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Survey: Dietary supplements poorly regulated

Monday, June 7, 2004
Charles Bell, (914) 378-2507
Janell Mayo Duncan, (202) 462-6262

9 of 10 Consumers Want Dietary Supplements to be Proven Safe Before Put on Store Shelves
National Survey Shows Most Believe Supplements are Poorly Regulated;
CU Testifies at Senate Hearing Tuesday on Weak Supplement

(Washington, D.C) – More than nine out of 10 consumers want dietary supplements to be proven safe and effective before they are marketed, and 96 percent of consumers say supplement makers should be required to report health problems caused by their products and label them with risk information, according to a new national survey by Consumers Union, publisher of Consumer Reports.
“Americans are emphatically telling the government the time is now to ensure the safety of the dietary supplements sold in our stores,” said Charles Bell, programs director for Consumers Union.
“Because the law governing supplements is so weak, it took 10 years to finally remove Ephedra from the market, despite numerous reports of disabling injuries and deaths,” Bell added. “Ephedra is the poster child for failed policy, and Congress needs to act to make sure we don’t repeat this tragedy.”
The national survey comes as Congress is considering legislation to strengthen the law governing supplements, the Dietary Supplement Health and Education Act of 1994. Bell is testifying at a Tuesday afternoon hearing on the law’s effectiveness by a subcommittee of the Senate Governmental Affairs committee.
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. Also, supplement manufacturers are not required to report adverse health events caused by their products to the Food and Drug Administration, making it extremely difficult for the government to detect and remove dangerous supplements from shelves.
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.
“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,” Bell said.
Consumers Union is supporting legislation that would require supplement manufacturers to promptly report serious adverse health events to the FDA; require stimulants go through the safety process required of new drugs before being placed on the market; give the Secretary of Health the authority to require manufacturers submit data their product is safe and be allowed to conduct recalls as needed; and to label supplements with warnings of possible adverse effects and interactions.
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.
The random sample, on-line survey of 1,221 adults found overwhelming concern about supplement safety. More than 8 in 10 respondents agreed that poor regulation of supplements posed a risk to their and their family’s health, and only 19 percent felt supplements are sufficiently regulated.
“It is clear the public is worried about their safety when it comes to dietary supplement use,” Bell said. “We believe Congress needs to take the appropriate steps to ensure consumers can feel confident that the supplements they find in stores won’t harm them.”
Click here to read the survey results.
Click here to read our testimony.