Search for “homeopathy” on the Internet, and one quickly discovers that this particular form of “alternative medicine,” does not have the greatest
reputation. Wikipedia, not always an unimpeachable source, but usually OK for our purposes, has a less than stellar description of the practice:
Homeopathy is a pseudoscience, which is a belief that is incorrectly presented as scientific, but is ineffective for treating any condition. . . .[H]omeopathic preparations . . . involve repeatedly diluting a chosen substance . . . well past the point where no molecules of the original substance remain. . . . Homeopathy is not a plausible system of treatment, as its axioms about how drugs, illness, the human body, liquids and solutions operate are contradicted by a wide range of discoveries across biology, psychology, physics and chemistry made in the two centuries since its invention. . . . The continued practice of homeopathy, despite a lack of evidence of efficacy, has led to it being characterized within the scientific and medical communities as nonsense, quackery, and a sham.
So why talk about homeopathy here? Because unlike many other controversial alternatives to modern medicine, homeopathic remedies are still around,
courtesy of Congress when it enacted the Food, Drug & Cosmetic Act. In the Act, Congress defined a “drug” so as to include “articles recognized in the . . . official Homœopathic Pharmacopœia of the United States.” 21 U.S.C. §321(g)(1); see 21 U.S.C. § 351(b) (“when a drug “is labeled and offered for sale as a homeopathic drug, . . . it shall be subject to the provisions of the Homeopathic Pharmacopeia of the United States”); 21 U.S.C. §360eee(13) (defining “product” as including “homeopathic drugs marketed in accordance with applicable guidance under this Act”). The FDA has issued standards for the labeling of homeopathic products authorized by the statute. See generally Compliance Policy Guide §400.400 (setting forth homeopathic labeling requirements).
Why Congress acted to protect and preserve the sale of homeopathic remedies we don’t know – Quackwatch speculates that it was because the original FDCA, back in 1938, “was shepherded through Congress by a homeopathic physician who was a senator.” In any event, the statutory provisions exist, and their constitutionally has been upheld in court:
[I]n our construction of this explicit Act, we must be sensitive to what Congress has written, and recall that “It is for us to ascertain neither to add nor subtract, neither to delete nor to distort.” . . . [I]it is clear that whenever there is a problem of construction, the duty of the courts is to liberally construe provisions of the Act, being mindful of its overriding purpose to protect the public health. . . . Under the Act, the safety of an article is not the determining factor. Instead, the determination under the Act is based upon the articles listing in the Pharmacopoeia or its intended use. . . .It would be error for this Court to strike down the precise language of the Act as written. It follows that plaintiff’s constitutional attack on the definition of the word “drug” is without merit.
Meserey v. United States, 447 F. Supp. 548, 553 (D. Nev. 1977) (citation omitted).
We’re interested in this quirk of the FDCA – expressly preserving the marketing of a type of medical product that many denounce as quackery – because like just about everything else, homeopathic remedies have become the target of the plaintiffs’ bar’s penchant for economic loss class actions. Asserting state law, plaintiffs have recently made allegations against homeopathic products such as their “active ingredients [being] so diluted that the ingredients are ‘effectively non-existent’ and the products are therefore not effective for their intended uses.” Allen v. Hyland’s Inc., 300 F.R.D. 643, 652 (C.D. Cal. 2014) (certifying part of action as a class). They claim that homeopathic remedies “are ‘worthless’ because they do not work, describing several of the [them] as mere ‘high-priced water’.” Allen v. Similasan Corp., 306 F.R.D. 635, 639 (S.D. Cal. 2015) (class certification granted in part and denied in part). In the same litigation:
Defendant argues that [plaintiffs’ expert’s] testimony must be excluded because it is directed at homeopathy generally and not specifically at Defendant’s Products. However, based on [his] discussion of the relevant literature and theory of homeopathy in general, his opinion as to Defendant’s Products is logical, and an examination of Defendant’s homeopathic Products would be unnecessary. Consequently, [his] report is both relevant and reliable.
Allen v. Similasan Corp., 2015 WL 1533463, at *8 (S.D. Cal. March 30, 2015).
