Case 1:20-cv-02066-RDM Document 27 Filed 10/23/20 Page 1 of 73
`
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF COLUMBIA
`
`
`
`MEDINATURA, INC.,
`
`
`
`
`
`FOOD AND DRUG ADMINISTRATION
`et al.,
`
`
`Plaintiff,
`
`
`
`v.
`
` Civil Action No. 20-2066 (RDM)
`
` Defendants.
`
`
`
`MEMORANDUM OPINION AND ORDER
`
`
`
`This case concerns the Food and Drug Administration’s (“FDA”) regulation of
`
`homeopathic drugs. For many years, the FDA did not regulate homeopathic drugs at all,
`
`promising to get around to them eventually. Then in 1988, to bring homeopathic drugs into at
`
`least partial compliance with the Federal Food, Drug, and Cosmetic Act (“FFDCA” or “Act”),
`
`the FDA issued Compliance Policy Guide 7132.15, Section 400.400 (“CPG 400.400” or
`
`“Policy”). CPG 400.400 established conditions under which homeopathic drugs could
`
`“ordinarily” be marketed without the FDA’s premarket approval, so long as the drugs complied
`
`with statutory and regulatory requirements for labeling, manufacturing, and registration. Three
`
`decades later, as part of an ongoing effort to change the regulatory framework that applies to
`
`homeopathic drugs, the FDA withdrew CPG 400.400 in 2019.
`
`Plaintiff MediNatura, Inc. is a purveyor of homeopathic products, including six
`
`prescription injectable drugs that it imports from Germany. In June 2020, following the
`
`withdrawal of the Policy, the FDA sent MediNatura a warning letter asserting that its injectable
`
`products violated the FFDCA. The agency also added the products to an Import Alert
`
`
`
`1
`
`

`

`Case 1:20-cv-02066-RDM Document 27 Filed 10/23/20 Page 2 of 73
`
`recommending that officials detain them at the border. MediNatura filed this lawsuit challenging
`
`the withdrawal of CPG 400.400 and the Import Alert and sought a preliminary injunction. In
`
`response, the FDA moved to dismiss. For the following reasons, the Court will GRANT in part
`
`and DENY in part the FDA’s motion to dismiss and will DENY MediNatura’s motion for
`
`preliminary injunction.
`
`I. BACKGROUND
`
`A.
`
`
`
`Statutory and Regulatory Background
`
`1.
`
`The FDA’s Regulation of New Drugs
`
`The FFDCA requires drug manufacturers to secure approval from the FDA before
`
`marketing any new drug. 21 U.S.C. § 355(a). The FFDCA defines “drug” to include, inter alia,
`
`articles recognized in either the “official United States Pharmacopœia” or the “official
`
`Homœopathic Pharmacopœia of the United States” (“HPUS”); articles intended for the
`
`“diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;” and
`
`articles, other than food, “intended to affect the structure or any function of the body of man or
`
`other animals.” Id. § 321(g). The Act defines “new drug,” in turn, as any drug “the composition
`
`of which is such that [it] is not generally recognized, among experts qualified by scientific
`
`training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for
`
`use under the conditions prescribed, recommended, or suggested in the labeling thereof.”
`
`Id. § 321(p). Even if a drug is so recognized, it is still a new drug if it has not “been used to a
`
`material extent or for a material time under such conditions.” Id. In other words, the FFDCA
`
`exempts drugs that are already in the marketplace and generally recognized as safe and effective
`
`(“GRAS/E”) from the requirements for new drugs.
`
`
`
`2
`
`

