November 2021 | FDA Guidance on Standards of Identity


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


Upcoming Holiday Closures

Please note in observance of the upcoming holidays, ESHA offices will be closed on the following dates:
Thanksgiving — November 25th & 26th
Christmas — December 23rd & 24th
New Year — December 31st



FDA Releases Guidance for Industry on Temporary Permits for Food Varying from Requirements of Standards of Identity

This guidance is to meant to clarify aspects of the application process for temporary marketing permits (TMP) and describes a change that simplifies the label review process in order to help the industry better understand and utilize the TMP application process.

American Beef Labeling Act to Reinstate Country of Origin Labeling

The American Beef Labeling Act, recently introduced by the U.S. Senate, seeks to reinstate the mandatory country of origin labeling (MCOOL) requirements for beef, as it along with pork were both subsequently removed from the MCOOL requirements in 2015.
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2019 Food Safety and Nutrition Survey Report

FDA released a summary of the 2019 Food Safety and Nutrition survey results. The FSANS tool shows responses to labeling questions along with consumer perception of different labeling claims and statements.

Seed-to-Sale buzz: Understanding FDA regulatory landscape for cannabis

The FDA’s regulatory authority also encompasses multiple product categories including drugs, medical devices, foods, and cosmetics. That also includes products in these categories that are made from cannabis. A public comments made by FDA officials may provide some clues to future regulatory trends.



Blog: Labeling Spices & Spice Blends

This blog will cover a variety of important factors to consider, including what is considered a spice, and how to treat spices in a recipe vs. as a standalone product, when labeling spices and spice blends.
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Blog: Dual Column Labeling

There may be times when you will need to use a Dual Column Label for your product. This blog walks you through when and how to create Dual Column labels.
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Q:  Is there a Nutrient Content Claim option for evaluating a recipe for FDA’s interim definition of “healthy” in Genesis R&D?

A:  The FDA is still in the process of defining “healthy” for a nutrient content claim. Therefore, it is not currently included. When the definition is finalized, we will assess how best to add it to Genesis R&D. In the meantime, however, you can use the Attributes feature and add “healthy” as a user-created attribute for tracking. We recommend that you use the F5 nutrient search option to search for foods high and/or low in certain nutrients (per your in-house definition), and save those to a “healthy” Group. You can then assign the “healthy” attribute to those foods.

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Recorded Webinar:

The latest release of Genesis R&D Foods, Version 11.11, is now available. This software update includes the addition of sesame as an allergen for U.S. packaging, revisions to the Nutrient Content Claims for the U.S. and Canada labeling modules, Menu Label module report updates, and other program improvements.

Watch the Recording » 

Recorded Webinar:

Genesis R&D Foods offers many filters to narrow your searches, helping you find exactly what you are looking for. When developing a recipe, you may want to search for ingredients by specific nutrient content, such as high in protein or low in saturated fat. Alternatively, you might want to find recipes that contain a particular ingredient. This webinar covers the different database search filters and other searching tips.

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Genesis R&D Foods: Creating a Recipe
This tutorial illustrates how to create a recipe and how you can use the recipe to build regulatory compliant Nutrition Facts Labels. Instructions are now in English and Spanish.
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Genesis R&D Foods: Creating a New Ingredient
When the exact ingredient you need is not in the database, you can add your own. This tutorial shows you how. Instructions are now in English and Spanish.
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Food Processor: Exporting Nutrition Reports & Other Data
This tutorial will show you how to export one report, copy/paste a report, or export many reports at once.
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Genesis R&D Supplements Exporting Labels as a Vector Files
Genesis R&D lets you output your Supplement Facts panels as a vector file, which your graphic designer can then open further edit in Adobe Illustrator or graphics design programs.
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Genesis R&D Foods
2-Day 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.

1-Day Genesis R&D Advanced Training

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

Training Schedule Dates
Nov. 30 – Dec. 2, 2021 — Online

Register Today »