Food Label News ArchiveFood Label News SubscriptionsNutritional Analysis Food Labels - Food Nutrition Facts LabelsFood Consulting Company: Nutrition-Labeling-Regulatory

Volume 16, Number 5 - May 2016

Hello from Food Label News! At the Federal Food Regulatory Conference later this month, Melissa Grzybowski of Food Consulting Company will answer common questions about ingredient labeling. If you can’t make it to the conference, be sure to read below as well as future issues of Food Label News for the ins and outs of ingredient labeling. We join food labelers everywhere waiting for the anticipated final rule on nutrition label changes (now at Office of Information and Regulatory Affairs for regulatory impact analysis) and will be sure to keep you posted as soon as there's more news to share.

In this issue you'll find:


"Your company is a pleasure to do business with. The method of communication for initiating and working through projects is very streamlined and professional."

– Russell Nabors  
Lopez Foods, Inc.  

Ins & Outs of Ingredient Labeling: An Overview

What's News in the Food Label Community

Reader Q&A: Is a U.S. Address Required on Food Labels?


Karen C. Duester, President

Ins & Outs of Ingredient Labeling:
An Overview

In our twenty plus years of working with food companies, we've focused on the myriad of details regarding ingredient labeling. What ingredients need to be included, can they be grouped, what to do about trace amounts, etc. At the Federal Food Regulatory Conference later this month we will share important takeaways for interpreting FDA ingredient labeling regulations and will discuss the topic further in upcoming issues of Food Label News.

Reader Favorites

And/or ingredient labeling


FDA's ingredient labeling regulations have remained essentially unchanged since the 1980's. But just because they haven't changed doesn't mean they are easy to interpret. The Code of Federal Regulations (21 CFR 101.4 and 101.22) calls out specific requirements for ingredient declarations yet there are many important nuances.


In some cases it is acceptable to group ingredients together under a collective name. For example, listing "spices" in the ingredient statement is allowed as an alternative to listing cinnamon, nutmeg and cloves separately.


Ingredients with an established common or usual name or standard of identity can be shown one of two ways in ingredient statements: 1) listed with sub-ingredients in order of predominance in parentheses following the common name or 2) no common name listed and sub-ingredients listed in descending order within the finished food. For example, margarine can appear on the label with the ingredients that comprise margarine in parentheses, or the component ingredients can be merged into the final ingredient statement without the word "margarine."


Colors, flavors, spices and chemical preservatives must appear in the ingredient listing, although there are nuances for each. For example: potassium sorbate, a preservative to maintain freshness, must include the preservative function with the ingredient name.


Ingredients that are 2% or less of the formula may be declared in any order at the end of the ingredient statement provided the phrase "Contains 2% or less of…" precedes these ingredients.


Incidental additives are exempt from ingredient labeling when they are present at insignificant levels and provide no technical or functional effect in the finished food. For example, a processing aid used in production may not always need to be declared in the ingredient list.

FDA pays close attention to ingredient declarations and mistakes are identified frequently in warning letters to food manufacturers. To ensure that your food labels are 100% compliant, be mindful of collective terms (e.g., vitamin mix), changing the order of ingredients when reformulating and labeling for chemical preservatives (e.g., BHA), among many other common and not so common issues.

What's News in the Food Label Community


FDA updates: 2016 Regulatory Agenda, NFP Final Rules submitted to OIRA, Final Guidance on Menu Labeling


When can you combine ingredients? (20+ comments)


Declaring "peppers" as an ingredient (14+ comments)


Labeling "high oleic" sunflower oil (13+ comments)


Declaring dried/powdered ingredients (12+ comments)

Join Food Label Community. Already a member, view Discussions.

Reader Q&A

Find answers to our readers' questions or send us your question for an upcoming issue.


I have heard that you always need to have a U.S. address on your food label but I can’t find the regulation that requires this. Can you clear this up for me?   
K.C., California, Food Manufacturer 


21 CFR 101.5 states that the manufacturer, packer or distributor name and place of business must be displayed prominently on every food label. If a product is manufactured outside the U.S., it is acceptable to label the address of its origin including the country name. However, there is also a mandate specific to dietary supplements in Section 403(y) of the FD&C Act [21 U.S.C. 343(y)] referenced in FDA guidance that requires a U.S. domestic address or phone number for the purpose of adverse event reporting. More Reader Q&As.

What Matters in Food Labeling

Food Label News, now in its 16th year, is a monthly e-newsletter reaching over 9,500 subscribers around the world. We welcome your colleagues to subscribe for news and insights about food labels:


Your Virtual Food Label Partner

Food Consulting Company, founded in 1993, provides nutrition analysis, food labeling, and regulatory support for more than 1,500 clients worldwide.
Our guarantee: 100% regulatory compliance. Contact us for the help you need now.

You may reprint all or part of this newsletter provided you attribute it to Food Label News and include a link to

© 2016. Food Consulting Company, Del Mar, CA. All rights reserved.