FDA, American Longevity Split Court Decision

SAN DIEGO--The U.S. District Court for the Southern District of California handed the Food and Drug Administration (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 the third-party literature section of the Dietary Supplement Health and education Act of 1994 (DSHEA), which the company contends is unconstitutional. At the center of Wallach vs. Crawford is the argument that the DSHEA section 21 U.S.C 343-2(a) restricts free speech because it limits use of the Physician's Desk Reference (PDR) section on magnesium in third-party literature to consumers by dietary supplement companies. Thus, the company sought to invalidate FDAs enforcement policy against such literature.

The court upheld the companys right to sue to invalidate the statute, but not the related FDA enforcement policy. However, the judge also concluded the FDA cannot use its intended use policy to block scientific literature with health claims that satisfy the statutory exemption; the court sided with the company on use of disclaimers to satisfy the exemption.

In issuing its judgment, the court further stated such literature is not inherently misleading, and any restriction placed upon it must be evaluated under the test for evaluating commercial speech (Central Hudson vs. Public Service Commission). By this test, the third-party literature section of DSHEA was deemed constitutional.

American Longevity will appeal the courts decision to uphold the constitutionality of the statute and will further seek an injunction to permit the dissemination of the PDR section on magnesium without any company promotional material.