In the last four years, theU.S. Food and Drug Administrationhas found violations of manufacturing rules in half of the nearly 450 dietary supplement firms it has inspected, according to agency officials.
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."
The FDA began conducting inspections in 2008 to assess compliance with new regulations governing the manufacturing, packing and holding of dietary supplements. Since then, 1 in 4 dietary supplement companies inspected by the agency have received a warning letter, considered a significant enforcement action.
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.
Cara Welch, vice president of scientific and regulatory affairs for the Natural Products Association, a large dietary supplement trade group based inWashington, D.C., called the inspection numbers "unfortunate" and a significant issue her organization has been tackling.
"We can't give up on the industry," Welch said. "We are going to make it as strong as can be."
Manufacturers large and small are making significant efforts to implement the regulations, including sections borrowed from the FDA's drug manufacturing rules, said Michael McGuffin, president of the American Herbal Products Association, a trade association based in Silver Spring, Md.
But it takes time for companies to come into compliance with such a large and complex set of rules and for the FDA to establish how the rules will be enforced, McGuffin said. "Not everybody was in compliance on the day the rule was passed, but that is not uncommon in any rulemaking," he said.
Fabricant disagreed. The final rule was published in 2007. "You can get a lot done in five years," he said.
Underscoring the importance of the issue, some customers have suffered serious health problems linked to companies' poor manufacturing practices.
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.
