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It’s time for another FDA update.
We monitor the FDA’s actions against homeopathic companies to understand the agency’s enforcement priorities and keep you up to date on issues that may affect your access to products.
In keeping with that practice, I’ve got good news and bad news.
First, the bad news: the FDA issued warning letters to 13 homeopathic companies during the 90-day period from August 25 to November 18, 2025. That’s a dramatic increase, considering they only issued six homeopathic warning letters in 2024, and none between November 2024 and June 2025.
Now the good news: all the issues cited in the most recent warning letters were predictable and/or preventable.
Below, I’ll summarize the data and what I think it means for those of us who use and trust homeopathy.
Of the 13 Warning Letters:
You probably recall that the FDA finalized new guidance on homeopathic drug products in December 2022, but it’s been operating under these guidelines since 2017.
In the new guidance, the FDA clearly indicated it intends to focus enforcement priorities on products with the potential for heightened safety issues, specifically including products for vulnerable populations, those utilizing alternative routes of administration (such as eye drops), products intended for the prevention or treatment of diseases, and products with significant quality issues.
All of the products cited in the new batch of warning letters have one or more of these characteristics.
In that sense, these warning letters were all entirely predictable. However, and this is important, none of the issues cited in the new warning letters are based on new rules. Rather, each of these issues could have been cited under the old rules. As a result, every one of these warning letters was easily preventable.
I don’t agree with all the FDA’s assertions in its new guidance for homeopathy – but I also don’t believe the recent flurry of homeopathic warning letters indicates our industry is being targeted. The FDA employs automated, AI-based tools to monitor social media and public websites, and it’s easy for them to identify products that make blatantly inappropriate disease claims or otherwise fall into their “high risk” categories.
What does this mean for your practice? In my opinion, very little.
These are not high-quality, professional-grade products used in clinical practice. Instead, they were likely FDA targets specifically because they are low-quality products and/or were marketed to vulnerable or other consumers, often with aggressive disease claims.
We can’t control the FDA, but there is a lot we can control. You can count on us to avoid obviously problematic claims and to ensure our products meet the highest quality standards.
One additional point is worth mentioning. The same automated tools the FDA uses to monitor product claims are almost certainly used by other regulators. Just as the FDA monitors us, don’t be surprised if the FTC, state attorneys general, and professional licensing boards are using similar tools to monitor many public-facing health claims, including those made on your websites or social media.
Additional regulatory resources:
Thanks for trusting us to support you and your practice. That’s a privilege we take seriously.
Mike Grubb
President & CEO
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