Hello!
Established in 1927 as a reorganization of President Roosevelt’s pre-existing Pure Food and Drug Act of 1906 (also known as the “Wiley Act” in deference to its tireless advocate, chief chemist of the US Department of Agriculture, Harvey Washington Wiley), the US Food and Drug Administration (FDA) continues to regulate food and drugs made domestically in, or being imported into, the States.
In terms of ophthalmic medicines – by their very nature a drug class commonly administered in a way that bypasses some of the body’s natural defenses – the FDA acts as a crucial gatekeeper – “protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.”
The FDA has now focused its attention on eight companies – CVS Health, Natural Ophthalmics, Similasan, TRP Company, DR Vitamin Solutions, OcluMed, Boiron, and Walgreens Boots Alliance – for “manufacturing or marketing unapproved ophthalmic drug products in violation of federal law.” The warning letters, sent out on September 11, 2023, relate to an assortment of eye-related, over-the-counter products for a variety of ophthalmic conditions, including cataracts (Cataract Eye Drops with Cineraria), glaucoma (Life Extension Brite Eyes III), dry eye disease (Optique 1 Eye Drops), and conjunctivitis (Pink Eye Relief Eye Drops).
Some of the products under the FDA spotlight, such as CVS Health Pink Eye Relief Drops, Similasan Dry Eye Relief, and Walgreens’ Stye Eye Drops, “are labeled to contain” silver as a preservative. The long-term use of silver can cause toxic levels of deposits to build up in the body, eventually leading to argyria – a condition where the skin and other body tissues – including the eye – permanently turn a gray or blue-gray metallic color. And though it’s considered a benign condition, the symptoms of argyria can often be irreversible.
Some of the companies on the receiving end of the FDA’s warnings have reacted swiftly; for example, CVS stopped the sale of its conjunctivitis eye drops, offering full refunds for consumers who’ve already bought them – others have yet to respond.
If these companies fail to respond within 15 days of receipt of the letters, the FDA may decide to take legal action, which includes potential product seizure, as well as getting court orders in place to stop the companies from manufacturing and distributing these medications.
These are OTC medications, which the FDA does not regularly examine unless they have been shown to produce significant side effects.
Although these products are 'eye products' Does this signal an awakening of the FDA to many products that are sold OTC with little to no regulation?
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