UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

ALLIANCE FOR NATURAL HEALTH, USA, et al.,

Plaintiffs, Case No. 24-cv-2989 (CRC) v.

UNITED STATES OF AMERICA, et al.,

Defendants.

MEMORANDUM OPINION AND ORDER

Homeopathy is an alternative medical practice based on the theory of similia similibus

curantur, or “like cures like.” In other words, homeopathic drugs are heavily diluted versions of

the substances that cause the very symptoms they seek to cure. Homeopathy is recognized by

the Federal Food, Drug and Cosmetic Act (“FFDCA”). For decades, however, homeopathic

drugs went relatively unregulated as the Federal Drug Administration (“FDA”) focused its

enforcement resources elsewhere. That began to change in 2019, when the agency formally

withdrew its permissive policy toward homeopathic drugs. And, in 2022, it elaborated on its

future enforcement approach toward the industry when it simultaneously denied a petition for

rulemaking concerning homeopathic drug regulation and published a related guidance document.

Plaintiff Alliance for Natural Health, USA (“ANH”), is an advocacy organization that

promotes freedom of choice in healthcare. Plaintiff Meditrend, Inc. (“Meditrend”), is a

homeopathic drug developer and distributor. They filed this lawsuit challenging the December

2022 petition denial and guidance document under the Administrative Procedure Act (“APA”).

The government has moved to dismiss Plaintiffs’ complaint for lack of subject-matter

jurisdiction and failure to state a claim. For the following reasons, the Court will grant the government’s motion as to all of Plaintiff’s claims save one, which the Court must wait to

resolve until it receives the administrative record.

I. Background

A. Legal Background

1. Regulation of Drugs Generally

The FFDCA charges the FDA with “protect[ing] the health and safety of the public” by

overseeing the production, sale, and distribution of food, drugs, and cosmetics. POM Wonderful

LLC v. Coca-Cola Co.,

, 108 (2014); see also

. One way it seeks to

achieve this objective is by mandating that all new drugs obtain FDA approval before entering

the market.

(a). The FFDCA defines “drug” to include “articles recognized in

the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United

States [(“HPUS”)], or official National Formulary[.]”

§ 321(g)(1)(A). A “new drug” is a

drug “not generally recognized, among experts . . . as safe and effective for use under the

conditions prescribed, recommended, or suggested in the labeling thereof.” Id. § 321(p)(1). The

corollary: A drug that is generally recognized as safe and effective (“GRAS/E”) is exempt from

the approval process required for new drugs. Further excepted are any drugs that were “subject

to” the FFDCA’s predecessor statute, the Food and Drugs Act of 1906. Id.

In 1972, the FDA established a review process for determining whether over-the-counter

(“OTC”) drugs were GRAS/E.

, 9473 (May 11, 1972) (codified at 21 C.F.R.

pt. 130). Per these regulations, the FDA undertook notice-and-comment rulemaking to recognize

OTC drugs as GRAS/E on a class-wide basis.

2 2. Regulation of Homeopathic Drugs

Homeopathy is an alternative medical practice based on the theory that “diseases can be

cured by substances that produce similar symptoms in healthy people.” MediNatura, Inc. v.

FDA,

, 424 (D.D.C. 2020) (citation omitted), aff’d,

(D.C. Cir.

2021). Accordingly, homeopathic drugs typically contain substances that cause the very

symptoms they seek to cure. But those substances are heavily diluted, often until “no molecules

of the original substance remain.”

That’s because of another important principle in

homeopathy, “the law of minimum dose—the notion that the lower the dose of the medication,

the greater its effectiveness.” MediNatura, Inc. v. FDA,

, 935 (D.C. Cir. 2021)

(quotation modified). As one example, the homeopathic ingredients in the cold-relief product

“Coldcalm” include flowers, insects, and “poison” and are diluted to up to one part per trillion.

Delarosa v. Boiron, Inc.,

(C.D. Cal. 2011).

Homeopathic drugs are typically marketed as safe and natural alternatives to

conventional drugs. MediNatura, 496 F. Supp. 3d at 430–31. And the FFDCA definition of

“drug” includes homeopathic products.

