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.
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 United States v. 29 Cartons of * * * an Article of Food,
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
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.
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.
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
Under the APA, the Court also must set aside an agency action that is found to be in excess of the agency's statutory jurisdiction, authority, or limitations. 5 U.S.C. § 706(2)(C). To determine whether an agency has exceeded its statutory authority under the APA, the Court turns to the two-step process of analysis set forth in Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). See Colorado Wild Horse and Burro Coal., Inc. v. Salazar, 639 F.Supp.2d 87, 91 (D.D.C.2009). First, the reviewing court must ask "whether Congress has directly spoken to the precise question at issue." FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 132, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000) (quoting Chevron, 467 U.S. at 842, 104 S.Ct. 2778). If so, the inquiry is at an end; the court "must give effect to the unambiguously expressed intent of Congress." Id. (quoting Chevron, 467 U.S. at 843, 104 S.Ct. 2778). "But if Congress has not specifically addressed the question, a reviewing court must respect the agency's construction of the statute so long as it is permissible." Id.; see also Bhd. of R.R. Signalmen v. Surface Transp. Bd., 638 F.3d 807, 810-11 (D.C.Cir.2011).
As a threshold question, the Court must address whether the plaintiffs have standing to bring this action. Under Article III of the Constitution, federal courts only have jurisdiction to resolve cases and controversies. Fund Democracy LLC v. SEC, 278 F.3d 21, 25 (D.C.Cir.2002). "Therefore, in order to bring an action within our jurisdiction, the party must demonstrate that it has standing to bring that action." Id. (citing Lujan v. Defenders of Wildlife, 504 U.S. 555, 560, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992)). To satisfy this standing requirement, a plaintiff must "demonstrate that it has suffered a concrete and particularized injury that is: (1) actual or imminent, (2) caused by or fairly traceable to an act that the litigant challenges in the instant litigation, and (3) redressable by the court." Id. (quoting Florida Audubon Soc'y v. Bentsen, 94 F.3d 658, 663 (D.C.Cir.1996) (en banc)); see also Commuter Rail Div. of Reg'l Transp. Auth. v. Surface Transp. Bd., 608 F.3d 24, 30 (D.C.Cir.2010) ("The irreducible constitutional minimum of standing contains three elements: (1) injury-in-fact, (2) causation, and (3) redressability.") (internal quotation marks omitted). At the summary judgment stage, a plaintiff asserting standing can no longer rest on "mere allegations," but "must set forth by affidavit or other evidence specific facts which for purposes
The Court will begin by analyzing whether the individual plaintiffs, Durk Pearson and Sandy Shaw, have met their burden to establish standing. As explained below, the Court concludes that Pearson and Shaw do have standing in this action.
The regulations challenged in this action do not directly apply to Plaintiffs Pearson and Shaw, who are scientists that formulate dietary supplements and license their formulations to manufacturers and retailers in exchange for royalties. See Pearson Decl.; Shaw Decl. Rather, the GMP regulations apply to third parties— the supplement manufacturers and retailers who are the individual plaintiffs' licensees. "[W]hen the plaintiff is not himself the object of the government action or inaction he challenges, standing is not precluded, but it is ordinarily `substantially more difficult' to establish." Summers v. Earth Island Institute, 555 U.S. 488, 129 S.Ct. 1142, 1149, 173 L.Ed.2d 1 (2009) (citing Lujan, 504 U.S. at 562, 112 S.Ct. 2130). Even so, plaintiffs Pearson and Shaw have established standing here because this case is one "where the record present[s] substantial evidence of a causal relationship between the government policy and the third-party conduct, leaving little doubt as to causation and the likelihood of redress." Nat'l Wrestling Coaches Ass'n v. Dept. of Educ., 366 F.3d 930, 941 (D.C.Cir.2004).
