FDA Can't Protect Americans from Dangerous Dietary Supplements, GAO Says
Beleaguered Agency Doesn’t Know Who, or What, It's Regulating
March 2, 2009
WASHINGTON—Add dietary supplements to the growing list of products the beleaguered Food and Drug Administration is failing to regulate.
Today, the Government Accountability Office will report to Congress that the FDA does not have even the most basic information to protect the public from hazardous supplements.
It doesn't have an accurate inventory of the supplement ingredients on store shelves. It doesn't have a firm handle on the number and nature of serious adverse reactions to dietary supplements. In fact, the GAO found, the agency doesn't even have a list of the names and locations of herbal supplement manufacturers. And several substances banned overseas are readily available on the Internet and in retail stores all over the U.S. even though they are variously linked to kidney damage, liver damage, seizures, and death.
"When it comes to dietary supplements, it's like the Wild West, and the bad guys know they don’t have to take the sheriff seriously," said CSPI legal affairs director Bruce Silverglade. "Even when confronted with people dying from a dangerous substance like ephedra, the FDA has limited authority to get the product off the market."
It took the FDA nearly 10 years to ban ephedra, also known as ma huang. Ephedra-containing dietary supplements, often marketed as weight-loss aids and performance enhancers, were linked to numerous deaths and thousands of adverse reactions, including irregular heartbeat and stroke. The herbal ingredients kava, lobelia, and supplements containing aristolochic acid are all banned in some countries, but FDA has taken no action short of issuing public warnings. Meanwhile, such products are available to consumers. St. John's wort, often marketed as an herbal anti-depressant, may interfere with birth control pills, a medicine used to treat HIV, and other prescription medications. While the FDA has issued alerts to that effect, it hasn't required warning labels on the products. As a result, some brands bear warnings while others do not.
Similarly, GAO pointed out that although such popular supplements as garlic, ginkgo biloba, ginseng, and Vitamin E may cause blood thinning and result in life-threatening complications during surgery, consumers are not warned of such risks. A CSPI market survey of warning labels on Vitamin E and other popular supplements found that such leading supplement manufacturers as GNC, Nature's Plus, and Rite Aid do not warn of the risks associated with Vitamin E.
"The supplement industry operates in a gray area where the loopholes loom larger than the law," Silverglade said. "Congress should close those loopholes by requiring that ingredients be reviewed for safety and effectiveness and that cautionary information appear on product labels."
Under current law, dietary supplements sold before 1994 are presumed safe, and manufacturers of new dietary ingredients only need to notify the FDA 75 days before marketing new products. The vast majority of the claims on the labels, like the substances themselves, do not require any FDA approval.
The GAO also found that the boundaries between dietary supplements and foods that contain herbal ingredients are not clear. The food industry often markets teas and other energy drinks as supplements to take advantage of weaker safety laws.
"This report highlights significant gaps in FDA’s ability to ensure the safety of dietary supplements," said Rep. Henry A. Waxman (D-CA), chairman of the Energy and Commerce Committee. "Because of limitations on FDA’s authority and its lack of resources, consumers don’t have the assurance they should that all supplements are safe."
CSPI has repeatedly urged the FDA to take enforcement action against supplements that contain ingredients the agency has told the industry are not recognized as safe for use in foods, including echinacea, ginkgo biloba, ginseng, chromium picolinate, guarana and gotu kola. Foods containing such ingredients include Arizona Rx Iced Teas, Snapple Awaken, and SoBe Lifewater Zingseng.
In addition, Mars continues to sell its Cocoa Via candy bars despite the fact FDA told the company that folate is not recognized as safe for use in candy. Fuze Black and Green Tea with Acai Berry also contains added folate in violation of FDA rules. Excess consumption of folate masks the presence of anemia in persons with a vitamin B12 deficiency.
The GAO pointed out the FDA lacks statutory authority to keep potentially hazardous supplement ingredients off the market and the resources to study adverse reaction reports or inspect manufacturing facilities. As with contaminated foods, the agency lacks mandatory recall authority.
In comments supplied to GAO, the FDA stated it generally agreed with the report's recommendations for improving regulation of the industry, which in 2007 had more than $23 billion in sales.