Friday, October 09, 2009

Baseball gets dietary supplement regulation back in the game

In part due to Major League Baseball, members of Congress are re-considering how the $25 billion U.S. dietary supplement industry is regulated.

Last week, the Senate Judiciary Committee Subcommittee on Crime and Drugs heard testimony on whether current laws and regulations are sufficient to protect consumers from ingredients that may appear in supplements, but not on their labels. The interest of Chairman Arlen Specter (Dem-PA) is due in part to the court case of Philadelphia Phillies pitcher J.C. Romero, who was suspended for 50 games this year after testing positive for a banned substance. Earlier this year, Romero sued the manufacturer of an over-the-counter supplement, blaming the company for his suspension on the claim that it misrepresented ingredients in its products.

Under current law, no government agency evaluates the contents of dietary supplements to confirm the presence of ingredients listed on the label (or to discover those unlisted). Furthermore, dietary supplement manufacturers do not have to prove the safety or efficacy of the product to gain Food and Drug Administration approval prior to marketing. Rather, companies must submit some evidence that the product has a history of use or benefit 75 days before selling it. The safety burden falls on the FDA: if it believes a supplement to be unsafe it must demonstrate the public health risk in court. NYU nutrition professor Marion Nestle covers the history of this issue in detail in her book, Food Politics, as well as on her blog.

In his testimony, Michael Levy, the Director of the Division of New Drugs and Labeling Compliance at the FDA, describes this as, “a painstaking investigative and analytical process to show that [the products] are violative.” He states that the process can take many months, during which the product in question remains on the market, limiting the FDA’s ability to effectively protect consumers.

The largest trade association for the natural products industry, the Natural Products Association, also supported stricter enforcement of supplement contents. However, rather than questioning the effectiveness of current procedures, Interim Executive Director Daniel Fabricant called for increased money and manpower to enforce current law. He argues that sufficient resources would enable the FDA to pursue a larger number of investigations and court cases.

Batting averages are not the only outcomes at stake in this regulatory debate. Use of steroid-like compounds has been associated with kidney failure, liver injury, and stroke.

It will be interesting to see how the debate unfolds. The Major League Baseball Players Association is reported to be lobbying Congress to require that a federally certified lab analyze all supplements to identify the ingredients that should be listed on the label. Professional athletes may hit a regulatory home run that consumer safety advocates have sought for more than a decade.

Written by Natalie Valpiani, a graduate student at the Friedman School of Nutrition Science and Policy at Tufts. Cross-posted from a University of North Carolina food seminar blog, Eats 101.


Anonymous said...

Don't hold your breath

It is not a coincidence that Orin Hatch carefully crafted DSHEA to essentially reduce if not remove FDA oversight of nutraceuticals and that a number of major nutraceutical manufacturers are located in Utah.

Dietary Supplements

From his website:

"1994: With the Dietary Supplement Health and Education Act (DSHEA) (P.L. 103-417), Hatch guaranteed Americans’ access to safe dietary supplements while providing a framework for the FDA to remove harmful substances from the market. Until this law, the Food and Drug Administration frustrated those who wanted better access to vitamins, herbs, and minerals. Supplements play a critical role in the health and well-being of more than 100 million Americans, many of whom are in Utah, where supplements are a thriving industry."

Harkin, as a long time supporter of complementary and alternative medicine "woo", and Hatch are long time collaborators in this effort.

Harkin Takes Aim At Efforts To Undo DSHEA

Search the ScienceBlogs with the term "DSHEA" for more of the story.

Anonymous said...

Much more of the DSHEA story on this blog post:

Will the government ever regulate dietary supplements?