On Friday, May 20, 2022, FDA published a policy on enforcement discretion regarding New Dietary Ingredients (NDIs) in the form of a draft guidance. The Dietary Supplement Health Education Act of 1994 (DSHEA) amended the FD&C Act and set up the dietary supplement regulations [...]
Hindsight and 2020: A look back at FDA activities in 2019 and a look forward to 2020.
Near the end of 2017 FDA published test results from a gluten free food product surveillance project. By way of background, recall that in 2013 FDA published a final rule on gluten free labeling of foods, including dietary supplements. The rule, codified in 21 CFR [...]
2017 was a bit of a wild year with many twists and turns, stops and starts in the form of FDA actions. The agency once more delayed enforcement of restaurant menu labeling regulations; now set for May 7, 2018. The enforcement date for the revised [...]
Updated June 13, 2017: Today FDA announced that they will extend the compliance dates for the new nutrition facts labels but they have not announced what the new dates will be. Here is the information published on the FDA website: "FDA Intends to Extend Compliance [...]
On August 11, 2016 FDA published their long-awaited revised draft guidance on New Dietary Ingredient Notifications.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 [...]
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 [...]
FDA has been busy in the past few months, publishing several draft guidance documents and proposed rules for food safety—including a proposal that would ban partially hydrogenated oils in foods. They also published updated guidance on cosmetic GMPs but have been relatively quiet about dietary [...]
Hello! Summer is in full swing here in the Northern Hemisphere and FDA is heating things up for the US dietary supplement industry. On Friday, July 1, 2011 FDA published the long-anticipated Draft Guidance for Industry on Dietary Supplement New Dietary Ingredient Notifications. You can [...]
Everyone is aware of today’s trend towards natural foods. Many manufacturers now substitute refined sugar with other cane products including “evaporated cane juice”. Yesterday the FDA issued a new guidance on labeling foods containing this ingredient. The guidance states that in FDA’s view “evaporated cane juice” [...]