Senate Hearing Discusses Weight-Loss Supplements 34025

Senate Hearing Discusses Weight-Loss Supplements

WASHINGTON--The Senate Subcommittee on Oversightof Government Management, Restructuring and the District of Columbia, headed bySen. Dick Durbin (D-Ill.), met July 31 in a hearing titled "When Diets TurnDeadly: Consumer Safety and Weight-Loss Supplements." Various stakeholdersin the dietary supplement industry met with the panel to answer questions thesubcommittee had given to them prior to the hearing.

Witnesses who testified before the subcommittee included JosephLevitt, director of the Center for Food Safety and Applied Nutrition (CFSAN) atthe Food and Drug Administration (FDA), and Michael McGuffin, president of theAmerican Herbal Products Association (AHPA).

Accompanying Levitt to the meeting was Christine Lewis Taylor,director of the office of Nutritional Products, Labeling and Dietary Supplementsat CFSAN, and John Taylor, director of the office of enforcement at FDA. Levittdiscussed the Dietary Supplement Strategic Plan (DSSP), launched on Jan. 3,2000, to implement the Dietary Supplement Health and Education Act (DSHEA) of1994. DSSP was divided into six sections: safety, labeling, boundaries,enforcement, science base and outreach. In terms of "safety," Levittreported CFSAN has "embarked on a significant effort to enhance its adverseevent reports [AERs]" through the CFSAN Adverse Event Reporting System (CAERS),which received $2.5 million in funding in fiscal 2002.

Levitt mentioned there have been many changes in the size andscope of the dietary supplement industry. He cited a survey by Preventionmagazine, which reported 158 million U.S. consumers use dietary supplements. Asa result, FDA provided Congress with a "Dietary Supplement Strategic PlanCost Out," in which FDA estimated $95 million to $140 million would beneeded to fully implement DSHEA as outlined in DSSP.

Michael Mangano, principal deputy inspector general for theDepartment of Health and Human Services, under which FDA falls, concurred withFDA that the agency's current AER system is lacking. "Many of theseshortcomings are due to the limited tools available to FDA regarding dietarysupplements," he stated, adding that FDA receives limited information onproducts, manufacturers, clinical information, customer use and the allegedinjured party, as well as has a limited ability to analyze trends.

The testimony turned to specific dietary supplements when thecommittee was addressed by Steven Heymsfield, M.D., professor of medicine atColumbia University, who has published research on Garcinia cambogia. He stated,"We can envision two types of dietary supplements exist for weight loss:one that is safe and ineffective and another that is effective but unsafe.Improved product safety testing, quality control, labeling and nomenclature areall needed in order to forestall or eliminate the problems now inherent with thedietary supplement category of weight-loss products."

The subcommittee posed questions to AHPA's McGuffin, such as"How does the supplement industry self-regulate and keep potentiallydangerous, ineffective or contaminated supplements from being sold toconsumers" and "What types of training, experience and certificationare required to become a dietary supplement manufacturer?" McGuffinreported that organizations such as AHPA, the National Nutritional FoodsAssociation and the Council for Responsible Nutrition engage in activitiesrelated to the safe use of uncontaminated supplements. He also mentioned theproposed feneral cGMPs (current Good Manufacturing Practices) for training andcertifying supplement manufacturers, but "no subsequent publication of aproposed rule for dietary supplement cGMPs has been forthcoming" since itwas published as an advanced notice of proposed rule-making on Feb. 6, 1997, inFDA's Federal Register.