FDA Cracks Down on Tainted Dietary Supplements

The U.S. Food and Drug Administration (FDA) is warning that tainted products marketed as dietary supplements are potentially dangerous. The agency is now working with trade associations to increase company vigilance and protect the public.

In a letter just sent to dietary supplement manufacturers, the FDA expressed concern about undeclared or deceptively labeled ingredients in products marketed as dietary supplements. These substances include the active ingredients in FDA-approved drugs or their analogs (closely-related drugs), or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients. The letter can be accessed here.

In recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products.

The FDA’s letter emphasizes that manufacturers and distributors are responsible for ensuring that their products comply with the law. Five major trade associations—the Council for Responsible Nutrition, the Natural Products Association, the United Natural Products Alliance, the Consumer Healthcare Products Association, and the American Herbal Products Association—are joining FDA on a call for media, and have agreed to share the letter widely within the industry.

“These tainted products can cause serious adverse effects, including strokes, organ failure, and death,” said FDA Commissioner Margaret A. Hamburg, M.D. “The manufacturers selling these tainted products are operating outside the law.”

The FDA is seeking input and collaboration from dietary supplement trade associations to educate the industry about this problem and to help develop new strategies to combat it, according to Hamburg.

The agency also announced a new RSS feed (accessible at: http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/TDS/rss.xml) to warn consumers more quickly about tainted products marketed as dietary supplements.

The FDA has noted the three most common categories of these illegal products:

Weight Loss Products: Containing active ingredients such as sibutramine, the active ingredient in the drug Merida, which was recently withdrawn from the market due to increased risk of heart attack and stroke. The FDA has discovered dozens of products, such as Slimming Beauty, Solo Slim, Slim-30, and others, containing sibutramine or analogs.

Bodybuilding products: Containing anabolic steroids or steroid analogs that can cause acute liver injury and increase the risk for heart attack, stroke, and death. Products like Tren Xtreme, ArimaDex, and Clomed have been labeled to contain either anabolic steroids or aromatase inhibitors, which prevent anabolic steroids from being converted to estrogen.

Sexual Enhancement product: Containing the same active ingredient or an analog of the active ingredient in the approved drugs Viagra, Cialis, and Levitra. The approved products are available only by prescription and should not be used by people with certain medical conditions, such as cardiovascular disease. Products determined to be in violation of federal law by the FDA include Vigor-25, Duro Extend Capsules for Men, and Magic Power Coffee, among others.

“The labeling of these tainted products may claim that they are ‘alternatives’ to FDA-approved drugs, or ‘legal’ alternatives to anabolic steroids,” said Michael Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research. “Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs. Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails.”

Companies that make or distribute tainted products may receive warning letters and/or face enforcement actions such as product seizures, injunctions, and criminal prosecution. Responsible individuals may also face criminal prosecution.

Lawful dietary supplements contain minerals, vitamins, or other dietary ingredients and are intended to be an addition to a standard diet. The FDA regulates these products under the Dietary Supplement Health and Education Act, passed by Congress in 1994. Unlike drugs, dietary supplements do not have to be approved by the FDA prior to marketing. Dietary supplement manufacturers and distributors are responsible for selling a safe product. FDA’s Current Good Manufacturing Practices require dietary supplement manufacturers to have proper manufacturing and quality assurance controls in place to ensure the quality of their products, including controls to prevent the inclusion of contaminants that could adulterate their products.