Unapproved Ophthalmic Products Crackdown
Non-OTC eye products continue to be targeted
FDA issued seven warning letters to companies that were selling non-compliant ophthalmic products. These are products that are added to the eyes like moisturizing drops. FDA takes their safety very seriously and for good reasons, as unregulated products may cause permanent eye damage.
These warning letters continue the ongoing trend of non-approved ophthalmic products being cited. The moral here is that selling non-approved products that go into the eyes will lead to a warning letter.
Some of the products cited in these letters are homeopathic or MSM eye drops and there is a long history of these types of products attracting warning letters. This includes companies like Amazon and Walmart getting in trouble for distributing these products.
Homeopathics (2023)
Amazon and Walmart (2023)
One of the products cited is a CBD eye drop which seems really dangerous, and when I looked at the website in more detail there were cancer and other serious disease claims elsewhere on the website. I applaud FDA for helping to remove the potentially dangerous CBD eye drops but am surprised they didn’t mention any of the disease claims.
Claims in social media videos were also cited. This is interesting, as the audio claims on Instagram and Facebook are not often mentioned. Finding any keyword on Instagram/Facebook video, images, and posts is something Apex Compliance does well!
From warning letter: “February 26, 2025 video post: “Seeing floaters, struggling with blurry vision, or dealing with dry, irritated eyes? …., powered by pure stingless bee honey, naturally hydrate, soothe, and protect your eyes—supporting clearer vision, cataract prevention, and overall eye health. Experience the power of nature!”
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