Some products marketed as dietary supplements are tainted with 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. The 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.
The 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)
The FDA is focusing on these illegal tainted supplements because 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. The 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.
They have found nearly 300 products marketed as dietary supplements that contain drugs, analogs of drugs, or anabolic steroids over the past several years, and suspect that only a small fraction of the tainted supplements on the market have been uncovered. Unfortunately, it is not possible for the 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 FDA tips for identifying tainted products.
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.
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.
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
If you suspect that a product is tainted, the FDA advises you to stop taking the product and consult a healthcare professional. They also ask consumers to report suspected tainted products marketed as dietary supplements to the FDA by sending an email to TaintedProducts@fda.hhs.gov and/or using the anonymous reporting form “Report Suspected Criminal Activity” located at: http://www.fda.gov/oci1.
If you have been injured by any of these tainted products, the FDA asks you to report your injury to their MedWatch Adverse Event Reporting program online, by regular mail, or by fax.