Pearson and Shaw submitted sworn declarations from themselves and from the CEO of one of their licensees, Life Enhancement Products, Inc. ("LEP"), to establish facts supporting their standing. Pearson and Shaw assert that they have been harmed by the GMP regulations because the increased compliance costs imposed by the GMP regulations have led their licensees to carry fewer of their products and have reduced their licensees' ability to pay royalty payments owed to them. Pearson and Shaw have licensing agreements with LEP for 60 supplement formulae. Pearson Decl.; Shaw Decl. LEP is a manufacturer, labeler, and retailer of dietary supplements and is regulated by the GMP regulations. Declaration of Will Block dated August 9, 2010 (hereinafter "Block Decl.") ¶¶ 2-3. LEP committed $112,166.56 to GMP compliance costs through the end of the 2010 fiscal year. Block Decl. ¶ 8. These expenses included salaries and benefits for compliance managers ($65,000), costs to construct upgrades in facilities (approx. $2,500), costs for testing procedures (approx. $8,000), costs for weekly quality meetings ($10,400), compensatory overtime ($6,000), label alterations ($4,000), and internal auditing ($5,000). Id. As of August 9, 2010, LEP owed Pearson and Shaw $67,752.62 in unpaid royalties, a debt that LEP asserts began to accrue in March 2009, after the company began implementing changes to comply with the GMP rules. Id. ¶ 6; see also Pearson Decl.; Shaw Decl. According to LEP, "[b]ut for the additional costs for cGMP compliance, [LEP] would have funds to pay Durk Pearson and Sandy Shaw their royalties under our licensing agreement," and "[u]ntil [LEP] began implementing business changes to comply with the FDA cGMPs, it had paid Durk Pearson and Sandy Shaw their royalties in full." Block Decl. ¶¶ 11-12. The FDA has not disputed these assertions of fact.
The Court concludes that these facts constitute substantial evidence of a causal relationship between the GMP regulations and a reduction in the individual plaintiffs' licensees' ability to pay royalties. The injury to Plaintiffs Pearson and Shaw is also
Because Pearson and Shaw have standing, the Court need not address the independent standing of the organizational co-plaintiffs who assert the same claims as Pearson and Shaw. See, e.g., Tozzi, 271 F.3d at 310 (declining to address Article III standing of remaining plaintiffs after finding a plaintiff with standing); Clinton v. City of New York, 524 U.S. 417, 431 n.19, 118 S.Ct. 2091, 141 L.Ed.2d 393 (1998) (same).
Therefore, the Court now turns to the merits of the plaintiffs' challenge.
Plaintiffs object to the GMP regulations for two main reasons. First, plaintiffs claim that various GMPs exceed the FDA's statutory authority to regulate dietary supplement production. Second, plaintiffs assert that various GMPs are un-constitutionally vague because they contain imprecise qualifier terms like "adequate," "suitable," and "qualified." For instance, plaintiffs object to GMPs requiring manufacturers to maintain "adequate" bathrooms and plumbing and to hire "qualified" employees. Plaintiffs assert that the purported vagueness of the GMPs also constitutes arbitrary and capricious agency action in violation of the APA. The Court will address these arguments in turn.
Plaintiffs argue that the FDCA does not authorize the FDA to issue many of the dietary supplement GMP regulations that the agency has adopted because of a statutory limitation prohibiting the FDA from issuing dietary supplement GMPs that impose "standards for which there is no current and generally available analytical methodology." Pls.' Mem. in Supp. of Mot. for Summ. J. ("Pls.' Mem.") at 5 (citing 21 U.S.C. § 342(g)(2)). The FDA contends that the plaintiffs' interpretation of this statutory limitation is flawed and that the FDA has not violated the statute. Mem. in Supp. of Defs.' Cross-Mot. for Summ. J. and in Opp'n to Pls.' Mot. for Summ. J. ("Defs.' Mem.") at 21-26. For the reasons discussed below, the Court agrees with the FDA's position.
