Judge Tosses Challenge to Dietary Supplement GMP Regulations

April 11, 2011

By Cassandra A. Soltis

In an opinion dated April 6, 2011, Judge Beryl Howell of the U.S. District Court for the District of Columbia granted summary judgment for the FDA in a case challenging the dietary supplement good manufacturing practice (“GMP”) regulations.  Alliance for Natural Health U.S. v. Sebelius, No. 09-1523, 2011 U.S. Dist. LEXIS 37027 (D.D.C. Apr. 6, 2011).  The plaintiffs included Duke Pearson and Sandy Shaw, scientists who formulate dietary supplements and license their formulations to dietary supplement manufacturers and retailers, as well as two organizations affiliated with the dietary supplement industry – the Alliance for Natural Health USA, and the Coalition to End FDA and FTC Censorship.  The plaintiffs sought to have various provisions of the dietary supplement GMPs declared invalid and to have their enforcement enjoined. 

After concluding that the two scientist plaintiffs had standing, the court addressed the plaintiffs’ challenges to the GMP regulations – that (1) various GMP regulations exceeded FDA’s statutory authority to regulate dietary supplements, (2) some GMP regulations were unconstitutionally vague, in violation of the Due Process Clause of the Fifth Amendment, and (3) because of the vague sections of the GMP regulations, the regulations were arbitrary and capricious and an abuse of discretion under the Administrative Procedure Act ("APA"). 

Plaintiffs asserted FDA exceeded its statutory authority because Section 402(g) of the Federal Food, Drug, and Cosmetic Act ("FDC Act") prohibits FDA from issuing GMP regulations “that impose ‘standards for which there is no current and generally available analytical methodology.’”  Id. at *16-17.  The court explained that “the plaintiffs read this clause to mean that the FDA is only permitted to issue GMP regulations that are based on analytical methodologies and that these methodologies must also be current and generally available”; in “contrast, the FDA reads the clause to mean that if and when the FDA issues a regulation that incorporates a standard based on an analytical methodology, then that analytical methodology must be one that is current and generally available.”  Id. at *18-19. 

Before addressing the conflicting interpretations of the FDC Act, the court stated that the plaintiffs were precluded from contesting FDA’s regulatory authority because the plaintiffs failed to raise this issue during the rulemaking process.  Id. at *30.  (This serves as a good reminder to submit comments on proposed regulations when there are regulatory and legal concerns.)  Nevertheless, the court proceeded to analyze the plaintiffs’ challenge to FDA’s statutory authority using Chevron’s two-step process – an analysis we predicted would be critical to the outcome of this case.  Under Chevron step one, the court analyzed the statutory text, structure, and legislative history and “conclude[d] that the clear meaning of Section 402(g) is the FDA’s interpretation of the statute.”  Id. at *42.  The court explained that “[i]f the FDA imposes a standard that requires the use of an analytical methodology, the methodology must be current and generally available to manufacturers.  The statute does not mean that the FDA may only adopt GMP regulations that require the use of such an analytical methodology.”  Id.

Even though the court found the meaning of Section 402(g) to be clear, it proceeded to analyze this section under the second step of the Chevron analysis.  Under Chevron step two, “if a statute is ambiguous with respect to a specific issue, the Court must uphold the agency’s interpretation if it is ‘based on a permissible construction of the statute.’”  Id. at *43 (quoting Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 843 (1984)).  The court determined that, given all of the reasons that support FDA’s interpretation of the statute, “the Court could not conclude that the FDA’s construction of the statute is impermissible.”  Id.

Regarding the plaintiffs’ argument that certain GMP regulations are unconstitutionally vague, the court disagreed, explaining that, although certain terms like “adequate,” “qualified,” and “suitable” are not defined in the GMPs, the regulations essentially explain the meaning of the terms by providing “numerous details clarifying what the FDA means by ‘adequately installed and maintained plumbing,’” for example.  Id. at *48-49.  The court stated that “[t]here are clearly many applications of the challenged GMP regulations under which the regulations would not be impermissibly vague.”  Id. at *54.  For this reason, the court concluded that the regulations are not facially unconstitutional and “are not arbitrary and capricious under the APA.”  Id. at *57-58.