(g)(1). But the FDA has never approved

a new homeopathic drug for market, and homeopathic drugs are excluded from the OTC drug

review process. MediNatura, 496 F. Supp 3d at 424–25. All marketing of homeopathic drugs is

thus technically in violation of the FFDCA. Yet, for decades after the FFDCA was first passed,

the FDA did not regulate homeopathic drugs whatsoever. Id. at 422. Then, in 1988, the FDA

issued Compliance Policy Guide 7132.15 § 400.400 (“CPG 400.400”), “Conditions Under

Which Homeopathic Drugs May be Marketed.” FDA Mot. to Dismiss Ex. A (“Final Guidance”)

3 at 3. 1 CPG 400.400 listed conditions under which homeopathic manufacturers could

“ordinarily” market drugs without approval. Compl. ¶ 28. In other words, CPG 400.400 drew “a

line in the sand” behind which homeopathic drug manufacturers were generally safe from

enforcement. MediNatura, 496 F. Supp 3d at 427 (citation omitted). That discretionary safe

harbor has allowed the homeopathic industry to flourish in the United States, reaching a

valuation of over $6 billion. Compl. ¶ 9.

Due in part to growing safety concerns around unapproved drugs, the FDA began

reevaluating CPG 400.400’s approach in 2015. See Homeopathic Product Regulation:

Evaluating the Food and Drug Administration’s Regulatory Framework After a Quarter-Century,

, 16,327–28 (Mar. 27, 2015). In 2017, the agency published a draft guidance

announcing its intention to “replace CPG 400.400 with a risk-based enforcement approach,”

Drug Products Labeled as Homeopathic,

, 60,405 (Dec. 20, 2017), and in

2019, it finalized its withdrawal of CPG 400.400, Compliance Policy Guide Sec. 400.400

Conditions Under Which Homeopathic Drugs May Be Marketed,

(Oct. 25,

1 Plaintiffs apparently intended to attach this guidance document and the FDA’s petition denial to their complaint but inadvertently did not. E.g., Compl. ¶ 10 (referencing “Exh. B,” labeled as the Final Guidance); id. ¶ 44 (same); id. ¶ 50 (referring to “Exh. E,” labeled as the petition denial); id. ¶ 91 (same). The Court may still consider them in assessing this motion to dismiss. See, e.g., Tellabs, Inc. v. Makor Issues & Rts., Ltd.,

(2007) (“[C]ourts must consider the complaint in its entirety, [including] documents incorporated into the complaint by reference[.]”); Trudeau v FTC,

(D.C. Cir. 2006) (“In determining whether a complaint fails to state a claim,” courts may consider “any documents either attached to or incorporated in the complaint and matters of which we may take judicial notice.” (citation omitted)); cf. Delta Air Lines, Inc. v. Exp.-Imp. Bank of United States.,

(D.D.C. 2015) (recognizing that courts “may consider materials outside the pleadings in deciding whether to grant a motion to dismiss for lack of jurisdiction” (quoting Jerome Stevens Pharms., Inc. v. FDA,

(D.C. Cir. 2005))). And it also “may generally take judicial notice of materials published in the Federal Register without converting the motion to one for summary judgment.” Banner Health v. Sebelius,

(D.D.C. 2011) (citing

). 4 2019). The notice announced that withdrawal was “applicable October 25, 2019.”

It further

emphasized that “nothing in the [FFDCA] exempts homeopathic drug products from any of the

requirements in the [FFDCA]. Id. at 57,440.

Shortly after the FDA withdrew CPG 400.400, Congress reformed and expedited the

OTC drug-review process through the Coronavirus Aid, Relief, and Economic Security

(“CARES”) Act of 2020, replacing notice-and-comment rulemaking with “a more expedient

administrative order process.” MediNatura, 496 F. Supp. 3d at 423; see also CARES Act

§§ 3851–56, 21 U.S.C. § 355h. But homeopathic drugs were never eligible for the OTC

procedures, and Congress specifically excluded them from these revisions, too. CARES Act

§ 3853 (“Nothing in this Act . . . shall apply to any nonprescription [homeopathic] drug”). It

went on to reinforce that “[n]othing in this section shall be construed to preclude or limit the

applicability of any other provision of the [FFDCA].” Id.

After the CARES Act and the rescission of CPG 400.400, the Americans for Homeopathy

Choice Foundation (“AHCF”), which is not a party to this case, submitted a petition for

rulemaking to the FDA. The petition sought, inter alia, GRAS/E determinations for

homeopathic drugs and assurances against enforcement. 2 Compl. ¶¶ 39–41.