As noted above, in 1994, Congress enacted DSHEA, which amended the FDCA to add provisions specific to dietary supplements. Pub.L. No. 103-417, 108 Stat. 4325. Among them is Section 402(g), which provides that a dietary supplement "shall be deemed to be adulterated" under the following conditions:
21 U.S.C. § 342(g). Thus, Congress directed that dietary supplements that are "prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations" are "deemed to be adulterated," and Congress authorized the FDA to issue regulations that "prescribe good manufacturing practices for dietary supplements." Id. Congress then specified that those regulations "shall be modeled after current good manufacturing practice regulations for food and may not impose standards for which there is no current and generally available analytical methodology." Id.
The dispute between the parties here turns on the interpretation of the second half of the second sentence in Section 402(g)(2): "Such regulations . . . may not impose standards for which there is no current and generally available analytical methodology." 21 U.S.C. 342(g)(2). To paraphrase the dispute, 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. See Pls.' Mem. at 11-12. By 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. See Defs.' Mem. at 25. Accordingly, the FDA believes that it may issue GMP regulations that are not based on analytical methodologies at all, while the plaintiffs disagree.
The term "analytical methodology" is not defined, but Congress has used the term "analytical method" in several other provisions in the FDCA, each time regarding testing to confirm the presence, absence, or quantity of a substance.
Based on their reading of Section 402(g), the plaintiffs argue that the FDA's GMP Final Rule overstepped the agency's authority by imposing various procedural, recordkeeping, and quality control requirements that are not based on any "analytical methodology."
The FDA responds that the plaintiffs' reading of Section 402(g) is flawed and that the FDA has not violated Section 402(g) because it has not imposed any standards for which there is no current and generally available analytical methodology. Defs.' Mem. at 23-26. According to the FDA, the statutory language instructing that the GMP "regulations . . . may not impose standards for which there is no current and generally available analytical methodology," 21 U.S.C. § 342(g), means that "if and when [the] FDA imposes a standard that requires use of an analytical methodology, it must be one where the methodology is both current and generally available." Defs.' Mem. at 25. "So, for example, [the] FDA could not insist that manufacturers perform a test to confirm the absence of a particular contaminant if there is no current and generally available analytical methodology for detecting the presence of that contaminant." Id. According to the FDA, Congress did not mean that the FDA could only prescribe
Before addressing the parties' conflicting interpretations of Section 402(g), the Court must consider the threshold question of administrative waiver. The FDA argues that the plaintiffs waived their ability to argue that "[S]ection 402(g) should be construed to limit to the CGMP regulations to those based on current and generally available analytical methodologies" because they did not raise that argument during the rulemaking period, although they did submit comments to the proposed rule and joined in comments submitted by others. See Defs.' Mem. at 22-23; Defs.' Reply to Pls.' Opp'n to Defs.' Cross-Mot. for Summ. J. ("Defs.' Reply") at 10-12.
The D.C. Circuit has previously held that parties waive their right to raise issues in challenging an agency rule by failing to raise the issues during the notice-and-comment rulemaking period. See Advocates for Highway and Auto Safety v. Fed. Motor Carrier Safety Admin., 429 F.3d 1136, 1148-50 (D.C.Cir.2005); see also Nuclear Energy Inst., Inc. v. EPA, 373 F.3d 1251, 1297 (D.C.Cir.2004) (per curiam) ("It is a hard and fast rule of administrative law, rooted in simple fairness, that issues not raised before an agency are waived and will not be considered by a court on review. . . . The rule applies with no less force to a statutory interpretation claim not brought to an agency's attention: `[R]espect for agencies' proper role in the Chevron framework requires that the court be particularly careful to ensure that challenges to an agency's interpretation of its governing statute are first raised in the administrative forum.'") (quoting Natural Res. Def. Council v. EPA, 25 F.3d 1063, 1074 (D.C.Cir.1994)).
