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US FDA Issues Warning Letters to Eight Companies for Selling Unapproved and Potentially Harmful Ophthalmic Products

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The U.S. Food and Drug Administration (FDA) has issued stern warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products that violate federal laws. These enforcement actions are part of the FDA's ongoing commitment to protect Americans from potentially harmful eye products.

The warning letters address a range of eye products that have been illicitly marketed to treat various eye conditions, including conjunctivitis ("pink eye"), cataracts, glaucoma, and more. Notably, some of these warning letters also highlight concerns about the quality of these products, specifically related to product sterility.

The FDA's primary concern is that these unlawfully marketed and unapproved ophthalmic drugs present an elevated risk to users due to the fact that drugs applied directly to the eyes can bypass certain natural defenses of the body. Some of these eye products are labeled as containing silver, which may appear as  silver sulfate, silver sulphate, or argentum. Prolonged usage of drugs containing silver can result in the permanent discoloration of the skin and other body tissues, including the eyes, leading to a condition known as "argyria." Additionally, the marketing of unapproved drugs that claim to cure, treat, or prevent serious conditions may lead consumers to delay or discontinue medically reviewed treatments that have been proven to be safe and effective through the FDA's rigorous evaluation process.

Jill Furman, Director of the Office of Compliance for the FDA's Center for Drug Evaluation and Research, emphasized the agency's commitment to ensuring the safety, effectiveness, and high quality of medicines consumed by Americans. She stated, "When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations. 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."

The FDA has issued warning letters to the following companies: Boiron Inc., CVS Health, DR Vitamin Solutions, Natural Ophthalmics, Inc., OcluMed LLC, Similasan AG/Similasan USA, TRP Company, Inc., Walgreens Boots Alliance, Inc.

Consumers who are currently using eye products from these companies that are mentioned in the warning letters are strongly advised to consult with their healthcare professionals. Furthermore, the FDA encourages consumers and healthcare professionals to report any adverse reactions or concerns regarding these products through the agency's MedWatch program.



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