About half of the American population uses dietary supplements, spending an estimated $32 billion per year in an effort to be healthier, skinnier, stronger or sexier. The FDA regulates dietary supplements, to a certain degree and only AFTER they have been put on the market, unlike prescription or over-the-counter drugs, which have to be approved BEFORE they can be sold. This has exposed millions of people to potential harm, because, ironically, dietary supplements often contain ingredients which are actually pharmaceuticals, and sometimes pharmaceuticals which were banned as prescription drugs. Approximately half of all FDA class-I drug recalls since 2004 have involved dietary supplements adulterated with banned pharmaceutical ingredients, according to Food Safety News.
For example, on October 10, 2014, the FDA advised consumers not to purchase or use Sit and Slim II, a product promoted and sold for weight loss. The reason: Sit and Slim II contains sibutramine, a controlled substance that was removed from the market in October 2010 because it is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product also contains phenolphthalein, a cancer-causing chemical that is not an active ingredient in any approved drug in the United States.
Example #2, O.M.G., a sexual enhancement product, was the subject of an FDA consumer advisory issued July 22, 2014, because it contains sildenafil, the active ingredient in the FDA-approved prescription drug Viagra. So what’s the problem with that, since Viagra is legal? Doctors won’t prescribe Viagra for some men (for instance, those with diabetes, high cholesterol or heart disease) because sildenafil may interact with other drugs they’re taking and may lower blood pressure to dangerous levels. It’s not hard to imagine that a man who can’t take Viagra might think it’s safe to take O.M.G. and be completely unaware that he is ingesting the same active ingredient.
Or how about Sport Burner, a product promoted and sold for weight loss? It contains fluoxetine – also known as Prozac – prompting the FDA to issue a warning about it on June 17, 2014. Again, Prozac/fluoxetine is an approved pharmaceutical drug, but it can have serious side effects, including suicidal thinking, seizures and sudden death. Here are the ingredients of Sport Burner, according to the label: LingZhi, Ebony, Fox-nut, Tuckahoe, Seman Pruni, Dioscoreae, Wheat Germ, Natural Substance. I don’t see fluoxetine there, do you?
And that’s the point. Some dietary supplement manufacturers are slipping dangerous ingredients in without declaring them on the label. Seems like that should be illegal, doesn’t it? But under the Dietary Supplement Health and Education Act, dietary supplement companies do not have to provide proof that their products are composed of the ingredients listed on their labels.
This week a study was published in the Journal of the American Medical Association which highlights an additional danger. Researchers found that even though some supplements have been pulled from shelves because they were found to contain anabolic steroids or powerful prescription drugs, about two-thirds were back on the market a year later with the same illicit ingredients.
Between 2009 and 2012, the FDA recalled at least 274 dietary supplements. For the recent research project, a doctor from Harvard Medical School and his colleagues were able to purchase 27 of the 274, even though they had been recalled an average of one year prior. Then they analyzed the ingredients. They found that two-thirds of the products contained at least one unlisted anabolic steroid, prescription drug or banned substance, usually the same illicit ingredient that led to its being recalled in the first place. And sometimes, some additional dangerous ingredients had been thrown in as well!
The researchers called it “very blatant flouting of the FDA’s requests” and called for changes in federal law to protect consumers, especially in the form of increased enforcement powers for the FDA.
If you or someone you care about has been hurt by a nutritional or dietary supplement, call The Injury Lawyer, Steven C. Heisler, of Baltimore. The FDA may not be able to protect you from harm before you take a supplement for weight loss, body building or sexual enhancement, but we will fight for your rights to compensation after you have been injured by a manufacturer who puts profits ahead of safety. Call (410) 625-4878 today.