Proposed New Definition of Healthy for Food Label Claims

The FDA has proposed a new definition of healthy and related terms for the purpose of food labeling.  The current definition became effective in 1994 and focuses on limited levels of total fat, saturated fat, cholesterol, and sodium to establish a food as “healthy”.  Under [...]

2023-03-28T18:27:28-06:00October 18, 2022|

Letter on proposed changes to GRAS regulations

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. 

2022-11-01T16:36:09-06:00June 13, 2022|

FDA and COVID-19

FDA has issued new policies affecting the food, dietary supplement, drug, and medical device industries in response to the COVID-19 pandemic.

2022-08-26T09:34:00-06:00March 24, 2020|

FDA Updates the List of Recognized Dietary Fibers

On June 14, 2018 FDA published two guidance documents on dietary fiber.  “Dietary fiber” was not defined per se prior to the publication of the revised nutrition labeling regulations of 2016.  The 2016 definition for dietary fiber has two parts.  First, it includes “non-digestible soluble [...]

2022-08-26T09:34:01-06:00June 28, 2018|

FDA Revises Draft Guidance on New Dietary Ingredient Notifications

On August 11, 2016 FDA published their long-awaited revised draft guidance on New Dietary Ingredient Notifications.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 [...]

2022-11-29T16:32:56-07:00August 12, 2016|

Menu Labeling Coming to a Restaurant Near You

Updated May 19, 2016: New Menu Labeling Guidance was published on May 5, 2016 so the enforcement date for the regulations is May 5, 2017.  See the full post here: http://fdasimplified.com/blog/ Updated March 9, 2016:  FDA announced that they will delay enforcement of menu labeling [...]

2022-11-29T16:32:56-07:00June 1, 2015|
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