FDA enforces against tainted products masquerading as supplements

Products that contain vitamins, minerals, herbs and other health-promoting ingredients are sold in countries all over the world. These products may be marketed as a category of food, as is the case with dietary supplements in the U.S., or in a drug category, such as the natural health products sold in Canada. These products are sold in full compliance with the legal and regulatory statutes in effect in various countries around the world.

The vast majority of dietary supplement products fully comply with applicable laws and are properly sold to consumers. However, some unscrupulous companies have threatened consumer confidence by selling tainted products that contain undeclared prescription drugs and other chemicals. Since 2008, FDA has identified nearly 400 such products. These unlawful ingredients have been found in capsules, tablets, powders, teas, and coffees. While these tainted products represent a tiny minority of all dietary supplements sold, it is important that consumers have confidence when buying their products from reputable companies.

The U.S. Food and Drug Administration called attention to this problem with the following statement:

FDA has identified an emerging trend where over-the-counter products, frequently represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. These deceptive products can harm you!

Any product that contains an undeclared drug is not a dietary supplement and is illegal for sale in the United States or any other country. Such products should not be present in the marketplace.

The American Herbal Products Association (AHPA) is the trade association and voice of the responsible herbal products industry. AHPA members believe that consumers deserve to be able to feel confident that the dietary supplement products they purchase only contain legal ingredients that are properly disclosed on the label. AHPA fully supports the efforts of the FDA to remove these illegal products from the market and encourages FDA to use its full enforcement authority to do so.

Key product categories

FDA has identified the three most common categories of illegal tainted products that unscrupulous companies have marketed, as listed below. More detailed information and lists of the actual products identified by FDA in each category can be found by following each of the links provided.

• Weight loss products containing active ingredients such as sibutramine or closely related analogs. Sibutramine is the active ingredient in the drug Merida, which was recently withdrawn from the market by FDA due to increased risk of heart attack and stroke.
• Body-building products containing anabolic steroids or steroid analogs. According to FDA, these steroid-spiked products can cause acute liver injury and increase the risk for heart attack, stroke and death.
• Sexual enhancement products that contain phosphodiesterase (PDE) inhibitors, such as sildenafil or an analog. PDE inhibitors are the active ingredients in the approved drugs Viagra, Cialis, and Levitra. These drug products are available only by prescription, and should not be used by people who have certain medical conditions, such as cardiovascular disease, due to significant health risks.

FDA has clearly identified all such tainted products as illegal. According to Michael Levy, director of FDA’s Division of New Drugs and Labeling Compliance, “These products are masquerading as dietary supplements—they may look like dietary supplements but they are not legal dietary supplements.” And on December 15, 2010, FDA Commissioner Margaret Hamburg, M.D., stated, “The manufacturers selling these tainted products are operating outside the law.”

What responsible supplement companies need to know

On December 15, 2010, FDA announced that it is working with U.S. trade associations, including AHPA, to make sure that supplement companies comply with the law. FDA also issued a letter to industry that addresses roles and responsibilities of companies to ensure that their products do not contain undeclared ingredients that would cause them to be adulterated. More specifically, FDA’s letter:

• Reminds dietary supplement companies of their obligation under current good manufacturing practice (cGMP) to establish and meet specifications on those types of contamination that may adulterate or lead to adulteration of the finished batch of dietary supplement (see 21 CFR 111.70(b) and 111.75(a)).
• Notes that a strong program of qualifying suppliers, testing incoming ingredients, and verifying the contents of finished products are all required by cGMP regulations and can help minimize the risk of adulteration.
• Encourages companies to report any suspected ingredients or finished products and the manufacturers or distributors who market these products to FDA. Reports can be submitted via email to TaintedProducts@fda.hhs.gov or via FDA’s anonymous reporting form “Report Suspected Criminal Activity” located at: http://www.fda.gov/oci.

AHPA has publicly expressed its support for FDA actions against marketers of products that masquerade as dietary supplements but contain illegal ingredients. AHPA encourages FDA to use its regulatory authority to hold accountable those who violate the law and jeopardize the public confidence, including all legal means to enforce the law.

Manufacturers and marketers may contact AHPA with any questions you may have on your manufacturing and labeling obligations.