Sen. Durbin plans to unveil a bill that seeks to undo key aspects of DSHEA and reign in functional foods and beverages. Melatonin brownies and energy drinks are seen as the instigators for his efforts. But does the bill go too far and could it even pass in today's Congressional climate?
Citing problems with the marketing and labeling of energy drinks and melatonin brownies, Sen. **** Durbin (D-Ill) announced on Tuesday, June 27, that he intends to introduce the Dietary Supplement Labeling Act this week mandating sweeping new regulations for the dietary supplements and functional foods industries.
"You can't make it to the cash register without encountering flashy advertising displays for energy supplements like Rockstar Energy Drink and 5-Hour Energy," Durbin said in a press release announcing the bill. "These products, which market themselves as dietary supplements that offer a boost of energy, are foods and beverages taking advantage of the less stringent safety standards for dietary supplements under current law."
Among other things, Durbin's bill would mandate the U.S. Food and Drug Administration (FDA) to:
• establish a definition for "conventional foods"
• require increased warning language on labels
• require manufacturers to register dietary supplements with the agency
According to executives from the supplement trade associations, the bill also includes other enhanced registration and labeling requirements the industry would consider either duplicative or excessive—especially given the relatively stellar safety record of supplements.
One fairly unprecedented aspect of the bill would require disclosure of the exact ingredient amounts of proprietary formulations. Would such a move strike at the heart of a company's intellectual property portfolio?
Absolutely, said Michael McGuffin, president of the American Herbal Products Association (AHPA). "It doesn't surprise me," McGuffin added. "**** Durbin, in his heart of hearts, would like to reduce back to tablets the dietary supplements class and try to roll back dietary supplements law to something he wishes it was, which is a limited choice of dietary supplements to consumers."
What is at stake Right in the crosshairs of the bill is the energy drink and energy shot market. According to Nutrition Business Journal estimates, U.S. consumer sales of energy drinks totaled $6.3 billion in 2010, while sales of the newer energy shot products hit $1.3 billion last year.
"Durbin lays out that energy drinks are little time bombs waiting to go off in the hands of consumers who don't understand what these products are, their dangers, their risks, and this is a travesty that requires federal regulation to fix," said Loren Israelsen, executive director of the United Natural Products Alliance (UNPA). "It's a fairly sexy headline."
Durbin identified the Drank beverage, which contains melatonin, as a product that, in his view, used loopholes in the regulatory structure to avoid FDA sanction. In response to a January 2010 FDA warning letter stating that melatonin was an unapproved food additive, the manufacturer of Drank relabeled the product as a dietary supplement.
"We don't want people producing things that are masquerading as supplements," said John Gay, executive director and CEO of the Natural Products Association (NPA). "We agree with him on that. But we certainly draw the line on saying that the entire supplements industry needs new regulations laid on top of it to address a small segment of the universe that should be addressed in large part through existing law."
"If this bill is the solution [to the problem of labeling of energy and relaxation beverages] it goes way beyond the problem it is focusing on," Gay added.
In announcing his intention to unveil this bill, Durbin also specifically called out 5-Hour Energy, the leading brand in the energy shot category. Current law states that such products are not to be represented as foods or beverages. To that end, these products contain a Supplements Facts box and not a Nutrition Facts box on the back of labels. (Representatives from 5-Hour Energy could not be reached for comment.)
According to McGuffin, products like energy shots conform to the letter of the law. "Congress intended us to sell supplement products in delivery systems other than pills or tinctures," said McGuffin. "They tolerate things like energy bars that are sold as dietary supplements."
Although the energy shot category is likely fine, what of energy drinks?
"That's a good question," said McGuffin. "Caffeine is GRAS for foods, vitamins and amino acids are food. If you're a functional food company marketing a food with a Nutrition Facts panel, you have to comply with food regulations. We have a broader list of ingredients we can sell in supplements. A company that tries to deliver dietary supplements in a food form must not represent the product as a food in order to comply with the law as it is today."
Timing, motives questioned
So why is Durbin releasing this bill now? According to UNPA's Israelsen, the senator's timing is concerning. FDA is mandated by the Food Safety Modernization Act (FSMA) to release its long-awaited New Dietary Ingredients (NDI) guidance document by July 3 or the next business day (180 days after the passage of FSMA). That document is expected to address many of the concerns raised by Durbin in terms of what ingredients should be subject to NDI filings, a process that focuses on safety.
"Here we are, all dressed up, ready to go the party, waiting to see what FDA comes up with," Israelsen said. "But—and this is my view—Durbin is saying he's going to head the NDI guidance off at the pass and make the discussion about how the industry can't be trusted."
The keen focus in Congress on the state of federal finances, while presumably not affecting the July deadline for NDIs, could still wreak havoc on the responsible part of the industry. That's because Congressional Republicans are looking to strip funding for the FSMA.
"We still have an affirmative obligation to abide by the law," said McGuffin. "If Congress takes money away for inspections, it doesn't mean I don't have to comply with the law. It means companies doing everything to comply will have no competitive advantage over less-conforming competitors because there are no inspectors.
Will the bill pass?
"Will it pass or not? I don't know," said Israelsen. "Is it a dangerous bill? Yes."
"The ideas are cruise missile shots at DSHEA, from a member of Congress who has the horsepower and the motive to advance the bill," he added.
Other observers see the current political climate in Washington, D.C., as being antithetical to the bill's chances. "Any bill with anything other than finances doesn't have a lot of interest in the 112th Congress," said McGuffin. "If Senator Durbin does not have a good range of co-sponsors, especially with our industry champions like Sen. Hatch, the likelihood of this passing is low."
Of course, even if the bill does not pass, Durbin will be able to use its creation and promotion to stir up headlines raising questions about the safety of dietary supplemetns, while also trumpeting his own position as a crusader for consumer safety.
Bottom line: Ingredients are safe
Despite assertions from Durbin and others, the vast majority of dietary supplements—and the ingredients that go in to them—are safe. All one has to do is look at data from FDA's Adverse Events Reporting system to see that.
According to AER data, the FDA received 33 reports of deaths associated with dietary supplements in 2008 and 2009. Of course, as McGuffin notes, association does not connote causation.
"One of the cases was an 80-year-old with cod liver oil in his medicine cabinet when he died, that got reported as an associated event," said McGuffin. "On the whole, the class of dietary supplement products is very safe. The FDA says there are 3,000 deaths a year caused by food-borne pathogens. There are more than 400,000 deaths associated with pharmaceutical drugs."