In December 2022, the FDA denied AHCF’s petition and published the final version of

the 2017 draft guidance (“Final Guidance”). See Final Guidance; FDA Mot. to Dismiss Ex. B

(“Petition Denial”). Both documents raised safety concerns with allowing unapproved

2 Specifically, AHCF requested that the FDA (1) promulgate regulations stating, among other things, that homeopathic drugs were GRAS/E by default; (2) recognize as GRAS/E properly labeled and manufactured homeopathic drugs in HPUS; (3) prohibit drugs not listed in HPUS from being marketed as homeopathic; (4) ensure that drugs in HPUS are properly manufactured; (5) ensure that any potential risk-based enforcement policy uses “generally accepted standards and procedures of risk assessment”; and (6) hold a public hearing if the petition is denied. Compl. ¶ 41. 5 homeopathic drugs to reach market. E.g., Final Guidance at 3 n.12; Petition Denial at 4. The

Final Guidance further described the FDA’s risk-based enforcement policy going forward. Final

Guidance at 4–5. Under this approach, the FDA’s enforcement priorities for homeopathic drugs

include unapproved “[p]roducts for routes of administration other than oral and topical,”

“[p]roducts for vulnerable populations,” and products intended to treat or prevent “serious and/or

life-threatening” ailments, among others. Final Guidance at 5.

B. Factual and Procedural Background

Plaintiff ANH is a nonprofit that describes itself as “work[ing] nationally to promote

sustainable approaches to healthcare and defend[] freedom of choice in healthcare through

lasting policy change and public education.” Compl. ¶ 16. Plaintiff Meditrend is a homeopathic

drug distributor “engaged in the development and distribution of innovative health solutions,

including OTC products marketed in the United States as homeopathic drugs.” Id. ¶ 17.

Meditrend commented on AHCF’s petition, arguing that “the FDA lacks authority to require all

OTC homeopathic drug products to have an approved new drug application to be lawfully

marketed[.]” Id. ¶ 55.

ANH and Meditrend filed this lawsuit and asserted four counts challenging the FDA’s

denial of AHCF’s petition and the Final Guidance. Count I alleges that subjecting homeopathic

drugs to the new-drug approval process is unlawful under APA § 706(2)(A) and (C) because it

contravenes the CARES Act and exceeds the FDA’s statutory authority. See id. ¶¶ 57–72. Count

II claims that the FDA’s petition denial was arbitrary and capricious under APA § 706(2)(A)

because it was based on “fundamental errors of law and fact.” See id. ¶¶ 73–80. Count III

asserts that the FDA’s imposition of heightened regulatory requirements is arbitrary and

capricious under APA § 706(2)(A) because it is based on “unsupported safety concerns.” See id.

6 81–98. Finally, Count IV contends that the Final Guidance violates Plaintiffs’ Fifth Amendment

due process rights both under APA § 706(2)(B) and directly under the Constitution. See id. ¶¶

99–111. The FDA moves to dismiss Plaintiffs’ complaint for lack of subject-matter jurisdiction

and failure to state a claim. FDA Mot. to Dismiss at 7.

II. Legal Standard

Under Federal Rule of Civil Procedure 12(b)(1), the plaintiff bears the burden of

establishing jurisdiction by a preponderance of the evidence. See Lujan v. Defs. of Wildlife,

(1992). “[T]he Court must treat the complaint’s factual allegations as true” but has

“an affirmative obligation to ensure that it is acting within the scope of its jurisdictional

authority.” Delta Air Lines, Inc. v. Exp.-Imp. Bank of United States,

(D.D.C. 2015) (citation modified).

When analyzing a motion to dismiss under Rule 12(b)(6), courts determine whether the

complaint “contain[s] sufficient factual matter, accepted as true, to ‘state a claim to relief that is

plausible on its face.’” Ashcroft v. Iqbal,

(2009) (quoting Bell Atl. Corp. v.

Twombly,

(2007)).

III. Analysis

A. Plaintiffs’ Standing

At the outset, the Court must determine whether Plaintiffs have Article III standing to

pursue their claims. To establish Article III standing, a plaintiff must show “(1) an injury in fact,

(2) a sufficient causal connection between the injury and the conduct complained of, and (3) a

likelihood that the injury will be redressed by a favorable decision.” Susan B. Anthony List v.

