Elena M. Quattrone and Zachary (Zach) Taylor, attorneys in the Health Care & Life Sciences practice, co-authored an article in Law360, titled “9th Circ. Scienter Ruling May Strengthen FDA's Leverage.” (Read the full version – subscription required.)

Following is an excerpt:

Attempting to operate compliantly in the dietary supplement industry is akin to the Wild West: Minimal guidance and regulations issued by the U.S. Food and Drug Administration, the leading regulatory authority in this space, give dietary supplement companies the impression that they have wide latitude to design, manufacture and distribute their products without concern for government enforcement.

But, in reality, that lack of guidance often presents challenges to dietary supplement companies that make these companies vulnerable to enforcement risk.

A recent decision related to scienter and violations of the Federal Food Drug and Cosmetic Act, U.S. v. Marschall in the U.S. Court of Appeals for the Ninth Circuit, highlights this reality.

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