By Susan Crane, Independent Advisor for OTC Labeling
It’s been clear for several years that the FDA, as well as the Federal Trade Commission (FTC), are turning up the heat on homeopathic drug products. It culminated in December 2017 when the FDA published a draft guidance document for both FDA staff and industry regarding their new approach to regulating “Drug Products Labeled as Homeopathic”. This followed on the heels of FTC’s “Enforcement Policy Statement Regarding Marketing Claims for Over-the-Counter Homeopathic Drugs” published in 2016.
The practice of homeopathy has been around for more than 200 years and has its share of both critics and adherents. Homeopathy is a form of alternative medicine based on the concept that a disease can be treated with minute quantities of natural substances that would, if given in larger amounts to a healthy person, produce symptoms of the same disease.
Prior to this most recent regulatory action, the FDA regulated homeopathic medicines as drugs under the Federal Food Drug and Cosmetic Act but did not otherwise evaluate their safety and efficacy as long as they were marketed for self-limiting conditions and contained active ingredients listed in the Homeopathic Pharmacopeia of the United States. The enforcement policy was described in a Compliance Policy Guide (“Conditions Under Which Homeopathic Drugs May be Marketed”) that was issued in 1988.
As the homeopathic industry grew, the Agency re-evaluated its position and announced in 2015 that it was going to evaluate the regulatory structure for these products. It hosted a public meeting that spring during which interested parties (manufacturers, health care professionals, industry associations, etc.) could provide input and make suggestions as to whether the current framework was appropriate for ensuring the safe use of these products. As a result of the meeting and FDA’s own evaluation, it determined that a new guidance document, applying a “risk-based” approach to enforcement, would better serve public health and be consistent with the Agency’s general approach to products marketed without FDA approval.
Because there are currently no homeopathic products approved by the FDA, the guidance document, when finalized, would serve notice that any product labeled as homeopathic could potentially be subject to enforcement action. However, the FDA recognizes that some categories of products pose a greater risk to public health and so provided a list that would receive prioritized enforcement. These include:
- Products with reported safety concerns
- Products that contain or purport to contain ingredients associated with potentially significant safety concerns
- Products for routes of administration other than oral or topical
- Products intended to be used for the treatment of serious and/or life-threatening diseases and conditions
- Products for vulnerable populations
- Products deemed to be adulterated under the Food, Drug and Cosmetic Act
As noted earlier, in addition to this increased FDA oversight, the FTC (which monitors marketing and promotional claims) is taking a more proactive approach to homeopathic drugs. In the aforementioned policy statement, it indicated that OTC homeopathic drugs would be held to the same standard as other products with regard to claims. In other words, companies either needed to have competent and reliable scientific evidence to back up the claims OR, alternatively, they could revise their labeling to include disclaimers communicating that “there is no scientific evidence that this product works and that its uses are based on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.” No longer would it be acceptable to rely on statements that the “FDA has not evaluated the product” or that the treatment relied on “homeopathic principles”.
These actions by the FDA and FTC are not encouraging to the homeopathic industry. How strictly this new approach will be enforced is unknown, especially in the current political climate of decreased regulation. However, it’s a safe assumption that any homeopathic product that presents a safety risk or makes egregiously deceptive claims, will likely come under scrutiny and could land the offending company in proverbial “hot water.”