August 12, 2009
Emord & Associates, P.C., has filed suit against the U.S. Food and Drug Administration (FDA) in U.S. District Court in the District of Columbia. The suit challenges the FDA’s Final Rule on Good Manufacturing Practices (GMPs) for dietary supplements.
The plaintiffs in the suit 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 suit alleges that the GMP Final Rule violates the DSHEA adulteration provisions (21 U.S.C. § 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.
The suit also alleges that 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 have challenged all rules affected by the law violations, and have asked the court to declare those rules unlawful. The plaintiffs have also asked the court to compel the FDA to explain what steps are required to satisfy those GMP rules that are unduly vague.
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