FDA Warns Rockstar on Coffee & Energy Line

For the second time this year, the Food and Drug Administration (FDA) has warned a beverage company that products labeled as supplements must be sold and marketed as supplements, not beverages. It was revealed today that the FDA sent a letter to Rockstar cautioning the company that, despite being labeled as supplements, its Coffee & Energy products are represented, advertised, and sold as beverages. And because the products contain Gingko, an unapproved food and beverage additive, the agency has deemed the line to be “adulterated.”

The letter to Rockstar follows a similar one that the FDA sent in March to Revolt Distribution, which markets Slowtivate Relaxation Drink. The FDA warned the company that even though Slowtivate is labeled as a dietary supplement, the product has the appearance and representation of a conventional beverage and considered unsafe because of its inclusion of melatonin, which, like Gingko, is an unapproved additive, according to FDA guidelines.

In its letter to Rockstar, the FDA states that the company’s use of the term “energy supplement” on its Coffee & Energy labels and the use of a “Supplement Facts” panel for nutrition labeling “do not make [its] products dietary supplements, because [the] products are represented for use as conventional foods.” The FDA lists a number of examples and factors to support its argument including Rockstar’s use of the word “coffee,” which the agency states is a word commonly held to describe a beverage and a conventional food.

Moreover, the FDA cites Rockstar’s use of the word “beverage” on its labels, and the overall similarity of the products to a “typical canned beverage in packaging and appearance,” as further evidence that its Coffee & Energy products fall into the category of conventional foods and beverages, not supplements.

The FDA also notes that “there is no food additive regulation which authorizes the use of Ginkgo… [and] we are not aware of any basis to conclude that Ginkgo is [Generally Recognized as Safe] for use in conventional foods.” The agency pointed to scientific reports that “have raised safety concerns about the use of Ginkgo in conventional foods,” with studies showing Gingko associated with carcinogenic activities in experiments on animals.

As the FDA continues to wade into the issue of companies labeling products as supplements versus conventional beverages, Justin Prochnow, an attorney with Greenberg Traurig and expert in regulatory issues regarding consumer product companies, said that beverage companies need to be extremely cautious in how they label and market their products.

“This follow-up to the Slowtivate letter posted in March over the use of melatonin in a product labeled as a supplement, but deemed to be a beverage by the FDA, only serves to further the notion that it is vitally important to be consistent in your labeling and references to your product,” said Prochnow. “If you sell your product as a supplement, reference it as a supplement at every turn.”