Industry groups and legal experts have condemned the Dietary Supplement Safety Act of 2010 as an unnecessary threat to existing legislation that is already empowered to ensure dietary supplements in the United States are safe.
The Council for Responsible Nutrition (CRN); Natural Products Association and the American Herbal Products Association (AHPA) all issued statements criticizing the Bill.
Introduced by Republican Senator John McCain of Arizona and Byron Dorgan of North Dakota the Bill seeks to amend the Federal Food, Drug, and Cosmetic Act, “to more effectively regulate dietary supplements that may pose safety risks unknown to consumers”.
Industry has attacked it for being motivated by false premises such as an over-estimation of the problem of sports contamination, and for stepping on the toes of a regulation (the 1994 Dietary Supplements and Health Education Act) that already provided measures to address the issues raised by the Bill.
“This bill is not only unnecessary, it is regulatory overkill,” said Virginia-based attorney, Jonathan W Emord.
It requires companies to report non-serious adverse events to the Food and Drug Administration (FDA); gives immediate recall rights over products suspected of contamination; creates an Accepted Dietary Ingredients list in place of New Dietary Ingredients provisions and demands all facilities to register on a list annually.
The bill can be found here .
Robust enforcement needed
The founder executive director of the American Botanical Council, Mark Blumenthal, added adequate implementation of DSHEA was required, not a new set of regulations that will do little to address the problems at hand.
“It is understandable why legislators and others might feel the need to hold hearings and propose additional legislation to attempt to prevent or correct some of the problems in the dietary supplement industry,” he said.
“This includes the need to address problems of poor quality, intentional adulteration, exaggerated and unsubstantiated claims, and other excesses that exist in some pockets of the industry.”
He said the fact DSHEA had not in 15 years been, “adequately, uniformly, fully, and robustly enforced” fuelled the creation of such a Bill, but observed, “what is really needed is robust enforcement of existing laws and regulations, not more laws.”
A host of major sporting bodies including the National Football League (NFL) and Major League Baseball (MLB) have thrown their weight behind the Bill after Senator McCain said one of the motivations for introducing it was to combat contamination of sports supplements.
“[The Bill] places new burdens on dietary supplements that are not required for any other class of food,” said Michael McGuffin, president of the American Herbal Products Association (AHPA).
“And at least in the case of the proposed policing responsibility for retailers, it appears to be more stringent than retailer requirements under current drug laws.”
Daniel Fabricant, PhD, the NPA’s vice president for scientific and regulatory affairs, said the current political climate in Washington made it difficult to predict how the Bill might be received on Capitol Hill.
“I think such a bill has a better chance of being tacked onto another bill as a floor amendment than being a standalone piece of legislation, so it will be monitored accordingly,” he said, noting industry had to respond to the challenge and up its efforts in defense of DSHEA.
He defended the industry against the scapegoating that has gone on from the likes of professional athletes and associations that have blamed certain transgressions on dietary supplements when other factors may have been involved.
“Let us not forget that a number of athletes have lied or withheld information on their steroid use when they testified in front of both the house and senate,” he told NutraIngredients-USA.com.
“The sporting leagues' failures to correct their drug testing policies should have no affect on the millions of Americans who safely and successfully use a supplement daily.”
You cannot be serious
On the matter of non-serious adverse event reporting (AER), CRN president and chief executive officer, Steve Mister, said an obligation to report non-serious AERs could be counterproductive as it may stretch FDA resources beyond breaking point.
“The best way to help consumers is through collaborative efforts with industry, government and other stakeholders, such as USADA (US Anti-Doping Agency), to implement the current laws, to provide more resources and funding to FDA, and to pass the food safety bill, which already includes many of these provisions,” he said.
Emord said a requirement to report non-serious adverse events was “laughable”.
“If it is not serious why bother?” he wondered, noting ‘seriousness’ had not been defined. “Is it when the vitamin bottle drops to the floor and the cat eats every one?”
“We are now likely to have a deluge of filings to the FDA, inundating it with non-serious junk mail that will overwhelm it and render it difficult to find all serious adverse event reporting.”
He added: “I think it is fair to say that this bill is Orwellian. It is more like 1984 than anything a Democratic member of Congress has produced. John McCain has outflanked his most liberal Democratic counterparts.”
USADA CEO Travis T Tygart stated: "The McCain bill is a fair and balanced approach that provides significant protections for all consumers of dietary supplements, while at the same time avoids placing unreasonable burdens on legitimate companies in the industry. We are grateful to Senator McCain for his strong leadership on this public health issue and urge other members of Congress to support this bill."