Effective Approaches for Successful New Dietary Ingredient Notifications

For companies planning to market a dietary supplement in the United States, it is important to understand when a new dietary ingredient notification (NDIN) is required, and what types of information is required to support a successful notification to the Agency. It is no secret that new dietary ingredient notifications have a historical high failure rate, which may be explained in part by a disconnect between FDA requirements under the Dietary Supplement Health and Education Act (DSHEA) and industry perceptions of their due-diligence requirements in establishing reasonable expectation of safety. Intertek is pleased to offer a complimentary webinar to address compliance requirements for new dietary ingredients under DSHEA which share knowledge gained from over 20 years of experience in submitting new dietary ingredient notifications to the FDA. Associate Director of Toxicology & Regulatory Affairs Ryan Simon reviews basic elements of an effective NDIN and highlights specific areas that are the common causes of objection letters from the FDA.