Driehaus,

, 157–58 (2014) (cleaned up). When a plaintiff is “‘an object of the

action (or forgone action) at issue,’ then ‘there is ordinarily little question that the action or

7 inaction has caused him injury, and that a judgment preventing or requiring the action will

redress it.’” Diamond Alt. Energy, LLC v. EPA,

, 2134 (2025) (quoting Lujan,

504 U.S. at 561–62). The Court will evaluate each plaintiff’s standing one by one, as “Article III

does not give federal courts the power to order relief to any uninjured plaintiff[.]” TransUnion

LLC v. Ramirez,

, 431 (2021) (quoting Tyson Foods, Inc. v. Bouaphakeo,

, 466 (2016) (Roberts, C.J., concurring)). As the Court will explain, Meditrend satisfies the

criteria for standing, though just barely. And because Meditrend is a member of ANH, ANH has

representational standing based on Meditrend’s interests.

First, the Court concludes Meditrend has plausibly alleged standing. Meditrend offers a

declaration from its founder attesting, albeit in a conclusory manner, that at some point during or

after 2023, “Whole Foods . . . removed all Meditrend products from its stores” because of “the

FDA’s revocation of [CPG 400.400],” Pls.’ Opp’n Ex. B (“Savage Decl.”) ¶ 11, “actions against

the homeopathic industry,”

and “harass[ment of] Homeopathics manufacturers and

marketers,”

Ex. B1 ¶ 4. 3 The removal of Meditrend’s products from stores is a classic

economic injury in fact. See Carpenters Indus. Council v. Zinke,

(D.C. Cir. 2017)

(“Economic harm to a business clearly constitutes an injury-in-fact.”). But the government

challenges whether this injury is traceable to the challenged actions, contending that Meditrend

has not shown that Whole Foods removed its products specifically because of the petition denial

or Final Guidance. FDA Reply at 6. At a threshold matter, the Court will generously construe

the challenged “actions against the homeopathic industry” to include the petition denial and Final

3 The submission of Mr. Savage’s declaration as an exhibit to Meditrend’s opposition brief does not prevent the Court from considering the facts it asserts about Whole Foods because “where necessary” on a 12(b)(1) motion, courts “may consider . . . the complaint supplemented by undisputed facts[.]” Coal. for Underground Expansion v. Mineta,

(D.C. Cir. 2003) (quoting Herbert v. Nat’l Acad. of Scis.,

(D.C. Cir. 1992)). The FDA did not challenge the facts asserted, instead arguing that they are too speculative to support standing. See FDA Reply at 5–9.

8 Guidance. And Meditrend has done just enough to show that its injury is traceable to these

actions. The “predictable” reactions of third parties to adverse government action can satisfy the

traceability and redressability requirements. Diamond Alt. Energy, 145 S. Ct. at 2134; see also

Haitian Refugee Ctr. v. Gracey,

(D.C. Cir. 1987) (“The traceability and

redressability requirements are closely related”; both “focus on the question of causation.”

(citation modified) (citing Von Aulock v. Smith,

(D.C. Cir. 1983))). Here, it is

at least plausible that the petition denial and issuance of the Final Guidance induced Whole

Foods to stop selling homeopathic drugs out of fear of enforcement, and a judicial rebuke of

those actions could alleviate that fear and encourage them to restart. Accordingly, at this early

stage, the Court finds this allegation sufficient to bring Meditrend across the threshold for

standing. But Meditrend must bear in mind that a plaintiff’s burden to demonstrate standing

increases over the course of litigation, see Lujan,

, and “this Court has a

continuing duty to examine its subject matter jurisdiction and must raise the issue sua sponte

when it comes into doubt,” Bronner v. Duggan,

, 294 (D.D.C. 2018) (citing

Henderson ex rel. Henderson v. Shinseki,

(2011). Should this litigation

continue, Meditrend will likely need to provide stronger and more specific evidence of this

Court’s subject-matter jurisdiction.

Turning next to ANH, the Court concludes it has representational standing. “An

association has standing to bring suit on behalf of its members when its members would have

standing to sue in their own right, the interests at stake are germane to the organization’s

purpose, and neither the claim asserted nor the relief requested requires individual members’

participation in the lawsuit.” Friends of the Earth, Inc. v. Laidlaw Env’t Servs (TOC), Inc.,

(2000). Meditrend is a member of ANH and has standing. The issue of

9 homeopathic drug regulation is “germane to” ANH’s claimed mission to “defend[] freedom of

choice in healthcare.” Compl. ¶ 16. Therefore, even had Meditrend not brought this suit, ANH

would be able to sue on its behalf.

