New Bill Demands FDA Enforce DSHEA

Originally Published NO June 2010

New Bill Demands FDA Enforce DSHEA

Senators Orrin Hatch (R–UT) and Tom Harkin (D–IA) introduced a new bill on May 25 that demands the Food and Drug Administration (FDA; Washington, DC) implement the regulatory powers provided by the Dietary Supplement Health and Education Act (DSHEA) of 1994. Called the Dietary Supplement Full Implementation and Enforcement Act of 2010 (DSFIE), the new bill would require that FDA receive increased sums of money to aid enforcement: at least $20 million in 2010, $30 million in 2011, and such sums as may be necessary for the remaining three years of the bill's term.

The bill calls on FDA to increase inspections of dietary supplement facilities to ensure they are compliant with good manufacturing practices (GMPs) and implement an annual registration process for supplement manufacturers, packers, and distributors.

A crucial part of the bill also asks FDA to finally establish clear guidelines for new dietary ingredients (NDIs). Without a process in place for companies to submit NDI notifications, FDA has been hampered in its ability to enforce against supplements that illegally contain unapproved substances.

Also along these lines, the bill asks that FDA and the Drug Enforcement Administration (DEA) communicate better to prevent anabolic steroids from being illegally marketed in dietary supplements.

FDA would also need to submit annual reports to Congress detailing the number of dietary supplement manufacturers that have been inspected for GMPs, the number of NDI notifications it reviewed, and a summary of all enforcement actions taken in relation to 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," says Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD).

The dietary supplements industry has often had to defend itself against the misconception that dietary supplements aren't regulated. Industry representatives point out that the creation of DSHEA in 1994 gave FDA powers to regulate the industry and police illegal activity, but that FDA has not fully utilized its powers.

FDA itself has in the past conceded that it has been unable to enact all of DSHEA's provisions. At the Council for Responsible Nutrition's (CRN; Washington, DC) annual meeting last fall, FDA principal deputy commissioner Joshua Sharfstein, MD, told industry members, "Some of the tools have been available for a while, but FDA can't get to [them] due to lack of resources."

Industry representatives, including CRN and AHPA, have voiced strong support for the new bill, having long advocated for the extra resources and funding that it provides.

The bill serves as an alternative to the Dietary Supplement Safety Act, legislation proposed by Senator John McCain (R-AZ) in February before he withdrew support in March. McCain's legislation did include similar provisions, such as requiring FDA to finalize guidance on NDIs, but it carried other provisions that industry members called too severe, such as requiring the reporting of all adverse events (even minor ones) related to supplements.

DSFIE is now positioned as the newest hope for improved dietary supplement regulation.