FDA Declares Relaxation “Supplement” a Drink, Threatens Shutdown

The FDA has taken a strong step toward remaking the relaxation drink category, warning a Georgia-based marketer that his product has the appearance and representation of a conventional food item despite his attempts to label it as a dietary supplement.

The ruling is important because the key ingredient in many relaxation drinks, the amino acid melatonin, is only allowed to be packaged in supplement form.

In a letter to Jeremy Nickels, the owner and CEO of Revolt Distribution, Inc. the FDA warned Nickels that marketing his Slowtivate Relaxation Drink “in a single serving can similar in size, shape and appearance to those in which single servings of beverages like soda, fruit juice, and iced tea are sold” was enough to place the product squarely in the realm of food product.

Attempts to reach Nickels by phone and electronic mail were unsuccessful. The Slowtivate web site shows an 8.4 oz. slim can with the words “Cage the Bull” stripped across the top. It is clearly labeled as a dietary supplement – but that is no longer enough, according to the FDA, which threatened to seize Slowtivate or go to court to prevent its sale.

More than shutting down Slowtivate (and its companion product, the Wownie Relaxation Cookie), the letter may also serve as a warning for all product manufacturers who are using beverage-type containers to market products that may contain ingredients that are only usable in dietary supplements. In the past, the relaxation beverage Drank had been forced by the FDA to re-label its product as a dietary supplement and change some marketing language, but the new letter indicates that the agency is going a step further.

“This basically says, hey, we don’t care how you’re selling it, we consider it to be a beverage,” said Justin Prochnow, an attorney with Greenberg Traurig who frequently deals with the FDA on labeling matters.  “The implication is that for any company that is selling a supplement product in packaging or serving sizes similar to a beverage, and using words that are associated with beverages, there’s now the possibility that the FDA will declare your product an adulterated food product.”

That means any one of dozens of products in cans, bottles, and food wrappers that is using a product like melatonin, one that can only be used in a dietary supplement, may soon face FDA action.

“Everyone,” Prochnow said, “should stand up and take notice.”

A copy of the FDA warning letter can be found here.

BevNET has been covering the potential ramifications of melatonin usage in relaxation drinks in several stories, most recently this story on Marley Beverage Co.