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FDC Nutrition Inc. was cited for marketing Inositol 100% Pure Free Form as an unapproved new drug by making disease claims on its website, including statements that the product could "reduce anxiety by affecting serotonin," "aid blood sugar control by improving insulin sensitivity," and "improve fertility in women with PCOS." The product violated the Federal Food, Drug, and Cosmetic Act because these therapeutic claims established it as a drug lacking FDA approval and without adequate directions for use. The company was selling the product through its website (www.fdcnutrition.com) without the required new drug application or safety and efficacy data to support the claimed uses.