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FDA official: 70% of supplement companies violate agency rules
Photo credit: Newsday / Jeffrey Basinger | About 70 percent of the nation's supplement companies have run afoul of the U.S. Food and Drug Administration's manufacturing regulations during the last five years, according to a top agency official. (Aug. 16, 2013)
About 70 percent of the nation's supplement companies have run afoul of the U.S. Food and Drug Administration's manufacturing regulations over the past five years, according to a top agency official.
Consumers are put at risk by poorly measured ingredients, uncleaned manufacturing equipment, pesticides in herbal products, supplements contaminated with illegal prescription medications -- even bacteria in pediatric vitamins, recall notices and agency inspection records have shown.
"We're seeing some real problems out there," said Dr. Daniel Fabricant, who heads the FDA's division of Dietary Supplement Programs, referring to manufacturing issues affecting a large number of dietary supplement companies.
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He said many companies don't even have basic recipes for the vitamins and other supplements they sell.
While most vitamins and supplements are not harmful -- and at least one vitamin brand was credited with an 8 percent reduction in cancer among men over 50 -- the industry is beset by repeated recalls, manufacturing problems and adverse reactions caused by tainted products, health experts and regulatory officials say. And there is little the FDA can do to improve the situation, Fabricant said, unless Congress legislates more regulatory authority for the agency.
Roughly half the U.S. population -- 150 million people -- consumes multivitamins, mineral tablets, weight-loss aids, herbal remedies, protein powders and a host of other products that fall under the vast rubric of dietary supplements.
Supplements, a $28 billion industry made up of about 450 U.S. companies, are deemed "food" by law and are not subject to the tough regulatory scrutiny of prescription drugs.
Mira Health Products in Farmingdale, which has had a clean FDA compliance record according to the agency, is under investigation because vitamins it manufactured were laced with anabolic steroids, FDA and state Health Department testing revealed.
The illegal compounds are sometimes used by bodybuilders to increase muscle mass.
Long Island firms eyed
Acting as a contract lab, Mira produced B vitamins, multimineral tablets and vitamin C supplements for another Long Island firm, Purity First Health Ltd. Purity, once located in Farmingdale, now is run out of an East Northport house.
Owner Candice Tripp said she hasn't had a problem in 23 years of selling vitamins. Mira's lawyer said the company is cooperating with authorities.
"We are answering the FDA's questions and responding to queries about manufacturing processes at the company," said lawyer Marc Ullman of Garden City.
The process, he noted, could take weeks.
Sixteen nationwide recalls and warnings have been issued in the past month and a half, including vitamins manufactured by Mira, which contained the risky steroids dimethazine, dimethyltestosterone and methasterone. More than 3,000 products were recalled nationwide last year.
Written product recipes at numerous supplement companies are nonexistent, Fabricant said, and many recipes -- known as master manufacturing records -- are apparently cobbled together when owners learn that government inspectors are on their way.
Worse, drums in which products are mixed are not always appropriately cleaned, Fabricant added, and in some firms these vessels are pitted -- damaged -- possibly from age and/or overuse.
Debris left from previous batches sometimes winds up in newly made products, he said.
Too often, dangerous drugs of all kinds -- from male sexual enhancement compounds to weight-loss medications -- are turning up in vitamins and other supplements nationwide.
Added deliberately
A report in the Journal of the American Medical Association in April noted that potent drugs are sometimes purposely added to supplements to increase strength, usually weight loss remedies and sleep aids.
Sibutramine, for example, which is now banned, causes weight loss but also can lead to heart attack or stroke.
Consumers also are put at risk, Fabricant said, by raw products from foreign sources. Most of what he calls "the alphabet vitamins" -- A, B, C, D and E -- have provenance in China. The same is true of botanicals, Fabricant said, some of which are found to be tainted with pesticides.
Pervasive pesticide usage abroad, he said, raises questions about the safety of so-called health products sold here.
"What we're finding is that people [manufacturers] are not testing their products," Fabricant said.
Whether Mira's situation involves tainted raw materials from abroad or drums that had been used to mix other products has yet to be determined. No one knows how the steroids found their way into Purity's vitamins.
The multitude of manufacturing lapses facing the industry, Fabricant and other experts say, constitutes a breach of the public trust.
Examples of that breach include:
A New Jersey family in 2011 receiving federal prison sentences and orders to pay fines totaling more than $1 million for the rodent infestation and filth at their protein powder enterprises. Rodent feces and urine were found in a product blending area and a rodent that had been chopped in half was found on a blender platform, according to an FDA report.
In April of this year, a Texas distributor of the weight loss supplements OxyElite Pro and Jack3D agreed to stop lacing their products with the stimulant dimethylamylamine -- DMAA. At least one U.S. death has been linked to the Jack3D supplement. The FDA first warned the distributor last year. Under federal pressure, the company destroyed its entire stock last month, worth about $8.5 million, according to the FDA.
Also this year, an analysis at the Kaiser Permanente Center for Health Research in Oregon found that several brands of vitamin D pills didn't contain the amount of active vitamin indicated on the label.
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