The row over the legal line between liquid dietary supplements, conventional beverages and energy drinks hit the headlines again this week with Senator Dick Durbin calling on the Food and Drug Administration (FDA) to enforce its own guidance.
In a letter sent to the FDA on April 3 Durbin (Dem -IL) said firms were continuing to market energy drinks as dietary supplements in order to circumvent rules about caffeine content.
While soft drink makers must restrict the use of caffeine (which is generally recognized as safe in cola-type beverages up to 0.02% or 200ppm) supplement makers are not subject to the same rules, claimed Durbin.
By contrast, he said, many energy drinks had “exceptionally high levels of caffeine” – a claim challenged by the American Beverage Association, which says “most mainstream energy drinks contain about half the caffeine of a similar size cup of coffeehouse coffee”.
The FDA was aware of the blurry line between drinks and supplements and had put out guidance in 2009 specifically to address it, he said. This said that if products looked like drinks, they should be marketed as drinks, and not as supplements, he said.
Durbin: Most energy drinks are marketed as supplements
Durbin added: “Most energy drinks are currently marketed as dietary supplements, therefore they do not need to establish evidence of their products’ safety or adhere to a limit on the level of caffeine. At the same time, many energy drinks come in single-use containers ranging from 8oz to 32oz and are marketed like beverages.
“I ask the agency to investigate energy drinks like Monster Energy, Rockstar, and Full Throttle to ensure they are not in fact conventional foods, based on the FDA’s 2009 ‘Guidance for Industry: Factors that Distinguish Liquid Supplements from Beverages’.
“I also ask the FDA to enforce its regulatory authority over the caffeine levels in energy drinks, including Red Bull and AMP currently marketed as beverages, and to investigate caffeine levels in energy drinks marketed as supplements.”
He also called on the FDA to “require manufacturers to provide scientific evidence that ingredients such as guarana, taurine, and ginseng, are safe for their intended used and when used in combination with other ingredients and caffeine”.
Attorney: Durbin is missing the point
But Manhattan-based attorney Steven Shapiro said making this about the distinction between supplements and foods was missing the point: “If there is a safety issue about caffeine, the FDA should address it directly.”
He added: “The FDA has more than sufficient authority to regulate dietary supplements if it has reason to believe that they are unsafe. The Dietary Supplement Health & Education Act has been in place for 17 years now so I thought we were past the point where you can say that you can put anything you want in a supplement because supplements are not regulated.
“Whether you are marketing a product as a food or a supplement, you still have to prove it is safe.”
The 2009 FDA guidance
Colorado-based attorney Justin Prochnow added: “Senator Durbin is apparently trying a different method after failing in several attempts to introduce new legislation. As industry has usually responded by stating that there are enough regulations and that they just need to be enforced more, he is now calling on FDA to do just that.”
Speaking at the Nutracon conference in Anaheim last month, Prochnow and Shapiro said a recent FDA warning letter – sent to the maker of the melatonin-laced Slowtivate Relaxation Drink – represented a “significant development” as it indicated the FDA might be stepping up enforcement of its controversial 2009 draft guidance.
“This looks like a big warning shot across the beverage industry,” said Prochnow.
Serious consequences for industry
If the FDA decided to start enforcing the draft guidance in earnest, there could be serious consequences for industry, said Shaprio, as you can’t simply switch from marketing your product as a supplement to selling its as a beverage if your ingredients do not have the relevant regulatory approvals.
“If you are selling a conventional food or drink - as opposed to a dietary supplement – then novel ingredients including herbal and other botanicals must be either approved food additives or Generally Recognized as Safe (GRAS) for their intended use,” said Shapiro.
Historically, argued Shapiro, the FDA had told industry it didn’t matter if a dietary supplement was packaged like a conventional food or beverage, as long as it was labeled as a supplement and featured a ‘supplement facts’ panel.
However, its 2009 draft guidance appeared to throw this on its head by arguing that where a dietary supplement was merchandised, what it looked like, how much liquid was in it and whether it physically resembled a conventional food/drink product did matter, he said.
ABA: Most mainstream energy drinks have less caffeine than coffee
The American Beverage Association (ABA) said:
“We have adopted a number of voluntary policies pertaining to energy drinks, including: listing total caffeine amount on pack; displaying an advisory statement, noting that energy drinks are not recommended for children, pregnant or nursing women and people sensitive to caffeine; not marketing energy drinks to children; and not offering energy drinks for sale in K-12 schools.
“ABA member companies, including The Coca-Cola Company, Dr Pepper Snapple Group, PepsiCo and Red Bull, have adopted these voluntary policies.”
Meanwhile, a recent report cited in Durbin's letter alleging that energy drinks were responsible for a growing number of emergency room visits, was a “troubling example of statistics taken out of context ”, said the ABA.