The plaintiffs assert that the "need for FDA's reliance on current and generally available analytical methodologies was indeed raised during the comment stage." Pls.' Reply at 20 (citing 72 Fed.Reg. 34805, 34852, 34854.) As the FDA points out, however, the comments cited by the plaintiffs do not appear to advance the plaintiffs' current interpretation of Section 402(g), which is that adulteration under Section 402(g) must be based on a showing that the "manufacturing practice contravenes a current and generally available analytical methodology." Defs.' Reply at 10 (citing Pls.' Reply at 12). Rather, the comments cited by plaintiffs primarily appear to address how to define a "current and generally available analytical methodology" in the context of regulations requiring testing of a product for purity, composition, and other measurable indicators of the product's content. See, e.g., Pls.' Reply at 20 (citing 72 Fed.Reg. 34852, Comment 191 and Response) (addressing scientific methods for testing); id. (citing 72 Fed.Reg. 34805, Comment 59 and Response) (addressing appropriate level of precision in defining the terms "`test,' `scientifically valid analytical method,' or `scientifically valid method,'" but not suggesting
72 Fed.Reg. 34853-54. The issue raised in this comment, however, is considerably narrower than the one raised by the plaintiffs. Here, the comment and the response appear to presume that Section 402(g)(2)'s limitation regarding analytical methodologies is directed to regulations involving the testing and analysis of substances. The comment does not address the plaintiffs' current, much broader contention that the FDA may not prescribe any GMP regulations—like recordkeeping and maintenance requirements—that are not based on an "analytical methodology."
Plaintiffs Pearson and Shaw submitted comments both to the Advanced Notice of Proposed Rulemaking, 62 Fed.Reg. 5700 (Feb. 6, 1997), and to the Proposed Rule, 68 Fed.Reg. 12158 (Mar. 13, 2003), in which they objected to numerous aspects of the proposed regulations, but did not advance their current interpretation of the statute. See A.R. 336-359, 894-900, 8570-8844, 8964-8986. In those comments, the plaintiffs discussed analytical procedures, but did not argue that all GMP regulations must be rooted in an analytical methodology. See, e.g., A.R. 899-900 (supplemental comments by, among others, Durk Pearson and Sandy Shaw) ("The proposed CGMPs would require extensive testing to determine the purity of herbs and botanicals. That requirement is illogical in light of the fact that laboratories lack the analytical procedures to establish the purity of many of the herbs and botanicals that are used as dietary ingredients. In cases where there are analytical procedures available, the techniques that must be used are so expensive that small companies would not be able to afford the testing as often as is required in the proposed CGMPs."); see also A.R. 8578-8579 (comments of Durk Pearson and Sandy Shaw addressing Section 402(g)).
Plaintiffs now ask the Court to invalidate more than 40 sections of the Final GMP Rule, which was the outcome of a lengthy agency rulemaking process that spanned a decade from the Advance Notice of Proposed Rulemaking in 1997 to the adoption of the Final Rule in 2007. See 62 Fed Reg. 5700; 72 Fed.Reg. 34752. There
Under these facts, the Court concludes that the plaintiffs are precluded from contesting the FDA's regulatory authority by arguing that the FDCA only permits the agency to issue dietary supplement GMPs that are specifically linked to an analytical methodology because that argument was not advanced during the rulemaking process.
Even if waiver did not preclude the plaintiffs' challenge to the FDA's statutory authority, the outcome would be the same because the FDA's interpretation of Section 402(g) reflects the statute's clear meaning. As noted above, the Court will apply the two-step analysis set forth in Chevron in reviewing the FDA's interpretation of its authority under the FDCA.
At the first step of the Chevron analysis, the Court must "exhaust the `traditional tools of statutory construction' to determine whether Congress has spoken to the precise question at issue." Natural Res. Def. Council, Inc. v. Browner, 57 F.3d 1122, 1125 (D.C.Cir.1995) (quoting Chevron, 467 U.S. at 843 n. 9, 104 S.Ct. 2778). Traditional tools of statutory interpretation include analysis of the statutory text, legislative history, and structure. See S. Cal. Edison Co. v. FERC, 116 F.3d 507, 515 (D.C.Cir.1997).