`

`Case 1:20-cv-02066-RDM Document 27 Filed 10/23/20 Page 3 of 73
`
`The primary means for a drug manufacturer to obtain the FDA’s approval for a new drug
`
`is through a New Drug Application (“NDA”), which must include “full reports of investigations”
`
`showing that the drug is both safe and effective for its intended uses.1 Id. § 355(b). The statute
`
`instructs the FDA to deny an NDA if those investigations fail to show that the drug is safe and
`
`effective for its intended uses; if the manufacturing process for the drugs is “inadequate to
`
`preserve its identity, strength, quality, and purity;” or if the drug’s labeling is “false or
`
`misleading in any particular.” Id. § 355(d); see also 21 C.F.R. § 314.105(c) (“FDA will approve
`
`an NDA after it determines that the drug meets the statutory standards for safety and
`
`effectiveness, manufacturing and controls, and labeling . . . .”). The statute further instructs the
`
`agency, in considering these various factors, to “implement a structured risk-benefit assessment
`
`framework in the new drug approval process to facilitate the balanced consideration of benefits
`
`and risks.” 21 U.S.C. § 355(d).
`
`In 1972, the FDA launched a review process for classifying over-the-counter (“OTC”)
`
`drugs as GRAS/E, known as the OTC Drug Review. Procedures for Classification of Over-the-
`
`Counter Drugs, 37 Fed. Reg. 9464 (May 11, 1972). Over time, that OTC Drug Review became a
`
`separate avenue by which manufacturers could bring over-the-counter drugs to market. See 21
`
`C.F.R. §§ 330.1, 330.10. Through notice and comment rulemaking, the FDA established
`
`monographs recognizing classes of OTC drugs as GRAS/E. Id. Drugs manufactured in
`
`accordance with those monographs are GRAS/E and thus exempt from the NDA process. In
`
`
`1 Although not at issue in this case, the statute also creates an Abbreviated New Drug
`Application (“ANDA”) process through which drug manufacturers may seek approval of generic
`versions of previously approved drugs. 21 U.S.C. § 355(j). Under the ANDA process, a drug
`manufacturer “need not submit clinical studies proving the drug’s safety or effectiveness but
`may, instead, demonstrate that the generic drug is, among other things, the chemical equivalent
`and bioequivalent of the relevant previously approved branded drug.” See STI Pharma, LLC v.
`Azar, No. 18-1231 (RDM), 2020 WL 1332004, at *2 (D.D.C. Mar. 23, 2020).
`3
`
`
`
`

`

`Case 1:20-cv-02066-RDM Document 27 Filed 10/23/20 Page 4 of 73
`
`2020, Congress reformed the OTC process in the CARES Act, replacing the notice-and-comment
`
`procedure for recognizing OTC drugs as GRAS/E with a more expedient administrative order
`
`process. Coronavirus Aid, Relief, and Economic Security Act, Pub. L. No. 116-136, §§ 3851–
`
`3856, 134 Stat. 281, 435–58 (2020).
`
`2.
`
`The FDA’s Import Enforcement Policies
`
`In addition to drugs manufactured in the United States, the FFDCA applies to imported
`
`drugs. 21 U.S.C. § 381(a). If it “appears” that an imported drug violates applicable FFDCA
`
`requirements, including the premarket approval requirements, that drug is subject to refusal of
`
`admission. Id. Chapter 9 of the FDA’s Regulatory Procedures Manual (“RPM”) governs the
`
`agency’s import operations. See Dkt. 11-3 (Ex. A) (RPM § 9). Before FDA denies admission to
`
`an imported drug, it first detains the drug. Dkt. 11-1 at 13. Because the FFDCA permits refusal
`
`of admission based on “examination of such samples or otherwise,” 21 U.S.C. § 381(a)
`
`(emphasis added), FDA regulations allow for “detention without physical examination” where
`
`other information or evidence suggests the drug is inadmissible, Dkt. 11-3 at 37–38 (Ex. A)
`
`(RPM § 9-8-2). Once a drug is detained, the FDA field office provides the importer notice and
`
`an opportunity to be heard. 21 C.F.R. § 1.94. A detained drug is formally denied admission only
`
`after the importer is given a chance to present evidence at an import hearing. Dkt. 11-3 at 55–56
`
`(Ex. A) (RPM § 9-10-5). After the hearing, the FDA field office will either release the drug,
`
`allow it to be brought into compliance with the FFDCA, or refuse admission. Dkt. 11-1 at 14.
`
`An importer may seek reconsideration of a field office’s decision to refuse admission.
`
`See 21 C.F.R. § 10.33.
`
`To guide FDA field officers in reviewing imports, the FDA issues import alerts. Dkt. 11-
`
`3 at 76 (Ex. A) (RPM § 9-15-4). Import alerts “identify those products or shippers that have met
`
`
`
`4
`
`

