By Hank Schultz Nutra Ingredients USA
Third time's the charm: Durbin, Blumenthal call on FDA to investigate energy drinks
Energy drink or supplement? Enforce your own guidance, says Sen Durbin to FDA
The energy beverage sector had a lively 2012, marked by a high-profile wrongful death suit against Monster Beverage Co., some high-profile negative press and even higher-profile attacks from a pair of US Senators. 2013 is shaping up, if anything, to be even livelier, with caffeine limits coming online in Canada.
The new Canadian regulations limit the amount of caffeine per single serving of an energy beverage to 180 mg, or about what’s in a strong cup of coffee. Larger size bottles, such as Monster’s 32-oz. size, will be limited to 400 mg. of caffeine per liter. According to reports in the Toronto Star, 28 products that were on the shelves in Canada at the end of 2012 will have to be reformulated.
The new rules also recategorize the drinks. Up to now they were sold as “natural health products.” The new regulation instituted by Health Canada now classifies them as “food.”
The relatively small number of products that fall outside the new limits is an indication that few manufacturers were really pushing the per-serving stimulation envelope, whatever their marketing campaigns might indicate. There is a consensus among health professionals that for most healthy adults, consuming 400mg or less of caffeine daily poses no particular risks.
No special risks
That was the point that FDA made in responses it made to the first two letters sent by Sens. Dick Durbin, D-IL and Richard Blumenthal, D-CN asking the agency to probe the safety of energy beverages. It also said that caffeine containing products have a long history of safe use, and that the amount of caffeine in energy drinks is not out of line with other sources of caffeine in the US diet. That didn’t stop the pair from sending a third letter to FDA with the same request later in 2012, and observers said it’s likely that Durbin will use the advent of the new rules in Canada to renew his calls for something similar from FDA.
“I definitely think that Dick Durbin has an agenda,” Phoenix-based beverage consultant Jim Tonkin told FoodNavigator-USA. “I think he has an axe to grind and I don’t think he is going to go away. I think he’s going to continue to drive the coversation forward.”
New York-based attorney Marc Ullman of Ullman, Shapiro & Ullman was more blunt about how Durbin and Blumenthal might greet the news of the new Canadian rules.
“They’ll jump up and down and say that FDA is being irresponsible,” he said.
Nevertheless, Ullman said he thinks it’s unlikely that barring some major trigger event that the pressure on the sector will result in new sweeping rules from FDA.
“Over the last several months I’ve expressed a lot of concern for what might happen to the category, but as it stands now without something more I just don’t see the mechanism that justifies action from FDA within our legal and regulatory framework,” Ullman said.
“The theme I’ve been seeing in this is parallel to ephedra, which took 11 years to come off the market. I don’t see anything happening here unless there is a game changing, high-profile event like we had with ephedrea with the pitcher from the Orioles.” (Steve Bechler, a pitcher for an Orioles minor league team, died in 2009 after a hot weather workout on a day he’d taken an overdose of the weight-loss ingredient.)
FDA agrees to take a second look
But Durbin’s pressure on FDA does seem to be having an effect. He has railed against energy beverages both because of their caffeine levels (which he often characterizes as excessive by comparing them to the levels of caffeine in soft drinks) and because they contain a host of other ingredients that may give rise to unintended, synergistic effects.
FDA responded to Durbin’s third letter shortly before Thanksgiving, saying it plans to seek outside advice on whether the caffeine levels in energy beverages or the combination of other ingredients in the presence of caffeine pose special risks in energy beverages. FDA did note one regulatory hurdle along that path, though; it evaluates the safety of food ingredients in isolation before they are approved to go onto the market. “FDA does not have the authority to require a manufacturer to submit each formulated product for a premarket review,” the letter stated.
The letter also said that limited resources would prevent as extensive an investigation of the issue as Durbin seems to be calling for, especially in regard to how ingredients might interact with each other. “Resource and capacity restraints preclude government or government-funded testing of all but a very small number of the possible combinations,” the letter said.
No new regulations foreseen
So, even as the pressure builds, the moment when the release valve starts shrieking seems a long way off.
“(FDA is) much more reactionary than they are dictatorial. They react to market conditions, adverse reporting, deaths, competitors turning other companies in. That’s what gets them going,” Tonkin said.
“They are chronically underfunded and understaffed. I don’t anticipate them sitting down to write a new regulation to scrub the energy drink business.
“We will still have to pay attention to which lobbyists are jamming and which ones aren’t, because that’s really what’s going to drive the conversation,” he said.
Ullman concurred, saying that the long history of the safe use of caffeine makes it unlikely that even if FDA looks more closely at the sector that it will find any particular health risks.
“I’ve said all along that the troubles the concerns seem to be more atmospheric and political,” he said.