Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistNew Sun Inc. was cited for marketing multiple unapproved new drug products, including dietary supplements and CBD products (Ultra CBD Oil, CBD Gummies, and Advanced CBD Oil), with disease-treatment claims that violated the Federal Food, Drug, and Cosmetic Act. The company's website and labeling established these products as drugs by representing them for the cure, mitigation, treatment, or prevention of disease, without FDA approval for safety, effectiveness, or quality. The FDA expressed particular concern that Advanced CBD Oil was marketed as safe for children despite lacking any safety evaluation, creating a heightened risk to a vulnerable population.