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Volume 12, Number 9 - September 2011

Hello from Food Label News. Happy Labor Day to our U.S. readers! We celebrate our work force and all that is American with our feature article "Made in the USA." Next month we will salute our neighbors to the north with a comparison between Canadian and U.S. food labels. In this issue, we also overview the five required components for food labels as we plan to kick off a series on the approved ways to format Nutrition Facts labels. Enjoy the remaining days of summer.

In this issue you'll find:


"Thank you for your swift response. We are pleased with the work you have done for us, and will definitely use your company again in the future."

– Jonathan Lin, 
Auna Kiwi

"Made in the USA"

5 Required Food Label Components

Reader Q&A: Enriched Flour in Canada

Helpful links to keep you current


Karen C. Duester, President

"Made in the USA"

Complying with the Made in USA standard is not as straightforward as it may seem. FTC (and not FDA) regulates this marketing claim to prevent deception and unfairness in the marketplace. FTC has required that a product advertised as Made in USA or Product of USA be "all or virtually all" made in the U.S. The term U.S. includes the 50 states, the District of Columbia, and the U.S. territories and possessions, such as Puerto Rico, Guam or the U.S. Virgin Islands. This U.S. origin claim applies to products and labeling, advertising, and other promotional materials.

When products contain foreign components but are packaged or assembled in the U.S. the concept of "substantial transformation" becomes relevant. Substantial transformation occurs when a new article emerges with a new name, use and character. For example, coffee beans that are imported from Brazil are substantially-transformed when they are made into a cappuccino beverage and packaged in the U.S.; this new food can be labeled Product of USA.

Here are some additional nuances to keep in mind when contemplating the Made in USA or Product of USA claim in your labeling.

  • "All or virtually all" means that all significant parts and processing that go into the product must be of U.S. origin. The product should contain no, or negligible, foreign content.

  • The food product's final processing must take place in the U.S.

  • Consider the overall impression of the labeling or advertising. Symbols or images such as the U.S. flag or outline of the U.S. map may imply a Made in USA claim.

See FTC's Complying with the Made in USA Standard for more information.

Helpful Links

CFR Title 21 for
FDA-regulated foods

CFR Title 9 for
USDA-regulated foods

FDA Food Labeling Guide

FTC Enforcement Policy on Food Advertising

USDA Policy Book for Food Standards and Labeling

Canadian Food & Drug Regulations

CFIA Guide to Food Labelling and Advertising

Silliker/Food Consulting Company Label Claims Guide

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for a discussion of the news

From the Archive

Regulatory Perspective on Marketing Claims

The Canadian corollary to Made in USA and Product of USA is Product of Canada which is covered by separate Canadian regulations. Product of Canada can be claimed if all major ingredients originate in Canada and non-Canadian ingredients total less than 2%. Canadian products of domestic and foreign materials may say Made in Canada from imported ingredients or Made in Canada from domestic and imported ingredients (but cannot claim Product of Canada) provided the last "substantial transformation" of the product took place in Canada. Other truthful Canadian processing claims such as "packaged" or "prepared" may also be made. See the CFIA guide for more details.

5 Required Food Label Components

Back by popular demand, is the helpful one-pager that outlines the five required components that must be on every food package label regulated by FDA. The five regulated label components include:

1. Product Identity

2. Net Contents

3. Nutrition Facts

4. Ingredient/Allergen Statement

5. Signature Line

Country of origin labeling is also required on all imported products. Click here for some of the most common food label mistakes.

Reader Q&A

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


Is enriched flour "natural" in Canada?
M.C., Washington, Food Label Community member


No. Per Canadian regulations, "a natural food or ingredient of a food is not expected to contain, or to ever have contained, an added vitamin, mineral nutrient, artificial flavouring agent or food additive." For discussion on this topic including natural requirements in the EU, join us on the LinkedIn Food Label Community More reader questions.

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Food Consulting Company, founded in 1993, provides nutrition analysis, food labeling and regulatory support to ensure 100% compliance with FDA regulations. With well over 1,000 clients worldwide, we’re pleased to provide information to address your food labeling needs.

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