Inspections Reveal Serious Problems in Dietary Supplement Industry

Basic manufacturing standards not being met

My post “Retailers Will Pump You Up with Undeclared Steroids”  referenced a 2009 study claiming 25% of all supplements on the market contain undeclared substances. Unfortunately for the dietary supplement industry, I believe the latest inspection reports from the Food and Drug Administration may be more damaging.

“At least half of the industry is falling on its face.”  — Daniel Fabricant, head of the FDA’s Division of Dietary Supplement Program.

FDA reports show that half of the 450 inspected dietary supplement firms were violating manufacturing rules.  The inspection reports reveal an industry that is struggling to meet basic manufacturing standards.  Violations listed in the reports include everything from verifying product ingredients to failure to inspect finished batches to unsanitary factories.  Some supplement firms didn’t even have the recipes, known as master manufacturing records, for their products.

In 2012 alone, FDA agency officials found violations of good manufacturing practices in 66% of the 204 inspections. Seventy of the inspections resulted in the agency’s most serious negative rating.

The good news and the bad news

The only good news here is that these failures have generally not negatively affected insurance premiums and rates.  Premiums and rates are at the lowest I’ve seen in my many years of selling Product Liability insurance.

But there’s bad news. Continued negative reports in the dietary supplement industry means Product Liability insurance will continue to be written on inferior claims-made policies.