The Regulation of Homeopathic Drug Products
Statutory Recognition of Homeopathic Drugs
Since the passage of the Federal Food, Drug, and Cosmetic Act (FDCA) in 1938, homeopathic drugs are the only form of alternative or complementary medicine which is explicitly recognized by FDCA. Section 301(g)(1) of the Act, 21 USC. 321(g)(1), defines a drug as, inter alia, an article “recognized in the official United States Pharmacopeia [or] official Homoeopathic Pharmacopoeia of the United States (HPUS).” Section 501(b) of FDCA, 21 USCA 351(b), provides that a drug shall be deemed to be adulterated, “if it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium.” Similarly, Section 502(e)(3), 21 USCA 352(e)(3), provides that a drug labeled as homeopathic is misbranded unless it bears the “established name” of that drug in the HPUS.
Prior to the issuance of the Compliance Policy Guide (CPG) 400.400 [i] in 1988, FDA followed a different compliance policy guide, one which asserted that all homeopathic drugs were prescription-only because of the supposed individuality of homeopathic diagnosis. That extreme position was substantially tempered by the fact that FDA very seldom enforced it and virtually never against domestic manufacturers. It did, however, episodically and inconsistently, enforce the Rx-only rule against imported homeopathic products.
Over-the-Counter (OTC) Drug Review Exclusion
In the aftermath of the 1962 U.S. Kefauver-Harris Amendment (or “Drug Efficacy Amendment”) to evaluate the safety and efficacy of drugs, FDA stated it would take a different approach for OTC drugs than for prescription drugs. Rather than review drugs individually, FDA would review OTC drugs by active ingredient category. In announcing the OTC Review in 1972, FDA said that it was taking this approach for several reasons: limited resources; removal of violative drugs would be enormously resource-intensive; litigation concerning the scope of the grandfather clauses “would more than exhaust all present resources of the agency.” FDA also stated in 1972 that “because of the uniqueness of homeopathic drugs,” it would “review them as a separate category at a later date after the present OTC drug review is complete.” However, more than a half century later, FDA had not completed its review of conventional OTC drugs. As a result, there are many allopathic OTC drug categories, as well as all homeopathic OTC drugs that have not undergone the OTC Review process.
The Advent of CPG 400.400
As noted, the origins of FDA’s CPG 400.400 go back to a series of meetings between industry and Agency enforcement personnel in the 1980s. The resulting CPG included restatements of existing statutory or regulatory requirements; the CPG also provided some education about homeopathy for FDA personnel. Entitled “Conditions Under Which Homeopathic Drugs May be Marketed,” CPG 400.400 contained key points, including:
- A definition of “homeopathic”;
- Reference resources for traditional uses of homeopathic drugs;
- How to handle instances in which the active ingredient was not in the HPUS;
- Recognition of the different way in which the strength of homeopathic active ingredients are declared (e.g., 10X, 20X, 10C); and
- A recitation of statutory and regulatory labeling requirements.
CPG 400.400 led to major changes in the homeopathic industry. Prior to 1988, the only indication on the label of most homeopathic drugs was, “Use accordingly to standard homeopathic indications.” While that fit well with the symptom-based approach at the core of homeopathy, FDA was unwilling to permit that approach to continue, insisting that the statute requires a specific indication, and the CPG restates that position. The addition of familiar indications to homeopathic labels aided many consumers as they sought alternatives to other available medicines.
FDA Enforcement Guidance
FDA conducted a public hearing in 2015 to evaluate its enforcement policies for drug products labeled as homeopathic from scientific, risk, and process perspectives. The Agency solicited opinions about whether and how to adjust the current enforcement policies to reflect changes in the homeopathic product marketplace since it published CPG 400.400 in 1988.
The outcome of the 2015 hearings and subsequent engagements between FDA and multiple stakeholders is the current guidance: Homeopathic Drug Products Guidance for Industry and FDA Staff. Finalized in 2022, FDA’s guidance is a risk-based enforcement priority policy. The guidance states, “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.”
The guidance contains important policy considerations, including several recommended by AAHP. The agency considers any drug that does not have an approved New Drug Application, or which is not subject to an OTC monograph, as being an “unapproved new drug”. While FDA unilaterally referred to homeopathic drug products as “unapproved new drugs” and “illegal drugs” in its guidance, this does not change the legal status of homeopathic drugs.
AAHP’s position is that FDA’s failure to fully implement the Drug Amendments of 1962 does not make homeopathic drugs illegal. In short, FDA inaction does not determine the legal status of these products.
Federal Trade Commission
The Federal Trade Commission Act (1914) is the primary statute of the Commission. Under this Act the Commission is empowered, among other things, to prescribe rules defining with specificity acts or practices that are unfair or deceptive, and establishing requirements designed to prevent such acts or practices. The FTC’s authority extends to claims made for healthcare products, including homeopathic drug products. Given the overlapping authority for healthcare products between FTC and FDA, a Memorandum of Understanding (MOU) was established in 1972. The MOU simply states that FTC would surveille and enforce advertising while FDA would surveille and enforce the product labels of OTC drugs.
Due to increasing consumer interest in homeopathic products, FTC conducted a workshop in 2015 to investigate the policies and practices of the industry and its own enforcement policies related to substantiation of claims made in advertising of homeopathic drug products. FTC published an enforcement policy statement in 2016 that stated it holds homeopathic drugs to the same standards of substantiation as other healthcare products. FTC went on to say that additional explanatory information in advertising could minimize the risk of consumer deception from product claims not substantiated by competent and reliable scientific evidence.
Today, AAHP recommends that product labels and advertising for homeopathic drug products not supported by clinical research bear the following disclosure: “Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.”
There is a well-established framework of guidelines, regulations, and quality standards. These are enforced by FDA through routine pharmaceutical manufacturing site inspections and surveillance of product labels marketed to consumers. This process safeguards public safety while ensuring consumer access to this drug class — known for its safety and medical-economic value.