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When people think about US FDA labeling requirements,
most people think of a nutrition facts chart.
Although nutrition facts charts are
an important part of FDA's
food labeling requirements,
FDA regulates many other aspects of food labeling.
The scope is very broad.
Even the name of a product can be regulated by FDA.
Did you know that in order
to call margarine margarine
it must conform to a complicated
set of regulations that specify which ingredients it may contain?
FDA also regulates how ingredients must be declared.
Ingredients must be declared
by their common names and
include any sub-ingredients found in the ingredient.
FDA specifies the order
in which they must be presented,
and the size of the type as well.
Food ingredients themselves can be
regulated in a number of different ways.
Some are generally recognized as safe,
while others can have strict
requirements regarding their use.
Color additives are among the
most strictly regulated and must be approved by FDA.
Think twice before adding that squid ink to your Mediterranean pasta.
Squid ink is not approved as a color additive
and can cause your product to be detained.
The nutrition facts chart may
look fairly simple,
but a tangled web of regulations govern it.
The size of your package
and the amount of nutrients govern
what kind you may use.
Even the size of a line
and whether a nutrient is declared
in bold-face type are written into regulation.
A big part of FDA's enforcement activities
are related to the claims on products.
Any statements related to the
amount or benefit of nutrients
in the product must conform to regulations.
Any claim related to the
effect of the product on the
structure or function of the body must conform.
Companies often make claims such as
reduces cholesterol, low sodium, fat free,
supports immunity, lowers blood pressure.
FDA considers certain claims
appropriate for dietary supplements
but not conventional foods.
Companies must understand the requirements
before making any claims on products.
Further, companies sometimes make
aggressive health claims on
websites or promotional materials.
FDA considers these claims a
part of your product's labeling,
just as if they were printed directly on the product.
Products have been detained for
website claims, even when
those claims were not on the immediate packaging.
As you can see,
FDA labeling requirements can be complicated.
Although FDA issues all labeling requirements in writing,
due to the diversity of products regulated by FDA,
there's no one
single place to find all
FDA labeling regulations.
Labeling regulations are found
amidst thousands of pages
of the code of federal regulations,
in countless guidance documents,
SCOGS reviews,
in GRAS notifications,
warning letters
issued to companies in violation,
and buried in hundreds of
pages of notices in the Federal Register.
If you would like more information
about labeling requirements for
your specific product
or if you simply want someone to review
your existing label just to
make sure it is compliant,
please feel free to contact Registrar Corp.
Simply phone our U.S. office
at 757-224-0177, or
go to our website at www.registrarcorp.com