Peter G. Lurie

Never underestimate the creativity of an American industry to exploit a market opening.

It’s like that small hole in your roof. The rain finds it and, before you know it, you’re sitting on your living room couch holding up an umbrella.

And so it goes with dietary supplements, a grab bag category of products, including vitamins, minerals, and herbals. The story dates to the late 1980s, when an outbreak of an obscure illness called eosinophilia-myalgia syndrome sickened more than 1,500 people and led to at least 37 deaths.

The outbreak was ultimately attributed to a contaminated L-tryptophan amino acid supplement made in Japan. As a result, the FDA moved to require “good manufacturing practices” and restrict misleading claims on supplements.

The supplement industry sprang into action, generating some 200,000 letters opposing FDA action. It also enlisted the help of powerful allies in Congress who had financial ties to the supplement industry.

The paradoxical result was the 1994 Dietary Supplement Health and Education Act (DSHEA), which left the FDA with even fewer tools to police the supplement marketplace than before.

That’s where the drip, drip, drip turned into a torrent. By 2017, what had been a fledgling industry tallied $43 billion in domestic sales.

And thanks to DSHEA, the FDA doesn’t even know what’s being sold. The vast majority of facilities go uninspected in any given year. When they are, more than half are cited for violations.

Moreover, the marketplace is contaminated by false or misleading claims. DSHEA permits companies to make so-called structure-function claims (like “promotes brain health”), but not claims that mention a disease (like “prevents Alzheimer’s”). Got that?

Most supplements have never been adequately tested—or, if they were, they failed to beat a placebo—in a randomized controlled trial. Meanwhile, the FDA has detected hundreds of supplements tainted with prescription drugs (usually for sexual enhancement or weight loss).

And some supplements can cause serious adverse effects (think ephedra, now banned) or drug interactions (think St. John’s wort). Others supplant effective drugs (think “opioid detox” supplements).

In February, the FDA sent letters warning 17 supplement companies that their claims to “prevent, treat or cure” Alzheimer’s or other diseases were unapproved drug claims. Commissioner Scott Gottlieb also promised a “larger effort” to strengthen the FDA’s regulation of supplements. That’s a good start.

It will be tough to squeeze this proverbial genie back into the pill bottle. The FDA needs more resources and more authority to police a marketplace flooded with ineffective and sometimes dangerous products. But that’s what you get when an industry with powerful friends finds a small hole in the roof.

Peter G. Lurie, MD, MPH, President

Center for Science in the Public Interest

Illustration: Jorge Bach/CSPI.