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 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.”
Lest you think that this issue doesn’t have potentially horrific consequences, consider the story of John Adams and 200 people who were poisoned by a supplement:
In 2008 more than 200 people — including a 4-year-old — were poisoned by selenium after taking liquid multivitamin dietary supplements that were sold in health stores and by chiropractors, according to a medical paper published on the mass poisoning. The products, called Total Body Formula and Total Body Mega Formula, contained an average of 40,800 micrograms of selenium per serving instead of 200, according to the paper.
John Adams, of Chipley, Fla., was one of the victims. His silver hair — which had earned him the nickname “Silvertop” at work — began falling out in clumps. His fingernails and toenails became discolored, peeled off, regrew and peeled off again. He had a hard time remembering how to do his job as a telephone repairman. He became so weak it was hard to get in and out of his work truck, and eventually he was forced to retire.
Adams and his wife, who also experienced problems, sued along with dozens of others. This year, the couple received a settlement. Adams, now 65, said he is still weak on his left side, has ruined fingernails and toenails that do not grow and struggles with memory problems.