EMORD SUES FDA: GMP FINAL RULE FOR DIETARY SUPPLEMENTS VIOLATES THE DSHEA ADULTERATION PROVISION
On August 7, 2009, Emord & Associates, P.C. filed suit against the FDA in the U.S. District Court for the District of Columbia, challenging FDA's Final Rule on Good Manufacturing Practices (GMPs) for dietary supplements. The suit seeks declaratory and injunctive relief against several provisions of the FDA's final rule that violate the Dietary Supplement Health and Education Act (DSHEA); the Fifth Amendment to the Constitution; and the Administrative Procedure Act. The plaintiffs are dietary supplement formulators Durk Pearson and Sandy Shaw, the Alliance for Natural Health US, and the Coalition to End FDA and FTC Censorship.
The GMP Final Rule violates the DSHEA adulteration provisions (21 USC 324 (f);(g)) and the Administrative Procedure Act (APA) prohibition on arbitrary and capricious agency action because it allows FDA to hold dietary supplements adulterated without first proving that supplements present a risk of illness or injury to the public or that the conditions under which the supplements are prepared, packed, or held violate the GMPs. Technical recordkeeping violations not tied to unsafe products are grounds for holding the products adulterated under FDA's rules. The rule also violates the Fifth Amendment prohibition against unduly vague laws because many of the rules do not explain what steps the supplement companies must take, at a minimum, to ensure compliance, and violation of those same rules can be prosecuted criminally. The plaintiffs challenge all rules affected by the law violations, ask the court to declare those rules unlawful, and ask the court to compel FDA to explain what steps are required to satisfy those GMP rules that are unduly vague.
"The plaintiffs are certainly not saying that the FDA is powerless to require safe products," said lead counsel Jonathan W. Emord. "They are saying that FDA must abide by the law in doing so." "FDA must abide by DSHEA requirements before it declares products adulterated, and FDA cannot constitutionally compel compliance (under threat of criminal prosecution) with unduly vague rules but must give dietary supplement companies clear direction on what they must do to avoid prosecution," he said. "The GMP rules are poorly written and unnecessarily a trap for the unwary. FDA has unbridled discretion to declare any company in the industry in violation of the rules because of their extreme vagueness," he said. "We hope the U.S. District Court will require FDA to eliminate the surprises, provide clear safe harbors, and abide by the requirements of the Constitution, the DSHEA, and the APA."