FDA Warns RockStar: Coffee Isn't a Supplement

NASHVILLE, Tenn.Coffee is not a supplement, according to FDA, even if the product labels itself as supplement and carries a Supplement Facts panel. FDA warned RockStar Inc. that its Rockstar Roasted Coffee & Energy products, as conventional foods, contain an illegal ingredient because it is neither a food additive or GRAS (generally recognized as safe).

FDA investigated the Rockstar facility in Livingston, TN, and collected product labels. The agency reported several of the company's products ) are adulterated  because they contain Ginkgo biloba leaf extract, an unapproved food additive. Any substance added to a conventional food must be either a food additive or  GRAS. However, as FDA noted, Ginkgo hold neither status.

FDA said the Rockstar coffee products are represented for use as conventional foods, even though the company uses "energy supplement" on its label and it uses a "Supplement Facts" panel for nutrition labeling. The products are identified as coffee, and FDA said coffee is a beverage (i.e., a conventional food), and the products are similar to a typical canned beverage in packaging and appearance.

The agency said no data establishes the general recognition of safety of Ginkgo for use as an ingredient in conventional foods. On the contrary, FDA pointed to a recent animal studies conducted by National Toxicology Program (NTP) that showed Ginkgo to have carcinogenic activities in the animals.

Ginkgo is a popular brain health ingredient used in dietary supplements that has also shown pain-reduction benefits and an ability to reduce hypertension. However, as FDA said, it is not allowed for use in conventional foods in the United States.

Last year, FDA also took issue the use of melatonin, a non GRAS ingredient, in a brownie that was labeled a dietary supplement. The issue of blending the line between supplements and conventional foods is an underlying reason Sen. Richard Durbin (D-IL) introduced the Dietary Supplement Labeling Act of 2011.

INSIDER's take:

Food is food and supplements are supplements, and FDA is pretty clear on the difference, even if product manufacturers aren't. If a company adds non GRAS or non food additive ingredients to a conventional food, such as a beverage in a 16-ounce can, it can expect a warning letter from FDA. Or, even worse, it can become the basis of unnecessary legislation that could potentially affect the entire industry.