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Does the FDA Do Enough to Regulate the Dietary Supplement Industry?

New article published in the New England Journal of Medicine (NEJM) found that the FDA’s proposed new authority to regulate the dietary supplement industry will not be enough to fix all problems with the industry.

New legislation aimed at increasing the FDA’s ability to regulate the dietary supplement trade has many in the booming industry up in arms. But a new article published in the New England Journal of Medicine (NEJM) states that the administration’s proposed new authority will not go nearly far enough. The dietary supplement industry currently markets approximately 55,000 products to American consumers who believe them safe to use as directed.

Dietary Supplement Side Effects Update 8/14/12: An article published in next month’s issue of Consumer Reports investigates the risks involved with taking vitamins, minerals, herbs, and so-called ‘dietary supplements.’ The report states that a large number of supposedly natural products are laced with active ingredients found in prescription drugs, and that users often experience serious side effects after taking them. Click here to learn more.

Dietary Supplement Lawsuit Update 8/13/12: A prominent U.S. Attorney has gone on record to state that the massive fines levied against and the DeLuca brothers should serve as a reminder to both retailers as well as manufacturers of dietary supplements to ensure that their products are safe and free of adultered ingredients. Sentencing in the monumental steroid spiking case against the website and Jeremy and Ryan DeLuca was confirmed last week: has agreed to pay a $7 million fine, and the DeLuca brothers will shell out a cumulative $1.1 million. Click here to learn more.

Dietary Supplement Update 4/10/12: Less than a third of active soldiers discuss dietary supplement use with their doctors prior to taking them, according to a new study about drug use by military service members. Many of these individuals don’t consider the use of supplements to affect medications. However, when taken simultaneously, prescription drugs and dietary supplements can significantly increase a person’s risk of potentially life-threatening side effects. Click here to learn more.

Free Dietary Supplement Lawsuit Evaluation: If you or a loved one has been injured by a dietary supplement, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the dietary supplement and we can help.

What’s the problem?

January 26, 2012 – To expand its nearly $30-million-a-year market, dietary supplement manufacturers have been increasingly synthesizing so-called ‘novel’ products containing minerals, plants, or amino acids. These supplements, which have not been widely circulated previously in the United States, appear newly promising and are sometimes offered in ‘mega-doses’ much higher than what are usually used in such products.

Since 1994, drugmakers marketing ‘novel’ supplements have been required to provide the FDA with a standard of evidence supporting the product’s potential safety and efficacy. However, in a NEJM article published earlier this week, Dr. Pieter Cohen, assistant professor of Medicine at Harvard University, stated that even that abstract standard has gone unenforced by the FDA and ignored by companies looking to get their products to market as quickly and cheaply as possible.

In an effort to keep up with the ever-expanding dietary supplement trade, the FDA last July laid out a series of updated requirements aimed at determining a ‘reasonable expectation of safety’ for those marketing ‘novel’ products. In some cases, the administration would accept a company’s documentation of a supplement’s ‘historical use’ outside the US. For products marketed as mega-dose supplements, the FDA would require evidence of safety from animal and test-tube studies.

Dr. Cohen feels the FDA’s new regulations fall short, and don’t go far enough to ensure public safety. The so-called ‘historical use’ of a dietary supplement where no one is looking for harmful side effects is a dangerous standard far too simplified to assure safety, he writes. Additionally, Cohen states that drugmakers are not required to share negative safety data on a product with the FDA, so long as they can provide additional information showing the product is safe to use as directed. And for supplements with no prior history of use, and in those sold at mega-dose strength, “not even single-dose tolerability studies in humans would be required” by the new rules.

“If the FDA succumbs to industry pressure, the public health consequences will be significant,” writes Cohen.

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Do You Have a Dietary Supplement Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in dietary supplement lawsuits. We are handling individual litigation nationwide and currently accepting new dietary supplement injury cases in all 50 states.

Free Dietary Supplement Lawsuit Evaluation: If you or a loved one has been injured by a dietary supplement, you should contact our law firm immediately. You may be entitled to compensation by filing a dietary supplement injury suit and we can help.

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