There is a bill before the Senate Committee on Health, Education, Labor, and Pensions that would drastically alter the path to market for new food ingredients. As an observer of FDA, I expect that this bill will have ramifications for the dietary supplement industry and the New Dietary Ingredient Notification process.
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20, 2022, FDA published a policy on enforcement discretion regarding New Dietary Ingredients (NDIs) in the form of a draft guidance.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 [...]
New ingredients for use in foods, dietary supplements, and pet foods each have unique review and approval processes mandated by FDA.
Hindsight and 2020: A look back at FDA activities in 2019 and a look forward to 2020.
The Food and Drug Administration (FDA) has historically worked in a reactionary manner. The original Pure Food and Drugs Act was passed by Congress on June 30, 1906 in response to studies that showed deleterious effects of food additives that were already in use in [...]
On August 11, 2016 FDA published their long-awaited revised draft guidance on New Dietary Ingredient Notifications.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 [...]
FDA has been busy in the past few months, publishing several draft guidance documents and proposed rules for food safety—including a proposal that would ban partially hydrogenated oils in foods.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 On Friday, July 1, 2011 FDA published the long-anticipated Draft Guidance for Industry on Dietary Supplement New Dietary Ingredient Notifications.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 [...]