Dietary ingredients for use in dietary supplements can either be old,
pre-DSHEA, grandfathered dietary ingredients (ODI) or New Dietary Ingredients depending on whether they were
marketed and sold in interstate commerce prior to October 15, 1994. Our regulatory experts will determine
whether your dietary ingredient is old or new.
NDI requirements are highly detailed, requiring an expert in NDI identity (chemistry) and safety (toxicology). Our team of regulatory experts, led by co-author of FDA’s NDI draft guidance for New Dietary Ingredient Notification and former FDA Branch Chief for Dietary Supplement Regulation Implementation, will provide you with a customized, all-in-one solution for successfully meeting NDI compliance.
Led by a former FDA Regulator, TulipLab's veteran regulatory experts provide crucial insights into regulatory operations, leading to the most effective pathway from product to market. Backed by a vast network of scientific, legal and regulatory professionals, you’ll receive dedicated support throughout each step of the process.GET A QUOTE