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Talk to a SpecialistTalk to a SpecialistNeuroHydrate LLC was cited for marketing HM-FORMULA as an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act by making disease claims on their website, including that the product was "specifically designed for Headache and Migraine prevention" and could "reduce the frequency, severity and duration of headache and migraine." The company failed to obtain FDA approval before introducing the product into interstate commerce and misbranded it by claiming medical efficacy for migraine prevention without proper drug authorization. The violations were identified during an FDA review of the company's website in January 2021.