On September 12, 2023, the U.S. Food and Drug Administration (FDA) issued warning letters to eight companies, including two major drugstore retail chains, for their involvement in the production or promotion of unapproved ophthalmic drug products, thereby violating the Food, Drug, and Cosmetic Act (FD&C Act).
The warning letters pertain to eye products that are being illegally marketed to treat conditions such as conjunctivitis (“pink eye”), cataracts, glaucoma, and others. Several of the warning letters also cite the companies for issues pertaining to the quality and sterility of their products. These ophthalmic products are regulated as drugs under section 201(g)(1) of the FD&C Act, because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. The FDA clarifies that even the ophthalmic drug products labeled as homeopathic products (with active ingredients measured in homeopathic strengths) are considered “drugs” because, under the FD&C Act, the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States, or any supplement to it. Homeopathic products that meet the statutory “drug” definition are subject to the same regulatory requirements as other drugs, and nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.
Of particular concern to the FDA appears to be the heightened risk of harm posed by these unlawfully marketed and unapproved ophthalmic drug products, given that ocular application of drugs bypasses certain natural bodily defenses. Some of these eye products are labeled to contain silver, which may be denoted as silver sulfate, silver sulphate, or argentum. The prolonged use of drugs containing silver can lead to permanent discoloration of certain areas of the skin and other tissues, including the eyes, resulting in a condition known as “argyria.” Moreover, unapproved drugs that claim to cure, treat, or prevent serious conditions may prompt consumers to delay or discontinue medical treatments that have been established as safe and effective through the FDA’s review process.
The eight companies that received warning letters include two major drugstore retail chains, two major homeopathic product manufacturers, three ophthalmic product manufacturers, and a major dietary supplement manufacturer. The FDA is asking these companies to provide a response within 15 days from the date of receiving the warning letters, detailing the steps they intend to take to rectify the cited violations. Failure to promptly address these violations may compel the FDA to pursue legal action, including the seizure of products and/or a court-ordered injunction, which could halt a company's production and distribution of an unapproved product. Additionally, the FDA has placed some of these companies on import alert, thereby preventing their products from entering the U.S. market and reaching consumers.
The FDA strongly encourages both consumers and healthcare practitioners to report any adverse reactions through the MedWatch program, the FDA’s medical product safety reporting program for health professionals, patients, and consumers. MedWatch receives reports from the public and, when appropriate, publishes safety alerts for FDA-regulated products such as prescription and over-the-counter medicines, biologics, medical devices, combination products, special nutritional products, cosmetics, and food. The FDA stated its inquiry into eye products is ongoing, and the agency may undertake further regulatory or enforcement actions as deemed necessary.
If you have any questions about how FDA warning letter and import alerts may impact your business, please contact Georgia Ravitz, Eva Yin, Shawn Lichaa, Scott Cohn, Marissa Hill Daley, or any member of the firm’s FDA regulatory, healthcare, and consumer products practice.
