Safety of Dietary Supplements Causing Concerns

We have long been reporting on recalled <"http://www.yourlawyer.com/practice_areas/defective_drugs">dietary supplement products, generally recalled because the products have been found to contain undeclared or dangerous ingredients. In other cases, the recalls have to do with any of a variety of herbal ingredients linked to dangerous adverse reactions. In some cases, the products are sold on the Internet; however, often, the recalled supplements are generally available in neighborhood shops.

For instance, pointed out the Wall Street Journal, so-called natural supplements that contain performance-enhancing medications and undeclared drugs were involved. Citing the U.S. Food and Drug Administration (FDA), the Journal quoted Linda Katz, interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition, “Consumers need to be their own advocate, and read and understand what they are taking.” But, that can be daunting to consumers and involves looking on the FDA site for known recalls or reviewing National Institutes of Health sites for effects and reliability information on various ingredients.

According to the Journal, the majority—about two-thirds—of all Americans take dietary supplements which includes, “vitamins, minerals, and herbal products,” according to the Council for Responsible Nutrition, an industry trade group, said the Journal. The group noted that the most commonly used supplements include multivitamins, calcium, as well as energy and muscle boosters and weight-loss products.

Part of the concern is that supplements are not as heavily regulated as medications, which require FDA approval to make it to market, said the Journal. Also, supplements that are made from products available on the U.S. market prior to 1994 can be sold without agency review, which includes a wide variety of products currently available, said the Journal. But, even those products that contain substances unavailable prior to 1994, need only advise the FDA and do not require approval to be sold, said the Journal.

Many of the recalls we have discussed in recent months concern ingredients that can cause dangerous cardiac, renal, and liver side effects, for example; dangerous, life-threatening interactions with prescribed medications; and questionable, in some cases, poisonous ingredients that make wild claims. And, while advocates have been fighting for tighter controls, some, including Officials at the Council for Responsible Nutrition say no such new laws are required given new FDA manufacturing standards being phased in for supplements, and a 2007 requirement that mandates supplement manufacturers advise the agency about serious side effect reports, said the Journal.

The supplement industry is a massive, growing industry. Mandating supplement safety is overwhelming and a Senate Judiciary subcommittee has a hearing scheduled later this month on the safety of dietary supplements, said the Journal.

In one 2007 survey cited by the Journal, undisclosed steroids were found in 25 percent of 52 samples studied. In a medical journal article the Journal cited from last year, a study tracking drug-induced liver injuries, found nine percent of 300 such cases were potentially linked to dietary supplements containing steroids. In under a year, the FDA has issued warnings on over 70 weight-loss supplements that contained potentially dangerous ingredients, including undeclared prescription drugs, said the Journal.

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