The Court thus concludes that both Meditrend and ANH have plausibly alleged standing

at this stage.

B. Finality of the FDA’s Actions

Without a separate statute providing jurisdiction, judicial review under the APA is

available only for “final” agency actions.

. To be “final,” an agency action must

meet two conditions. First, it must be the “consummation of the agency’s decisionmaking

process—it must not be of a merely tentative or interlocutory nature.” Bennett v. Spear,

, 177–78 (1997) (citation modified). Second, “the action must be one by which ‘rights or

obligations have been determined,’ or from which ‘legal consequences will flow.’”

(citation

modified). Here, while the FDA’s petition denial satisfies the criteria for final agency action, the

Final Guidance does not and is thus not reviewable under the APA.

1. FDA’s Petition Denial

It is well established that the denial of a rulemaking petition constitutes final agency

action for purposes of APA review. See Fox Television Stations, Inc. v. FCC,

(D.C. Cir. 2002) (“There is no question . . . . an agency’s denial of a petition to initiate a

rulemaking for the repeal or modification of a rule is a final agency action subject to judicial

review.”); Gage v. U.S. Atomic Energy Comm’n,

, 1222 n.27 (D.C. Cir. 1973).

And third parties can challenge denials of petitions for rulemaking as long as they establish

Article III standing to challenge that denial, as Plaintiffs have done here. Therefore, the FDA’s

denial of AHCF’s petition is a final agency action reviewable here.

10 2. The Final Guidance

The 2022 Final Guidance, by contrast, is not final agency action because it has no legal

consequences, failing the second Bennett prong. This situation approximates that in National

Mining Ass’n v. EPA,

(D.C. Cir. 2014) (Kavanaugh, J.), where the EPA

published a “Final Guidance” that the plaintiffs claimed made obtaining mining permits more

difficult, but this Circuit concluded held no legal weight. Like that Final Guidance, the FDA’s

Final Guidance here “imposes no obligations or prohibitions on regulated entities,” and it “may

not be the basis for an enforcement action against a regulated entity.” Nat’l Mining,

; see also Pac. Gas & Elec. Co. v. Fed. Power Comm’n,

, 38–39 (D.C. Cir. 1974).

For example, if the FDA initiates an enforcement action against a homeopathic drug developer, it

cannot point to the Final Guidance as justification—it must use its statutes and regulations. The

revocation of CPG 400.400 brought homeopathic products under the mainstream requirements

for new drugs; the Final Guidance does nothing to change that. Further, the FDA repeatedly

emphasized that the guidance contains only “nonbinding recommendations,” Final Guidance at

1–5, and the document is “devoid of relevant commands”—exactly like the guidance in National

Mining,

. In form and effect, the Final Guidance is a “general statement of

policy” and not final agency action. See

.

Plaintiffs counter by insisting that the Final Guidance was the true revocation of CPG

400.400, which, in turn, was a final action. Pls.’ Opp’n at 16–17. But the two actions are

undeniably separate. As described above, the 2019 rescission of CPG 400.400 was explicitly

“applicable October 25, 2019.” Compliance Policy Guide Sec. 400.400 Conditions Under

Which Homeopathic Drugs May Be Marketed,

(Oct. 25, 2019). That

rescission, not the Final Guidance, marked the end of the FDA’s longstanding policy toward

11 homeopathic drugs. Plaintiffs’ argument also trips over itself by pointing to MediNatura to show

that CPG 400.400 had legal effect. Pls.’ Opp’n at 16. But MediNatura deemed that CPG

400.400’s rescission was a final agency action in 2020—over two years before the Final

Guidance. 496 F. Supp. 3d at 444. CPG 400.400 cannot have been revoked twice.

Accordingly, of the two challenged actions, only the FDA’s petition denial is eligible for

judicial review under the APA. The portions of Counts I, III, and IV that target the Final

Guidance under the APA are therefore dismissed. The remainder of Counts I and III can be

neatly folded into the alleged “errors of law and fact” in Count II. As a result, only Count II and

the Fifth Amendment claim of Count IV proceed to the next stage of analysis.

C. Whether Plaintiffs Have Stated a Claim Upon Which Relief Can Be Granted

Plaintiffs bring a due process challenge to the Final Guidance directly under the Fifth

Amendment. They also challenge the petition denial on four fronts under APA § 706(2)(A).

