Is it safe to buy an eye drop? “FDA issues warning letters to 8 companies for marketing unapproved eye products”

The recent news about people losing vision, eyes, and even lives from contaminated artificial tears already seems enough to convince us that “all eye drops are suspect.” This week’s FDA warning about 8 companies marketing “unapproved” eye products only heightens these concerns. Or does it? The good news is that - to my knowledge, no untowards injuries have been attributed to these products as yet. More good news is that the FDA is “on guard.,” as they should be - to protect us consumers from companies that don’t follow their rules (and their rules are strict for a good reason).

As most of you who follow my posts would know, my practice is devoted to keeping people safe - and helping them help keep their eyes in tip top shape. This means the bulk of what I do is to help my patients make more and better tears while ensuring the health of their ocular surface. In a perfect world, there would be no need for “artificial tears” (or related products) as everyone would have perfect tears. So my practice shyes from recommending artificial tears, as they can mask symptoms and allow patients who could make adequate tears if they worked at it. That “kicking the can down the road” without dealing with root causes, encourages the tear-making apparatus to stall and then to whither and go dry. Keeping that apparatus in good shape takes work - kind of like keeping teeth in good shape. And while we all appreciate eating, we tend to take vision for granted.

It is important to acknowledge that some - despite best efforts and for a variety of reasons beyond their control, simply cannot make a healthy tear in sufficient quantities, to keep the surface of their eyes healthy. And in today’s hard driving world of staring at screens all day, even the best tear producers may need a little help now and again. I therefore do recommend an “as needed” use of artificial tears and related products when it is necessary - but continue to push my patients (and readers) to work on making their best tears. My hat is off to the FDA and all of the people involved in keeping companies on track providing safe, effective products crucial to our health. The short story about these companies is here (and the full story from the FDA is in a link below that): From Healio:(https://www.healio.com/news/optometry/20230914/fda-issues-warning-letters-to-8-companies-for-marketing-unapproved-eye-products?utm_source=selligent&utm_medium=email&utm_campaign=news )

“September 14, 2023

1 min read

FDA issues warning letters to 8 companies for marketing unapproved eye products

The FDA has issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products, the agency announced in a press release.

In an effort to protect U.S. consumers from potentially harmful eye products, the FDA addressed those that have been illegally marketed to treat conditions such as conjunctivitis, cataracts and glaucoma. Some of the warning letters also cited quality issues related to product sterility.

Eight companies received letters from the FDA that warn of legal action should they fail to correct violations for manufacturing and marketing unapproved ophthalmic products. Image: Adobe Stock.

The companies that received warning letters are Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan AG/Similasan USA, TRP Company and Walgreens Boots Alliance.

“The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality,” Jill Furman, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research, said in the release. “When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations.”

The FDA requested that the companies respond within 15 days of receiving the letters and include a plan to correct the violations. Should the companies fail to comply, the FDA plans to pursue legal action, which may include product seizure and a court order to stop the manufacturing and distribution of an unapproved product. Some companies were also placed on import alert to keep their products from entering the U.S.

“We will continue to investigate potentially harmful eye products and work to ensure violative products stay off store shelves so that consumers can continue taking the medicines they need without concern,” Furman said in the release.”

The FDA link here for those who want the deeper dive:

https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-unapproved-eye-products

Stay safe!

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