A new dietary ingredient (NDI) is any substance not marketed in the U.S. as a dietary supplement before October 15, 1994. If your supplement includes an NDI, you may be required to submit a New Dietary Ingredient Notification (NDIN) to the FDA at least 75 days before launch. This process ensures your ingredient is safe for consumers and compliant with federal regulations. Whether it’s a botanical extract, synthetic compound, or novel substance, identifying and documenting an NDI properly is essential. Companies that overlook this step risk enforcement actions, recalls, or product delays—making early regulatory planning a must.