`

`Case 1:20-cv-02066-RDM Document 27 Filed 10/23/20 Page 5 of 73
`
`the criteria for detention without physical examination.” Id. at 75 (Ex. A) (RPM § 9-15-3). The
`
`alerts “significantly improve the uniformity of enforcement in import problem areas,” id. at 76
`
`(Ex. A) (RPM § 9-15-4), but an importer whose drugs are detained pursuant to an import alert
`
`may still administratively challenge the detention using the procedures described above.
`
`3.
`
`The FDA’s Regulation of Homeopathic Drugs in CPG 400.400
`
`
`
`Homeopathy is a system of alternative medicine developed in Germany in the late 18th
`
`century. See National Institutes of Health, Homeopathy, https://www.nccih.nih.gov/health/
`
`homeopathy (last updated July 2018). Homeopathic medicine generally relies on two
`
`“unconventional” theories. Id. The first, known as “like cures like,” is the notion that diseases
`
`can be cured by substances that produce similar symptoms in healthy people. Id. The second,
`
`known as the “law of minimum dose,” is the idea that smaller amounts of an active ingredient
`
`produce greater effects. Id. In accordance with the latter theory, “[m]any homeopathic products
`
`are so diluted that no molecules of the original substance remain.” Id.
`
`
`
`Although homeopathic drugs are included in the FFDCA’s definition of “drug” and are
`
`therefore subject to regulation by the FDA, see 21 U.S.C. § 321(g), the agency has never
`
`approved an NDA for a homeopathic drug, nor has it determined that any homeopathic drugs are
`
`exempt from the NDA process because they are GRAS/E, see Dkt. 11-1 at 15. And yet, millions
`
`of Americans receive homeopathic treatments every year. See Dkt. 1 at 11 (Compl. ¶ 41) (citing
`
`National Institutes of Health, Homeopathy, https://www.nccih.nih.gov/health/homeopathy (last
`
`updated July 2018)). The continued distribution of homeopathic drugs in apparent violation of
`
`the FFDCA has resulted from a long-standing detente between Congress, the FDA, and the
`
`homeopathic drug industry.
`
`
`
`5
`
`

`

`Case 1:20-cv-02066-RDM Document 27 Filed 10/23/20 Page 6 of 73
`
`In 1972, the American Institute of Homeopathy commented on FDA’s notice of proposed
`
`rulemaking for the OTC Drug Review program and requested that the agency exclude
`
`homeopathic medicines from the review. The agency obliged: “Because of the uniqueness of
`
`homeopathic medicine, the Commissioner has decided to exclude homeopathic drugs from this
`
`OTC drug review and to review them as a separate category at a later time after the present OTC
`
`drug review is complete.” 37 Fed. Reg. at 9,466. The OTC Drug Review then became an
`
`ongoing program that, although reformed in the CARES Act, has never been completed, and the
`
`FDA has not gone on to review homeopathic drugs as a separate category. As a result, there are
`
`currently no FDA drug monographs for homeopathic medicines, nor has the agency created any
`
`other separate review process for determining the safety and effectiveness of homeopathic drugs,
`
`whether OTC or prescription. Dkt. 1 at 5 (Compl. ¶ 19).
`
`Instead, in 1988, the FDA issued CPG 400.400, titled “Conditions Under Which
`
`Homeopathic Drugs May [B]e Marketed.” Dkt. 1 at 29 (Ex. A); see also id. at 40 (Ex. B) (dating
`
`CPG 400.400 to 1988). In its “Background” section, the document included a brief history of
`
`homeopathy, which noted that traditionally “homeopathic drugs have been marketed on a limited
`
`scale by a few manufacturers who have been in business for many years and have predominantly
`
`served the needs of a limited number of licensed practitioners.” Dkt. 1 at 29 (Ex. A). As a
`
`result, homeopathic drugs historically bore little or no labeling. Id. But in the years leading up
`
`to 1988, the FDA had observed “significant” growth in the homeopathic industry. Id. The
`
`agency therefore issued CPG 400.400 to “provide[] guidance on the regulation of OTC and
`
`prescription homeopathic drugs and [to] delineate[] those conditions under which homeopathic
`
`drugs may ordinarily be marketed in the U.S.” Id.
`
`
`
`6
`
`

