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Sal Nature LLC marketed "FertilHerb for Women" as a dietary supplement while making disease treatment claims that classified it as an unapproved drug under the Federal Food, Drug, and Cosmetic Act. The company's website contained numerous claims indicating the product was intended to treat or prevent fertility-related conditions, including statements that it was "a perfect natural alternative to fertility drugs," could restore fertility in PCOS patients, and could treat endometriosis and amenorrhea. These therapeutic claims violated FDA regulations by positioning the product as a drug without the required approval, safety testing, and labeling. The warning was issued jointly by the FDA's Center for Food Safety and Applied Nutrition and the Federal Trade Commission following website reviews conducted in March and May 2021.