Monster Making Giant Move Away from Supplements

CORONA, Calif.Monster Beverage Corp. is planning to change the labels on its energy drinks in a move that subjects them to conventional food rules.

Rodney Sacks, the CEO of Monster, told Beverage Digest the cans will now disclose caffeine content and list "Nutrition Facts" rather than "Supplement Facts".

Monster on Thursday said it's making the change for a number of business reasons, including to put the company on more equal footing with its rivals like Red Bull, whose conventional food products are exempt from sales taxes and eligible for redemption with food stamps in certain states.

The company said it plans to keep its current ingredients even after the changes are put into effect. It didn't specify when precisely those changes would occur other than saying "when new packaging is manufactured and new products are introduced."

Some Democrats on Capitol Hill and other energy-drink critics have raised concerns over the caffeinated beverages and claimed companies like Monster are evading strict regulations by classifying their drinks as dietary supplements. Supplements are subject to a different set of rules than conventional food. Generally, manufacturers of dietary supplements don't need federal regulatory approval before selling their products.

"The company saw no reason to continue being subjected to the erronerous and misguided criticism that its Monster Energy drinks are being marketed as dietary supplements to avoid FDA regulation," Monster said in a statement. "As we have always said, dietary supplements are subject to as much if not more FDA oversight than are conventional foods, and in any case, Monster Energy drinks could equally satisfy the regulatory requirements applicable to both regulatory categories."

Marc Ullman, an attorney with New York-based Ullman, Shapiro & Ullman LLP, said Monster will no longer be required to report serious adverse events to FDA because foods aren't subject to this requirement. Several reported incidents have linked Monster to fatalities, although the company has vigorously denied that its drinks were the cause of any deaths including that of 14-year-old Anais Fournier.

Ullman said Monster also will no longer have to comply with so-called CGMPs (Current Good Manufacturing Practices) for dietary supplements and instead will be subject to food GMPs that are "not nearly as rigorous".

Although Monster plans to keep its ingredients, what remains to be seen is how it plans to do so under the new regulations. Under conventional food regulations, Monster can only include ingredients that are approved food additives or that are generally recognized as safe longhand for GRAS in FDA lingo.

"For a substance to be GRAS," FDA explains on its website, "the scientific data and information about the use of a substance must be widely known and there must be a consensus among qualified experts that those data and information establish that the substance is safe under the conditions of its intended use."

In an interview with The Associated Press, EAS Consulting Group senior advisor Elizabeth Campbell said taurine is not approved for use in food and is not listed in the database of notifications for GRAS ingredients.