SummaryOn October 24, the FDA released a draft guidance describing the intended risk-based approach for regulatory actions toward homeopathic drug products marketed in the United States without the required FDA approval. The FDA has not approved a single homeopathic product thus far. The agency is currently restructuring its enforcement and regulatory priorities in this space.
While homeopathic drugs have historically been prepared by homeopathic physicians for individual patients, today they are mass manufactured and marketed over the counter (OTC) across the country.
The growth in the number of products on the market along with several cases of serious adverse events and, in particular, seriously concerning violations of Current Good Manufacturing Practices led the FDA to begin reviewing its regulatory framework for homeopathic drug products in 2017. These reevaluations have led to the release of the recent guidance titled “Drug Products Labeled as Homeopathic” and the withdrawal of the 1988 Compliance Policy Guide 400.400 titled “Conditions Under Which Homeopathic Drugs May Be Marketed.”
While the FDA determines if most OTC drugs are generally recognized as safe and effective (GRAS/E), this has not been the case for homeopathic drug products. In response to the FDA’s 1972 rulemaking on drug safety and effectiveness, the American Institute of Homeopathy requested that homeopathic medicines be excluded from the OTC review. Following this comment, the FDA excluded homeopathic drug products from the OTC drug review and decided to review them as a separate category, deferring consideration of them. Since then, no homeopathic drug products have been reviewed by the FDA. Yet any drug labeled and offered for sale as a homeopathic drug remains subject to the same regulatory requirements as other drugs, including those related to labeling, adulteration, and misbranding. Homeopathic products are additionally subject to the provisions of the Homeopathic Pharmacopoeia of the United States (HPUS).
The draft guidance, “Drug Products Labeled as Homeopathic,” provides the FDA’s working definition of a homeopathic drug product and describes the agency’s risk-based approach to enforce regulations involving specific categories of homeopathic drug products. According to the guidance, to be considered a homeopathic drug, a product must list “homeopathic” on its label and contain only active ingredients identified in the HPUS. The FDA recognized that homeopathy relies upon the principles that “the more diluted a substance, the more potent it is” and that “like cures like.”
The FDA notes the general assumption that all homeopathic products are highly diluted and therefore unable to cause serious harm. While the level of dilution does often reach Avogadro’s limit—and therefore the dose likely lacks even a single molecule of active ingredient—the FDA is clear to point out that the safety of any product depends on a multitude of factors, including product’s intended use, dosage form, frequency of use, manufacturing quality, intended patient population, and the quantity and combination of ingredients. To account for these many factors impacting safety of a product, the FDA will prioritize regulatory action against homeopathic drug products that fall within the following categories:
- Products with reports of injury that, after evaluation, raise potential safety concerns
- Products that contain or purport to contain ingredients associated with potentially significant safety concerns
- Products for routes of administration other than oral and topical
- Products intended to be used for the prevention or treatment of serious or life-threatening diseases or conditions
- Products for vulnerable populations
- Products with significant quality issues
Comments are to be submitted to the FDA in either written or electronic format by January 23.
View the full FDA guidance.
To receive Avalere updates, connect with us.
Find out the top 2020 healthcare trends to watch.
produces measurable results. Let's work together.