FDA and Energy Drinks

In April, U.S. Senator Richard Durbin (D-IL) sent a letter to FDA Commissioner Margaret Hamburg calling on the agency to “take regulatory action to address the rising health concerns around energy drinks.” Durbin’s request for an investigation followed his learning the story of Anais Fournier, a Maryland teenager with a heart condition who died last December of a cardiac arrhythmia allegedly linked to caffeine toxicity after drinking 48 oz of an energy drink in a 24-hour period.

According to public relations expert Brad Chase in an April 13 FOX News commentary, “It is human nature to search for someone or something to blame for such a tragedy.…But it’s a major overreaction to use this one story as evidence that the industry is irresponsible. Or that young Americans are incapable of controlling their intake of energy drinks.”

Elsewhere in Durbin’s letter to FDA, he cited FDA’s December 2009 draft guidance “Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods.” In a nutshell, this guidance-although not law-put makers of liquid supplements on notice that if their products resemble conventional beverages in name, size, or packaging, makers of these products may well be slammed for selling adulterated products based on the presence of any non-GRAS herbal ingredients and especially if caffeine levels are arguably high.

If It Quacks Like a Beverage…

“Well, I think the argument that Durbin’s office is making, and the general framework of the 2009 guidance regarding supplements versus beverages, is that these products that are being marketed and sold as supplements in 8-, 12-, 16-, and sometimes 20-oz containers are really ‘beverages in supplements clothing,’” said attorney Justin Prochnow in an interview with Nutritional Outlook. “The argument is that these products are only being marketed and sold as supplements to get around the GRAS and safety procedures for food and beverages, as opposed to the more liberal, and less restrictive, supplement ingredient parameters. They come in containers just like beverages, are often called energy ‘drinks’ and energy ‘beverages,’ and are identical to beverages other than the labeling with a Supplement Facts panel. FDA’s position in the 2009 guidance was that it will take a closer look and may determine that if something looks like a beverage and ‘quacks like a beverage,’ it’s a beverage.”

This is an about-face on FDA’s part, according to attorney Steven Shapiro. In a 2009 article for Natural Products Insider about the 2009 guidance, Shapiro wrote that in 2001, “FDA stated that a dietary supplement could have ‘physical attributes that are essentially the same as a conventional food.’ With this new guidance, it is obvious FDA has changed its collective mind.”

Case in point, consider the December 8, 2011, warning letter FDA sent to the makers of the Slowtivate Relaxation Drink, which contains melatonin. Never a fan of melatonin, FDA also likely focused on the use of the word drink in the product’s original packaging, as well as its quasi-beverage size of 8.5 oz. (The product is now called Slowtivate Relaxation Bliss Dietary Supplement.)

FDA may wish to enforce against energy drinks it believes should be regulated as conventional drinks. But could one argue that FDA is using draft guidance as a “poor man’s” approach to circumventing DSHEA?

Does FDA Have the Right?

FDA always takes care to state that any agency draft guidance simply reflects agency thinking and does not represent actionable law. However, are FDA’s guidance documents more truly expressions of how the agency would prefer that the law was written?

Moreover, could the agency use these relatively inexpensive warning letters as an enforcement tactic to scare whole categories of the industry into changing their practices in fear of more robust enforcement tools down the road? In this way, if industry reactively or preemptively changed how 99% of liquid supplements are labeled, marketed, and packaged, this may indicate that guidance documents do in fact convey the force of law or expressed regulation, even though they are supposed to be merely opinion.

“I think this is a great point,” said Prochnow. “I do believe that FDA publishes the guidance documents to purport to give a clear accounting of the law, with their definite viewpoints mixed in. While FDA does put a disclaimer at the beginning of each guidance document indicating that it is merely FDA’s viewpoint, it would be difficult for most people to discern what is a specific recounting of the law and what is FDA’s opinion of how the law reads. So, I think you are correct that FDA hopes that a large percentage of people will follow the guidelines set out in guidance documents-which cuts down on the resources that FDA has to expend to initiate enforcement actions.”

“I personally believe that FDA’s position in the draft liquid dietary supplement guidance is contrary to the clear language in DSHEA and earlier positions taken by FDA in Federal Register notices that promulgated the dietary supplement labeling regulations,” Shapiro told Nutritional Outlook. “If FDA attempts to enforce a position taken in the draft liquid supplement guidance that is contrary to the language set forth by Congress in DSHEA, it would be contrary to the law and open to challenge in court.”

What of Senator Durbin’s request? “Energy drinks are an easier target and Senator Durbin’s best opportunity to try to restrict the supplements industry,” says Prochnow. “Since he has failed at every turn to introduce new legislation to restrict the supplements industry, he has now turned to a public call for FDA to use current regulations to restrict supplements. The fastest way to do this would be for FDA to treat energy supplements as beverages, similar to the manner outlined in the warning letter on Slowtivate, and then to declare that the levels of caffeine in those products are not GRAS in a carbonated beverage. Otherwise, new legislation, as we know, is a time-consuming process, and it would be unlikely that anything could be done faster than a couple of years down the road.”

Moving forward, said Shapiro, “The industry needs to comply with DSHEA and market safe dietary supplements with claims that are based on sound science. If there are numerous reports of unsafe dietary supplements being sold, and people are being injured, then the opponents of DSHEA might use such incidents to promote an agenda that ‘guts’ DSHEA and makes it difficult or even impossible to sell many of the dietary supplements that are currently on the market.”

However, he added, while industry members need to remain vigilant that they are selling safe products, industry members also need to remember their rights, and the rights of FDA, under current law. “Perhaps the industry is becoming too complacent and has forgotten that it took a fight with FDA to get DSHEA in the first place. It has been many years since the dietary supplement industry regularly challenged FDA in court. But we need to remember that DSHEA came about, in large part, because industry was compelled to challenge FDA’s incorrect position in a number of courts...”

He advised, “If a company believes that its product is compliant with DSHEA, and it receives a warning letter or other FDA enforcement action based on a position taken in a guidance that is incorrect under the law, the company should object to FDA’s position-and if FDA continues in its enforcement, the matter will eventually come before a federal judge where hopefully the correct result will be achieved.”