With respect to this type of product, the plaintiffs may even be right (something we don’t say often), but the fact remains that the FDCA expressly allows the marketing of homeopathic remedies, and state-law plaintiffs are pursuing theories that, if allowed, would force this class of products off the market via litigation – a result that, evidently, Congress didn’t want. That’s a no-no, as the FDA itself can tell you. See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 139 (2000) (where Congress “reveal[ed] its intent that tobacco products remain on the market . . . [a] ban of tobacco products by the FDA would therefore plainly contradict congressional policy”).
In the past, we’ve scoured the legal landscape for obscure places that might give rise to useful FDCA preemption precedent, such as state attempts to:
(1) ban FDA-approved products they didn’t like (here and here), (2) evade FDA prohibitions on importation of cheaper drugs from abroad (here), or (3) require genetically modified food labeling where the FDA has not (here). Homeopathic product litigation seemed to be another oddball area worth keeping an eye on.
Now, something’s happened. Last month, in Herazo v. Whole Foods Market, Inc., 2015 WL 4514510 (S.D. Fla. July 24, 2015), a homeopathic remedy seller found some traction with an argument that private plaintiffs were trying to ban, through litigation, something that Congress intended to allow. Herazo was another purely economic loss class action alleging that various homeopathic products “d[id] not deliver the benefits promised to consumers.” Id. at *1. Among other things, plaintiffs sought to enjoin the sale of these products. Id. Because the FDCA authorized the sale of homeopathic remedies generally, and the FDA had allowed these specific products as over-the-counter “drugs,” the defendants sought abstention “based on the safe harbor, implied preemption, and primary jurisdiction doctrines.” Id. at *4.
The “safe harbor” at issue in Herazo that of Florida’s consumer fraud statute, which exempted any “act or practice required or specifically permitted by federal or state law.” Fla. Stat. §501.212(1). We’ve always been interested in such provisions (a majority of consumer fraud statutes have them) as defenses to statutory claims, most recently discussing them here. The defendant failed to prove this defense in Herazo. While the defendant “has generally shown that it is required to provide labels on its homeopathic products,” it failed “to show that the Food and Drug Administration specifically authorized the labels at issue in this case.” Herazo, 2015 WL 4514510, at *4. Better luck next time.
Except there won’t be a next time, at least not in Herazo. The court granted relief under the other two defenses. The court found the plaintiffs’ attacks upon homeopathic labeling impliedly preempted:
Plaintiffs’ suit seeking to change the labeling requirements of Defendant’s homeopathic medication conflicts with federal policy and should be impliedly preempted. Notwithstanding the Court’s finding that Plaintiffs lack standing to bring a claim for injunctive relief, the Court additionally finds that allowing the claim for injunctive relief to go forward would undermine the purpose for which Congress enacted the uniformity provision and thwart the Food and Drug Administration’s ability to carry out its oversight of marketing of homeopathic products.
Id. at *5.
Invoking the FDA’s “primary jurisdiction,” the court also decided to abstain from deciding the plaintiff’s claims, in favor of the FDA addressing the issues:
The Food and Drug Administration has the necessary experience and expertise in regulating labeling of homeopathic medication and it is within the Agency’s purview to decide whether the labels are compliant with federal law and the comprehensive regulatory scheme it has devised. . . . In this case, however, given the extensive regulatory scheme to oversee homeopathic drug marketing and the questions presented over the labels in this case, the Court finds abstention appropriate under the primary jurisdiction doctrine.
Id. at *5. Thus, homeopathic remedy litigation has (as we hoped) produced favorable preemption and primary jurisdiction precedent.
Even though we have our doubts about the effectiveness of homeopathic products generally, we think that the court got it right in Herero. Given that the FDCA expressly permits these products to be sold (provided they meet the FDA’s usual requirements for “drugs”), state-law plaintiffs should not be allowed to force them off the market via litigation. The Supreme Court has already rejected state-law “stop-selling” theories in the context of generic drug conflict preemption in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2477-78 (2013), and the same general observations should apply here. Once Congress/the FDA OKs a product for sale, there’s an inherent conflict with any state-law claim that would remove that same product from the market. Removing an entire class of products (such as homeopathic remedies) from the market despite the FDCA’s express language would flout congressional intent even more overtly.
Congress allowed homeopathic products to be sold as “drugs” back in the 1930s. It may well be time to revisit that decision. But it’s a decision for Congress, not state-law plaintiffs, to make.