New Dietary Ingredient Notifications
New ingredients for use in foods, dietary supplements, and pet foods each have unique review and approval processes mandated by FDA.
FDA Revises Draft Guidance on New Dietary Ingredient Notifications
On August 11, 2016 FDA published their long-awaited revised draft guidance on New Dietary Ingredient Notifications. The guidance contains numerous requirements that will significantly affect the dietary supplement industry and establishes a 60 day comment period if manufacturers wish to affect the final rule. The [...]
Recent FDA Guidance on Beverages, Liquid Supplements & Their Ingredients
In mid-January FDA issued two important guidance documents, Distinguishing Liquid Dietary Supplements from Beverages (http://tinyurl.com/m443cla) and Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements (http://tinyurl.com/nhwqz26). I will discuss the guidances in detail below but will start with the parts that are particularly [...]
Warning Letters: Gelatin and Water as Dietary Ingredients
FDA warning letters continue to provide information that give insight into the level of detail of FDA inspection, which are relatively new to the dietary supplement industry and may help your company avoid problems when your inspection comes up. In a February 9, 2011 letter [...]