HBO aired the program on Tuesday, May 19 at 10 p.m. ET
Washington, D.C., May 21, 2015 – The Natural Products Association (NPA) is the leading representative of the dietary supplement and natural products industry. NPA CEO and Executive Director Daniel Fabricant, Ph.D., former director of the Dietary Supplements Division at the Food and Drug Administration (FDA), comments on HBO’s Real Sports segment of 5-19-15 attempting to link “Orrin Hatch’s dietary supplement legislation to military fatalities.” NPA is expecting our rebuttal to be published in the Salt Lake Tribune. We will provide that update in the near future and respond appropriately through additional media outlets.
Bill Clinton, Ted Kennedy and Tom Harkin Supported FDA Dietary Supplement Regulation and Enforcement that Some Say Doesn’t Exist
Here we go again. HBO Real Sports with Bryant Gumbel is the latest to jump on the bandwagon with those falsely claiming that dietary supplements are unregulated. The Salt Lake Tribune suggests that there have been “ongoing attempts to limit the supplement industry from being regulated.” It may make for sensational media coverage posing as investigative reporting, but it is far from being accurate.
Dietary supplements are regulated, which can easily be found on the U.S. Food and Drug Administration’s (FDA) website, HERE. In addition, bipartisan majorities in the Congress have updated and modernized the rules several times since then with important new consumer safety protections and stringent requirements for manufacturers. As the nation’s largest association of dietary supplement manufacturers, retailers, and distributors, we reached out to HBO repeatedly to explain these enforcement mechanisms, but no one bothered to return our calls.
DMAA, the ingredient the HBO story suggests was responsible for the tragic fatalities despite an official Department of Defense review that concluded otherwise, was one I dealt with directly as one of the nation’s top enforcement officials for dietary supplements at the FDA from 2011 to 2014. In 2013, we declared that DMAA was illegal and immediately instructed companies manufacturing DMAA to remove any products containing the ingredient from the market. At the same time, we recalled and destroyed $22 million worth of illegal products manufactured by USPlab’s OxyElite Pro, one of the companies that was manufacturing illegal products containing DMAA. Those who broke the law were punished. We took action.
That is just one example. Our investigations into other products also sent criminals to jail. John Edward Mullikin, who was falsely promoting a weight loss product, is now serving time in a federal prison after being sentenced in June, 2013. These are just two examples of how FDA enforced the law during my tenure.
Unfortunately, snake oil salesmen are as old as the American West. But there are two key differences between then and now. Today’s con artists use the internet to showcase their “miracle” products, rather than a stage show from the back of a colorful horse-drawn carriage. And more important, today’s con artists can be fined and jailed for scamming or hurting the American public, because they are breaking the law. The government can also seize illegal products and have them removed from the marketplace.
There is no question that some products posing as supplements on the Internet today are illegal, potentially harmful, adulterated, and misbranded – especially in the areas of fitness, weight loss, and sexual performance. This is criminal activity which should be prosecuted to the full extent of the law. But that does not mean that the supplement industry is unregulated, nor does it mean that the current regulatory framework is ineffective.
It also doesn’t mean that a single Senator – yes, one Senator! – is solely responsible for the entire federal government’s regulatory enforcement of the industry. Senator Orrin Hatch (R-UT) is certainly an influential and skilled legislator who played a leading role in crafting the rules governing the industry, but even he would concede that it takes more than one Senator to enact major consumer safety legislation for a product that millions of Americans use every day as part of a balanced and healthy lifestyle.
This is exactly the point. All of the critics who conveniently ignore the past 20 years of federal oversight of this industry are also ignoring the fact that former President Bill Clinton, Senators Edward Kennedy (D-MA) and Tom Harkin (D-IA), and Congressman John Dingell (D-MI) – what many would consider a pantheon of consumer safety advocates – supported the law. I guess these Democrat Hall-of-Famers are just pawns of the dietary supplement industry, too.
In our system of constitutional government, it also takes a President to enact legislation. President Clinton said the new rules were “common sense” legislation that “treats consumers and these supplements in a way that encourages good health” when he signed the bill into law.
In conclusion, we feel compelled to reassure consumers that the vast majority of products they use every day, often at the advice of their doctor or medical professional, are safe and part of a balanced healthy lifestyle. And legitimate and respected manufacturers continue to do their part to improve quality and safety. The Natural Products Association, where I currently serve as CEO and Executive Director, recently launched a collaborative program with Underwriters Laboratories to provide additional training to manufacturers and a logo for those who have completed UL certification, giving consumers additional confidence that their vitamins and supplements are safe.
So yes, Virginia, dietary supplements are regulated by the federal government—and quite effectively so. Millions of Americans who take them safely each and every day are the best living proof.
Dan Fabricant is the former head of the Dietary Supplement Division at the Food and Drug Administration and currently serves as CEO and Executive Director of the Natural Products Association in Washington, DC.