On March 5, 2024, the US Food & Drug Administration (FDA) released final guidance titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” The guidance is meant to...more
On March 5, FDA published its long-awaited Final Guidance on New Dietary Ingredient Notification (NDIN) Procedures and Timeframes (Final Guidance). This new guidance updates and finalizes Section V of FDA’s revised 2016 Draft...more
While the intention is never to create a product that will be recalled, it is a fairly common occurrence. And while the scope of a recall may vary greatly depending on the product and individual facts at issue, the days...more
The U.S. Food and Drug Administration (“FDA”) in March 2020 temporarily halted its domestic inspection program amid the coronavirus disease (COVID-19) pandemic. During this time, FDA continued to use other tools, including...more