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Questions and Answers on Tainted Products Marketed as Dietary Supplements
What are tainted products marketed as dietary supplements?
They are products marketed as dietary supplements but that contain the same active ingredients as FDA-approved drugs, analogs of the active ingredients in FDA-approved drugs, or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients. FDA has found that products that are marketed as dietary supplements and that contain hidden or deceptively labeled ingredients are often promoted for weight loss, sexual enhancement, and body building.
What types of ingredients are in these products?
FDA laboratory tests have revealed alarming varieties and amounts of undeclared active ingredients in products marketed as dietary supplements. Examples of active ingredients found in these products include:
- Erectile Dysfunction drugs (e.g. sildenafil, tadalafil, vardenafil)
- Anabolic Steroids (e.g. madol, androstenedione, turinabol)
- Weight loss drugs that have never been approved or have been removed from the market for safety reasons (e.g. sibutramine, cetilistat, rimonabant, fenfluramine)
- Cancer causing agents (e.g. phenolphthalein)
- Anticonvulsants (e.g. phenytoin)
- Cholesterol drugs (e.g. lovastatin)
- Blood pressure drugs (e.g. propranolol)
- Controlled substances (e.g. sibutramine and anabolic steroids)
Why is FDA focusing on these illegal tainted supplements?
The ingredients in these products can pose considerable dangers to consumers who may take these products without knowing that the ingredients are present, that the ingredients may be associated with death or serious injury, or that they may interact in dangerous ways with other products consumers may be taking. FDA has received numerous reports of serious adverse events associated with consumer use of these tainted products including strokes, acute liver injury, kidney failure, pulmonary embolisms (artery blockage in the lung), and death. Make no mistake, these products can kill you.
How many tainted products has FDA discovered over the past several years?
FDA has found nearly 300 products marketed as dietary supplements that contain drugs, analogs of drugs, or anabolic steroids. We suspect that we have only uncovered a small fraction of the tainted supplements on the market. Unfortunately, it is not possible for FDA to test and identify all tainted products. This is why it is so important for consumers to exercise extreme caution with these types of products and to read our tips for identifying tainted products.
What types of enforcement actions have been taken?
Where FDA investigations have discovered products marketed as dietary supplements that contain the same active ingredients as in FDA-approved drug products, analogs of such drug ingredients, or other compounds of concern, such as novel synthetic steroids, FDA has issued warning letters and conducted seizures and criminal prosecutions.
Where are these products found?
These products can be found on the internet (major distributors and online marketplaces), and in retail stores, like gas stations, salons, spas, grocery stores, and even popular dietary supplement stores.
How can consumers protect themselves from tainted dietary supplements?
Consumers should be very careful with products with the following characteristics:
- Product Categories – Weight loss, bodybuilding, sexual enhancement
- Labeling claims like
- “Alternative to [approved drug product]” or “legal alternative to [anabolic steroid]”
- Sexual enhancement or weight loss products claiming immediate effects
- Directions and warnings that resemble FDA-approved drug products
- “May cause positive result in performance enhancing drug test”
- Labels primarily in a foreign language
- Products marketed through email spam
What can people do if they suspect that a product is tainted?
FDA advises consumers to stop taking the product and consult a healthcare professional.
We also ask consumers to please report suspected tainted products marketed as dietary supplements to FDA. We have created two tools to receive this information about suspected tainted products. Consumers can email TaintedProducts@fda.hhs.gov and/or use our anonymous reporting form “Report Suspected Criminal Activity” located at: http://www.fda.gov/oci.
If the consumer has been injured we ask that they please report their injury to FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax.