Alliance For Natural Health U.S. v. Sebelius

• Decision Date: 06 April 2011
• Docket Number: Civil Action No. 09–1523 (BAH).
• Citation: 775 F.Supp.2d 114
• Parties: ALLIANCE FOR NATURAL HEALTH U.S., et al., Plaintiffs,v.Kathleen SEBELIUS, et al., Defendants.
• Court: U.S. District Court — District of Columbia

775 F.Supp.2d 114

ALLIANCE FOR NATURAL HEALTH U.S., et al., Plaintiffs,
v.
Kathleen SEBELIUS, et al., Defendants.

Civil Action No. 09–1523 (BAH).

United States District Court, District of Columbia.

April 6, 2011.

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Jonathan W. Emord, Emord & Associates P.C., Clifton, VA, for Plaintiffs.Andrew E. Clark, Perham Gorji, U.S. Department of Justice, Washington, DC, for Defendants.

MEMORANDUM OPINION BERYL A. HOWELL, District Judge.

Dietary supplement producers and industry groups brought this lawsuit challenging several regulations adopted by the Food and Drug Administration (“FDA”) to establish current good manufacturing practices for dietary supplements. The plaintiffs argue that the challenged regulations violate the Food, Drug, and Cosmetic Act (“FDCA”) and the Administrative Procedure Act (“APA”) because they exceed the regulatory authority that Congress granted to the FDA under the FDCA. The plaintiffs also argue that the challenged regulations violate the Due Process Clause of the Fifth Amendment to the U.S. Constitution because they are impermissibly vague, and that, for the same reason, they also constitute arbitrary and capricious agency action in violation of the APA. The plaintiffs ask the Court to reverse the regulations and remand to the FDA for further rulemaking. For the reasons explained below, the Court must deny the plaintiffs' motion and grant judgment for the FDA.

I. Background

Under the FDCA, 21 U.S.C. § 301 et seq., a “dietary supplement” is a “product ... intended to supplement the diet” that contains, inter alia, “a vitamin, a mineral, an herb or other botanical, an amino acid, or a dietary substance for use by man to supplement the diet by increasing the total dietary intake.” 21 U.S.C. § 321(ff). A dietary supplement also “is not represented for use as a conventional food or as a sole item of a meal or the diet” and is “labeled as a dietary supplement.” Id.

In 1994, Congress passed the Dietary Supplement Health and Education Act (“DSHEA”), which amended the FDCA to add several specific provisions regarding the regulation of dietary supplements, including the definition cited above. Pub.L. No. 103–417, 108 Stat. 4325. Prior to that time, the FDA had attempted to regulate dietary supplements under its authority to regulate food additives. See

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United States v. 29 Cartons of * * * an Article of Food, 987 F.2d 33, 35–36 (1st Cir.1993). Since DSHEA's enactment, dietary supplements have remained generally regulated as a subset of foods, rather than drugs, but several statutory provisions now govern the regulation of dietary supplements specifically. See, e.g., 21 U.S.C. § 321(ff); 342(f)-(g).

As relevant here, DSHEA defined certain circumstances in which dietary supplements “shall be deemed to be adulterated” under the FDCA, including when a dietary supplement “has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.” 21 U.S.C. § 342(g). The law delegated authority to the FDA “to prescribe good manufacturing practices for dietary supplements.” Id. The FDA had previously prescribed good manufacturing practices (“GMP” or “CGMP”) for foods, drugs, and devices, so the GMP concept was a familiar one in the sphere of FDA regulation. See, e.g., 21 C.F.R., Pt. 110 (food); Pt. 211 (drugs). DSHEA's delegation of authority to prescribe dietary supplement GMPs led to a decade-long process of administrative rulemaking that culminated in the regulations challenged in this action.

On February 6, 1997, the FDA published an Advance Notice of Proposed Rulemaking for dietary supplement GMPs. See Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements, 62 Fed.Reg. 5700 (Feb. 6, 1997). The FDA solicited public input on whether it should adopt dietary supplement GMPs and, if so, what the regulations should include. Id. at 5707–08. The FDA received more than 100 comments in response. See Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements, Proposed Rule, 68 Fed.Reg. 12158, 12159 (Mar. 13, 2003).

After considering the comments received in response to the Advance Notice of Proposed Rulemaking and conducting outreach efforts, including holding five public meetings and touring supplement manufacturing facilities to observe existing practices, the FDA drafted and issued a Proposed Rule in March 2003 suggesting GMPs for dietary supplements. Id. at 12158–61. Following announcement of the Proposed Rule, the FDA conducted three further public meetings and other outreach activities and received approximately 400 comments on the Proposed Rule. See Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Final Rule, 72 Fed.Reg. 34752, 34756 (June 25, 2007).

