Loading…
iwi was warned that its iwi Cholesterol product was being marketed as a drug rather than a dietary supplement based on disease-treatment claims made across its website, Amazon, and Walmart product pages, including statements that the product "clinically shown to decrease cholesterol" and "protect your heart by lowering bad cholesterol." The company violated the Federal Food, Drug, and Cosmetic Act by introducing an unapproved new drug into interstate commerce without proper FDA authorization, as the marketing claims established the product's intended use for the cure, mitigation, treatment, or prevention of disease. The FDA identified specific violations including clinical efficacy claims (such as a 25% reduction in VLDL cholesterol in 3 months) and implied drug claims through the product name itself.