R.J. Reynolds obtains decision overturning FDA's attempt to impose preapproval requirements for many label changes
Clients R.J. Reynolds Tobacco Company and related entities
On behalf of R.J. Reynolds Tobacco Company and related entities, Jones Day and its co-counsel persuaded the court to invalidate the U.S. Food and Drug Administration's effort to impose preapproval requirements for many changes to labels and brand names for tobacco products. In 2015, FDA published a so-called "Guidance" document asserting that numerous changes to product labels and brand names must be preapproved by the Agency. After R.J. Reynolds and other tobacco companies filed a challenge to this FDA-imposed requirement, the court invalidated FDA's attempt to mandate preapproval of many changes to labels and names for tobacco products.
Philip Morris v. U.S. Food & Drug Admin., No. 1:15-cv-544 (D.D.C.)