FDA issues warning letters to 8 companies over unapproved eye products

The FDA issued warning letters to eight companies over the illegal manufacturing or marketing of unapproved drug products for certain ocular conditions.

First things first: which companies?

We’ll just get just straight to it:

Now what does a warning letter mean?

An FDA warning letter is sent to a manufacturer when, following an internal investigation, the agency has found it has significantly violated FDA regulations.

Such violations can include:

Poor manufacturing practices
Inaccuracies with claims of a product’s indication
Incorrect direction for use

Each letter also mandates that companies must correct the issue, with an agency-set timeframe and directions provided for the company to notify the FDA of its plans moving forward.

See here for details on the different types of warning letters.

So what did these letters say?

Per the FDA, the companies’ unapproved eye products “are illegally marketed to treat conditions such as conjunctivitis (“pink eye”), cataracts, glaucoma and others.”

The agency also stated that a few of the letters include quality issues related to product sterility for some of the companies.

And these eye products?

There’s quite a lot … identified in each of the eight letters, the unapproved eye products include:

Boiron Inc.
- Optique 1 Eye Drops
CVS Health
- CVS Health Pink Relief Drops
DR Vitamin Solutions
- Vision Clarity Eye Drops
- Life Extension Brite Eyes III
- Can-C Eye Drops
- Longevity Science Visual Ocuity
Natural Ophthalmics, Inc.
- Women’s Tear Stimulation Dry Eye Drops
- Allergy Desensitization Eye Drops
- Ortho-K Thin (Daytime) Eye Drops
- Ortho-K Thick (Night) Eye Drops
- Tear Stimulation Forté Dry Eye Drops
- Cataract Eye Drops with Cineraria
OcluMed LLC
- OcluMed Nutritional/Lubricant Eye Drops
Similasan AG/Similasan USA
- Similasan Dry Eye Relief
- Similasan Complete Eye Relief
- Similasan Allergy Relief
- Similasan Kids Allergy Relief
- Similasan Red Eye Relief
- Similasan Pink Eye Relief
- Similasan Kids Pink Eye Relief
- Similasan Aging Eye Relief
- Similasan Computer Eye Relief
- Similasan Stye Eye Relief
- Similasan Pink Eye Nighttime Gel
- Similasan Dry Eye Nighttime Gel
TRP Company, Inc.
- Dryness Relief Eye Drops
- Pink Eye Relief Eye Drops
- Allergy Eyes Relief Eye Drops
- Red Eye Relief Eye Drops
- Eye Strain Relief Eye Drops
- Eye Lid Relief PM Ointment
- Aging Eye Relief Eye Drops
- Blur Relief Eye Drops
- Eye Floaters Relief Eye Drops
- Eye Twitching Relief Eye Drops
- Stye Relief Eye Ointment
Walgreens Boots Alliance, Inc.
- Walgreens Allergy Eye Drops
- Walgreens Stye Eye Drops
- Walgreens Pink Eye Drops

What’s the concern?

The agency expressed its concern that these products pose a heightened risk of harm to consumers, with some of them being labeled as containing silver: silver sulfate, silver sulfate, or argentum.

Of note, the FDA stated that long-term use of silver-containing drugs may cause areas of the skin and other body tissues (the eyes included) to permanently turn gray or blue-gray (called “argyria”).

Anything else?

Further concern is that these unapproved drugs that “claim to cure, treat or prevent serious conditions” could potentially result in consumers postponing or halting such medical treatments already deemed safe and effective via the FDA’s review process.

So what’s the next step?

The FDA has requested the companies to respond within 15 days of receiving their respective letters with how they plan to correct the violations.

And what happens if they don’t?

Per the agency, the FDA will “pursue legal action, including product seizure and/or a court order” that requires the company to stop the manufacturing and distribution of the specific products.

That’s it?

Oh no, there’s more: the FDA also stated that it’s placed some of the eight companies on its “import alert” list in an effort to prevent their respective products from entering the United States.

Among the listed companies is Similasan AG. See here for the complete list.

What if my patient uses these products?

The agency is directly any consumers currently using the unapproved drugs to speak with their health care professional (HCP) regarding next steps.

Either a patient or HCP can report any adverse reactions to these drugs to the FDA’s MedWatch program.

*Disclaimer: The information provided in this article does not and is not intended to constitute legal advice; instead, all information, content, materials available herein are for general information purposes only.