Dietary Supplements’ Safety Amounts to ‘Roulette,’ Doctor Says
Dr. Perlmutter’s comment:
As you read this article, consider the fact that according to the American Medical Association more than 70,000 Americans die each year as a concequence of taking pharmaceutical medications “appropriately.”
Consumers who take dietary supplements promising weight loss, increased strength or improved sexual performance may be playing “American roulette” with their health, said a Harvard Medical School doctor who urged stricter regulation of the products.
The U.S. Food and Drug Administration has identified about 140 contaminated products such as weight-loss pills that may cause high blood pressure, seizures, heart attacks or strokes, and body-building products that may cause liver injury and kidney failure from undeclared ingredients, said Pieter Cohen, a professor of medicine at Harvard Medical School in Boston. Current law allows dietary supplements to be sold without clearance from the FDA as long as they aren’t advertised as preventing, treating or curing disease.
About 114 million people, or half the U.S. adult population, take dietary supplements including vitamins, minerals and herbs, and sales of the treatments reached almost $24 billion in 2007, according to a report from the Government Accountability Office in March.
“Instead of pulling the trigger of a revolver at our head, we’re swallowing unknown substances that could have life- threatening effects,” said Cohen, whose article appears online today in the New England Journal of Medicine. “Selecting a dietary supplement is our version of spinning the cylinder of the revolver.”
Consumers should avoid products advertised as body- altering, Cohen said. Doctors should ask patients if they are taking supplements, particularly if they can’t easily diagnose symptoms.
“We have no idea what’s inside dietary supplements because the regulatory framework is so weak, they are not being approved by any government agency and there’s no proof of safety,” said Cohen, who also is an internist at Cambridge Health Alliance, in Cambridge, Massachusetts, in a telephone interview yesterday. “Without changing the regulatory framework, I don’t think it’s possible to make dietary supplements safer.”
As of next June, all dietary supplement manufacturers must follow new manufacturing practices that establish industry procedures for quality control and ensure that companies produce properly labeled supplements, said Andrew Shao, vice president of scientific and regulatory affairs for the Council for Responsible Nutrition, a trade association for dietary supplement manufacturers and ingredient makers.
“The majority of the dietary supplement industry is compliant, however we do feel that for the few outliers in the industry, the minority of the industry, we do very much endorse stepped up enforcement by the FDA,” he said yesterday in a telephone interview. “There is no FDA-regulated product that is immune completely to these kinds of problems. The majority of dietary supplement products are well made, are safe and there are no reasons for consumers who use supplements to change their behavior.”
Since 2007, the manufacturers have been required to notify the FDA of supplement-related deaths, hospitalizations and significant disabilities. Most of the 50,000 adverse events that the FDA estimates occur each year, including those that are mild and moderate, remain unreported, according to the GAO report released in March.
Approval Not Needed
“Consumers and health care providers should be aware that manufacturers and distributors do not need FDA approval to sell their dietary supplements,” Margaret Hamburg, the FDA commissioner, said yesterday in an e-mail. “This means that FDA does not keep a list of manufacturers, distributors or the dietary supplement products they sell.”
Manufacturers have the primary responsibility under the law to make sure their products are safe, Hamburg said. The law places the burden on the agency to demonstrate safety problems exist before acting. Reporting adverse events isn’t mandatory for consumers or health care providers and it’s important for consumers to be informed about the products they’re buying, she said.
The FDA warned yesterday that dietary supplements containing silver may cause permanent discoloration of the skin or mucous membrane. Large amounts of silver may quickly turn the skin, gums or nails or eyes shades of gray or blue, according to the advisory.
Colloidal silver, or metal particles suspended in liquid, is often marketed as an alternative to antibiotics or to treat diseases such as diabetes, HIV and cancer, according to the National Center for Complementary and Alternative Medicine.
Under current law, manufacturers of supplements must list all product ingredients on the label.
In July the FDA also issued a consumer advisory warning to avoid body-building products with labels that say the supplements contain steroids or steroid-like substances. That same month the U.S. Department of Justice filed a complaint against three New Jersey companies alleging they manufactured their dietary supplements and protein powders under filthy conditions and didn’t list known food allergens on the product labels.
Robert Saper, director of integrative medicine and an assistant professor at Boston University School of Medicine, said dietary supplement manufacturers should have to demonstrate that their products are safe before they go on the market. One way to do that would be having an independent third party verify those products, he said.
Saper’s study last year in the Journal of the American Medical Association found that one in five herbal products used in Ayurvedic, or traditional Indian, medicines contained harmful levels of toxic metals.
Cohen said Congress must give the FDA more authority and resources to regulate the dietary supplement industry.
As of 2008, about 75,000 dietary supplements were available to consumers, an increase from about 4,000 in 1994, according to the GAO report.
Calcium, Folic Acid
Using supplements such as calcium and folic acid as well as other alternative medicines should be allowed as long as it’s safe, said Cohen of Harvard.
“If people want to take a garlic pill, I see no reason that they shouldn’t be able to take a garlic pill, but if they go and buy a garlic pill, they should make sure garlic is the only thing in there,” he said.
Shao, the supplement industry representative, said consumers should be cautious about products promising a “magic bullet” and should choose supplements made by brands they know and trust.
“These few companies, these outliers, they are undermining consumer confidence,” he said. “We support regulators going after them.”