April 2022 | FDA Issues Draft Guidance and Final Rule for the Industry


Our newsletter covers this month’s highlights, but to stay up to date on ESHA news, please visit our blog/


ESHA offices will be closed May 30, 2022 for the Memorial Day holiday.



FDA Releases Draft Guidance on Enforcement Discretion for Certain NAC Products

The FDA issued a draft guidance announcing enforcement discretion with respect to N-acetyl-L-cysteine (NAC), and said it is “likely to propose a rule providing that NAC is not excluded from the definition of a dietary supplement.”

FDA Releases Final Rule for Added Fluoride Levels in Bottled Water

The FDA issued its final rule for added fluoride levels in bottled water. This final rule amends the allowable level for fluoride in domestically packaged and imported bottled water and requires fluoride to be declared in the ingredient list. The final rule will become effective June 19, 2022.

FDA Issues Draft Guidance on Evaluating the Public Health Importance of Non-Listed Food Allergens

The draft guidance will outline the FDA’s approach to evaluating the public health importance of food allergens that are not one of the major food allergens identified by law in the U.S. This is part the FDA’s efforts to evaluate emerging evidence about food allergens other than the Major Nine.
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Agencies Ask for Feedback on Proposed Scientific Questions for the DGA

HHS and USDA are requesting public comments on the proposed scientific questions that will inform the development of the Dietary Guidelines for Americans, 2025-2030. The public comment period will be open for 30 days starting April 15, 2022, through May 16, 2022.
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Blog: How To Compare Recipes Side-by-Side

Oftentimes our customers ask us how they can review and compare recipes onscreen at the same time. The Tile Vertical option under the View tab lets you view recipes, ingredients, Nutrition Facts Labels, and other documents side-by-side.

Blog: How to Move Files from the Cloud to Your Local Computer

When you save a record in your cloud version of an ESHA program, you are saving that record to the cloud database. This blog goes over how to move a file locally during the save process and how to browse and move more than one file at a time by opening the cloud File Explorer.



Q: I’m new to food labeling. Where can I get a jump start on understanding the regulations?

A: There are a lot a resources available online, like the Code of Federal Regulations and on the ESHA website, or use the REX Regulatory Document Search Portal. Because these can often be hard to navigate and understand, especially for a newcomer, we are also offering a Regulatory Seminar that will help you learn the basics of nutrition labeling laws.



Upcoming Seminar:

The first step to complying with regulations is understanding them. This training will provide a deep dive into the U.S. food labeling regulatory landscape, with a focus on FDA regulations. Attendees will walk away with an understanding of the requirements of, nuances to, and exemptions for food product labeling.
Register » 

Recorded Webinar:

Because Added Sugars contribute only empty calories to a diet, their overconsumption can make getting enough essential vitamins and minerals difficult. To encourage consumer awareness of Added Sugars in food products, the FDA’s 2016 Food Labeling Revisions established Added Sugars as a mandatory label nutrient and clarified the definition.
Watch the Recording » 



Genesis R&D Foods: Add User-Defined Allergens To The Database

Users can modify and create new items in the food and nutrition database within Genesis R&D Food, such as unique allergens. Any changes made in the database portion of the program are stored in the database and available to any Genesis R&D user in your organization. This tutorial will show you how to add allergens to the database.
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Food Processor: Advanced Search Finding Recipes That Contain Certain Ingredients

You can use the Advanced Search to find Ingredients inside of Recipes and the Search results will display those Recipes only.
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Trainings are available online or in-person.

Genesis R&D Professional + FDA Regulations

Topics covered include FDA regulations, creating ingredients and composite ingredients, building recipes/formulas, nutrition analysis, moisture loss, reporting, labeling, best practices.

Genesis R&D Advanced Training

Topics covered include using PDCAAS, International Food Labeling, Advanced Label Settings, and more.

See the Genesis R&D Foods Training Schedule »