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Thea Pharma, Inc. was cited for marketing IVIZIA sterile lubricant eye drops as an unapproved new drug in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act, as well as misbranding violations under section 502(ee). The company sold the product without FDA approval through its website and Amazon storefront, making drug claims such as "for use as a lubricant to prevent further irritation or to relieve dryness of the eye" that established the product's intended use as a drug rather than a cosmetic. The FDA inspection on August 29, 2024 determined that the product's labeling and marketing materials contained therapeutic claims that rendered it a drug requiring pre-market approval before interstate distribution.