FDA WARNING_LETTER - ForYou, Inc. - February 21, 2020

The FDA inspected For You, Inc. in Loris, SC, from February 19-21, 2020, revealing serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering products adulterated. Additionally, product labels, brochures, and the company website (foryouinc.com) were reviewed in July 2020, leading to conclusions that several products are unapproved new drugs and misbranded drugs and dietary supplements.

Key violations include: - **Unapproved New Drugs and Misbranded Drugs:** Products like Advanced Formula BioAnti-Oxidant, Advanced BioEnzymes, and others are deemed unapproved new drugs due to therapeutic claims (e.g., "Nutritional Support: Arthritis, Pain, Gout, Fibromyalgia") on labels, brochures, and the website, indicating intent for disease cure, mitigation, treatment, or prevention. These products are not generally recognized as safe and effective and lack FDA approval. They are also misbranded as they lack adequate directions for layperson use, being intended for conditions requiring professional supervision. - **Adulterated Dietary Supplements (CGMP Violations):** - Failure to establish and follow written procedures for quality control operations, including material review, disposition decisions, and reprocessing approval (21 CFR 111.103). - Failure to establish and follow written procedures for holding and distributing