Muscle Milk Warned by FDA

The Food and Drug Administration has issued a warning letter to Muscle Milk maker Cytosport saying the dominant protein drink brand’s labels could be misleading to consumers.

The agency’s concerns strike at the brand’s very core: the chief labeling issue is that the company’s RTD beverage is called “Muscle Milk” when it does not contain milk. The FDA also cited other nutrient content claims in a variety of Muscle Milk products, including its shakes and energy bars.

The FDA, which sent the notice on June 29, gave Cytosport 15 days to reply and outline actions to correct the violations. But there may be no simple remedy.

““I think they’re going to have to rethink their entire brand identity,” said Justin Prochnow, an attorney with Greenberg, Traurig, who has handled many cases dealing with FDA regulations. “Basically, FDA is saying there’s not milk in it and yet you identify it with milk so much. It’s a big problem for them.”

Nevertheless, the FDA has been slow to follow up on warning letters like the one it sent Cytosport; a warning letter to relaxation drink Drank insisting that the company change its label and marketing to identify itself as a dietary supplement instead of a beverage was filed two years ago, Prochnow said, and the brand continues to call itself a beverage.

“I think it’s a case of them not having the resources to go back and follow up over time,” Prochnow said.

For Cytosport,the warning letter comprises the latest development in a case that has aggravated the company in one form or another for the past two years. In 2009, Cytosport competitor Nestle USA – which makes milk-derived products like Nesquik — filed a complaint about Muscle Milk with the Better Business Bureau, which referred the case to the FDA and the Federal Trade Commission.

The brand has been something of a pioneer in the sports and nutrition drink category, taking its powdered mixes and successfully turning them into an RTD product with sales exceeding $25o million and a distribution deal with PepsiCo.

Muscle Milk had previously entered into an agreement with at least one government agency, the FTC, to ward off regulatory penalties, agreeing to include the phrase “contains no milk” on its labels. The FTC closed the case in May 2010, after the company agreed to the labeling and marketing concessions.

But the FDA expressed concern with the exact same labels that the FTC approved, telling Cytosport that because the product listed milk-derived ingredients like calcium and sodium caseinate, milk protein isolate, and whey, but its label also contained an allergen statement that Muscle Milk contains ingredients derived from milk, “The ‘contains no milk’ statement could give consumers the impression that these products are free of milk-derived ingredients.”

Nestle had also filed requests with the U.S. Patent and Trademark Office to revoke Muscle Milk’s trademarks, although those were also dismissed in May of 2010.

Calls to Cytosport’s office were not returned.