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 cant
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.
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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.
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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. |
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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.
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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." |
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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. |
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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. |
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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. |
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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.
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What's
News in the Food Label
Community
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Reader Q&A
Find
answers to our readers'
questions or send us
your question for an
upcoming issue.
Q. |
I have heard that you always need to have a U.S. address
on your food label but I cant find the regulation that
requires this. Can you clear this up for me?
− K.C., California, Food Manufacturer |
A. |
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. |
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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:
www.foodlabels.com/subscribe
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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
www.foodlabels.com.
© 2016. Food Consulting Company, Del Mar, CA. All rights reserved.
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