`

`Case 1:20-cv-02066-RDM Document 27 Filed 10/23/20 Page 7 of 73
`
`Although CPG 400.000 noted that “[a] product’s compliance with requirements of the”
`
`Homœopathic Pharmacopœia of the United States, the United States Pharmacopœia, or the
`
`National Formulary “does not establish that it has been shown by appropriate means to be safe,
`
`effective, and not misbranded for its intended use,” id. at 31 (Ex. A), the Policy said nothing
`
`further about the FFDCA’s NDA or safety and effectiveness requirements. Instead, the Policy
`
`referred its audience to Dr. John Henry Clarke’s A Dictionary of Practical Materia Medica as a
`
`“guide to the use of homeopathic drugs (including potencies, dosing, and other parameters).” Id.
`
`And CPG 400.400 instructed the FDA’s “compliance personnel . . . particularly [to] consider
`
`whether a homeopathic drug is being offered for use (or promoted) significantly beyond
`
`recognized or customary practice of homeopathy,” in which case “priorities and procedures
`
`concerning the agency’s policy on health fraud would apply.” Id. at 29 (Ex. A).
`
`CPG 400.400 did, however, specify various other requirements for marketing
`
`homeopathic drugs. Most notably, CPG 400.400 stated that all homeopathic drugs “must comply
`
`with the labeling provisions” found in the FFDCA and relevant FDA regulations. Id. at 31
`
`(Ex. A). Under the general labeling requirements set forth in the Policy, homeopathic drug
`
`labels were required to include a name and place of business associated with manufacturing,
`
`packing, or distribution, directions for use, a statement of ingredients, and an established name.
`
`Id. at 31–32 (Ex. A). Because many homeopathic drugs at that time bore Latin names, and
`
`because the FFDCA and FDA regulations require drug labeling to be in English, CPG 400.400
`
`mandated that “the industry is required to translate these names from Latin to their common
`
`English names as current labeling stocks are depleted, or by June 11, 1990, whichever occurs
`
`first.” Id. at 32 (Ex. A). In addition, CPG 400.400 included more specific labeling requirements
`
`
`
`7
`
`

`

`Case 1:20-cv-02066-RDM Document 27 Filed 10/23/20 Page 8 of 73
`
`for drugs depending on their prescription or OTC status, which was to be determined in
`
`accordance with the FFDCA. Id. at 32–34 (Ex. A).
`
`CPG 400.400 went on to list requirements for homeopathic drugs beyond labeling. It
`
`required that firms that “manufacture, prepare, propagate, compound, or otherwise process
`
`homeopathic drugs must register as drug establishments” in accordance with the FFDCA. Id. at
`
`34 (Ex. A). The Policy also required that homeopathic drugs “be packaged” and “be
`
`manufactured” as specified in the FFDCA, except for certain carveouts for homeopathic drugs
`
`that the FDA had promulgated in previous regulations. Id. CPG 400.400 thus expressly
`
`subjected homeopathic drugs to many of the requirements of the FFDCA, including for
`
`manufacturing, packaging, and labeling, but it did not expressly require that homeopathic drugs
`
`demonstrate their safety and efficacy through the NDA process or otherwise, even though doing
`
`so is required under the FFDCA. In a section titled “Regulatory Action Guidance,” the Policy
`
`concluded by stating that “[t]hose firms marketing homeopathic drugs which are not in
`
`compliance with the conditions described above will be considered for regulatory follow-
`
`up.” Id.
`
`At a hearing that the FDA hosted on April 21, 2015, on the topic of “Homeopathic
`
`Product Regulation,” Daniel Michels, the director of the Office of Compliance within the FDA’s
`
`Center for Drug Evaluation and Research at the time the Policy was issued and one of its primary
`
`authors, addressed the question of “why . . . a CPG [was] needed in the first place, and why . . . it
`
`ha[s] this particular construct.” See Transcript at 261–62, Homeopathic Product Regulation:
`
`Evaluating the Food and Drug Administration’s Regulatory Framework After a Quarter
`
`Century, FDA (2015), available at https://www.fda.gov/media/92580/download (hereinafter
`
`“Hearing on Homeopathic Product Regulation”). Michels explained that before the 1980s, “[w]e
`
`
`
`8
`
`