1. Fifth Amendment Claim

The Court will begin with Plaintiffs’ Fifth Amendment challenge to the Final Guidance.

Although Plaintiffs cannot challenge the Final Guidance under the APA because it is not final

agency action, federal courts do have jurisdiction “to issue injunctions to protect rights

safeguarded by the Constitution.” Bell v. Hood,

(1946); see also Free Enter.

Fund v. Pub. Co. Acct. Oversight Bd.,

, 491 n.2 (2010). Therefore, Plaintiffs may

proceed with such an implied equitable cause of action challenging the Final Guidance under the

Fifth Amendment. But it, too, fails. Plaintiffs have not stated a claim for a Fifth Amendment

violation because the requirements for homeopathic drugs are not “unconstitutionally vague.”

As Plaintiffs concede, there are clear processes for homeopathic drugs to lawfully reach the

market—Plaintiffs just find them unsuitable. See Compl. ¶ 105 (“FDA fails to provide the

12 regulated class . . . with any standards . . . other than . . . the Section 355 pre-market new drug

approval requirements[.]” (emphasis added)). Because Plaintiffs have no viable Fifth

Amendment claim, the Court will dismiss Count IV in its entirety.

2. APA Claims

Moving to the APA § 706(2)(A) claims, the core of Plaintiffs’ challenges to the petition

denial are as follows: (1) regulating homeopathic drugs under

is inconsistent

with the CARES Act; (2) the FDA erroneously concluded that it lacks a statutory basis to define

a separate GRAS/E standard for homeopathic drugs based on the views of homeopathic experts

alone; (3) the FDA erroneously deemed all pre-1938 OTC homeopathic drugs to be “new drugs”;

and (4) the FDA’s purported safety concerns about homeopathic drugs were insufficient to justify

the petition denial. Compl. ¶¶ 79–80.

The Court must first parse what it can and cannot decide at this stage. Typically, a court

cannot reach the merits of a § 706 claim “without having the entire administrative record before

it.” Int’l Longshoremen’s Ass’n, AFL-CIO v. Nat’l Mediation Bd., No. 04-cv-824 (RBW),

, at *4 (D.D.C. Mar. 30, 2005); see also Walter O. Boswell Mem’l Hosp. v. Heckler,

, 792 (D.C. Cir. 1984);

(“[T]he court shall review the whole record

or those parts of it cited by a party[.]”). But when a challenge to agency action is “purely legal,”

“there is no inherent barrier to reaching the merits at the 12(b)(6) stage.” Marshall Cnty. Health

Care Auth. v. Shalala,

(D.C. Cir. 1993). Questions that “can be resolved

with nothing more than the statute and its legislative history” are reviewable here. Am. Bankers

Ass’n v. Nat’l Credit Union Admin.,

(D.C. Cir. 2001). Because Plaintiffs’ first

three APA challenges raise purely legal questions of interpretation, the Court can safely decide

13 them now and will dismiss Plaintiffs’ claims. The Court will, however, refrain from resolving

the final question until an administrative record is available.

a. The CARES Act Challenge

Count II alleges that “[t]he FDA erroneously concluded that Congress pursuant to the

CARES Act intended all homeopathics (including OTC homeopathic drugs) to be regulated

under

.” Compl. ¶ 79. This count fails for two reasons. First, the FDA came to

no such conclusion. The FDA’s petition denial merely notes that the agency will not make

GRAS/E determinations for homeopathic drugs under the CARES Act because the CARES Act’s

OTC drug review reform “does not apply to homeopathic drug products.” Petition Denial at 3.

It does not state that the CARES Act itself required the FDA to regulate all homeopathics under

.

Second, and more important, Plaintiffs’ argument fails because regulating homeopathic

drugs under

is perfectly consistent with the CARES Act. Section 3853(a) reads:

“Nothing in this Act . . . shall apply to any nonprescription [homeopathic] drug . . . which was

excluded by the [FDA] from the [OTC] Drug Review[.]” CARES Act § 3853(a). Section

3853(b) continues: “Nothing in this section shall be construed to preclude or limit the

applicability of any other provision of the [FFDCA].” Id. § 3853(b). Homeopathic drugs were

already excluded from the OTC drug review process before the CARES Act; Congress simply

declined to bring them into its revamped version. Therefore, to read the provision differently—

to relax or heighten regulatory burdens on homeopathic drugs—would be to rewrite it. See

Lamie v. U.S. Trustee,

(2004) (“It is well established that when the statute’s

language is plain, the sole function of the courts—at least where the disposition required by the

text is not absurd—is to enforce it according to its terms.” (internal citation omitted)). Moreover,

14 construing § 3853(a) to exempt homeopathic products from the new-drug approval process under

would directly transgress § 3853(b), which maintains the applicability of all

FFDCA provisions.

