Homeo-what-ic?

By Ivan J. Wasserman

Once limited to a relatively small group of practitioners and limited distribution, many homeopathic drug products now have gone mainstream. Even with the popularity of some of these products, there still seems to be confusion about exactly what they are and how they can be marketed. Following is a brief overview of what homeopathic drugs are and how they are regulated. The short story: homeopathic drugs are a class of therapeutic products that (1) do not need to be approved by the Food and Drug Administration (FDA) before being marketed; (2) can bear claims which cannot be made for dietary supplements; but (3) do not provide a “free pass” to marketers to make any claims in labeling or advertising without adequate scientific substantiation.

In the late 1700s, Dr. Samuel Hahnemann founded the practice of homeopathy in Germany. Based on the theory of “like curse like” or “law of similars,” homeopathic practitioners believe that disease symptoms can be treated by small doses of substances that produce similar symptoms in healthy individuals. In other words, if a substance gives a healthy person a headache, taking a very small amount of that substance when you have a headache will treat it. Further, believing that a substance’s effectiveness as a treatment increases the more dilute it is, homeopathic practitioners create medicines that repeatedly are diluted by factors of 10, which results in some homeopathic medications that are so dilute, it can be very difficult to detect the presence of the “active” ingredient.

FDA REGULATION
Thanks to the efforts in 1938 of Senator Royal Copeland, a chief sponsor of the Food, Drug and Cosmetic Act (the “Act”) and a homeopathic practitioner, the definition of “drug” under the Act includes any product that is listed in the Homeopathic Pharmacopoeia of the United States (HPUS). The HPUS is a set of standards-or “monographs”-for the source, composition and preparation of homeopathic drugs. Homeopathic drugs products are drugs under the Act, not dietary supplements. As such, claims for homeopathic products are not restricted to claims that they affect the structure or function of the body, as they are for dietary supplements. Rather, like any drugs, homeopathic drugs can claim to treat, cure or prevent diseases.

The key document governing how FDA regulates homeopathic drug products is Compliance Policy Guide 7132.15, Conditions Under Which Homeopathic Drugs May be Marketed (the “CPG”). If a homeopathic drug does not meet the guidelines described in the CPG, it will be considered an unapproved new drug and cannot be lawfully marketed.

The primary requirement for homeopathic drugs is that they must meet the standards set out in the HPUS. Importantly, if a product complies with the HPUS, it does not automatically mean it can be sold over the counter (OTC). In some instances, the HPUS itself will specify whether a product can be sold OTC (often specifying an OTC “strength” and a prescription strength). In other cases, the FDA takes the position that homeopathic products intended solely for self-limiting conditions that consumers are able to self-diagnose may be sold OTC, otherwise, they must be marketed as a prescription product. According to the FDA, “colds, headaches and other minor health problems that eventually go away on their own” are indications that may be marketed OTC. Homeopathic products may not contain non-homeopathic active ingredients. Also, the FDA has taken the position that transdermal dosage forms (e.g., patches) are not appropriate homeopathic products.

Like other drug products, homeopathic drug manufacturers must register their establishments with the FDA and must submit drug listing forms for each product. OTC homeopathic products must comply with the FDA’s drug labeling requirements, including statement of identity, indications for use, directions, warnings and net quantity of contents.

The CPG clarifies FDA’s position that a “product’s compliance with requirements of the HPUS…does not establish that it has been shown by appropriate means to be safe, effective and not misbranded for its intended use.” The FDA refers to two sources for information on the use of homeopathic products: A Dictionary of Practical Materia Medica and A Clinical Reperatory to the Dictionary of Materia Medica, both by John Henry Clarke, M.D. FDA specifies that “[t]hese references must be reviewed in conjunction with other available literature on these drug substances.”

ADVERTISING
Under the Federal Trade Commission (FTC) Act, advertising claims for all products, including homeopathic drugs, must be truthful and nonmisleading, and health claims must be supported by competent and reliable scientific evidence. Such evidence, according to the FTC, is generally defined as “tests, analysis, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”

Therefore, the question is do the HPUS and the Materia Medica constitute adequate substantiation for claims in advertising for homeopathic drugs? The answer is, like the answer to most questions in advertising law, “it depends.” However, as a general matter, because those reference materials can be both so specific with respect to product formulations and so general with respect to uses, it is very difficult to develop specific advertising claims for finished drug products relying only on those references for support.

“I do not recall an instance where we reviewed claims for a product that was truly a homeopathic drug,” says Richard L. Cleland, assistant director of the FTC’s Division of Advertising Practices. “The products purporting to be homeopathic were, in fact, not homeopathic because the indications, formulations or dosage forms did not fit the specific standards in HPUS.” Cleland continues, “Even if a product was a true homeopathic product, I am very skeptical that a claim that a product has been “scientifically proven” can be substantiated by a homeopathic proving alone.”

In a recent case, the National Advertising Division of the Council of Better Business Bureaus (NAD) challenged claims that a homeopathic product provided fast, safe relief of headaches and other indications. The advertiser argued that claims were substantiated because the product was in compliance with the CPG, and the efficacy of the active ingredients was proven by the HPUS and the Materia Medica. The NAD disagreed and, according to its Miralus Healthcare report, found: “notwithstanding the advertiser’s submissions regarding ‘clinical provings’ in support of the OTC indications of [the] active ingredients or their HPUS status, the record is devoid of any testing (clinical or otherwise) on [the] products as formulated for sale for use as directed, and the advertiser failed to provide any evidence permitting extrapolation from the clinical provings to the specific claims made for its product as formulated for sale.”

The NAD contrasted the case to other cases involving homeopathic products, such as its Matrixx Initiatives, Inc., report, that it has reviewed in which the advertisers provided clinical studies and other information in addition to information on compliance with the HPUS and provings from the Materia Medica, to support their claims.

The NAD noted that in certain situations, it may be possible to craft claims based on “traditional uses” of homeopathic products “where claims are based upon historical/traditional uses as demonstrated by inclusion in recognized homeopathic material medica.” Such claims must be “appropriately qualified to clearly and prominently reflect the absence of scientific substantiation,” and must be “presented in such a way that consumers understand that the sole basis for the claim is a history of use for a particular purpose.”

When considering a “traditional use” claim, advertisers must be careful to ensure that the formulation and dosage form of the marketed product is consistent with the traditional use. According to Cleland, “traditional use claims may be possible for true homeopathic drugs, but they will be carefully scrutinized, especially if they are marketed to treat a serious disease state.”

Ivan J. Wasserman is a member of the law firm Collier Shannon Scott in Washington, D.C., and practices in the firm’s Advertising Law Group and Food and Drug Group. He can be reached via e-mail at [email protected].