The FDA issued the Final Rule establishing current good manufacturing practices for dietary supplements on June 25, 2007 (“GMP Final Rule”). Id. The GMP Final Rule establishes the requirements for activities related to dietary supplement manufacturing and includes sections related to personnel, physical plant and grounds, equipment and utensils, production process and control systems, holding and distributing, returned dietary supplements, product complaints, and records and recordkeeping. See 21 C.F.R., Pt. 111.

The FDA staggered the compliance date for the Final Rule based on company size. The compliance date was June 25, 2008 for large businesses; June 25, 2009 for businesses that employ fewer than 500, but 20 or more full-time equivalent employees; June 25, 2010 for businesses that employ fewer than 20 full-time equivalent employees. 72 Fed.Reg. 34752.

Four plaintiffs brought this action challenging various regulations contained in the GMP Final Rule. Plaintiffs Duke Pearson and Sandy Shaw are scientists who

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formulate dietary supplements and license their formulations to dietary supplement manufacturers and retailers in exchange for royalties. See Declaration of Durk Pearson dated August 9, 2010 (hereinafter “Pearson Decl.”); Declaration of Sandy Shaw dated August 9, 2010 (hereinafter “Shaw Decl.”). The other two plaintiffs are organizations that claim an affiliation with dietary supplement industry participants—the Alliance for Natural Health USA and the Coalition to End FDA and FTC Censorship. The plaintiffs seek a declaration invalidating various provisions of the GMP Final Rule and enjoining their enforcement.

The defendants are Kathleen Sebelius, in her official capacity as Secretary of the United States Department of Health and Human Services, the United States Department of Health and Human Services, Margaret A. Hamburg, M.D., in her official capacity as Commissioner of the United States Food and Drug Administration, the Food and Drug Administration, and the United States of America (collectively, the “FDA” or the “defendants”).

The plaintiffs brought this action on August 12, 2009. ECF No. 3. The FDA filed the administrative record (“A.R.”), which is extremely voluminous, on April 1, 2010. ECF No. 16. On April 28, 2010, the plaintiffs moved for summary judgment on their claims. ECF No. 17. The FDA cross-moved for summary judgment on July 9, 2010. ECF No. 19.

The parties' cross-motions for summary judgment are now before the Court.

II. Standards of ReviewA. Summary Judgment

Pursuant to Federal Rule of Civil Procedure 56, the Court will grant a motion for summary judgment “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law” based upon the pleadings, depositions, and affidavits and other materials in the record. Fed.R.Civ.P. 56(a), (c); Tao v. Freeh, 27 F.3d 635, 638 (D.C.Cir.1994). The Court must view all inferences in a light most favorable to the nonmoving party. Tao, 27 F.3d at 638 (citing Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986)). To the extent that the plaintiffs raise constitutional claims, this standard of review applies.

B. Administrative Procedure Act

For claims involving review of a final agency action under the Administrative Procedure Act, the standard set forth in Rule 56(c) does not apply because of the limited role of a court in reviewing the administrative record. See 5 U.S.C. § 706; Cottage Health Sys. v. Sebelius, 631 F.Supp.2d 80, 89 (D.D.C.2009); see also Local Civil Rule 7(h)(2) (in cases “in which judicial review is based solely on the administrative record,” the parties are not required to submit statements of disputed or undisputed material facts). Summary judgment in the APA review context serves as the mechanism for deciding, as a matter of law, whether the agency action is supported by the administrative record and otherwise consistent with the APA standard of review. Cottage Health Sys., 631 F.Supp.2d at 90.

Under the APA, the Court is to set aside an agency action that is “arbitrary and capricious, an abuse of discretion, or otherwise not in accordance with the law.” 5 U.S.C. § 706(2). “ ‘The party challenging an agency's action as arbitrary and capricious bears the burden of proof.’ ” City of Olmsted Falls, Ohio v. F.A.A., 292 F.3d 261, 271 (D.C.Cir.2002) (quoting Lomak Petroleum, Inc. v. FERC, 206 F.3d 1193, 1198 (D.C.Cir.2000)). While the “scope of

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review under the ‘arbitrary and capricious' standard is narrow,” the agency must “articulate a satisfactory explanation for its action including a ‘rational connection between the facts found and the choice made.’ ” Motor Vehicle Mfrs. Ass'n of United States v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983) (quoting Burlington Truck Lines, Inc. v. United States, 371 U.S. 156, 168, 83 S.Ct. 239, 9 L.Ed.2d 207 (1962)); see also CSI Aviation Servs., Inc. v. DOT, 637 F.3d 408, 414 (D.C.Cir.2011) (“The agency...