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Posted September 14, 2023

FDA Warns CVS, Walgreens, Similasan & Others for Eye Drop Violations

On September 11, 2023, the FDA issued Warning Letters to the following eight sellers of homeopathic and other types of eye drops regarding the products noted in italics due to a variety of violations of FDA regulations, mostly notably that they were marked with claims suggesting that they could cure, mitigate, treat, or prevent eye diseases. However, they are not approved FDA-approved drugs:
 

  • Boiron, Inc.Optique 1 Eye Drops
  • CVS HealthCVS Health Pink Eye Relief Drops products
  • DR Vitamins, LLC dba DR Vitamin SolutionsVision Clarity Eye Drops, Life Extension Brite Eyes III, Can-C Eye Drops, and 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 Eye Drops, and Cataract Eye Drops with Cineraria
  • OcluMed LLCOcluMed Nutritional/Lubricant Eye Drops
  • Similasan AGSimilasan Dry Eye Relief, Similasan Complete Eye Relief, Similasan Allergy Eye Relief, Similasan Kids Allergy Eye 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, and Similasan Dry Eye Nighttime Gel
  • TRP Company, IncDryness Relief, Pink Eye Relief, Allergy Eyes Relief, Red Eye Relief, Eye Strain Relief, Eye Lid Relief, Aging Eye Relief, Blur Relief, Floaters Relief, Twitching Relief, and Stye Relief
  • Walgreens Boots Alliance, Inc.Walgreens Allergy Eye Drops, Walgreens Stye Eye Drops, and Walgreens Pink Eye Drops

In addition to being unapproved new drugs, some of these products were found to be adulterated because they were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMP). This is the case for the products from Similasan AG, which the FDA warned about violations of CGMPs at its manufacturing facility in Switzerland. The products sold by CVS, TRP Company, Inc, and Walgreens that are listed above were also produced in a facility with CGMP violations and it is likely that this was the Similasan AG facility, although the name of the facility was redacted in the Warning Letters to those companies.

Some products were also found to contain silver, which can cause some areas of the skin and eyes to turn gray or blue-gray with long term use.

In addition, some products were found to be misbranded because the packaging did not include adequate directions for their intended use, and certain companies’ products.

The companies must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address these violations.

Consumers and healthcare providers can report any adverse reactions to the FDA’s MedWatch Voluntary Reporting Program.

See ConsumerLab’s Review of Vision Supplements.

Also see CL’s answers to the following questions:

Can castor oil eye drops improve or dissolve cataracts? Is castor oil or tea tree oil helpful for other eye conditions such as blepharitis or dry eye?

Can supplements, natural eye drops, or lifestyle modifications improve symptoms of dry eye?

Do any supplements help prevent or reduce eye floaters?

Do any supplements help prevent or improve cataracts?

For more information, use the link below.

FDA Issues Warning Letters to Firms Marketing Unapproved Eye Products

See related recalls and warnings:

Dr. Berne’s MSM and Castor Oil Eye Drops Recalled Due to Bacterial and Fungal Contamination

Recalled Eye Drops Linked to Vision Loss and One Death

FDA Warns Seller of Vision and Allergy Supplements

Seller of Omega-3, Ginkgo, Vision Supplements & More Warned for Drug Claims

FDA Warns Seller of Vision, Calcium & Magnesium Supplements and More