...Tsouderos’ article, Dietary supplements: Manufacturing troubles widespread, FDA inspections show, is an indictment of the entire supplement industry.
It also shows that, due to lack of resources, the FDA [Food and Drug Administration] is clearly not up to the task of exercising even the minimal level of oversight required by the DSHEA.
In the last four years, according to Tsouderos, the FDA has found major violations of manufacturing rules in nearly half of the 450 companies it has inspected:
The inspection reports portray an industry struggling to meet basic manufacturing standards, from verifying the identity of the ingredients that go into its products to inspecting finished batches of supplements.
Some firms don’t even have recipes, known as master manufacturing records, for their products.
Others make their supplements in unsanitary factories. New Jersey-based Quality Formulation Laboratories produced protein powder mixes and other supplements in a facility infested with rodents, rodent feces and urine, according to government records. FDA inspectors found a rodent apparently cut in half next to a scoop, according to a 2008 inspection report.
“It’s downright scary,” said Daniel Fabricant, head of the FDA’s Division of Dietary Supplement Programs. “At least half of industry is failing on its face.”
As a result of these inspections, one in four supplement manufacturers has received a warning letter, which is considered significant, and:
So far this year, FDA inspectors have found violations of good manufacturing practices during two-thirds of the 204 inspections they have conducted in nearly 200 supplement firms’ facilities, agency officials said.
Seventy of these inspections resulted in the agency’s most serious rating.