Summary Judgment Granted to FDA in Challenge to Dietary Supplement Good Manufacturing Practices

Apr 12, 2011   
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The U.S. District Court for the District of Columbia granted summary judgment for the U.S. Food and Drug Administration (FDA) in a case challenging good manufacturing practice (GMP) regulations for dietary supplements. The order, dated April 6, 2011, can be found here.

In the case Alliance for Natural Health U.S. v. Sebelius, No. 09-1523, 2011 U.S. Dist. LEXIS 37027 (D.D.C. April 6, 2011), the plaintiffs include Sandy Shaw and Duke Pearson, scientists who formulate dietary supplements and license the formulations to dietary supplement distributors and manufacturers. Other plaintiffs to the lawsuit include industry organizations, 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 the enforcement of the GMPs enjoined. The FDAs dietary supplement GMP regulations and guidance documents can be found here.

The plaintiffs challenges to the GMP regulations included the following:

1) That several GMP regulations went beyond the statutory authority of the FDA to regulate dietary supplements;

2) Some of the GMP regulations were unconstitutionally vague and in violation of the Fifth Amendments Due Process Clause; and

3) Due to the vague sections of the GMP regulations, these regulations were arbitrary and capricious and an abuse of the FDAs discretion under the Administrative Procedure Act (APA).

The plaintiffs asserted that under Section 402(g) of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 342(g)), the FDA is prohibited from issuing GMP regulations that “impose Ëœstandards for which there is no current and generally available analytical methodology.”

In Judge Beryl Howells order, the court explains 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” while on the other side “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.”

The court first stated that the plaintiffs were precluded from contesting the FDAs regulatory authority because the plaintiffs had failed to raise this issue during the rulemaking process. The court then proceeded to evaluate the plaintiffs challenges to the the FDAs statutory authority using the two-step analysis of Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984). Under the first step of Chevron, the court analyzed the text of the FDCA, as well as the structure and legislative history, and “conclude[d] that the clear meaning of Section 402(g) is the FDAs interpretation of the statute.” The court stated that once “the FDA imposes a standard that requires the use of an analytical methodology, the methodology must be current and generally available to manufactures. The statute does not mean that the FDA may only adopt GMP regulations that require the use of such an analytical methodology.”

The court went on with the second step of its Chevron assessment and found, quoting Chevron, that “if a statute is ambiguous with respect to a specific issue, the Court must uphold the agencys interpretation if it is Ëœbased on a permissible construction of the statute.” Under the two steps of the Chevron analysis, the court held that it “could not conclude that the FDAs construction of the statute is impermissible.”

The court went on to address the plaintiffs contention that certain GMP regulations are unconstitutionally vague by stating that, while certain words are not defined in the GMPs (like “adequate,” “suitable,” “qualified,” etc.), the regulations explain the terms by providing “numerous details clarifying what the FDA means.” The court ultimately concluded that the regulations are not facially unconstitutional and “are not arbitrary and capricious under the APA.”