`

`Case 1:20-cv-02066-RDM Document 27 Filed 10/23/20 Page 9 of 73
`
`in the compliance area thought that this was something we’d never have to worry about” because
`
`the practice of homeopathy was “was dying, forget it, it’ll be gone by the time we retire.” Id. at
`
`263. But that assumption turned out to be “[n]ot true” because of “new growth in homeopathy.”
`
`Id. And the FDA was particularly concerned about homeopathic drugs that “were being offered
`
`for clearly health fraud conditions, cure your cancer, fix your broken leg.” Id. at 264. But the
`
`FDA had a “knowledge gap” because it “didn’t know what homeopathic products were.” Id. at
`
`265. In Michels’s telling, FDA officials “didn’t know” how homeopathic drugs were
`
`manufactured, how they were labeled, how to distinguish between prescription and OTC
`
`homeopathic drugs, or even where to find a copy of the HPUS. Id. at 265–66. Through
`
`extensive research into the industry, the FDA concluded that it “could not, in the 1980s, treat
`
`homeopathic products with the same regulatory construct that we applied to the other
`
`‘traditional, pharmaceutical products.’” Id. at 266.
`
`Based on that realization, Michels explained, the FDA created CPG 400.400 as an
`
`alternative regulatory framework, which applied all of the FFDCA’s requirements for drugs to
`
`homeopathic products, with the notable exception of “final product testing”—that is, the NDA
`
`process. Id. at 268. With respect to the various labeling requirements that CPG 400.400 applied
`
`directly to homeopathic products for the first time, Michel said that “the industry and the
`
`community took on that challenge.” Id. at 269. As to the standards for manufacturing
`
`homeopathic drugs, Michels said that, because the HPUS was out of date at the time the Policy
`
`was published, the FDA included “other reference materials [that] are cited there as dispositive
`
`in terms of the regulatory status and standards for these products.” Id. In sum, Michels
`
`explained that CPG 400.400 “enhanced FDA’s ability to take regulatory action when necessary,
`
`
`
`9
`
`

`

`Case 1:20-cv-02066-RDM Document 27 Filed 10/23/20 Page 10 of 73
`
`against products containing or alleged to contain homeopathic ingredients” by establishing a
`
`“line in the sand” beyond which “outliers” would face enforcement action. Id. at 270.
`
`Although Congress has never codified CPG 400.400 in a law exempting homeopathic
`
`drugs from the NDA process, it has on occasion included in legislation references to the FDA’s
`
`accommodation of the homeopathic drug industry. When Congress enacted new requirements
`
`for tracking prescription drugs through the supply chain as part of the Drug Quality and Security
`
`Act in 2013, for instance, it exempted homeopathic prescription drugs from those provisions by
`
`excluding from the definition of “product” any “homeopathic drugs marketed in accordance with
`
`applicable guidance under this chapter.” See 21 U.S.C. § 360eee(13). Likewise, when amending
`
`the OTC Drug Review program in the CARES Act, Congress exempted from its new regulatory
`
`scheme “any nonprescription drug . . . which was excluded by the Food and Drug Administration
`
`from the Over-the-Counter Drug Review in accordance with the paragraph numbered 25 on page
`
`9466 of volume 37 of the Federal Register, published on May 11, 1972,” which incorporates by
`
`reference the original exclusion of homeopathic drugs from the FDA’s OTC Drug Review.
`
`Coronavirus Aid, Relief, and Economic Security Act, Pub. L. No. 116-136, § 3853, 134 Stat.
`
`281, 454 (2020).2
`
`
`2 MediNatura also refers in its briefing to certain correspondence between members of Congress
`and the FDA regarding the impact of legislation on CPG 400.400. Dkt. 15 at 26 n.6. In 2012,
`Congress passed the Food and Drug Administration Safety and Innovation Act, Pub. L. No. 112-
`144, 126 Stat. 993 (2012). That statute gave the FDA greater authority to regulate the
`importation of drugs. Dkt. 23 at 22 n.6; see also 21 U.S.C. § 381(r). In a letter, Jeanne Ireland,
`then-Assistant Commissioner for Legislation at FDA, wrote to Senator Tom Harkin, Chairman of
`the Committee on Health, Education, Labor, and Pensions, that the new legislation “will not
`affect FDA’s implementation of CPG 400.400 with regard to the importation of homeopathic
`drugs.” See Letter from Jeanne Ireland, Assistant Comm’r for Legislation, Food & Drug
`Admin., to Sen. Tom Harkin, Chairman, Comm. on Health, Educ., Labor, and Pensions (Aug.
`10, 2012), available at https://www.theaahp.org/wp-content/uploads/2014/01/harkin-
`response.pdf; Dkt. 15 at 26 n.6.
`
`
`
`10
`
`

