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Princess Lifestyles, LLC marketed unapproved new drugs and misbranded dietary supplements including TMAXX, PS Brain, Hemorlyn, and Liver King through their website www.princesslife.com without FDA approval. The company made disease treatment and prevention claims—such as stating TMAXX would "balance the regulation of cholesterol" and PS Brain would improve cognitive function in Alzheimer's patients—thereby establishing these products as drugs under the Federal Food, Drug, and Cosmetic Act. These products lacked the required FDA approval for marketing as drugs and violated regulations prohibiting unapproved new drug introduction into interstate commerce.