US FDA released the long overdue draft guidance on New Dietary Ingredient Notifications on 12th Aug 2016 with a 60 day comment period for all stakeholders, replacingthe draft guidance issued in July 2011. A dietary ingredient could be a vitamin, mineral, amino acid, botanical or extract or their combination. A New Dietary Ingredient (NDI) is defined as a dietary ingredient that was not marketed in the U.S. before October 15, 1994 and under FD&C Act, the manufacturer or distributor of a new dietary ingredient (NDI) that has not been present in the food supply as an article used for food, or a dietary supplement containing such an NDI, must submit a premarket safety notification to FDA before introducing the product into commerce.
If the companies have changed the manufacturing process for a dietary ingredient that was marketed in the U.S. prior to October 15, 1994, then depending on the extent to which the manufacturing process change affects the resulting ingredient, an NDI notification may be required. FDA indicates that many manufacturing changes may affect the identity of the food substance, its safety and suitability for certain conditions of use. Manufacturing changes that alter the physicochemical structure or properties, purity and impurities, or biological properties like bioavailability of the ingredient, will also require an NDI notification.
Many suppliers who may have changed their process or formulations to improve the bio-efficacy of their ingredients or changed the source material may have to go for an NDI notification. Companies marketing a supercritical fluid extract must submit an NDI notification, as FDA indicates that supercritical fluid extraction was not commonly used prior to 1994, and there is no evidence of extracts like this having being marketed as food prior to 1994. FDA also notes that a change in extraction solvents would likely affect theingredient’s identity.
FDA considers each strain of a bacterial or yeast species to be a separate ingredient. Therefore NDI evaluations of a microbial sourced ingredientmust be based on the specific strain and not on genus/species. According to the new guidance, companies can submit a confidential “NDI master file” to FDA which provides the companies much needed protection for their investments in research and studies to generate data on NDI submissions. This move should benefit and encourage companies to invest in scientific studies for their ingredients and would act as deterrent for “me too” ingredient suppliers who rely on data generated by others.
It is hoped that this new draft guidance will address the concerns which the industry had on the draft issued in 2011. The 60 day comment period for stakeholders ends on Oct 11, 2016.