Plaintiffs' argument that the statute bars the FDA from imposing any GMP regulation that is not based on a current and generally available analytical methodology relies on reading the second half of the second sentence in Section 402(g)(2) in isolation: "Such regulations . . . may not impose standards for which there is no current and generally available analytical methodology." See, e.g., Pls.' Mem. at 1, 11, 14-16. Yet courts consider statutory language within the context of the statute as a whole. See United States v. Morton, 467 U.S. 822, 828, 104 S.Ct. 2769, 81 L.Ed.2d 680 (1984) ("We do not . . . construe statutory phrases in isolation; we read statutes as a whole.").
Reading the statute as a whole, the Court concludes that the plain reading of Section 402(g) comports with the FDA's interpretation. The first sentence of Section 402(g)(2) states that: "The Secretary may by regulation prescribe good manufacturing practices for dietary supplements." 21 U.S.C. § 342(g). The statute then continues by stating that "[s]uch regulations shall be modeled after current good manufacturing practice regulations for food . . ." Id. When Congress chose to use the phrases "good manufacturing practices" and "current good manufacturing practice" in delegating authority to the FDA, it was necessarily aware of the prior application of theses phrases in the FDCA and its corresponding regulations. FAIC Sec., Inc. v. United States, 768 F.2d 352, 363 (D.C.Cir.1985) (recognizing principle that "whenever Congress passes a new statute, it acts aware of all previous statutes on the same subject") (quoting Erlenbaugh v. United States, 409 U.S. 239, 244, 93 S.Ct. 477, 34 L.Ed.2d 446 (1972)). Both
The plaintiffs' interpretation of Section 402(g) is thus problematic for two key reasons. First, the purported requirement that all dietary supplement GMP regulations be tethered to an analytical methodology is difficult to reconcile with the Congressional directive to prescribe GMP regulations modeled on those for food and with the use of the phrase "good manufacturing practices" in the FDCA context generally. Internally inconsistent interpretations of statutes are disfavored. See Am. Soc. of Travel Agents, Inc. v. Blumenthal, 566 F.2d 145, 163-64 (D.C.Cir. 1977) (Bazelon, J., dissenting) ("[C]ontradictory interpretations of differing statutory sections are avoided on the assumption that statutes constitute the expression of a coherent purpose") (citing cases). At best, if plaintiffs' reading of the statute were correct, that would mean that the statute is ambiguous and must be analyzed under Chevron Step Two because it provides internally inconsistent directives. Second, and more fundamentally, the plaintiffs' interpretation of the statute defies common sense. It is not reasonable to assume that Congress would charge the FDA with prescribing good manufacturing practices for dietary supplements, and then cabin the
Plaintiffs' arguments also frequently invoke Section 402(f) of the FDCA, but this section is not relevant to the dispute over the proper interpretation of Section 402(g). See, e.g., Pls.' Mem. at 21 ("[T]he GMP Final Rule violates . . . 21 U.S.C. § 342(f);(g) of the FDCA [sic] by exceeding FDA's statutory authority . . ."); Pls.' Reply at 13 ("FDA prefers to operate without even acknowledging the existence of its Section 342(f) and 342(g)(2) burdens of proof."); Pls.' Reply at 11 (asserting that "[t]he FDA's GMP regulations are not lawful unless they satisfy one or the other statutory burdens placed on the agency [referring to Sections 402(f) and (g)]"). Section 402(f), inter alia, establishes that a dietary supplement that "presents a significant or unreasonable risk of illness" shall be deemed to be adulterated. 21 U.S.C. § 342(f). Sections 402(f) and (g) provide independent and parallel criteria for establishing adulteration under the FDCA. Section 402(f) is not implicated by the GMP regulations challenged in this action because those regulations were authorized under Section 402(g). Accordingly, Section 402(f) does not appear relevant to the plaintiffs' argument, especially in light of the plaintiffs' apparent concession that Sections 402(f) and (g) operate independently. See Pls.' Reply at 10-11, 14. To the extent that the plaintiffs argue that the two subsections do not operate independently and that valid GMP regulations must comply with Section 402(f) in some way, there is no support in the statutory text for this argument because Section 402(f) does not reference GMP regulations at all, while they are precisely the subject of Section 402(g).
