Senate Hearing Discusses Weight-Loss Supplements

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

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

Accompanying Levitt to the meeting was Christine Lewis Taylor, director of the office of Nutritional Products, Labeling and Dietary Supplements at CFSAN, and John Taylor, director of the office of enforcement at the FDA. Levitt discussed the Dietary Supplement Strategic Plan (DSSP), launched on Jan. 3, 2000, to implement the Dietary Supplement Health and Education Act (DSHEA) of 1994. DSSP was divided into six sections: safety, labeling, boundaries, enforcement, science base and outreach. In terms of "safety," Levitt reported CFSAN has "embarked on a significant effort to enhance its adverse event 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 and scope of the dietary supplement industry. He cited a survey by Prevention magazine, which reported 158 million U.S. consumers use dietary supplements. As a result, FDA provided Congress with a "Dietary Supplement Strategic Plan Cost Out," in which FDA estimated $95 million to $140 million would be needed to fully implement DSHEA as outlined in DSSP.

"The agency firmly believes that its DSSP will provide the necessary blueprint, using a phased-in approach, for a comprehensive program that will implement the additional regulatory responsibilities required of FDA by DSHEA," Levitt concluded.

Michael Mangano, principal deputy inspector general for the Department of Health and Human Services, under which FDA falls, concurred with FDA that the agency's current AER system is lacking. "Many of these shortcomings are due to the limited tools available to FDA regarding dietary supplements," he stated, adding that FDA receives limited information on products, manufacturers, clinical information, customer use and the alleged injured party, as well as has a limited ability to analyze trends.

The testimony turned to specific dietary supplements when Steven Heymsfield, M.D., professor of medicine at Columbia University, addressed the subcommittee. He stated that "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 are all needed in order to forestall or eliminate the problems now inherent with the dietary supplement category of weight-loss products," said Heymsfield, who has published research on Garcinia cambogia.

The subcommittee posed questions to AHPA's McGuffin such as "how does the supplement industry self-regulate and keep potentially dangerous, ineffective or contaminated supplements from being sold to consumers" and "what types of training, experience and certification are required to become a dietary supplement manufacturer?" McGuffin reported that organizations such as AHPA, the National Nutritional Foods Association and the Council for Responsible Nutrition engage in activities related to the safe use of uncontaminated supplements. He also mentioned FDA's cGMP (current good manufacturing practices) for training and certifying supplement manufacturers, but "no subsequent publication of a proposed rule for dietary supplement cGMP has been forthcoming" since it was published as an advanced notice of proposed rulemaking on Feb. 6, 1997 in FDA's Federal Register.