7 Homeopathic Eye Product Warning Letters
Ensure vendors are properly qualified
Eight companies received warning letters for selling homeopathic and other eye-lubricating products. This signals the continued shift in FDA’s enforcement priorities towards homeopathics.
Most of these companies were selling ophthalmic homeopathic products with some disease claims. I assume that if there were no GMP concerns, the products were not for use in the eyes, the target audience was adults, and there were no serious disease claims, many of these companies would not have received warning letters.
FDA probably cited this group of products because they are (ophthalmic) added to the eyes, which may potentially endanger eye health. There are allowable OTC monographs for these types of products, but it seems the products were homeopathics, not labeled as OTCs (Drug Facts Panel), or in at least one instance, the product was labeled as an OTC but was not submitted to the required National Drug Code Registry. Products added to the eyes can be dangerous, and eye two lubricant products contain NAC, which I don’t think is approved for ophthalmic delivery. When I was a supplement manufacturer, I always said NO to making these types of products.
From warning letter, “Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.”
Here are some other highlights:
🔷 This company was cited for making disease claims in testimonials. It is worth noting that testimonials were showcased and promoted in a banner. If the testimonials were part of a 3rd party review widget, such as those uncurated reviews that come in through a service like Trustpilot, they probably would not have been cited.
🔷 My “day job” is running a regulatory consulting company. Contact me to discuss reviews, labels, or online marketing compliance questions. This helps support my WLW writing passion (smiles).
🔷 Normally, there has to be commerce for a company to receive a warning letter. This company does not appear to conduct commerce on its website and only offers a practitioner login option. The company was selling ophthalmic products with disease claims, which led to the warning letter even though there does not seem to be public commerce on the site. This is VERY INTERESTING and should be a wake-up to companies using this strategy to push the compliance boundaries.
🔷 This well-known homeopathic company was cited for not only making ophthalmic homeopathic products and disease claims, but this warning letter also includes numerous GMP violations. Products from this company were placed on import alert, which speaks to the severity of the alleged GMP issues. I assume that FDA “followed the breadcrumbs” for other products made at this facility, which led to the Walgreens and CVS warning letters. This highlights the need for supplier qualification, something consultant Nate Call is an expert at.
🔷 A four-year-old social post was cited, which is another reminder to remove language from all social media, no matter how old.
🔷 From warning letter. “February 9, 2019 Twitter post: An image of the “Vision Clarity Eye Drops” with the text, “Carnosine, a cataracts worst nightmare.”
Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.