FDA Oversight of Dietary Supplements Criticized at Senate Hearing
At a Senate Committee on Commerce, Science and Transportation hearing on Tuesday, senators criticized the FDA for not taking a "harder regulatory stance" against some dietary supplement products and pushed for the agency to increase enforcement efforts against products that are known health risks, the Los Angeles Times reports. The FDA classifies dietary supplements as food and does not require them to meet the same standards as prescription drugs. Under the 1994 Dietary Supplements Health and Education Act, supplements can enter the market without FDA approval, and manufacturers are not required to inform the FDA of any adverse affects that are associated with supplements. "There is no excuse for a supplement manufacturer to market products that are unsafe or inaccurately labeled or that make outlandish claims," Sen. Orrin Hatch (R-Utah), a co-sponsor of the 1994 law, said. He added, "Unfortunately, a small number of irresponsible supplement companies are taking advantage of consumers." Hatch and Sen. Tom Harkin (D-Iowa) have proposed a measure that would give the FDA additional funds to "more aggressively pursue manufacturers of the products that cause concern," such as ephedra, which has been linked to seizures, heart attacks and deaths, the Times reports. "The FDA simply does not have the staff to do its job. I say Congress should remedy that," Hatch said (Govindarajan, Los Angeles Times, 10/29). Committee Chair John McCain (R-Ariz.) "repeatedly made clear" his "unhappiness" with FDA inaction on dietary supplements, but he did not indicate his plans, CongressDaily/AM reports (Rich, CongressDaily/AM, 10/29). "We're always playing catch-up. We're playing catch-up rather than assessment," McCain said. Sen. Richard Durbin (D-Ill.), who has introduced a bill that would require manufacturers to report any adverse health affects to the FDA, asked, "Did anyone imagine we would be selling these witches' brews of chemicals that no one has tested?"
John Taylor, FDA associate commissioner for regulatory affairs, testified that the agency is in the process of determining whether dietary supplements should have labels that "clearly state" their ingredients and their amounts, but he did not say how long it would take to reach a decision, the Times reports. The Times reports that the FDA is also working with the Federal Trade Commission, which has prosecuted dietary supplement manufacturers that have engaged in false advertising (Los Angeles Times, 10/29). Dr. Arthur Grollman, a professor of pharmacological sciences and experimental medicine at the State University of New York at Stony Brook, testified that the 1994 dietary supplement law "freed the dietary supplement industry from effective oversight by the FDA by transferring the burden of proof" for establishing dietary supplement safety "away from the manufacturer and to the FDA." However, David Seckman of the National Nutritional Foods Association testified, "There is no issue with dietary supplements, be it safety, efficacy or quality, which cannot be addressed under the current regulatory and legal framework" as long as the FDA gets enough funds to "fully implement the law" (CongressDaily/AM, 10/29).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.