The GAO released a 77-page audit report today critical of the FDA’s efforts to protect consumers from dangerous diet supplements. Since manufacturers became required to report adverse events, well-known to be underreported even in the best of circumstances, the FDA has seen a three-fold increase in the number of adverse events reported. Over 948 adverse event reports were received, and 596 of them were mandatory reports submitted by industry. Those included 9 deaths, 64 life-threatening illnesses, and 234 hospitalizations. Once underreporting is accounted for, the FDA estimates that the true number of adverse events exceeds 50,000 adverse events. The audit was conducted at the request of Congressman Henry Waxman, and several other members of Congress.
The GAO ticked off the items we know already: that the FDA should request more power from Congress to regulate the diet supplement industry, that the FDA can’t require that a company remove tainted supplements from the marketplace, that the public does not know there has been no testing of the products for safety and efficacy, and that manufacturers should register with the FDA and disclose the specific supplements and ingredients to the agency. We certainly know that “consumers remain vulnerable to risks posed by potentially unsafe products.”
Key Events in the Regulation of Dietary Supplements
The Nutrition Labeling and Education Act of 1990 amended the Federal Food, Drug, and Cosmetic Act to require most foods, including dietary supplements, to bear nutrition labeling.
DSHEA amended the Federal Food, Drug, and Cosmetic Act to create a new regulatory category, safety standard, labeling requirements, and other rules for dietary supplements. Under DSHEA, dietary supplements are generally presumed to be safe.
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 amended the Federal Food, Drug, and Cosmetic Act to require all food companies, including dietary supplement companies, to register with FDA no later than December 12, 2003, to provide information on the name and address of the facility and, to some extent, the types of products they manufacture or sell.
FDA was successful in banning ephedra after thousands of adverse events, including a number of deaths, and a lengthy legal process.
The Dietary Supplement and Nonprescription Drug Consumer Protection Act amended the Federal Food, Drug, and Cosmetic Act to require dietary supplement companies that receive a serious adverse event report to submit information about the event to FDA.
FDA finalized its Current Good Manufacturing Practice regulations to establish quality control standards for dietary supplements. The final rule became effective on August 24, 2007, but companies have 10, 22, or 34 months from the effective date of the rule to comply, depending on company size.
Serious adverse event reporting requirements for dietary supplement companies became effective on December 22.