FDA WINS PYRRHIC VICTORY IN
WALLACH V. CRAWFORD

 

 

Dated: March 30, 2005
Contact: Jonathan W. Emord
Emord & Associates, P.C.
(202-466-6937)

Washington, D.C. - The U.S. District Court for the Southern District of California
handed FDA a pyrrhic victory on March 29, 2005, granting in part and denying in part FDA’s motion to dismiss and for summary judgment in Wallach v. Crawford. Joel D. Wallach, D.V.M., N.D. and American Longevity, Inc. sued the FDA in federal Court on February 3, 2004, alleging that the so-called “third party literature” section of the Dietary Supplement Health and Education Act (DSHEA) (21 U.S.C. 343-2(a)) was an unconstitutional restriction of free speech because it did not permit the unfettered dissemination of the Physician Desk Reference (PDR) section on magnesium to consumers by dietary supplement companies. Wallach and American Longevity also argued that the FDA’s policy of prohibiting the dissemination of scientific literature containing health claims and drug claims even if exempt under the statute (i.e., “FDA’s intended use policy”).

The Court rejected FDA’s argument that Wallach and American Longevity lacked standing to sue to invalidate the statute but accepted FDA’s argument that they did not have standing to sue to invalidate the enforcement policy. The Court accepted Wallach and American Longevity’s argument that if the statutory exemption is satisfied, FDA cannot use its intended use policy to block the dissemination of scientific literature containing health claims and drug claims. The Court also accepted Wallach and American Longevity’s argument that literature of this kind is not inherently misleading and any restriction upon it must be evaluated under all prongs of the test for evaluating commercial speech (Central Hudson) but decided that the statute was constitutional under
that test. The Court additionally accepted Wallach and American Longevity’s arguments that disclaimers were effective means to satisfy the statutory requirements and rejected FDA’s contrary argument.

Dr. Wallach and American Longevity will appeal the Court’s decision upholding
the constitutionality of the statute but will file a new suit with the same Court seeking an injunction from the same Court to permit dissemination of the PDR section on magnesium shorn of all company promotional material. The appeal will be filed with the U.S. Court of Appeals for the Ninth Circuit.