Plaintiffs also argue that the FDA's interpretation of the statute effectively reads Section 402(g)(2)'s limitation regarding analytical methods out of the statute entirely, violating the well-settled canon of construction favoring interpretations that give effect to all parts of a statutory text. See Pls.' Reply at 14. Plaintiffs' argument is incorrect. The FDA's interpretation does not read the restriction out of the statute. Rather, that interpretation gives the restriction a coherent meaning that, unlike the plaintiffs' interpretation, is also consistent with the overall text of the statute: "[W]hen [the] FDA imposes a standard that requires use of an analytical methodology, it must be one where the methodology is both current and generally available." Defs.' Reply at 9. Put another way, the FDA cannot require the use of an analytical methodology that is not current and generally available. If it were to do so, that would violate the statute.
The FDA's interpretation of the statute is also most consistent with the statute's legislative history, despite the plaintiffs' arguments to the contrary. Plaintiffs argue that the "express purpose of DSHEA was to ensure that `the Federal Government erects no regulatory barriers that impede the ability of consumers to improve their nutrition through the free choice of dietary supplements.'" Pls.' Mem. at 19 (quoting 140 Cong. Rec. S11705-06, at S11706, 1994 WL 424971 (Aug. 13, 1994) (proposed draft for DSHEA submitted by Senators Hatch and Harkin)). Based on this proposed language and other legislative history, the plaintiffs argue that the
Other parts of the legislative history, however, specifically support the FDA's interpretation of Section 402(g). In a Senate Report on DSHEA, the Section-by-Section Analysis of the bill described Section 12, which became Section 402(g), as follows:
S.Rep. No. 103-410 (1994), 1994 WL 562259, at *36. This report strongly supports the FDA's interpretation of Section 402(g)—i.e., that the intent of the "analytical methodology" limitation is to prohibit the FDA from enacting regulations that would require manufacturers to provide the agency with data through methods that are not currently and practically available to them. Significantly, the report does not in any way suggest that all GMPs must be based on an analytical methodology.
Even if the meaning of the Section 402(g) were determined to be ambiguous rather than clear, the Court would still uphold the FDA's interpretation of the statute. Under the second step of the Chevron analysis, 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." Chevron, 467 U.S. at 843, 104 S.Ct. 2778. For all of the reasons discussed above that support the FDA's interpretation of the statute, the Court could not conclude that the FDA's construction of the statute is impermissible here. Thus, the FDA's interpretation would prevail at the second step of the Chevron analysis as well.
The Court will now turn to the plaintiffs' vagueness arguments.
The plaintiffs argue that several sections of the GMP Final Rule violate the Due Process Clause of the Fifth Amendment and the APA prohibition on unconstitutional agency action because they are unconstitutionally vague and allow arbitrary and discriminatory enforcement. Specifically, the plaintiffs find fault with the use of qualifier terms like "adequate," "suitable," "qualified," and "appropriate." See Pls.' Mem. at 23-26. As explained below, the Court concludes that the challenged sections of the GMP Final Rule are not unconstitutionally vague.
When a regulation that does not implicate constitutionally protected conduct is challenged as unconstitutionally vague on its face, the regulation will be upheld unless it is impermissibly vague in all of its applications.
"The degree of vagueness that the Constitution tolerates . . . depends in part on the nature of the enactment." Hoffman, 455 U.S. at 498, 102 S.Ct. 1186. For example, as relevant here, "economic regulation is subject to a less strict vagueness test," id., but, on the other hand, where, as here, a regulation carries the potential for criminal sanctions, courts undertake a comparatively stricter vagueness review.
Plaintiffs object to the use of terms like "adequate," "qualified," and "suitable" in the GMP Final Rule. For example, the plaintiffs assert that 21 C.F.R. § 111.15(h) "requires restrooms to be `adequate' and `readily accessible' but defines neither term such that the regulated class can discern its meaning." Pls.' Mem. at 24. Similarly, the plaintiffs contend that Section 111.15(f) requires "physical plant plumbing [be] `of an adequate size and design and be adequately installed and maintained' but does not define the term `adequate' such that the regulated class can discern its meaning." Pls.' Mem. 23-24. Plaintiffs raise similar objections to provisions requiring employees to be "qualified" (§ 111.12(a)), equipment and utensils to be "of appropriate design, construction, and workmanship" (§ 111.27(a)(1)), and so on. The Court concludes that these terms do not render the regulations unconstitutionally vague for several reasons.
