Give FDA more bite, Senate hearing told as DSHEA Implementation Bill is reintroduced

By Shane Starling

- Last updated on GMT

Related tags Dietary supplement Dietary supplements United states senate Food and drug administration Congress

Council for Responsible Nutrition (CRN) chief Steve Mister will tell a Senate Special Committee on Aging meeting today that the dietary supplements industry is adequately regulated, but the FDA requires more funding to police it.

The CRN’s chief executive officer and president will give testimony from a statement co-signed by the other major trade groups – the American Herbal Products Association (AHPA); the Consumer Healthcare Products Association (CHPA); the Natural Products Association (NPA); and the United Natural Products Alliance (UNPA).

The hearing will discuss supplements safety and marketing and coincides with the reintroduction to Congress of a 2003 Bill by Senators Orrin Hatch and Tom Harkin that requests about $20m in increased funding over five years to better implement the 1994 Dietary Supplements and Health Education Act (DSHEA).

Ideal opportunity

Mister told the meeting, at which a Government Accountability Office (GAO) report into herbal supplements will be presented, would provide an ideal opportunity to educate Congress about dietary supplement issues that went beyond concerns for the elderly.

The meeting begins at 2pm and will be webcast live here.

“We are expecting a good reception and are glad to have the opportunity to educate committee members and their staff about what DSHEA does,” ​Mister said. “This is vital when you consider that most people in Congress were not around when DSHEA came to be in 1994.”

The deputy commissioner of the Food and Drug Administration (FDA) Dr Joshua Sharfstein will also testify that the FDA requires further funding boosts to continue its increased policing efforts that have been noticeable under the Obama administration.

Mister said the fact supplements and foods both fell under the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), meant every time there was a food scare funds were siphoned from the pool that could be used to better police and regulate the supplements industry.Hence more funding was required.

The Dietary Supplement Full Implementation and Enforcement Act of 2010

In addition to calling for boosted resources, Hatch and Harkin’s Bill – the Dietary Supplement Full Implementation and Enforcement Act of 2010 – calls for the FDA to annually report to Congress, something backed by industry groups.

Dan Fabricant, the NPA’s vice president of scientific and global government affairs, echoed industry sentiments when he said: “The McCain Bill went too far in the demands it made of responsible players in this industry, but Senator Hatch and Harkin’s Bill increases facility inspections and requires the FDA to explain to Congress what it is doing.”

AHPA President Michael McGuffin said: “Such an annual accountability report to Congress will provide a written record of FDA’s continuing regulation of dietary supplements. Building a collection of facts and figures related to FDA’s enforcement of DSHEA is key to setting the record straight when it comes to the regulation of this class of goods.”

But it is unknown how much traction the Bill is likely to gain in Congress.

Other speakers at the Senate hearing are Greg Kutz, the head of the Government Accountability Office Forensic Audits and Special Investigations; Dr Tod Cooperman, the president of third party product testing agency,; and Charles Bell, programs director at Consumers Union.

The GAO report was leaked to the New York Times​ which said it pointed out many supplements were contaminated with mercury, cadmium and arsenic but not to levels dangerous to human health.

The FDA's Sharfstein has said he is not concerned about the safety of dietary supplements.

It also published results of a secret shopper campaign that showed dietary supplement misinformation was sometimes given out by staff in retail outlets.

“While the findings of the GAO may be explained by turnover common in the retail sector, or by new retailers entering the market unaware of their obligations; any violation of the law is not acceptable,”​ said NPA chief John Gay in a statement.

Related topics Regulation

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