FDA, American Longevity Split Court Decision 32595

FDA, American Longevity Split Court Decision

SAN DIEGOThe U.S. DistrictCourt for the Southern District of California handed the Food and DrugAdministration (FDA) a partial victory in a lawsuit filed by Joel D.Wallach,D.V.M., N.D., and American Longevity against the agencys enforcement of thethird-party literature section of the Dietary Supplement Health and EducationAct of 1994 (DSHEA), which the company contends is unconstitutional. At thecenter of Wallach vs. Crawford isthe argument that the DSHEA section 21 U.S.C 343-2(a) restricts free speechbecause it limits use of the Physicians DeskReference (PDR) section on magnesium in third-partyliterature to consumers by dietary supplement companies. Thus, the companysought to invalidate FDAs enforcement policy against such literature.

The court upheld the companys right to sue to invalidate the statute, butnot the related FDA enforcement policy. However, the judge also concluded FDAcannot use its intended use policy to block scientific literature with healthclaims that satisfy the statutory exemption.

In issuing its judgment, the court further stated such literature is notinherently misleading, and any restriction placed upon it must be evaluatedunder the test for evaluating commercial speech (CentralHudson vs. Public Service Commission). By this test,the third-party literature section of DSHEA was deemed constitutional.

American Longevity plans to appeal the courts decision to uphold theconstitutionality of the statute and will further seek an injunction to permitthe dissemination of the PDR sectionon magnesium without any company promotional material.