts panels and carry a statement of identity labeling them as dietary supplements or some other descriptive word, such as energy supplements, [and] the FDA has issued a Supplement Labeling Guide.”