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Flora Inc was cited for marketing multiple products as unapproved drugs based on disease claims made on their website and social media, including claims that products could reduce traveler's diarrhea, antibiotic-associated diarrhea, and notably that Elderberry+ could mitigate, prevent, treat, diagnose, or cure COVID-19. The company violated the Federal Food, Drug, and Cosmetic Act by introducing these products into interstate commerce with therapeutic claims that established them as drugs under section 201(g)(1)(B), without obtaining required FDA approval. The violations were identified during an FDA review of Flora Inc's website (florahealth.com/us) and Pinterest social media pages conducted between March and May 2021.