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Herbal Vitality, Inc. was cited for manufacturing and distributing unapproved new drugs and misbranded drugs, including 21 herbal products such as Acute Kidney Stone Relief, Children's Antibiotic Formula, Hepatitis C Formula Glycerite, and Lung Tonic COPD that made disease claims in their labeling and product catalog. The FDA's inspection of their Sedona, Arizona facility from July 11-15, 2022 determined that these products were intended for the cure, mitigation, treatment, or prevention of disease based on their names and marketing claims, thereby violating the Federal Food, Drug, and Cosmetic Act as unapproved drugs requiring FDA approval before marketing.