FDA lists companies fraudulently marketing products for serious diseases

FDA lists companies fraudulently marketing products for serious diseases

The FDA recently began alerting consumers "to companies fraudulently marketing products for the treatment or prevention of serious disease." Each of these companies sells products regulated by the FDA and each has a received a warning letter that their products are illegally being marketed "to treat, cure, mitigate, or prevent diseases."If, after 30 days,the company fails to correct its marketing practices, it is placed on a list publicly available on the FDA's website.

Four companies are the first to gain the dubious honor of making the FDA's list. And guess what they're selling? Surprise! Dietary supplements.

One, Active Herb, specializes in Chinese herbal remedies. Another, Discount Remedies, has a broader selection of products. In addition to dietary supplements, it sells a variety of "magnetic therapy products," like the "magnetic pet pad" and natural health books covering subjects like "detox" and liver "cleansing." Herbalmax is run by a California TCM practitioner and acupuncturist.  According to her, she is able to successfully treat a wide variety of conditions, from hair loss to MS, with a combination of these herbal products and acupuncture. The fourth company, Merchants of the World "Godsent [sic] Alternative Health Division" not only sells dietary supplements but, for "as little as $499.95," will make you a distributor, giving you the opportunity to "earn up to $1000.00 a day."

The problem with advertising your product as treating, curing, mitigating or preventing diseases is that only drugs can legally make those claims after going through the FDA's drug approval process, which determines whether the drug is actually safe and effective for its intended use.

Dietary supplements, on the other hand, don't go through any pre-market approval process to determine safety and efficacy. They are limited to nebulous "structure and function" claims and are supposed to have substantiating evidence for those claims somewhere in their files, although they don't have to share that information with the FDA or the public.

I suppose if you are going to make illegal claims, you might as well go for the big time. 

All companies had, and were told to remove, cancer treatment and cardiovascular disease claims. Some companies made claims for their products' effectiveness in treating infectious diseases: HIV/AIDS, influenza virus H3N2, herpes, malaria, hepatitis, pneumonia and TB. Other diseases included Alzheimer's, Parkinson's, schizophrenia, asthma, diabetes, glaucoma and macular degeneration.

Consider how easy it is to change a website. Consider the fact that these companies had 30 days to remove their claims. And consider how dangerous their claims are. Yet, each of the companies blew off the FDA's warning letter.

Why? I imagine they know how stretched the FDA's resources are, how Congress has put the burden on the FDA to catch violators rather than on the dietary supplement industry to demonstrate compliance with the law pre-market. They likely know they can simply take down a claim at the last possible minute without penalty because, once they comply, the FDA will leave them alone, even long after they've gotten a warning letter.

And how hard is compliance? As long as you say your product "supports heart health" instead of "mitigates the effect of heart disease" you're within the law. What consumer understands that nicety? According to a report from the Department of Health and Human Services Office of Inspector General, they don't.  Which leads one to wonder: why did these companies bother to cheat? After all, the easier way to mislead consumers about the safety and effectiveness of your products is simply comply with the law

Points of Interest 11/08/2015

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