FDA warns eight companies regarding unapproved ophthalmic drugs

Published 8:50 am Sunday, September 24, 2023

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The U.S. Food and Drug Administration issued warning letters on September 11, 2023 to eight companies for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law.

Eye products addressed in the eight warning letters are illegally marketed to treat conditions such as conjunctivitis (“pink eye”), cataracts, glaucoma and others. Some of the FDA warning letters also cite the companies involved for quality issues related to product sterility.

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.

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Some of these eye products are labeled to contain silver, which may be characterized as silver sulfate, silver sulphate or argentum. Long-term use of drugs containing silver can cause some areas of the skin and other body tissues, including in the eye, to permanently turn gray or blue-gray, which is called “argyria.” Additionally, unapproved drugs that claim to cure, treat or prevent serious conditions may cause consumers to delay or stop medical treatments that have been found safe and effective through the FDA review process.

Consumers currently using eye products included in these warning letters should speak to their health care professional. The FDA encourages consumers and health care professionals to report any adverse reaction to the agency’s MedWatch program.

The FDA has asked the companies to respond within 15 days of receipt of the letters, stating how they will correct the violations. Failure to correct the violations promptly may result in the FDA pursuing legal action, including product seizure and/or a court order requiring a company to stop manufacturing and distributing an unapproved product. Additionally, the agency has placed some of these companies on import alert to help stop their products from entering the U.S. and reaching consumers.

The FDA’s investigation of eye products is ongoing, and the agency may take additional regulatory or enforcement actions, as warranted.

The agency issued warning letters which detail social media and website reviews in July and August 2023 and citations to online advertising, for an unapproved drug or drugs offered for sale in the United States. The warning letters were sent to:

Boiron, Inc. Janick Boudazin, 4 Campus Boulevard, Newton Square, PA 19703 United States

Boiron SA, 2 Avenue de l’Ouest Lyonnais, Messimy, Rhone, France
Product: Optique 1 Eye Drops

CVS Health. Karen S. Lynch, President & CEO, One CVS Drive, Woonsocket, RI 02895 United States

Product: CVS Health Pink Eye Relief Drops

DR Vitamins, LLC dba DR Vitamin Solutions. Jonathan Formby, President, 7804 Harwood Rd., North Richland Hills, TX 76180-5901 United States

Products: Vision Clarity Eye Drops, Life Extension Brite Eyes III, Can-C Eye Drops, and Longevity Science Visual Ocuity. The company’s Amazon storefront has Vision Clarity Eye Drops.

Natural Ophthalmics, Inc. Linda Axelrod, President, Natural Ophthalmics, Inc., 778 W. Baseline Rd., Lafayette, CO 80026 United States

Products: 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, and Cataract Eye Drops with Cineraria.

OcluMed LLC. 401 Commerce Drive Suite 201Fort Washington, PA 19034 United States

Sent to Agent of OcluMed LLC, 1280 Stillwater Dr., Miami Beach, FL 33141

Product: OcluMed Nutritional/Lubricant Eye Drops.

Similasan AG. Urs Lehmann, CEO, Industriestrasse 276060 Sarnen Switzerland. Inspection from March 27 to April 4, 2023.

Products: Similasan 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. This warning letter also summarizes significant violations of Current Good Manufacturing Practice regulations for finished pharmaceuticals, making the products considered adulterated.

TRP Company, Inc. Thomas Pominville, Owner, 1575 Delucchi Lane, Suite 208 Reno, NV 89502 United States. Cited in September 2022 and again in July 2023

Products: 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, and Stye Relief and added Dryness Relief PF.

Walgreens Boots Alliance Inc., Stefano Pessina, Executive Chairman, Walgreens Boots Alliance, Inc., 108 Wilmot Rd., MS #2002, Deerfield, IL 60015 United States

Products: Walgreens Allergy Eye Drops, Walgreens Stye Eye Drops, and Walgreens Pink Eye Drops