Homeopathic Oral Care Products
Disease claims + safety concerns = warning letter
There are some interesting learning opportunities in this warning letter. Let’s explore.
FDA does not like homeopathics. This company sells homeopathic oral care products like mouth gel and mouth wash. It’s no secret that FDA does not care for homeopathics, especially when they make disease claims or pose a possible safety concern, as exemplified by FDA’s crackdown on homeopathic ophthalmic (eye) products. Type in “homeopathic” here to see previous Warning Letter Wednesday writeups.
Instagram, Facebook, and YouTube claims. Some of the disease claims in this warning letter were found on social platforms, which shows that FDA is still looking at social media noncompliance. As with most social media claims, FDA draws a commercial bridge from the social channels or posts with this statement. If there were no links to commerce the likelihood of scrutiny decreases.
From warning letter: “Your social media accounts direct consumers to your website to purchase your products.”
From warning letter: “On your YouTube social media account October 9, 2020 featured video: In the past I would see wounds opening up, I would see membranes not only exposed but being lost, I would see bone grafts being lost . . . the use of the Oral Care program has just been really spectacular and I love the overall wound healing that I’m seeing.”
I ran Apex Compliance on the company’s YouTube channel and found lots of current potential issues. Here is what the summary dashboard looks like. I love this feature, what do you think?
Apex Compliance YouTube channel scan dashboard report sample
FDA investigation trigger. What likely tipped off FDA was last year’s recall for microbial contamination against the manufacturer. Recalls can sometimes signal to FDA that deeper quality issues may be present and trigger deeper scrutiny. In this instance the recall was June 2024, but FDA didn’t look at the brand holder online marketing until 11 months later. The timing is curious, but this may represent FDA’s resource-light approach to enforcement, as this letter didn’t require a GMP visit or product testing, just some web searching and the administrative paperwork that goes along with it. Companies who have had recalls or 483s in the past 18 months should take extra steps to ensure their online content is compliant.
Vulnerable Populations. These include the elderly, children, those with mental health diseases, drug abuse issues, and FDA pays special attention to products marketed to these groups.
From warning letter: “Your … homeopathic drug products are especially concerning from a public health perspective because they are marketed for use in vulnerable populations, i.e., children and patients at high risk for developing an infection, such as those with open oral wounds or postoral surgery. Use of your products in these populations is even more concerning because some of your products have been recalled due to microbial contamination.”
Read the warning letter here.
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