On December 18, 2017, the Food and Drug Administration (FDA or Agency) announced a sweeping change to its regulation of homeopathic drugs. The Agency unveiled its new risk-based approach to regulation of homeopathic drugs in a press release while simultaneously withdrawing its previous policy and releasing a new draft guidance document.
The new draft guidance sets forth the Agency’s enforcement plan and represents a reversal of policy that will likely leave the homeopathic drug industry in a state of limbo as it struggles to interpret and comply with the new regulatory regime. Specifically, the new regime categorizes homeopathic drugs as unapproved new drugs subject to the Agency’s enforcement discretion, depending on the perceived risk/benefit of the products. This action is in addition to the FTC’s release last year of an enforcement policy statement on the marketing of over-the-counter (OTC) homeopathic products. Our previous client alert discussing the FTC’s involvement in regulating the homeopathic industry is available here.
By way of background, homeopathy is the practice of treating symptoms with very small doses of substances that have produced similar symptoms in healthy subjects, and it is based on the principle that “like cures like.” In one sense, homeopathic medicine is the grandfather of vaccines and allergy shots, which are based on the same principle. Homeopathy is a system of medicine that has a well-established framework for demonstrating the effectiveness of products; in particular, effectiveness is shown using “provings,” a procedure employed in healthy individuals to determine the dose of a drug sufficient to produce symptoms. Unlike traditional drugs, which contain measurable levels of active ingredients, homeopathic drugs are intended to have only trace amounts of a particular substance, making a traditional drug active ingredient analysis futile for homeopathic substances. Importantly, homeopathic drugs are explicitly recognized as drugs in the federal Food, Drug and Cosmetic Act (FDCA) at 21 U.S.C. § 201(g)(1)(A) and have been since 1938, when the FDCA was enacted (replacing the Federal Food and Drugs Act of 1906). The FDCA, which was sponsored by Senator Royal Copeland (D-NY), a homeopathic practitioner, was concerned only with the safety of drugs (and did not yet address effectiveness). By specifically recognizing remedies listed in the Homeopathic Pharmacopeia, the FDCA indicated that these products met the quality standards established by the legislation. Thus Congress recognized the practice of homeopathy as legitimate and set criteria by which homeopathic drugs could be deemed safe.
The FDA recognized the uniqueness of homeopathic drugs when it decided in 1988 to treat homeopathic drugs differently from other drugs. In particular, the FDA released Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed. For OTC homeopathic drugs, the criteria set forth for marketing a product included complying with certain labeling requirements under 21 C.F.R. Part 201, current good manufacturing requirements under 21 C.F.R. Part 211, registration and listing requirements under 21 C.F.R. Part 207, and adhering to applicable Homeopathic Pharmacopoeia of the United States (HPUS) standards. While the FDA has at times called into question the efficacy of these products, it has maintained the CPG criteria for permitting homeopathic drugs to be marketed for almost 30 years.
In a single decision this week, the FDA withdrew the established conditions under which homeopathic drugs have been marketed for the last quarter of a century, instead replacing them with a document that states that “any product labeled as homeopathic that is being marketed illegally” (i.e., that is being marketed without FDA drug approval) “is subject to FDA enforcement action at any time.” It also sets forth the Agency’s risk-based approach to enforcement. The new enforcement policy classifies all homeopathic drugs as unapproved new drugs, requiring FDA premarket approval based on a showing of safety and effectiveness (e.g., via traditional allopathic clinical trials).
