Who is liable for the sale of dangerous substances?

Americans love their dietary supplements.  It’s a huge market in the US economy; for example, in 2009 alone, according to the Nutrition Business Journal and cited by Consumer Reports, Americans spent more than $26 billion on health supplement products.  

But many consumers don’t realize that these supplements are part of a market that is left largely unchecked by regulators, with products out on the market promoting your health—all while they have failed to first even demonstrate that they are effective or safe.  

An Unchecked Marketplace.

According to the FDA, dietary supplements generally are not FDA-approved.  That’s because under a regulation from the 1990’s, manufacturers of dietary supplements are not required to obtain FDA approval before they issue their drugs on the market.  Because of an industry-friendly regulation from 1994 called the Dietary Supplement Health and Education Act (or DSHEA), makers of supplements are virtually free from federal oversight under the FDA and are free to distribute their drugs with unchecked ingredients and false claims.

Instead, it’s the responsibility of the drug manufacturing company—not the U.S. government—to ensure that the products are safe.  This, however, screams of conflict of interest: the private companies that want to make money off American consumers are the entity that is supposed to self-regulate to protect Americans from harmful substances.  

Fortunately, Congress passed a law closing that loophole in 2007.  The year after the loophole was closed, the FDA reported that it received more than 1,300 reports of harmful health effects from manufacturers, and another 600 or so more directly from consumers and health professionals.  

But even with the new law, many Americans do not realize that these supplement drug manufacturers routinely—and legally—sell their supplements on the American market without having to first prove that they are safe for consumers.  And that leaves the marketplace of health supplements much more dangerous that it should be.

What Action Can the FDA Take?

Under DSHEA, the FDA can take action when distributors and makers of dietary supplements sell products that are either misbranded or adulterated.  

And under DSHEA’s terms, it is difficult for the FDA to take these drugs off the market.  In fact, the FDA has only successfully fully banned one ingredient: ephedrine alkaloids, which are sold under ephedra weight loss products.  That effort alone took about 10 years, and meanwhile these supplements were associated with thousands of health reports including deaths.  

After that dragged out battle against ephedrine, the FDA changed its tactic.  Now, instead of attempting to get full bans of products, the agency issues warnings against harmful supplements, detains imported products, and issues public requests to manufacturers and distributors to recall products that are unsafe.  

The FDA is also taking a stand against exaggerated claims made by makers of dietary supplements, enforcing laws that make it illegal for consumer companies to make false claims and advertisements about their products.  Under this tactic, the FDA has filed or settled 30 cases against marketers of dietary supplements for false claims and false advertising.