FDA Finds Supplement Claims Fraudulent

From an article by Charley Cameron on Inhabitat.com with the headline "FDA finds majority of herbal supplements at GNC, Walmart, Walgreens, and Target don’t contain what they claim – instead cheap fillers like wheat and soy powder"

The New York State Attorney General’s Office is demanding that GNC, Walmart, Walgreens, and Target remove store brand herbal supplements from their shelves after the pills were found to be packed with a strange array of fraudulent—and in some cases hazardous—ingredients. Popular supplements such as ginseng, valerian root, and St. John’s Wort sold under store brand names at the four major retailers were found to contain powdered rice, asparagus, and even houseplants, while being completely void of any of the ingredients on the label.

It’s fairly baffling as to how this situation came about, and came to be so widespread. But what we do know is that while supplements are exempt from the strict regulations imposed on prescription medications, manufacturers and retailers are required by the FDA to correctly label all ingredients. But using DNA bar coding, the FDA was able to determine that highly popular supplements sold at major retailers are in clear violation of these requirements. Among that fraudulent supplements found at the retailers, the NYS Attorney General’s office highlights several examples:

•At GNC, the agency found a number of unlisted fillers, including powdered legumes—a potentially significant hazard for those with peanut or soybean allergies.
•At Target, ginkgo biloba, St. John’s wort and valerian root contained none of the advertised ingredients, and instead were made up of powdered rice, beans, peas, and wild carrots. In other words, a fairly healthy diet if freshly cooked.
•At Walgreens, ginseng pills are quite simply powdered rice and garlic.
•At Walmart, ginkgo biloba was made up of powdered radish, houseplants, and wheat, while being labelled as wheat- and gluten-free.

The response from retailers has been varied; the New York Times reports that Walgreens is to pull the supplements from all stores nationwide, even though only NYS has demanded it. Walmart, meanwhile, claims to be working with its suppliers to fix the problem, Target has yet to respond, and GNC has stated it will cooperate, but maintains that “it tested all of its products using validated and widely used testing methods.”

Dr. Pieter Cohen, an assistant professor at Harvard Medical School and an expert on supplement safety, told the Times that it is possible that the manufacturing process had destroyed some of the DNA of the herbs, which could explain the very extreme results of the FDA’s study. But, as the NYS AG’s office emphasized “The absence of DNA does not explain the high percentage of contaminants found in these products… The burden is now with the industry to prove what is in these supplements.”

In the meantime, you may start to see some of your regular supplements disappear from the shelves as New York pushes forward with its efforts to get fraudulent items off the shelves.



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Diet Supplement Causes Nearly 100 Hepatitis Cases

Original article, called Diet Supplement Causes Nearly 100 Hepatitis Cases, by Rachael Rettner, Senior Writer at Live Science

A popular diet supplement has caused an outbreak of severe liver disease, sickening nearly 100 people in 16 states since it was first reported in Hawaii last year, according to a new paper. The publication calls for a better system to remove dangerous supplements from the market.

As of February, OxyElite Pro, a dietary supplement manufactured by USP Labs that claims to help people burn fat, has been linked to 97 cases of hepatitis, including 47 people who were hospitalized, three who needed liver transplantations and one person who died, according to the paper, which was authored by Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School and a general internist at Cambridge Health Alliance.

Although people who took the supplement started getting ill in May last year, the Food and Drug Administration did not learn of the cases until four months later, in September, when doctors reported a cluster of liver illnesses in Hawaii. USP Labs stopped selling the product in October.

Health officials suspect that a new ingredient called aegeline that was added to the supplement caused the illnesses, Cohen said. Because the FDA regulates supplements only after they come to market, companies are not required to prove that their products are safe and effective before marketing them.

"This really points to the fact that there's no safety testing … before a new ingredient shows up in a supplement in the United States," Cohen said. "Guess who's the experimental animal — the consumer."

Dangerous supplements are supposed to be identified and removed quickly, but this is often not the case, as demonstrated by the hepatitis outbreak, Cohen said. Doctors can report adverse events tied to dietary supplements through an online portal called MedWatch.

But in most cases, the FDA does not receive reports of the harmful effects of supplements, Cohen said. Those cases might be reported to a poison control center, which does not communicate with the FDA, or they might not get reported at all, he said.

"Dangerous supplements remain on store shelves for weeks, months or years" because the FDA has a fractured system for monitoring supplements, Cohen said.

He proposes that all dietary supplements should be registered, and information about the supplements and their ingredients should be incorporated into a database maintained by the FDA and poison centers.

Under this organization, if a person has an adverse reaction to a supplement, it would be reported to a response team made of up doctors, toxicologists, pharmacologists and chemists. The team would then investigate the case, report to the FDA and offer advice about treating the patient.

"In the situation where we know that some supplements out there may be dangerous, we'd better have a really good system" to detect them, Cohen said.

While improved monitoring of supplements is needed, it is not the ultimate solution, Cohen said. Congress should change the law regulating supplements to require that all supplement ingredients undergo safety testing before they come to market, he said.

"Until that happens, consumers and physicians cannot be assured that the pills, powders and potions labeled as dietary supplements are safe for human consumption," Cohen wrote in the April 3 issue of the New England Journal of Medicine.

MyAchingKnees comment:  Let the buyer beware.  When you by non-pharmaceutical grade supplements without any certification or guarantee, you are taking a chance, possibly a large chance, on not getting what is on the label as well getting some ingredients that are not on the label.
 


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