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FDA Issues Warning Letters to Companies Marketing Unapproved Ophthalmic Drugs

The U.S. Food and Drug Administration (FDA) has taken action against eight companies for manufacturing or marketing unapproved ophthalmic drug products in violation of federal regulations. This move is part of the FDA’s ongoing efforts to safeguard the American public from potentially harmful eye products.

The warning letters issued by the FDA address eye products that are being illegally marketed to treat various eye conditions, including conjunctivitis (“pink eye”), cataracts, and glaucoma. Some of the warning letters also cite quality issues related to product sterility.

The FDA is particularly concerned about the risks associated with these illegally marketed, unapproved ophthalmic drugs. Eye medications applied directly to the eyes bypass certain natural defenses in the body, making them potentially more harmful. Some of these products are labeled to contain silver, which can lead to a condition called “argyria” when used long-term. Argyria causes some areas of the skin and other body tissues, including the eyes, to permanently turn gray or blue-gray. Additionally, unapproved drugs that claim to cure, treat, or prevent serious conditions may discourage consumers from seeking FDA-approved and proven medical treatments.

Jill Furman, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research, emphasized the FDA’s commitment to ensuring the safety, effectiveness, and quality of medicines consumed by Americans. She noted that when the FDA identifies illegally marketed drugs and quality lapses that could pose risks, the agency takes action to notify the companies involved of these violations.

The FDA has issued warning letters to the following companies:

1.      Boiron Inc.

2.      CVS Health

3.      DR Vitamin Solutions

4.      Natural Ophthalmics, Inc.

5.      OcluMed LLC

6.      Similasan AG/Similasan USA

7.      TRP Company, Inc.

8.      Walgreens Boots Alliance, Inc.

Consumers currently using eye products from these companies that have received warning letters are encouraged to consult their healthcare professionals. The FDA also encourages consumers and healthcare professionals to report any adverse reactions to the FDA’s MedWatch program.

The companies have been asked to respond within 15 days of receiving the warning letters, outlining how they intend to rectify the violations. Failure to promptly correct these violations may lead to legal action by the FDA, including product seizure and court orders to cease manufacturing and distributing unapproved products. In some cases, the FDA has placed these companies on import alert to prevent their products from entering the U.S. market.

The FDA’s investigation of eye products is ongoing, and the agency may take further regulatory or enforcement actions as needed to protect public health. You may also find helpful information on: FDA Warns Against Use of Contaminated Eye Drops: Dr. Berne’s and LightEyez Products Under Scrutiny


Christiana Gobina (BPharm)

Pharmacist Christiana holds a Bachelor of Pharmacy degree (BPharm) from the University of Ilorin. She is a dedicated healthcare professional with passion for Pharmacovigilance and medication safety particularly in underserved communities.

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