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Elements Brands Inc. distributed eb5® Skin Lightening Cream, an unapproved new drug containing 2% hydroquinone that was misbranded in violation of the Federal Food, Drug, and Cosmetic Act. The product violated section 505(a) because it was an unapproved new drug introduced into interstate commerce and violated section 502(ee) due to misbranding, with evidence of intended drug use found on product labeling and the company's website (eb5.com) making claims about lightening dark spots, age spots, and fading discoloration. The company's labeling and marketing materials explicitly identified hydroquinone as a "skin lightener" and "known inhibitor of excess melanin," establishing the product's intended use as a drug without FDA approval.