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FDA Warns 8 Companies for Marketing Unapproved Eye Products

FDA Warns 8 Companies for Marketing Unapproved Eye Products

September 13, 2023

On Monday, the US Food and Drug Administration (FDA) took action by sending warning letters to several companies, including CVS and Walgreens, due to concerns regarding the manufacturing and marketing of unapproved eye products.

According to the FDA, these products are being marketed illegally for the treatment of various eye conditions, such as conjunctivitis (commonly known as pink eye), glaucoma, and cataracts. Additionally, some of the warnings issued by the FDA pointed out sterility issues associated with these products.

The FDA specifically issued warning letters to the following companies: CVS Health, Walgreens Boots Alliance Inc., Boiron Inc., DR Vitamin Solutions, Natural Ophthalmics Inc., OcluMed LLC, Similasan AG/Similasan USA, and TRP Company Inc. Furthermore, some of these companies have been placed on an import alert list to prevent their products from entering the United States.

“The FDA is particularly concerned that these illegally marketed, unapproved ophthalmic drug products pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” it said. Some of the products contain silver, which can cause areas of the skin or eye to permanently turn gray or blue-gray. People also might delay or stop safe and effective medical treatments while using these unapproved drugs, the agency said.

“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,” Jill Furman, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research, said in a statement.

Consumers who are currently using eye products mentioned in these warning letters are advised to consult their healthcare provider. The FDA encourages both consumers and healthcare professionals to report any adverse reactions through the agency's MedWatch program.

The FDA has requested the implicated companies to respond within 15 days of receiving the letters, outlining their plans to rectify the identified violations. Failure to promptly address these issues may lead to the FDA pursuing legal actions, which could involve product seizure and/or obtaining a court order to halt the manufacturing and distribution of unapproved products by the company. Additionally, certain companies have been placed on an import alert list to prevent their products from entering the United States and reaching consumers.

The FDA's investigation into eye products remains ongoing, and the agency may take further regulatory or enforcement actions as deemed necessary.

The products that received a warning letter are listed below:

1. Boiron Inc.

● Optique 1 Eye Drops

2. CVS Health

● CVS Health Pink Eye Relief Drops

3. DR Vitamin Solutions

● Vision Clarity Eye Drops

● Life Extension Brite Eyes III

● Can-C Eye Drops

● Longevity Science Visual Ocuity

4. 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

5. OcluMed LLC

● OcluMed Eye Drops

6. Similasan AG/Similasan USA

● Similasan Dry Eye Relief

● Similasan Complete Eye Relief

● Similasan Allergy Eye Relief

● Similasan Kids Allergy Eye Relief

● Similasan Red Eye Relief

● Simil asan 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

7. TRP Company, Inc.

● Dryness 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

● Stye Relief

● Dryness Relief PF

8. Walgreens Boots Alliance, Inc.

● Walgreens Allergy Eye Drops

● Walgreens Stye Eye Drops

● Walgreens Pink Eye Drops

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