Rockville, MD — Since the U.S. Food and Drug Administration (FDA) released its Revised Draft Guidance for New Dietary Ingredient (NDI) Notifications in August, industry has been working hard to understand how exactly it has changed since 2011, where it has improved and where further revisions should take place. It...
When it was announced that the U.S. Food and Drug Administration (FDA) was releasing its latest Draft Guidance of New Dietary Ingredient (NDI) Notifications, the industry held its breath. The original 2011 draft left much to be desired and naturally, there was a great deal of concern. Its release was...
Dana Point, CA—Since officially undertaking the process of designing a product registry in April of this year, the Council for Responsible Nutrition (CRN) finally unveiled its new Supplement Online Wellness Library (OWL), at its annual symposium, The Conference, on Thursday, October 27. As reported previously by WholeFoods, the intention of...
Silver Springs, MD—The U.S. Foods and Drug Administration (FDA) has issued a proposed rule for the use of the term “healthy” on human food products and opened the issue up for public comment for 120 days. Under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C), a food...
Washington, D.C. – On Tuesday, the U.S. Food and Drug Administration (FDA) announced vinpocetine did not meet the definition of a dietary ingredient and would be excluded from the definition of a dietary supplement in the Federal Food, Drug and Cosmetic Act. According to the FDA, vinpocetine is synthetically produced...
The U.S. Food and Drug Administration (FDA) issued a final rule on August 24th that extends and clarifies the compliance dates for certain provisions in four of the seven foundational rules for the Food Safety Modernization Act (FSMA). The changes, which will include “providing more time for manufacturers to meet...
Washington, D.C.—On Thursday, the Natural Products Association (NPA) submitted a request to the U.S. Food and Drug Administration (FDA) for an extension of the comment period on the newly revised guidance re-draft for New Dietary Ingredient (NDI) Notifications. The draft guidance, which was released on August 11, currently has a...
FDA Releases Draft Guidance for NDI Notification The U.S. Food and Drug Administration issued a long-awaited revised draft guidance on Aug. 11 seeking to clarify new dietary ingredient (NDI) notifications for industry. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, manufacturers and distributors must notify FDA at...
