One top food attorney says he is not wholly surprised by Monster Beverage Corporation's decision to reclassify its energy drinks as beverages rather than dietary supplements, and that it will actually remove many US regulatory complications.
Marc Ullman, from New York-based Ullman, Shapiro & Ullman told BeverageDaily.com that the move confirmed by Monster Beverage Corporation last week was, “not totally a surprise, as in many ways there are less regulatory complications when you market food (as opposed to supplements)”.
Once a company had completed the FDA’s Generally Recognized as Safe (GRAS) process for its ingredients, Ullman added, there was “really no reason not to make the move”.
“Conventional foods don’t have to report Serious Adverse Events, supplements do. Conventional foods are also manufactured under less rigorous GMP’s (Good Manufacturing Practices) than dietary supplements,” the lawyer told this publication.
Dousing the senatorial fires?
Ullman did not think Monster was making the move to counter criticism from politicians like Senator Dick Durbin, who argue that some energy brands masquerade as dietary supplements to bypass, for instance, the need to establish evidence of product safety [N.B. this point is tenuous] or adhere to upper limits on caffeine in soft drinks (200ppm).
“I’m not sure how the switch would have that effect [of countering criticism],” Ullman said. “There’s actually more information on the supplement labels. If the FDA is going to do anything, I don’t think it would matter much whether this product is a food or a supplement.”
(Monster rival Red Bull is already classified as a beverage, and must include a ‘Nutrition Facts’ label. A recent one is shown below, above a Monster Energy ‘Supplement Facts’ label from 2011.)
Finally, did Ullman think that Monster would have to reformulate the drink to cut out additives such as taurine (given the need for either an FDA pre-market review of novel ingredients, or GRAS status for them, now only applies to standard beverages), or cut caffeine levels?
“We don’t know if the company has completed a self-GRAS assessment for taurine or any of its other ingredients at this point,” Ullman said.
It’s probably pretty safe to assume that whatever ingredients are in the product when it comes out with a nutrition facts label will be GRAS. (Remember, there is no need to tell FDA when a company completes a self-GRAS assessment.)”
‘Busting some of the myths’
Justin Prochnow, a high-profile lawyer whose specialisms include beverage and supplement regulation at Denver, Colorado practice Greenberg Traurig, told BeverageDaily.com that he believed public misunderstanding was rife concerning laws surrounding energy drinks and supplements.
He said he would seek to “bust some of the myths” at a forthcoming speaking slot at Expo West/Nutracon 2013 (March 6-7, 2013).
Discussing how the labeling switch would affect controversial ingredients like taurine, Prochnow noted that this was actually GRAS at low levels for flavoring, despite not being GRAS regulated for use in foods.
“This does not mean it can't be GRAS and must be removed. It means that a company must get self-affirmed GRAS status for taurine to legally sell it. This can be achieved by either going through a service provider like GRAS Associates or AIBMR, on empaneling your own GRAS experts,” he said.
By reclassifying as a beverage, Monster was not required to list caffeine levels, Prochnow added, although CEO Rodney Sacks has been quoted in the media as saying that the company would do so.
“In fact, the only requirement is as a supplement. You are supposed to list the amount of each ingredient unless they are part of a proprietary blend,” Prochnow explained.
Historically, the FDA has told industry it doesn’t matter if a dietary supplement was packaged like a conventional food or beverage, as long as packaging featured a ‘supplement facts’ panels.
But 2009 draft guidance from the FDA on distinguishing beverages from supplements – in response to Durbin the agency said last August that it planned to publish full guidance “in the near future” – suggests that the agency will address supplement resemblance to conventional drinks.