While the plaintiffs only cite isolated snippets of the challenged regulations, many of the challenged regulations contain further details that flesh out the meaning of terms like "adequate," "suitable," and "qualified" in context. For example, as noted above, the plaintiffs object that Section 111.15(f) requires "physical plant plumbing [be] `of an adequate size and design and be adequately installed and maintained'" without defining the term "adequate." Pls.' Mem. 23-24. Yet the full text of Section 111.15(f) reads:
Thus, the full text provides numerous details clarifying what the FDA means by "adequately installed and maintained" plumbing. Other challenged sections of the GMP Final Rule also contain similar clarifying details. For example, the plaintiffs object to Section 111.15(i) because it requires hand-washing facilities that are "adequate, convenient, and furnish running water at a suitable temperature" without defining "adequate," "convenient," or "suitable," Pls.' Mem. at 24, but the full text of the regulation explains further that hand-washing facilities should be "designed to ensure that an employee's hands are not a source of contamination of components, dietary supplements, or any contact surface." 21 C.F.R. § 111.15(i).
Even without the presence of additional explanatory details, the use of the terms like "adequate," "appropriate," "suitable," and "qualified," in the GMP Final Rule is not impermissibly vague because "a reasonably prudent person, familiar with the conditions the regulations are meant to address and the objectives the regulations are meant to achieve, would have fair warning of what the regulations require." Freeman, 108 F.3d at 362 (upholding mining regulation requiring that "structures. . . shall be maintained in good repair to prevent accidents and injuries . . .") (emphasis added). Courts recognize that "specific regulations cannot begin to cover all of the infinite variety of conditions which [regulated parties] must face," and that "by requiring regulations to be too specific courts would be opening up large loopholes allowing conduct which should be regulated to escape regulation." Id. (internal quotation marks and alteration omitted). Indeed, here, the FDA "was tasked with developing CGMP regulations that apply to a diverse industry . . . [and the] FDA [has] explained that using qualifying terms like `adequate' is necessary to address the `variety of conditions that exist at different companies.'" Defs.' Mem. at 43-44 (citing 72 Fed.Reg. 34788, 34767). When the challenged regulations are viewed within the overall regulatory scheme for dietary supplement manufacturing practices, the Court concludes that a "reasonably prudent person, familiar with the conditions the regulations are meant to address and the objectives the regulations are meant to achieve" would have "fair warning of what the regulations require."
The FDA's food and drug GMP regulations are also replete with provisions that are similar to the challenged dietary supplement GMPs.
Plaintiffs also raise the specter of FDA inspectors exploiting the flexibility in the regulations in abuse of their power. See Pls.' Reply at 27 ("FDA enforcement officers are capable of engaging in harassment and falling prey to bias"). In reviewing a facial challenge to a regulation, however, the Court must presume the agency will act in good faith. See Shays v. FEC, 528 F.3d 914, 930 (D.C.Cir.2008) ("Shays doubts whether the Commission will enforce the safe harbor provision in a way that actually requires meaningful firewalls, but as a court reviewing this facial challenge we must presume that the Commission will enforce its rule in good faith.") (citing Sullivan v. Everhart, 494 U.S. 83, 94, 110 S.Ct. 960, 108 L.Ed.2d 72 (1990)).
