Dietary supplements often lack reliable evidence to support health claims

Twenty percent of studied supplements made prohibited disease-fighting claims, an OIG report says. Some lacked disclaimers that benefits were not evaluated by the FDA.

By — Posted Oct. 15, 2012

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Some patients of internist Raul Seballos, MD, try to lower their cholesterol by taking dietary supplements such as red yeast rice and fish oil. The labels on those products often tout their ability to maintain and reduce cholesterol levels.

Yet when Dr. Seballos examines the patients’ blood test results, he often finds their cholesterol is not at a healthy level.

“I tell them, ‘[The supplements aren’t] working. You need to be on prescription medication,’ ” said Dr. Seballos, vice chair of preventive medicine at Cleveland Clinic.

Supplements often feature claims that promote particular health benefits of the product, such as the ability to treat the common cold and prevent diabetes. But these claims are not always true, health professionals say.

Many supplements intended for weight loss and immune support (among the most popular types of supplements) lack the proper scientific evidence to verify their purported health benefits, says a report issued Oct. 3 by the Office of Inspector General for the Dept. of Health and Human Services. Such supplements often make claims of treating or preventing diseases, which is prohibited, the report said.

Researchers found that 20% of the 127 studied supplements wrongly claimed to treat or prevent diseases.

“Consumers rely on a supplement’s claims to determine whether the product will provide a desired effect,” the report said. “Supplements that make disease claims could mislead consumers into using them as replacements for prescription drugs or other treatments for medical conditions, with potentially dangerous results.”

Products with disease claims must be regulated as drugs, according to the Food and Drug Administration. Conventional drug products such as prescription medications cannot be released to the public until the FDA confirms that they are safe and effective for their intended uses.

On the other hand, supplement manufacturers or distributors — not the FDA — are responsible for ensuring that their products are safe and their health claims accurate. Once a supplement is on shelves, the FDA can restrict its use or remove it if the agency proves the product is unsafe.

In the OIG study, 7% of the assessed supplements were missing the required disclaimer that the stated health benefit “has not been evaluated by the Food and Drug Administration” and that the product “is not intended to diagnose, treat, cure or prevent any disease.”

For physicians, the report’s findings reinforce the importance of not just asking patients what types of supplements they use and researching their potential drug reactions, but also educating individuals about the risks and benefits of such products, health professionals say.

Dr. Seballos asks patients to bring to office visits the supplements they take. He reads the products’ labels and asks patients why they take those supplements.

“If they want to take it and they’re not having side effects, I tell them, ‘You can take it. It’s pretty safe. But don’t believe that it’s going to lower your risk for high blood pressure or diabetes,’?” Dr. Seballos said.

The American Medical Association recommends that doctors routinely inquire about patients’ use of alternative or unconventional therapies and educate themselves and their patients on the latest data.

Unsupported claims in supplements

Sixty-eight percent of U.S. adults take nutritional or dietary supplements, according to data issued Oct. 4 by the Council for Responsible Nutrition’s online Consumer Survey on Dietary Supplements. The council is a Washington-based trade association that represents dietary supplement manufacturers and ingredient suppliers.

Seventy-six percent of those who use supplements say they do so regularly, compared with 18% of people who take supplements occasionally and 6% who use the products seasonally, data show.

The council raised concerns about the findings in the OIG report.

“We are disappointed that despite the fact that the large majority of dietary supplement companies in this industry are holding up their end of the bargain with consumers, there are still some companies that are not meeting their obligations under the law,” the council said in a statement. “Further, we are concerned by [the] FDA’s apparent lack of enforcement against [the] problems.”

For its report, the OIG purchased 67 immune support supplements and 60 weight-loss supplements from retail stores and Internet sites nationwide. All of the products had at least one structure/function claim.

Claims related to weight loss generally focused on reducing body fat, increasing metabolism and suppressing appetite. Many claims for immune support supplements addressed free radicals or antioxidant properties, increasing antibody production or supporting general immune function.

The supplements were purchased in stores in Chicago, Dallas, Los Angeles, New York and Seattle.

Researchers asked manufacturers of the studied supplements to share the scientific evidence behind their health claims. Sixty-six manufacturers submitted 1,624 documents on 72 of the studied supplements.

“Overall, the documents they sent us didn’t reflect what [the] FDA recommends,” said Melissa Hafner, a Boston-based program analyst at the OIG. “Most of the evidence didn’t involve the actual supplement, and most didn’t even test the supplement or its active ingredients in humans, as [the] FDA recommends. Some of the documents didn’t qualify as evidence at all.”

Documents included a handwritten, 30-year-old college term paper, news releases for supplements and Wikipedia pages on a particular ingredient in a product.

The report calls on the FDA to seek authority to review the scientific evidence behind structure/function claims and update the agency’s tracking system for claims so it will know if manufacturers are complying with requirements. The report also recommends the FDA enhance surveillance of supplements to make sure it catches illegal disease claims.

The FDA recognizes the concerns raised in the report and “intends to consider and address the OIG recommendations as its resources and priorities allow,” said FDA spokeswoman Tamara Ward.

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External links

“Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements,” Office of Inspector General, Dept. of Health and Human Services, Oct. 3 (link)

“Dietary Supplements: Companies May be Difficult to Locate in an Emergency,” Office of Inspector General, Dept. of Health and Human Services, Oct. 2 (link)

Food and Drug Administration information on dietary supplements (link)

Information on dietary and herbal supplements, National Center for Complementary and Alternative Medicine (link)

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