In the statement, McCain said: “Opponents have stated that the legislation would seek to limit consumers’ ability to purchase dietary supplements, vitamins, or prescription drugs. That is completely false…. If you take a vitamin now, this bill will in no way restrict your ability to take that vitamin.”
Senator McCain’s Bill 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.
It has drawn heavy criticism from industry which criticized it for being unnecessary, reactionary, regressive and potentially destructive of a healthy industry and the Dietary Supplement Health and Education Act (DSHEA) that governs it.
Senator McCain however said his Bill had been miscast and stated: “Opponents also claim the bill establishes a new regulatory structure for dietary supplements. That is completely false.”
Responding, the Alliance for Natural Health-US (ANH-US) said: “The broad regulatory framework for supplements at the moment is provided by DSHEA. McCain’s bill guts the protections provided by DSHEA and gives the FDA complete and arbitrary authority. If that isn’t a new regulatory structure, what is?”
The ANH-US pointed to Association of Poison Control Centers statistics that showed there were no dietary supplements-related deaths in 2008, the last year on record, despite claims from McCain that, “people have died from taking dietary supplements… and thousands have had to be hospitalized…”.
The bill can be found here .
Robust enforcement needed
Criticism of the Bill included that from founder and executive director of the American Botanical Council, Mark Blumenthal, who stated:
“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. 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.
US Anti-Doping Agency chief executive officer 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."