Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a Specialist1st Phorm LLC was cited for marketing unapproved new drugs and misbranded products, specifically Whole Heart Cardiovascular Health Formula and Full-Mega Omega-3 Fish Oil, based on disease claims made on their website. The company violated the Federal Food, Drug, and Cosmetic Act by making statements indicating these products were intended to cure, mitigate, treat, or prevent diseases such as cardiovascular disease, heart attacks, high blood pressure, arthritis, and acne—claims that established the products as drugs requiring FDA approval. Specific violations included therapeutic statements such as "designed to combat cardiovascular disease and heart attacks" and claims that the products could "help decrease unhealthy levels of LDL cholesterol" and "lower inflammation," which the FDA determined lacked the required new drug applications.