`

`Case 1:20-cv-02066-RDM Document 27 Filed 10/23/20 Page 11 of 73
`
`4.
`
`The FDA’s Efforts to Rescind and Replace CPG 400.400
`
`In 2015, the FDA announced that it was reconsidering its regulation of homeopathic
`
`drugs and invited the public to attend a hearing, described above, and to submit comments. See
`
`Homeopathic Product Regulation: Evaluating the Food and Drug Administration’s Regulatory
`
`Framework After a Quarter-Century, 80 Fed. Reg. 16,327 (March 27, 2015). In the hearing
`
`notice, the FDA explained that since 1988, under CPG 400.400, “prescription and
`
`nonprescription drug products labeled as homeopathic have been manufactured and distributed
`
`without FDA approval.” Id. at 16,328. The agency noted the continued “upward growth
`
`trajectory” in homeopathic drug sales, going from a multimillion-dollar industry in 1988 to one
`
`with about $2.9 billion in sales as of 2007. Id. The FDA also discussed adverse health effects
`
`related to “[h]omeopathic [a]gents.” Id. And, CPG 400.400 notwithstanding, the notice
`
`emphasized that “nothing” in the FFDCA “exempts drugs labeled as homeopathic from any of
`
`the requirements related to approval” and therefore, insofar as “a drug labeled as homeopathic is
`
`a new drug” within the meaning of the FFDCA, that product “is subject to the same premarket
`
`approval requirements and the same standards for safety and efficacy as all new drugs.” Id.
`
`In December 2017, the FDA issued a draft guidance titled “Drug Products Labeled as
`
`Homeopathic,” in which the agency announced its intention to replace the more categorical
`
`provisions of CPG 400.400 with a “risk-based approach.” Dkt. 1 at 40 (Ex. B). The draft
`
`guidance, like the hearing notice, explains that, under the FFDCA, homeopathic drugs are
`
`subject to the same regulatory requirements as all other drugs, including the same premarket
`
`approval requirements. Id. at 41 (Ex. B). Because premarket approval, whether through an
`
`NDA, Biologics License Application, or the OTC Drug Review plays “an essential role in
`
`ensuring that drugs are both safe and effective,” the FDA cautioned that “[d]rugs marketed
`
`
`
`11
`
`

`

`Case 1:20-cv-02066-RDM Document 27 Filed 10/23/20 Page 12 of 73
`
`without required FDA approval may not meet modern standards for safety, effectiveness, quality,
`
`and labeling.” Id. Unlike the mandatory “must” phrasing of Section 400.400, the 2017 draft
`
`guidance included boilerplate language that, when finalized, it would “not establish any rights
`
`for any person” and will “not [be] binding on FDA or the public.” Id. at 40 (Ex. B).
`
`In light of the growth of homeopathic medicine and attendant safety concerns, the FDA
`
`proposed in the 2017 draft guidance that it would “apply a risk-based enforcement approach to
`
`the manufacturing, distribution, and marketing of drug products labeled as homeopathic.” Id. at
`
`42 (Ex. B). Under that risk-based approach, the FDA would prioritize enforcement actions
`
`against certain classes of homeopathic medicines, including “[p]roducts with reported safety
`
`concerns,” “[p]roducts intended to be used for the prevention or treatment of serious and/or life
`
`threatening diseases and conditions,” and, as relevant here, “[p]roducts for routes of
`
`administration other than oral and topical.” Id. at 43–44 (Ex. B). The draft guidance observed
`
`that “unapproved injectable drug products and unapproved ophthalmic drug products pose a
`
`greater risk of harm to users due to their routes of administration (e.g., bypassing some of the
`
`body’s natural defenses, differences in absorption) and the potential risk of harm from
`
`contamination.” Id. at 43 (Ex. B).
`
`Notwithstanding those priorities, the FDA stated that the draft guidance, when finalized,
`
`will “provide notice that any product labeled as homeopathic that is being marketed illegally is
`
`subject to FDA enforcement action at any time.” Id. at 43 (Ex. B) (emphasis added). And
`
`because no homeopathic product is marketed in accordance with the FFDCA, that will render
`
`every homeopathic product subject to enforcement at any time. Finally, the 2017 draft guidance
`
`signaled FDA’s plan to rescind Section 400.400 “[s]imultaneous[ly] with the issuance of the
`
`final guidance.” Id. at 40 (Ex. B).
`
`
`
`12
`
`

