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Infusionz, LLC was cited for manufacturing and distributing unapproved CBD products—including gummies, fruit snacks, gum, candy, oil/tinctures, and lollipops—that violated the Federal Food, Drug, and Cosmetic Act by containing unsafe food additives and lacking FDA evaluation for safety and effectiveness. The FDA was particularly concerned that many products were formulated in child-appealing formats (gummies, candies, lollipops) that could be mistaken for traditional foods, creating heightened risk for vulnerable populations like children who may experience unpredictable adverse reactions to untested drugs. The company's CBD products were deemed adulterated and prohibited from interstate commerce, with the FDA noting that CBD is an active ingredient in the approved drug Epidiolex and therefore requires proper drug approval before marketing.