Products Aimed at Vulnerable Populations Pose Higher Risk
Homeopathics + disease claims + risky product category = warning letter
A company specializing in homeopathic nasal swabs for children received a warning letter due to a series of issues. Let’s see what we can learn. I was inspired to write this after speaking at a microbiome conference yesterday in San Diego. Fun stuff.
Vulnerable populations increase risk.
FDA takes products marketed to vulnerable populations, such as children, older adults, or pregnant or nursing moms very seriously. This is because they treat these populations as needing heightened protection because they can be more sensitive to unsafe products. The vulnerable population in this warning letter was young children.
High-risk product categories.
FDA has been on an enforcement tear lately against potentially unsafe ophthalmic (eye) products, as products that go into the eyes can cause severe damage. The product in question is a nasal swab, and the FDA had identified microbial contamination (and there was a recall) which poses a significant risk, as it can directly introduce microbes to this vulnerable population.
From warning letter: “This contamination is particularly concerning because …. is a nasal swab product and directed for use in young children.”
Homeopathics and disease claims.
FDA does not like homeopathics, and when these companies make disease claims, it “crosses the compliance line” and increases the likelihood of receiving a warning letter. Search “homeopathics” here on my WLW site to see years of posts about this.
From warning letter: “So effective at fighting cold, flu and allergies.”
The company’s tagline, “Protect your Booger Biome,” is clever marketing, but the FDA also cited this as the intended use of the product.
This warning letter is an oldie but a goodie.
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