`

`Case 1:20-cv-02066-RDM Document 27 Filed 10/23/20 Page 13 of 73
`
`The FDA received thousands of comments on the 2017 draft guidance, including from
`
`manufacturers, prescribers, and patients of homeopathic medicine, many of whom requested that
`
`aspects of CPG 400.400 be retained, arguing that the new guidance provided the industry with
`
`“an incomplete list of what it probably cannot market and no guidance as to what can be
`
`marketed.” Dkt. 1 at 6–7 (Compl. ¶ 23) (citing comments from the American Association of
`
`Homeopathic Pharmacists and the Homoeopathic Pharmacopoeia Convention of the United
`
`States). Commenters also “challenged [the] FDA’s position that injectable products raise
`
`inherent safety concerns.” Id. at 6 (Compl. ¶ 23) (citing comments from the American
`
`Association of Homeopathic Pharmacists, National Health Freedom Action, and the Consumer
`
`Healthcare Products Association). And the comments highlighted the reliance interests of
`
`homeopathic drug manufacturers who had made significant investments on the understanding
`
`that they would be able to market their products in accordance with CPG 400.400. Id. at 8
`
`(Compl. ¶ 27) (citing comment from the American Association of Homeopathic Pharmacists).
`
`Several months after the release of the 2017 draft guidance, the FDA received a citizen
`
`petition from Americans for Homeopathy Choice.3 Dkt. 12-12 (Ex. K). The petition requested
`
`that the FDA establish an expert advisory committee on homeopathy, convert CPG 400.400 into
`
`a regulation (with slight modifications), withdraw the 2017 draft guidance, and, in the interim,
`
`leave CPG 400.400 in place. Id. at 2–3 (Ex. K). The petition argued (1) that although
`
`homeopathic medicines qualify as drugs under the statute, they should not be considered new
`
`drugs because they had been in continuous use in the United States since 1825, and (2) that
`
`
`3 Drug manufacturers or others can request administrative action from the FDA through a citizen
`petition process. See 21 C.F.R. §§ 10.25, 10.30. Any “interested person” may petition the FDA
`to “issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form
`of administrative action.” Id. § 10.25.
`
`
`
`
`13
`
`

