May 25, 2010
Senators Tom Harkin (D-IA) and Orrin Hatch (R-UT) unveiled new proposed legislation on May 25 that would give the U.S. Food and Drug Administration (FDA) more muscle to effectively enforce longstanding provisions of the Dietary Supplement Health and Education Act (DSHEA) of 1994. The bill asks Congress to give at least $20 million to FDA for DSHEA enforcement.
The bill includes other provisions designed to address issues that have frustrated supplement companies attempting to navigate the intricacies and ambiguities surrounding DSHEA and its enforcement. For example, the bill mandates that FDA provide industry with guidance on existing rules that apply to new ingredients, according to a press release from the American Herbal Products Association (AHPA). In addition, it requires FDA to submit to Congress an annual accountability report including information on the number of dietary supplement manufacturers inspected under FDA’s Good Manufacturing Practice (GMP) regulation, the number of new dietary ingredient (NDI) notifications reviewed, a brief summary of all enforcement actions taken in relation to dietary supplements, and other specific data related to the agency’s regulation of dietary supplements, AHPA reports.
“Such an annual accountability report to Congress will provide a written record of FDA’s continuing regulation of dietary supplements,” said AHPA President Michael McGuffin. “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.”
Like AHPA, the Council for Responsible Nutrition has come out in support of the bill. “DSHEA was enacted to ensure consumers have access to beneficial, high quality supplement products,” Steve Mister, president and CEO, said in a statement. “It also provides an important regulatory framework that safeguards the general public from adulterated, mislabeled or harmful products. Many of the challenges our industry continues to face can be attributed to the lack of enforcement of these basic tenets of DSHEA. CRN believes this legislation will go a long way to demonstrate that DSHEA works and to reinforce the safety, quality and benefit of supplement products to the public.”
The NBJ bottom line: Many players in the dietary supplement industry will view this news with a sigh of relief. The threat of more draconian legislation remains throughout the global supplement industry—witness Europe’s Nutrition and Health Claims Regulation that has effectively shut down the pipeline of new functional ingredients seeking a health claim—but, in the United States, the industry’s champions in Congress are committed to fixing the current law instead of reinventing it. This is a “lesser of all evils” option that will hopefully allow the legitimate supplement companies to differentiate themselves and add credibility across the industry.
Related NBJ links: