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Talk to a SpecialistTalk to a SpecialistNatural Relief Inc. was cited for marketing two unapproved drug products—Edema NatRelief 6 and BP NatRelief 11—with disease treatment claims including relieving joint inflammation and swelling, and reducing cholesterol and triglycerides, without FDA approval or demonstration of safety and effectiveness. The FDA identified these products as "new drugs" under federal law based on website claims establishing intent to cure, mitigate, treat, or prevent disease, violating the Federal Food, Drug, and Cosmetic Act. The violations were discovered during an FDA inspection of the company's Ohio facility in March-April 2023, followed by review of product labeling and the company's website in June 2023.