First of all, get your minds out of the gutter. Second, remember two weeks ago when we noted how rarely we discuss lawsuits against FDA? We are doing it again. Third, although we have talked about the strange regulatory shadowland in which homeopathic drugs have resided, they have not seen much action in litigation. When
What follows is a guest post by John Feldman, a partner in Reed Smith’s Entertainment and Media Industry Group. John closely follows all things Federal Trade Commission and approached us when he saw the FTC weighing in a group of products that falls under the first word of our title. We have weighed in before on FDA’s regulation of homeopathic drugs, but FDA is not the only regulator in town.
As always, our guest posters are entitled to all of the credit, and any blame, for their efforts.
“Eye of newt, and toe of frog. For a charm of powerful trouble, Like a hell-broth boil and bubble.” Hey, if it works for you, more power to ya.
That’s the FTC’s attitude toward homeopathic drugs. Following up on a homeopathic drug workshop in conducted in 2015, the staff at the FTC is apparently convinced that generally there is no medical basis for most claims on homeopathic drug labels and marketing materials. The FTC recognizes that thousands if not millions of people use and find value in homeopathic drugs. And it may be that many if not most of the users of such products know that the science underpinning the products is shaky at best and possibly non-existent, but the FTC believes that many people purchasing homeopathic drugs do not even understand what homeopathy is.
Enter: The FTC Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs.
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).
It’s difficult to draw concrete conclusions in the world of homeopathic drugs. It seems that we don’t know exactly what they are, why they work or whether they even do work. We’re not exactly sure why we take them, but our friend at the yoga studio said they worked and so did Dr. Oz. So we take them, hoping that they’re more fix than fairy dust.
In the preemption and FDA world, it’s even more difficult to draw concrete conclusions when homeopathic drugs are involved. The FDA recognizes these drugs and has in fact devoted a section of its Compliance Policy Guide (“CPG”) to them. CPG § 400.400, “Conditions Under Which Homeopathic Drugs May be Marketed.” But after reading it, it’s not entirely clear how much the FDA is regulating these drugs. For OTC homeopathic drugs, it’s even less clear. For the most part, these drugs must comply with labeling requirements, meaning that their labels must include directions for use, ingredients, the dilution and the indication. Id.; see also 21 C.F.R. §§ 201.5, 201.10, 201.61, 201.62. Depending on certain particulars, homeopathic drugs must also be recognized by and comply with requirements of the Homeopathic Pharmacopeia of the United States, the United States Pharmacopeia, or the National Formulary. But none of that means that the drugs will perform as indicated or are not misbranded. CPG § 400.400.
Given this almost half-hearted regulation, it’s not all that surprising that certain courts see a way around preemption when it comes to state-law claims against homeopathic drugs. In Forcellati v. Hyland’s, Inc., 2015 U.S. Dist. LEXIS 3867 (C.D. Cal Jan. 12, 2015), a putative class sued the manufacturer of homeopathic cold medicines, seeking financial damages under the usual trio of claims based on the California Legal Remedies Act, False Advertising Law and Unfair Competition Law, as well as warranty claims and a claim for violation of the Magnusson-Moss Act. The FDCA has an express preemption clause for OTC homeopathic drugs that applies if the claims touch upon the same subject matter as FDA regulations and seek to impose a requirement that is “different from or in addition to, or that is otherwise not identical with” FDA regulations. 21 U.SC. §379r(d)(1). It’s similar to the FDCA preemption clause that applies to medical devices. While there is an exception to preemption for product liability claims, that preemption exception doesn’t apply to claims like these seeking only financial damages.