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Formulation Technology, Inc. was cited for manufacturing and distributing unapproved new drugs in the form of dietary supplement products, including a product with claims suggesting it could cure, mitigate, treat, or prevent migraines. The FDA determined that the product labeling and product name established drug intent under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act, and since the product was not generally recognized as safe and effective for these therapeutic uses, it constituted an unapproved new drug introduced into interstate commerce without prior FDA approval. The violation was identified during an FDA inspection of the company's Oakdale, California facility conducted from October 24 through November 9, 2023, and the company's December 5, 2023 response to the inspection observations was found inadequate to address the compliance failures.