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A federal judge just issued a ruling in the suit related to the FDA’s regulations around homeopathy. To understand the significance of that ruling, let’s start with the historical background.
The FDA issued new draft guidance, outlining how it intends to regulate homeopathic drug products. The new guidance replaced the previous policy with a stricter – but in many ways more ambiguous – risk-based approach.
While the FDA’s new guidance was still in draft form, Americans for Homeopathy Choice (AFHC) filed a citizen’s petition, asking the FDA to adopt a regulatory framework tailored specifically to homeopathic medicines, rather than considering homeopathy under the framework(s) for other drugs.
A citizen’s petition is a formal process that allows anyone to request policy changes from the FDA. By law, the FDA must respond with a reasoned decision and its response is considered a final agency action, which can be challenged in court.
Shortly after it finalized the new guidance, the FDA denied AFHC’s petition.
In its denial, the FDA argued that homeopathic remedies are legally considered drugs under the law and therefore cannot be exempted from standard approval and safety requirements. The FDA also argued that homeopathic remedies are subject to potential quality/safety issues associated with contamination or inconsistent manufacturing practices, and are sometimes marketed for serious conditions without evidence of effectiveness.
This is where the plot gets interesting.
The Alliance for Natural Health (ANH), an industry advocacy group, filed suit against the FDA in federal court, arguing that the FDA had exceeded its authority in developing new guidance and in denying AFHC’s petition.
ANH argued that the FDA’s denial of AFHC’s petition was arbitrary because it relied on overstated safety concerns and ignored the long history of safe homeopathic use, and that FDA’s actions were inconsistent with the intent of Congress in recent OTC drug reforms (the CARES Act). Additionally, ANH raised broader constitutional claims, asserting that the FDA’s approach unfairly restricted consumer and practitioner access to homeopathic products.
Not surprisingly, the FDA moved to dismiss the case by ANH, arguing in part that ANH lacked standing to bring the suit.
Recently, a federal judge issued several rulings related to ANH’s suit.
The judge dismissed most of ANH’s claims, including its constitutional arguments. However, the judge ruled that ANH has standing to bring the suit, and that FDA’s denial of AFHC’s petition is a final agency action that can be challenged in court. As a result, ANH’s petition-denial suit will continue, albeit with a considerably narrower scope.
As the suit moves forward, the FDA must show that its denial of AFHC’s petition was based on legitimate evidence, and must produce all the documents and data it relied on when it denied the petition. This is where the focus will be in the legal battle.
Perhaps more importantly, at least in my view, is the judge’s ruling that the FDA’s new homeopathy guidance “has no direct legal consequences;” it’s only a statement of priorities.
So, even if the judge eventually rules against ANH in the petition-denial suit, the recent ruling has already made it clear that FDA’s new guidance hasn’t changed the legal status of homeopathy. The guidance reflects the FDA’s view of how it hopes to enforce the laws – but it doesn’t have the authority to make them. That distinction is exactly why courts can step in and review the FDA’s decisions — as they are now doing with the petition denial.
I know it’s disconcerting when the FDA’s posture and rhetoric are negative toward homeopathy. In fact, as a leading manufacturer of professional-grade homeopathic remedies, our stake in this issue is as big as anyone’s. And from that perspective, I want you to know two things.
First, we’ve analyzed every enforcement action the FDA has taken against homeopathic products since it started operating under the new guidance in 2017. That analysis suggests there isn’t a significant threat to the products you use most commonly in your practice.
And second, you can count on us to continue working to protect your access to the products you need.
In Health,
Mike Grubb
President & CEO
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