Federal regulators announced Thursday that they would step up scrutiny of claims made on dietary supplement (search) labels and advertisements and would also increase their monitoring of the products’ safety.
FDA officials say they are implementing a new system to detect potential safety issues with dietary supplements that includes monitoring adverse event reports, media articles, and foreign regulatory actions.
The agency also issued draft guidance to dietary supplement makers instructing them on proposed stricter standards of evidence for making health claims when selling their products. Dietary supplements are regulated by the federal government, but unlike with prescription drugs, manufacturers don’t have to prove that their products are safe or effective before marketing them.
Supplements are regulated under a 1994 law called the Dietary Supplements Health and Education Act (search), or DSHEA. That exemption has come under closer scrutiny in the last year as regulators moved to ban supplements containing ephedra and the steroid precursor androstenedione because of safety concerns.
"We now have a clear roadmap to share with the dietary supplement industry while at the same time giving consumers a higher level of assurance about the safety of dietary supplement products and the reliability of their labeling," FDA acting director Lester Crawford says in a statement.
Supplement makers are also awaiting expected regulations from the agency governing manufacturing practices in the industry. Proposed rules were released in March 2003 but no final regulations have yet been issued.
In a statement announcing the changes, the agency says it “does not anticipate immediate changes to its enforcement process.”
Karen Robin, a spokeswoman for the American Herbal Products Association, an industry group, says the guidance should help responsible manufacturers set themselves apart from unscrupulous ones that knowingly market unsafe products or use unsound manufacturing. She suggests that the FDA has been slow to act.
“It’s gratifying that 10 years after the passage of the law they’re finally generating some guidance, she says.
The FDA says it sent letters to eight distributors selling weight loss supplements over the Internet to warn them that the product claims were unsubstantiated and that the supplements were “misbranded.”
By Todd Zwillich, reviewed by Brunilda Nazario, MD
SOURCES: Lester Crawford, Acting director, FDA. Karen Robin, spokesperson, American Herbal Products Association.
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