My 2009 blog post “Retailers Will Pump You Up with Undeclared Steroids” referenced a study that claimed 25 percent of all supplements on the market have undeclared substances in them. 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,” says 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 included just about everything from verifying product ingredients to failure to inspect finished batches to unsanitary factories. Some supplement firms didn’t even have recipes, known as master manufacturing records, for their products.
In 2012 alone, FDA agency officials found violations of good manufacturing practices in two-thirds of the 204 inspections. Seventy of the inspections resulted in the agency’s most serious negative rating.
I guess if there is any good news for the dietary supplements industry it’s that these failures have generally not negatively affected insurance premiums and rates. Premiums and rates are at the lowest I’ve seen in my 13 years of selling Product Liability insurance.
The bad news is that if negative reports in the dietary supplement industry continue, Product Liability insurance will continue to be written on inferior claims-made policies.
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