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Agreement reached on dietary supplement legislation

Sen. John McCain, R-Ariz., and Sen. Byron Dorgan, D-N.D., have withdrawn support of their proposed Dietary Supplement Safety Act, saying they would instead work to incorporate key provisions of the bill into other legislation.

The senators introduced the supplement safety bill in February, citing football players who tested positive for a substance banned by the National Food League after using dietary supplements the athletes said they believed were safe and legal. The legislation would have required dietary supplement manufacturers to register with the Food and Drug Administration and fully disclose the ingredients contained in the supplement. The bill also gave the FDA recall authority. McCain said the legislation was necessary so consumers would know the exact ingredients of dietary supplements they use.

But earlier this month McCain and Dorgan said they would instead propose incorporating key provisions of their bill into the Food Safety Modernization Act. They sent a letter to Sen. Tom Harkin, D-Iowa, and chairman of the Senate Committee on Health, Education, Labor and Pensions; Michael Enzi, R-Wyo., a committee member; and Sen. Orrin Hatch, R-Utah, saying they had found “common ground” on certain issues and would work together on four areas:

Require all dietary supplement manufacturing, processing and holding facilities to register with the Secretary of Health and Human Services.

  • Ensure the FDA has the authority to issue a mandatory recall if there is a reasonable probability that any dietary supplement is adulterated or misbranded or use of the supplement could cause serious health consequences such as death

  • Require the FDA commission to publish guidelines on new dietary ingredients.

  • Mandate that the FDA notify the Drug Enforcement Administration when a newdietary ingredient premarket notification is rejected because the product contains a synthetic anabolic steroid.

Travis Tygart, CEO of the nonprofit U.S. Anti-Doping Agency, headquartered in Colorado Springs, Colo., called the provisions “needed improvements. The agreement provides much-needed additional consumer protections without risking access to legal supplements.”

In a statement, Steve Mister, president and CEO of the Washington, D.C.-based Council for Responsible Nutrition, a trade group for the dietary supplement industry, praised the withdrawal. “We are gratified to learn that Senator McCain will withdraw his original legislation and plans to work with Senators Hatch, Enzi and Harkin to develop legislation that will take a more measured, constructive approach to address his concerns regarding outlier products that contain illegal substances. CRN appreciates Senator McCain’s receptiveness to the industry’s very real and very serious concerns about (the Dietary Supplement Safety Act) and our inability to support his bill.”

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