There has been a spate of blog posts on our site regarding dietary supplements and yet again today we are addressing a newly issued revised draft Guidance, entitled, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues (here). FDA notes that, under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350b(a)(2)), 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 at least 75 days before introducing the product into interstate commerce. This revised draft Guidance is designed to update the Agency’s previous version of the Guidance first issued July 2011. This new Guidance is 102 pages, so have fun reading it!
The Guidance answers many frequently posed questions and clarifies many issues on new dietary ingredient (NDI) notification based primarily upon comments submitted in response to the 2011 draft Guidance. Some of the topics covered include:
- What qualifies as an NDI;
- When an NDI notification is required;
- What are the procedures for submitting an NDI notification;
- What types of data and information FDA recommends you consider when you evaluate the safety of NDIs and dietary supplements containing an NDI; and
- What FDA recommends you include in an NDI notification.
The Guidance contains the current FDA thinking (albeit in draft) in the what, when, and how of NDI notification and issues like submission of the NDI electronically, the impact of chemical alteration of dietary ingredients, manufacturing changes that create an NDI, issues related to synthetic substances, among other issues. When there is a long period between issuance of a draft Guidance and then there is a long time before a revised draft is issued, one of the questions that always pops into the mind of ex-FDAers is – why now? Does the recent activity related to the draft Guidance issuance, FDA warning letters and actions on dietary supplements, concentration on cGMP issues spell trouble for dietary supplement manufacturers? Is FDA taking these steps with an eye on further and increased enforcement action? While there is no clear indication, what is clear is that dietary supplements are on FDA’s mind.