Alerts and Updates
In a Regulatory "One-Two," FDA Modifies Terms of Oversight Concerning Homeopathic Drugs
October 31, 2019
On October 24, the FDA denied a petition by Americans for Homeopathy Choice asking the FDA to withdraw its draft guidance and convert CPG 400.400 into an official regulation.
Late last week, the FDA—in denying a citizen petition and issuing two Federal Register notices—modified published guidance on the manufacture and distribution of homeopathic drugs and declined to convert a current policy guide (CPG) provision into an official regulation. Importantly, the FDA cautioned industry participants and consumers alike that its CPG withdrawal “does not represent a change in the legal obligations that apply to homeopathic drugs”; rather, the CPG—issued in 1988—merely no longer reflects the “current thinking” of the FDA, as it is inconsistent with the agency’s “risk-based approach to enforcement generally.”
Homeopathic drugs—as long as they are considered “new drugs” within the meaning of the Food, Drug & Cosmetic (FD&C) Act—are subject to the premarket approval requirements contained in § 505 of the FD&C Act or § 351 of the Public Health Service (PHS) Act. CPG 400.400 (now withdrawn), issued in 1988, set forth certain enforcement policies pertaining to the distribution of drug products labeled “homeopathic” in the United States; it established the FDA’s expectations concerning the manufacture and marketing of “homeopathic” products and, from an industry perspective, helped to eliminate substandard products from the market.
In 2017, nearly 30 years after the issuance of CPG 400.400, the FDA released draft guidance for drug products labeled as homeopathic. Therein, the FDA explained that it had by that point “developed a risk-based approach under which [it] intends to prioritize enforcement and regulatory actions involving 21 specific categories of such products that potentially pose a higher risk to public health.” The FDA also recognized that “many products labeled as homeopathic will fall outside the risk-based categories” and stated its intent to withdraw CPG 400.400 “[s]imultaneous with the issuance of the final guidance.” (Emphasis added.) Until last week, as the guidance remained in draft stage, CPG 400.400 remained intact.
But on October 24, the FDA denied a petition by Americans for Homeopathy Choice asking the FDA to withdraw its draft guidance and convert CPG 400.400 into an official regulation. In so doing, the FDA explained that notwithstanding the existence of CPG 400.400, health issues associated with the use of homeopathic drug products persisted. In supporting its assertion, the FDA recounted scores of health issues related to the use of homeopathic products, including the presence of poisonous belladonna alkaloids in certain products and reports of anosmia associated with use of products. Moreover, the FDA noted the potential harms associated with consumers opting for unapproved homeopathic products in lieu of “medical products that have been scientifically proven to be safe and effective.”
Repeating those risks, and highlighting the divergence between the enforcement policies embodied in CPG 400.400 and the FDA’s current priorities, the FDA withdrew CPG 400.400 on October 25, 2019. That same day, the FDA announced a revised version of the 2017 draft guidance:
The revised draft guidance, like the original version, describes how FDA intends to prioritize enforcement and regulatory action with regard to drug products, including biological products, labeled as homeopathic and marketed in the United States without the required FDA approval that potentially pose higher risk to public health.
Comments on the draft guidance may be submitted to the FDA by January 23, 2020.
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