`

`Case 1:20-cv-02066-RDM Document 27 Filed 10/23/20 Page 14 of 73
`
`medicines recognized in the Homeopathic Pharmacopoeia of the United States are “bona fide”
`
`under the law “as long as they are manufactured according to their ‘expected identity, strength,
`
`quality, and purity.’” Id. at 3 (Ex. K). The petition posited that these proposals would “create a
`
`system that allows homeopathy to continue to be a safely utilized, effectively regulated and
`
`accessible choice for consumers.” Id. at 23 (Ex. K). And it further asserted that retaining
`
`essential elements of CPG 400.400 would honor reliance interests by allowing “consumers
`
`represented by Petitioner[], Americans for Homeopathy Choice, and the professionals they
`
`consult, continued access and use of these medicines.” Id. at 14 (Ex. K).
`
`In October 2019, the FDA did three things at roughly the same time. First, it issued a
`
`revised version of the 2017 draft guidance for further public comment. Dkt. 1 at 46 (Ex. C). The
`
`updated 2019 draft guidance was substantially similar to the 2017 draft. The FDA added a
`
`definition of “homeopathic drug product” and clarified that the agency “anticipates that many
`
`homeopathic drug products will fall outside the categories of drug products that FDA intends to
`
`prioritize for enforcement and regulatory action.” Id. at 49 (Ex. C). The FDA also elaborated on
`
`its safety concerns by detailing “multiple situations in which homeopathic drug products posed a
`
`significant risk to patients.” Id. at 51 (Ex. C). The agency focused primarily on two examples of
`
`safety concerns related to homeopathic drugs. Id. First, a 2016 search of the FDA Adverse
`
`Event Reporting System revealed 99 adverse events “consistent with belladonna toxicity,
`
`including reports of infant deaths and seizures, possibly related to teething products.” Id.
`
`“Further investigation revealed that the poisonous belladonna alkaloids in some of the
`
`[homeopathic] products far exceeded the labeled amounts . . . .” Id. Second, “by 2009,” the
`
`FDA had received more than 130 reports of Zicam homeopathic intranasal zinc products causing
`
`
`
`14
`
`

`

`Case 1:20-cv-02066-RDM Document 27 Filed 10/23/20 Page 15 of 73
`
`users to lose their sense of smell. Id. The revised guidance continued to identify injectable
`
`products as posing a particularly high risk. Id. at 53 (Ex. C).
`
`At the same time, the FDA withdrew CPG 400.400—not waiting until it was ready to
`
`publish the final guidance, as the agency had indicated it would do in the 2017 draft. See
`
`Compliance Policy Guide Sec. 400.400 Conditions Under Which Homeopathic Drugs May Be
`
`Marketed; Withdrawal of Guidance, 84 Fed. Reg. 57,439, 57,440 (Oct. 25, 2019). In the Federal
`
`Register notice accompanying the withdrawal, the FDA discussed the “broad misconception that
`
`all homeopathic products are highly diluted and generally composed of ‘natural’ ingredients, and
`
`that they are therefore incapable of causing harm.” Id. On the contrary, the agency cautioned,
`
`the “FDA has encountered situations in which homeopathic products either caused or could have
`
`caused significant harm, even though the products, as labeled, appeared to meet the conditions
`
`described in CPG 400.400.” Id. The growth of the homeopathic drug industry, which led to
`
`“increased population exposure,” contributed to the “FDA’s enhanced focus on the safety of
`
`homeopathic drugs in recent years” and led it to rethink the 30-year-old CPG 400.400. Id. The
`
`FDA decided to rescind CPG 400.400 immediately, rather than waiting until the final
`
`replacement guidance was ready, because of “the recent growth of safety concerns associated
`
`with homeopathic drug products” and the agency’s conclusion that “CPG 400.400 is inconsistent
`
`with the [FDA’s] risk-based approach to enforcement generally.” Id. Finally, the FDA noted
`
`that the withdrawal of the guidance does not change the legal obligations of homeopathic drug
`
`manufacturers, which were always subject under the FFDCA to the FDA’s premarket approval
`
`process, even if (consistent with CPG 400.400) no homeopathic medicine had ever been
`
`approved through that process. Id.
`
`
`
`15
`
`

`

`Case 1:20-cv-02066-RDM Document 27 Filed 10/23/20 Page 16 of 73
`
`Along with the revised draft guidance and the withdrawal of CPG 400.400, the FDA also
`
`denied the citizen petition filed by Americans for Homeopathy Choice. Dkt. 12-13 (Ex. L). The
`
`denial letter retread much of the same ground covered in the draft guidance and the notice of
`
`withdrawal. Near the end of the letter, the FDA included a section addressing “Alleged Reliance
`
`on CPG 400.400.” Id. at 15–16 (Ex. L). The agency asserted that any claims of reliance were
`
`based on “the incorrect belief that withdrawing CPG 400.400 represents a change in the legal
`
`obligations that apply to homeopathic drugs under the statutes FDA administers.” Id at 15
`
`(Ex. L). Because the FFDCA requires premarket review and approval of all new drugs, CPG
`
`400.400 “did not, and legally could not, provide a path for