CHICAGO — Federal inspections of companies that make dietary supplements — from multivitamins and calcium chews to capsules of echinacea and bodybuilding powders — reveal serious and widespread manufacturing problems in a $28 billion industry that sells products consumed by half of all Americans.
In the past four years, the U.S. Food and Drug Administration has 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.
FDA inspectors found a rodent apparently cut in half next to a scoop, according to a 2008 inspection report
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 the 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 every 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 in Washington, 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 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.
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.
“What is a person in America to do to be healthy?” Adams wrote in an e-mail. “Who can you trust? Not the supplement industry because it does not take long for a tainted product to make you very sick.”
Read more: Manufacturing problems unsanitary, widespread – The Denver Post http://www.denverpost.com/nationworld/ci_21028850/manufacturing-problems-unsanitary-widespread#ixzz224HGVptR
Editors Note: I have been associated with the Shaklee Corporation the number 1 Natural Nutrition Company in the US. Shaklee takes their role very seriously. In 56 years they have never had a recall on any of their supplements. Why? Shaklee runs over 80000 quality tests each year for purity and safety. They run them on the raw materials and they run them on the finished product.Shaklee would rather protect the safety of the end consumer then make a quick buck.
Here is a testimony of a pharmacist who answered someone on choosing a prenatal and why he chose Shaklee..just another confirmation of Shaklee’s quality.
“Why do I take Shaklee vitamins? From a pharmacist’s view you have to look at the clinical research that is done by Shaklee. Mrs. Lindley and I are writing a book on prenatal nutrition — not quite complete — and we requested clinical studies from the makers of prenatal vitamins and NO major company (except Shaklee) could provide us with any studies! Also, as you know, the Shaklee vitamins are natural as opposed to the synthetic prenatal vitamins available in drug stores. The makers of those prenatal vitamins stress the amount of folic acid in them, which is 1 mg. Because they have 1 mg of folic acid they have to be on prescription because folic acid can mask pernicious anemia, but if you look at the prenatal vitamins they have very few of the other vitamins and most leave out biotin completely. It is funny that you ask me this question because a few weeks ago I had a nurse call in for some prenatal vitamins and I asked her what was the best prenatal vitamin and she said, “I don’t know.” So I asked her how did they determine what brand of vitamin to give to the patients and she said, “Whatever they can tolerate”. There are so many reasons why I take Shaklee over the vitamins I could get from pharmaceutical companies. I don’t have time to explain all, but the main reason is because the Shaklee vitamins produce results!” – Mr. Lindley /pharmacist
View this short video below on the Testing they do with their products
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