In a last effort to save their interpretation, Plaintiffs invoke a “presumption against

change in existing regulations” principle of statutory construction. But this argument again

ignores that, by the time of the CARES Act, the FDA had already withdrawn CPG 400.400 and

publicized its intent to tighten homeopathic drug enforcement. MediNatura, 496 F. Supp 3d at

444; Compl. ¶ 6. Thus, even if such a principle somehow controlled and crystallized the existing

regulatory framework, it would not help Plaintiffs because the presumption would be in favor of

tighter enforcement. As a result, the Court will dismiss Plaintiffs’ CARES Act challenge.

b. Statutory Basis to Define a Separate GRAS/E Standard for Homeopathic Drugs Next, Plaintiffs attack the FDA’s conclusion that it has no “statutory basis,” Compl. ¶ 79,

to “establish a separate standard for GRAS/E determinations” for homeopathic drugs, Petition

Denial at 12. The Court rejects this challenge because the FDA’s conclusion is correct. Per

(p), a drug must be deemed GRAS/E by “experts qualified by scientific training and

experience to evaluate the safety and effectiveness of drugs[.]” And, as noted above,

homeopathic drugs are “drugs” like any other under the FFDCA. Other than the CARES Act,

which the Court has already analyzed, Plaintiffs do not point to any statutory provision that could

provide basis for a separate GRAS/E avenue for homoeopathic drugs. The Court will therefore

dismiss Plaintiffs’ claim on this front as well.

c. The FDA’s Determinations Regarding Pre-1938 Homeopathic Drugs

Plaintiffs’ third challenge to the petition denial fails because it conflicts with the

decision’s language. Plaintiffs accuse the FDA of “deeming all OTC homeopathic drugs

15 marketed subject to HPUS monographs predating 1938 to be ‘new drugs’ under Section 321(p).”

Compl. ¶ 80. But the petition denial reaches no such blanket conclusion. The FDA emphasized

that “whether a drug product is or is not a new drug under the 1938 grandfather clause of the

[FFDCA] is a fact-intensive determination[.]” Petition Denial at 15. And it explicitly refused to

issue any categorical decisions, including AHCF’s sought default determination that “any

specific homeopathic drug” is GRAS/E absent a finding otherwise. Id. at 13. Plaintiffs therefore

attempt to challenge a nonexistent action, and this claim is also dismissed.

d. Whether the FDA had Sufficient Safety Concerns for the Petition Denial

Finally, without an administrative record, the Court cannot rule on whether the FDA had

sufficient safety concerns about homeopathic drugs to justify the petition denial. The FDA lists

several examples to substantiate its safety concerns, including “99 cases of adverse events

consistent with belladonna toxicity,” “more than 130 reports of anosmia (loss of the sense of

smell) associated with the use of Zicam homeopathic intranasal zinc products,” and a worry that

consumers may forego other treatments for homeopathic drugs. Id. at 4. In its simultaneously

published Final Guidance, the FDA asserts that these are but a few “examples among many.”

Final Guidance at 3 n.12. The agency’s safety concerns may well be warranted. But whether

they justify increased enforcement is a factual, not legal, determination. Therefore, the Court

cannot reach a decision without a full record. See Walter O. Boswell Mem’l Hosp., 749 F.2d at

792;

.

IV. Conclusion

For the foregoing reasons, it is hereby

ORDERED that [ECF 5] Defendants’ Motion to Dismiss is GRANTED in part and

DENIED in part. It is further

16 ORDERED that Defendants shall answer the remaining count, which alleges that the

FDA had insufficient safety concerns to justify the petition denial, by July 29. It is further

ORDERED that the parties shall meet and confer and submit a proposed schedule for

producing the Certified Administrative Record and briefing summary judgement by July 29.

SO ORDERED.

CHRISTOPHER R. COOPER United States District Judge

Date: July 15, 2025

17