On Oct. 24, 2019, in a joint statement from U.S. Food and Drug
Administration (FDA) acting Commissioner Norman E. Sharpless, and the
Center for Drug Evaluation and Research (CDER) Director Janet Woodcock,
that it had re-examined its policies related to homeopathic drug products.
FDA said its current Compliance Policy Guide (CPG) “is inconsistent with
[FDA’s] risk-based approach to regulatory and enforcement action generally
and therefore does not reflect [FDA’s] current thinking.” Accordingly, FDA has withdrawn its
and issued a revised draft guidance document describing its intent to
prioritize enforcement actions for unapproved homeopathic drug products.
What Are Homeopathic Drugs?
Homeopathy is an alternative form of medicine based on the theory that a
disease can be cured with a substance that produces similar symptoms in
healthy people, by using the original substance in a diluted form, under
the principle of “like cures like.” (See the National Institutes of Health overview of homeopathy.)
Homeopathic drugs are listed in the Homeopathic Pharmacopeia of the United
States (HPUS) and are included in the legal definition of a drug as defined
in the Federal Food, Drug, and Cosmetics Act (FDCA). As such, they are
subject to the same pre-market requirements as allopathic drugs. (See
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(g)(1)(A).) Since the
passage of the FDCA, FDA has exercised enforcement discretion and allowed
for the marketing of any homeopathic drug recognized in the HPUS without
Why Is FDA Now Enforcing?
FDA’s recent shift to enforcement is due to the rise of homeopathic
products being attributed to adverse events, specifically toxicity. FDA
cites several cases of homeopathic products, used according to their
labeling, which harmed and even killed patients due to the products
containing higher-than-advertised levels of toxic substances. FDA pointed
to 99 cases of belladonna toxicity potentially related to teething products
in 2016, and more than 130 reported cases of patients losing their sense of
smell due to their use of an intranasal zinc product. Additionally, FDA has
seen a rise in current good manufacturing practice (cGMPs) violations by
manufacturers of homeopathic drugs. FDA expressed concern that homeopathic
drugs are often found next to over-the-counter (OTC) products, are not
labeled as homeopathic, and are marketed to treat serious diseases and
conditions, thus increasing the risks to consumers. Until now, FDA has not
reviewed any homeopathic drug products under the OTC drug review because
FDA considers them a completely separate product category.
What Is in the New Guidance?
The newly issued guidance expands upon and amends the 2017 draft guidance,
which described FDA’s intent to switch to a risk-based enforcement approach
for homeopathic products marketed without FDA approval. The revised draft
guidance includes a definition of homeopathic drug product, with any
product labeled as such containing only active ingredients and dilutions
referenced in the HPUS. It also specifies the categories of products for
which the agency will prioritize enforcement and regulatory actions:
- Products with reports of injury that, after evaluation, raise potential
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 for vulnerable populations
Products with significant quality issues
Furthermore, enforcement will not be limited solely to these categories.
FDA stated that its updated guidance is “intended to provide notice that
any homeopathic drug product that is marketed without FDA approval is
subject to FDA enforcement action at any time.” Of note, FDA has issued
more than 10 warning letters to manufacturers and distributors of
homeopathic drug products so far this year; expect that number to rise
significantly in the future.
FDA requested comments on the revised draft guidance, with the comment
period closing Jan. 23, 2020.