Federal inspections report significant and widespread manufacturing problems of companies that produce dietary supplements – including calcium chews, multivitamins, echinacea and bodybuilding powders. Half of all Americans consume one or more of these products, in an industry that annually earns $28 billion dollars. Since 2008 the FDA has conducted inspections to evaluate compliance with new regulations administering the manufacturing, packing and holding of dietary supplements. Since the inspections started, 1 in 4 of the companies inspected by the FDA have received warnings. So far this year, FDA inspectors have found violations in two-thirds of the 204 inspections they have conducted… 70 of those inspections resulting in the agency’s most serious rating. “It’s downright scary,” said Daniel Fabricant, head of the FDA’s Division of Dietary Supplement Program. “At least half of the industry is failing on it’s face.” So what are these concerning issues? Unsanitary factories, failure to identify the ingredients that go into the products, and a lack of recipes known as master manufacturing records are some of the problems.
Michael McGuffin, president of the American Herbal Products Association believes manufacturers are making serious attempts to come into adherence with FDA inspections. “Not everybody was in compliance on the day the rule was passed, but that is not uncommon in any rule making,” he said. Fabricant of the FDA disagrees. “You can get a lot done in five years,” he said.
The gravity of this issue is seen in the serious health problems some consumers have suffered due to the poor manufacturing practices of some companies. Kirkman Labs began a voluntary recall of 15,000 bottles of zinc and other products in 2009. The FDA had reported that some of the company’s products contained undeclared antimony, a heavy metal. An 11-year-old boy who has autism spectrum disorder had been given a nightly dose of Kirkman’s liquid zinc since March of 2009. He began having health problems, and a lab test showed an unusual level of antimony in his system. The family is suing Kirkman, and a trial is set for next year. Kirkman CEO David Humphrey stated in an email that the company has been working diligently to prevent this from happening again. The attorney for the family sees things differently. According to Ben Mouton, “I think everybody was working on the assumption that anything that went into those supplements was being tested, especially because of this patient population. You would think there would be the same oversight as prescription drug manufacturers, but there is not.”
So, how do we know if the supplements we are taking are not causing us harm? While sending supplements to a lab for testing is the only way to know for sure what they contain, here are a few tips that may help minimize your concern:
ConsumerLab.com tests dietary supplements, and has lots of information on its website. If you want detailed results of its testing of brand-name supplements there is a membership fee of about $3 a month.
The FDA website, fda.gov lists brands that have been involved in a recall, or have received a warning letter from the U.S. Food and Drug Administration. Some brands however don’t do their own manufacturing, so it may be hard to figure out which companies to check.
Natural Products Association, one of the industry’s largest trade groups certifies dietary supplement companies in good manufacturing practices. To find out what companies have met the group’s criteria, which include the FDA’s standards, visit npainfo.org. The Chicago Tribune July 1, 2012