Peter’s Memo: Make supplements safer

Magnum XXL 9800, Jaguar Power, Kangaroo Intense Alpha 3000. Those are just a few of the tainted dietary supplements that, until recently, were sold on walmart.com and other websites.

Last year, the Food and Drug Administration warned that these and similar supplements illegally contained hidden sildenafil. That’s the active ingredient in Viagra, which requires a prescription because it can cause dangerously low blood pressure when taken with certain medications. (By law, supplements can’t contain drugs.)

Yet the FDA’s action was just a drop in the bucket.

“Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market,” says the agency’s own website. 

Not exactly reassuring.

But that may soon change. The Senate is considering legislation that would:

• require companies to publicly list their supplements in an FDA database,
• prioritize inspections for high-risk supplements (like those for weight loss, diabetes, or body building), and
• explicitly prohibit products that are fraudulently marketed as supplements.

That’s a step forward, but Congress could do better. It’s high time for legislators to overhaul the 1994 Dietary Supplement Health and Education Act (DSHEA) to protect consumers. 

For example, a new law should: 

• close the loophole that lets companies bypass the FDA’s pre-market safety review by deciding that a new ingredient is “Generally Recognized as Safe” without even notifying the agency,
• require companies to report all, not just serious, adverse events caused by supplements, 
• authorize the FDA to levy civil penalties against individuals and companies that sell dangerous or misbranded supplements,
• strengthen the rules that allow the FDA to remove unsafe, adulterated supplements from the market, and
• appropriate funds to help the FDA keep the marketplace safer.

U.S. regulators have the authority to pull dangerous toys from stores, ground unsafe planes, and recall contaminated food, but it’s a huge challenge for the FDA to remove dangerous supplements from the market or punish manufacturers who make unsubstantiated claims.

Without stronger laws, the FDA can’t possibly regulate a $40 billion industry that harms not just our pocketbooks but our safety.