There are clearly many applications of the challenged GMP regulations under which the regulations would not be impermissibly vague. To take just one example, the plaintiffs object to Section 111.15(h), which requires manufacturers to provide "employees with adequate, readily accessible bathrooms." See Pls.' Mem. at 24; 21 C.F.R. § 111.15(h). A reasonably prudent manufacturer familiar with the objective of this requirement would be on fair notice that he has violated it if his facility's bathrooms lack running water, or if the bathroom doors are locked and employees can only open them with the permission of a supervisor. See Defs.' Mem. at 33. While the Court does not dismiss the possibility that the challenged provisions of the GMP Final Rule might be impermissibly vague in certain enforcement contexts, the plaintiffs have not established that "no set of circumstances exists under which the [regulations] would be valid.'" Rancho Viejo, LLC, 323 F.3d at 1077-78 (quoting Salerno, 481 U.S. at 745, 107 S.Ct. 2095). Accordingly, the regulations are not facially unconstitutional.
In a variation on the plaintiffs' claim that various sections of the GMP
First, as noted above, courts have previously upheld similar GMP provisions. See Nat'l Ass'n of Pharm. Mfrs., 586 F.Supp. at 753-54 (FDA drug GMP regulations using words such as "adequate," "appropriate," "designed to assure," "proper," "sufficient," and "suitable" are "sufficiently definite and precise to comport with constitutional standards and are not arbitrary or capricious on grounds of vagueness."). The fact that existing FDA regulations have similar wording also undermines the plaintiffs' dire warnings that the dietary supplement GMPs will "compel FDA inspectors to employ their own guesswork as to what is required, creating chaos, fear, and panic in the industry due to uncertainty." Pls.' Reply at 36.
Second, while the plaintiffs argue that the FDA could have adopted regulations with a greater degree of specificity, it is not the Court's role to dictate what level of specificity is appropriate. "When Congress has not specified the level of specificity expected of the agency, . . . the agency is entitled to broad deference in picking the suitable level." Shays, 528 F.3d at 930 (quoting Cement Kiln Recycling Coal. v. EPA, 493 F.3d 207, 217 (D.C.Cir.2007)). Congress has not specified a particular level of specificity here, although Congress did instruct the agency that the GMP regulations should be modeled on food GMPs, which contain regulations of similar specificity to those challenged by the plaintiffs. See 21 U.S.C. § 342(g); see also supra n. 9 (listing similar food GMPs). In addition, the FDA has articulated a rational explanation for its selected level of specificity in the GMP Final Rule. See 72 Fed.Reg. 34787-88 (explaining that the agency could not "predict with mathematical precision how many inches or feet, for example, would be `adequate space' to allow for cleaning a particular piece of equipment that could be applied to every size of facility and every operation . . . [D]efining such terms too precisely would unduly restrict the application of the regulation to a very narrow, limited set of circumstances and not provide industry with the needed flexibility to address the number and variety of types of manufacturing operations that Congress intended for [the GMP Final Rule] to cover."). Thus, the FDA has "articulate[d] 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, 463 U.S. at 43, 103 S.Ct. 2856 (internal quotation marks omitted).
Finally, the plaintiffs argue that even if Congress did not dictate a particular level of specificity for the GMP regulations, the regulations are nevertheless arbitrary because they lack a "comprehensible level of specificity." As discussed above regarding the plaintiffs' constitutional vagueness argument, when the challenged provisions of the GMP Final Rule are read in their full context and in light of the regulations' purpose, they are sufficiently comprehensible to the regulated class. Moreover, the cases cited by the plaintiffs do not support sustaining their pre-enforcement APA challenge on vagueness grounds. See Pls.' Mem. at 30-31; Pls.' Reply at 36-37. For example, Pearson v. Shalala, 164 F.3d 650 (D.C.Cir.1999), a case heavily relied upon by the plaintiffs, involved a post-enforcement challenge to an FDA decision. In that case, the D.C. Circuit held that the
Accordingly, the Court concludes the challenged provisions of the GMP Final Rule are not arbitrary and capricious under the APA.
The plaintiffs' remaining contentions are without merit.
For the reasons stated above, the Court concludes that the challenged sections of the GMP Final Rule did not exceed the FDA's statutory authority, are not impermissibly vague under the due process clause, and are not arbitrary and capricious under the APA. Accordingly, summary judgment is GRANTED for the defendants and DENIED for the plaintiffs.
