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FDA Plan to Ensure Safety of Dietary Supplements Falls Short

Friday, Nov. 5, 2004
Janell Mayo Duncan, (202) 462-6262

FDA Plan to Ensure Safety of Dietary Supplements Falls Short;
Does Not Call for Mandatory Reporting of Adverse Reactions

(Washington, D.C) – An initiative by the Food and Drug Administration to help ensure the safety of dietary supplements falls far short of protecting consumers because the agency is not requiring supplement makers to report adverse reactions associated with the use of their products – a major reason it was so difficult for the government to ban the dangerous dietary supplement Ephedra.
The FDA announced Thursday a plan to implement a “signal review” process to determine possible safety problems, based in part on reports of adverse health reactions to supplements. But the plan relies on “voluntary” reporting by manufacturers of reactions to their products, and does not seek legislation that would require mandatory reporting. Without this adverse event information, Consumers Union says it will be extremely difficult for the FDA to determine the scope or severity of possible health risks associated with a dietary supplement.
“It took the government 10 years to finally remove Ephedra from the market, and one of the primary reasons was that the manufacturers weren’t disclosing reports of the disabling injuries and deaths linked to their product,” said Janell Mayo Duncan, legislative and regulatory counsel for Consumers Union.
“Simply hoping supplement makers will turn this information over to regulators just doesn’t make sense,” she added. “FDA must either use existing authority or seek the power to demand this important information from manufacturers.”
In June, a national survey conducted by Consumers Union, publisher of Consumer Reports, found that 96 percent of consumers thought that supplement makers should be required to report health problems caused by their products to the government. More than nine out of 10 consumers also wanted dietary supplements to be proven safe and effective before they are marketed. Unlike prescription and over-the-counter drugs — which must be proven safe and effective before they are marketed — dietary supplements, under the law, can be marketed without any such proof.
Duncan also said the “Good Manufacturing Practices” initiatives the FDA discussed Thursday — designed to ensure supplements contain ingredients in the amounts stated on the label — have been in the works since 1997, indicating the agency is acting too slowly to ensure supplement safety.
“It appears that the FDA is in no hurry to enact critically needed efforts, and is failing to take significant action to improve the safety of dietary supplements sold on store shelves,” she said.
In the May issue of Consumer Reports, 12 supplements were named that, according to government warnings, adverse-event reports and medical experts, are too dangerous to be on the market. Four of the herbs were on a 1995 list of dangerous supplements published by the magazine; the only supplement on the 1995 list to be removed from sale is Ephedra.
FDA had stated that it would conduct a full safety review of the CR named supplements, and in July Consumers Union requested the agency complete the review by October. Consumers Union is not aware that the review has been done.
“Four of the dangerous supplements named by Consumer Reports are flagged on the FDA’s own website because of safety concerns. Until the FDA announces that it is seeking to remove these products from the market, the agency’s actions are horribly inadequate,” Duncan said.
Consumers Union is supporting legislation that would require supplement manufacturers to promptly report serious adverse health events to the FDA; require that stimulants go through safety evaluation required of new drugs before being placed on the market; give the Secretary of Health the authority to require that manufacturers submit data indicating the safety of their products and to the ability to conduct recalls as needed. The Secretary should also be enabled to require and approve labeling of supplements with warnings, interactions with other drugs, and an FDA telephone number to call for reporting of adverse reactions.
S. 722, sponsored by Sen. Richard Durbin, and HR 3377, sponsored by Reps. Susan Davis, John Dingle and Henry Waxman, would enhance FDA’s authority to ensure supplements are safe and require manufacturers to report adverse events.
“While many dietary supplements, including most vitamins and minerals, are generally safe, there are some highly questionable products that are being sold to consumers right now that ought to be removed from the shelves. We need to put in place a preventive safety system where dangerous products can be more easily pulled from stores, and new supplements are reviewed for safety prior to being sold,” Duncan said.