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Proposed bill would modify supplement regs, alter DSHEA, Food Drug & Cosmetic Act

Senator John McCain (R-AZ), flanked by a crew of celebrity athletes from the sports of skiing, swimming, cycling, baseball and football, today introduced legislation to add stringent guidelines for dietary supplements as part of a new bill called the Dietary Supplement Safety Act of 2010. The proposed Act is a legislative extension of the US Anti-Doping Agency's Supplement Safety Now campaign, which is designed to clean up problems with illegal steroids and drugs being sold as dietary supplements.

To listen to a podcast conversation with Steve Mister, CEO of the Council for Responsible Nutrition, on this story, go here.

"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," said USADA CEO Travis T. Tygart. "We are grateful to Sen. McCain for his strong leadership on this public health issue and urge other members of Congress to support this bill."

A statement on the US Olympic Committee Website added that the bill "would go a long way in protecting Americans from consuming tainted over-the-counter supplement products labeled as 'healthy’ but containing designer steroids and other dangerous drugs."

If approved as is, the bill would require changes in adverse events reporting, facility registration, policing responsibility on the part of retailers and remove the grandfather clause from DSHEA for ingredients introduced before October 15, 1994, replacing it with a new list of "accepted dietary ingredients," to be determined by the Secretary of Health and Human Services office.

Some industry members are uncertain to how the proposed bill will prevent criminally-minded companies from illegally selling drugs as supplements. Time will tell whether the bill would "avoid placing unreasonable burdens on legitimate companies," as USADA maintains.

"Our industry has long supported efforts to remove the relatively few bad actors who market adulterated products. We have advocated for additional enforcement funds for regulators, and for giving regulators additional authority to act. What we cannot support is wholesale changes to a regulatory structure that is working, and could work better if the measures we have supported were adopted. A series of new laws for criminals to ignore is not the answer. Some seek to paint with an awfully broad brush. For example, the idea that the 150 million Americans who use dietary supplements are gambling with their health by shopping at mainstream stores just doesn't stand up to scrutiny. Hyperbole does not lead to sound policy," said John Gay, executive director and CEO of the Natural Products Association (NPA), in a statement.

The Council for Responsible Nutrition says they support most of the recommendations for changes to industry regulations put forth in a 2009 GAO report. These include annual registration for dietary supplement facilities as well as mandatory recall authority for FDA, citing these provisions as part of the Senate Food Drug and Administration Food Safety and Modernization Act, S.510 (which is under review).

But the proposed bill takes regulation to a whole new level. For example, all adverse events, both serious and minor, would need to be submitted to FDA annually.

"We do not believe that requiring manufacturers to report all adverse events—not just serious adverse events—would do anything to protect consumers. Instead, it could do the opposite by stretching the Agency beyond its limits. FDA itself has stated that this would overburden the Agency and would not help protect consumers. The best way to help consumers is through collaborative efforts with industry, government and other stakeholders, such as USADA, 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," said Steve Mister, President and CEO of CRN.

Even small changes can have unintended consequences, such as straining FDA resources. One seemingly minor change would require dietary supplement companies to register their facilities yearly as do food companies. While facility registration would be required by FDA, a burden could be placed on retailers to confirm documentation from manufacturers, who must in turn have confirmation from their supplier that they are also in FDA compliance.

The issue raises questions about how well FDA can manage such a process when a recent OAG report showed that as many five per cent of selected food facilities failed to register with FDA and as many as 52 per cent of the food facility managers reported that they were even not aware of FDA's registry requirements.

The bill would also replace the definition of "New Dietary Ingredients" (NDI). Under the Dietary Supplement Health and Education Act (DSHEA), an NDI is any ingredient marketed in the United States after October 15, 1994. The new bill would replace NDIs with a new list of ingredients called "Accepted Dietary Ingredients."

The list would be prepared, published and maintained by the office of the Secretary of Health and Human Services. As such an NDI would be any ingredient that doesn't end up on the ADI list. According to the bill, revisions could be made to the current NDI process in that even ingredients that are presently used in food and would used for the first time in a supplement are subject to notification.

Lastly, the bill would give FDA mandatory recall authority. FDA would issue a cease-distribution order if it determines that there is a "reasonable probability that a dietary supplement or a product marketed or sold as a dietary supplement would cause serious, adverse health consequences or death, or is adulterated or misbranded." At present FDA has authority to do so only for certain medical devices.

For more, see these stories:

Podcast: New regulations could upend industry

Todd RunestadDietary Supplement Safety Act of 2010 Q&A with Steve Mister, CEO of Council for Responsible Nutrition.

Listen to the podcast...

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