This position misunderstands the fundamental nature of homeopathic drugs and ignores the FDA’s history of regulating such products. Under the previous CPG 400.400, the FDA required that homeopathic drugs meet the standards for strength, quality, and purity set forth in the HPUS. This is important because before an ingredient is included in the HPUS, it must be determined safe and effective by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS). Effectiveness is generally established through a proving, a clinical verification process consisting of a double-blinded or placebo-controlled trial where a sample population is exposed to an infratoxic level of the test substance, providing symptom notes that are then aggregated and analyzed by both qualitative and quantitative methods. Effectiveness can also be established through the submission of two adequately controlled double-blind clinical studies using the drug as the single intervention. Safety is established through a review of toxicology and safety data by two different committees, one comprising scientists and pharmacists, and another comprising clinicians. Once an ingredient passes both rounds of review and is granted inclusion in the HPUS, the HPUS standards set the safe level of use, indicating which dilutions are appropriate for OTC products. Essentially, the HPUS creates a monograph for homeopathic drugs to follow, not dissimilar to the OTC drug monographs that FDA has developed for allopathic drugs. Accordingly, by virtue of an ingredient’s inclusion in the HPUS, the ingredient has already been closely examined and determined to be safe and effective by the HPCUS. Compliance with the HPUS functions as a premarket review of safety and effectiveness in the homeopathic context. By classifying homeopathic drugs as unapproved new drugs, the FDA is requiring a second showing of safety and effectiveness, a step that is unnecessary, not to mention impractical, given that the Agency intends to hold homeopathic products to an allopathic standard that is inappropriate, given the nature of homeopathic products.
The FDA’s history of regulating homeopathic drugs also runs contrary to the rationale for the Agency’s new enforcement plan. The FDA deliberately excluded homeopathic drugs from both the Drug Efficacy Study Implementation (DESI) review (the process by which all drugs approved between 1938 and 1962 were retrospectively evaluated by the FDA for effectiveness) and the OTC Drug Review in 1972 (the process used to develop OTC drug monographs for allopathic drugs), deciding instead in the latter case to regulate homeopathic products separately because of their uniqueness. By withdrawing the CPG and classifying all homeopathic drugs as unapproved drugs subject to FDA drug approval, the FDA is now requiring higher regulatory thresholds for OTC homeopathic drugs than are applicable to allopathic OTC drugs, many of which are permitted to be sold pursuant to the FDA monograph system. This move in effect penalizes an entire industry for the Agency’s 1972 decision.
Though the FDA has identified six categories of high-risk products for which it intends to prioritize enforcement, the new enforcement policy has broad implications for the homeopathic drug industry as a whole, including products classified as low-risk. The FDA has stated it plans to exercise its enforcement discretion for products that are safe and not used to treat a serious disease condition, but the Agency fails to recognize the practical implications of classifying these low-risk products as unapproved new drugs. Uncertainty exists as to how the FDA will treat low-risk homeopathic drugs at the border; indeed, the FDA has historically taken the position that it does not have enforcement discretion at the border to allow unapproved new drug products into the country. Without a clear policy describing how the Agency plans to exercise its enforcement discretion at the border, all homeopathic products, even those likely exempt from domestic enforcement under the new policy, will likely be denied entry to the U.S. because of their new status as unapproved new drugs. Additionally, low-risk homeopathic drugs now face potential challenges from plaintiff attorneys, who may now be able to use the violation of a federal or state statute as the basis of a deceptive trade practices class action lawsuit. As the FDA now classifies low-risk homeopathic drugs as unlawful but exempt from enforcement in certain circumstances, the new enforcement policy provides the foundation for a lawsuit against virtually any homeopathic drug company, as consumers can claim that they are being misled that these products are being sold lawfully when they are not. Furthermore, we have seen the FDA take issue with low-risk drugs exempt from enforcement when the Agency finds noncompliance with current Good Manufacturing Practices (cGMPs) upon inspection. Warning letters resulting from these inspections may now state that the company is marketing unapproved new drugs.
The FDA’s new enforcement policy on homeopathic drugs leaves more questions than answers. While we can expect that the FDA will not waste time in pursuing enforcement actions against high-risk homeopathic drugs, the operating risk for homeopathic drugs classified as low-risk under the new enforcement policy is undetermined. With all companies in the homeopathic drug industry now at risk, the FDA can expect significant confusion as the industry tries to respond to the unapproved new drug status of all homeopathic drugs.
There was significant hope that with a new administration, the FDA would take a more practical view of enforcement. The opposite, however, is playing out in the case of homeopathic drugs.
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Comments may be submitted to the FDA before March 20, 2018. If you have questions regarding the FDA’s announcement or would like to discuss submitting comments, please contact one of the authors.