FDA Finalizes Guidance Re Enforcement Policy for Homeopathic Drugs

On December 7, 2022, FDA announced the availability of the final guidance regarding the enforcement policy for homeopathic drug products.  This concludes FDA’s reevaluation of the regulation of homeopathic drugs which it started in 2015.

As we reported previously, here, and here, as a result of the growth of the industry and safety issues, in 2015 FDA started the reevaluation of its regulatory framework for homeopathic products.  In 2017, it decided to withdraw the compliance policy guide (CPG; from 1988) under which, for decades, the Agency essentially had permitted the marketing of over-the-counter homeopathic drug products. FDA concluded that the CPG limited its ability to act against unsafe homeopathic drug products and decided to develop a risk-based enforcement policy.  It issued a draft guidance in 2017 which was subsequently revised in 2019.

The final guidance issued last week is the same as the 2019 draft guidance except that the final guidance includes a paragraph in which FDA mentions that the provisions of the CARES Act regarding OTC monograph reform do not apply to homeopathic drug products.

As we previously reported, the 2017 draft guidance generated many comments including a citizen petition by  Americans for Homeopathy Choice.  FDA denied that petition in 2019.  Not deterred by this denial, Americans for Homeopathy Choice submitted another citizen petition in 2020.  The 2020 petition requested that FDA issue a proposed regulation for homeopathic drugs.  As described in the executive summary of the petition:

Petitioners [sought] to have FDA establish regulations that would assure consumers: that drug products labeled “homeopathic” are either included in the HPUS or can be reasonably expected to be accepted for inclusion in the HPUS because they meet eligibility thresholds, as determined by relevant third-party review; that products that do not meet the foregoing criteria are not permitted to be labeled “homeopathic;” that homeopathic drugs are free of adulteration and properly labeled; and that FDA applies standards appropriate for low-risk products when evaluating the risks of homeopathic drugs. Further, petitioners [sought] recognition by FDA that homeopathic drugs, properly manufactured and labeled, and evaluated by appropriate standards, do not meet the legal definition of “new drugs,” and therefore are not subject to premarket review other than satisfying the requirements of current or likely inclusion in the HPUS

FDA issued its denial of this second petition a day before the final guidance became available.  Consistent with its prior thinking,  FDA’s response lays out FDA’s conclusion (consistent with its prior thinking) that homeopathic drug products are new drugs; they are not eligible for any exception and may legally be marketed only if they are approved by FDA.

FDA’s actions and statements leave no uncertainty that FDA has concluded that homeopathic drug products are unapproved drugs.  That said, the Agency acknowledges that many homeopathic drug products will fall outside the categories of drug products for which FDA intends to prioritize enforcement and regulatory action as described in its final guidance.  Although FDA is authorized to take action against those products, any enforcement action is not likely in the absence of evidence that a product poses a risk described in the guidance.