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Food Safety and Inspection Service (FSIS) Statement
of Interim Labeling Guidance
The Labeling of Factual Statements on Nutrients in Meat and Poultry Products |
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[This is an interim policy statement and may be withdrawn or modified if information is received
by FSIS that shows that significant consumer confusion exists in this subject area.]
This policy provides guidance on how factual statements can be declared for nutrients in a serving
of meat or poultry product when the nutrients come from a food that is produced or fortified under
the jurisdiction of the Food and Drug Administration (FDA) for the purpose of improving the overall
nutritional profile of the finished food. Unapproved nutrient content claims (or implied claims)
about specific nutrients, as well as the direct fortification of meat or poultry products, are
not permitted.
FSIS has received an increasing number of requests to approve labels that make factual statements
about the amount of various vitamins, minerals and other nutrients present in meat or poultry
products. In accordance with FDA’s fortification policy in
Title 21 of the Code
of Federal Regulations (CFR), Section 104.20, FSIS does not permit the addition of nutrient
additives (e.g., vitamins and minerals) to meat and poultry. FSIS continues to believe that the
indiscriminate addition of nutrients to meat and poultry is not in the best interest of consumers
since, to-date, there is no demonstrated need or consensus in the scientific community that the
fortification of meat and poultry is necessary.
FSIS does not object to the addition of foods that are fortified under FDA’s jurisdiction to meat
and poultry products in a Federal establishment (e.g., an enriched spaghetti noodle that is added
to a sauce with meatballs in order to make “spaghetti with meatballs” which is under FSIS jurisdiction).
If a company intends to make a nutrient content claim or factual statement on the level of the
particular nutrient contributed by the FDA fortified food, FSIS expects that the statement will
identify the food that is the source of the nutrient (e.g., “enriched pasta is a good source of
Calcium, Vitamin D, and Magnesium”). Similarly, FSIS does not object to a food produced under
FDA’s jurisdiction that contains a substance not specified in FDA’s fortification policy (e.g.,
Lycopene, Omega-3 Fatty Acids, and Lutein) being added to a meat or poultry product as long as
the safety of the use of the substance in meat and poultry products has been established. If a
company intends to make a factual statement on the presence or level of such a substance on the
meat or poultry product label, the statement will also need to identify the food that is source
of the nutrient (e.g., “250 mg Omega-3 Fatty Acids per serving from the Flax seed in crust” or
“250 mg of Omega-3 Fatty Acids per serving from fish oil in breading”). This information on labeling
is to inform consumers about what food component has been added to the meat or poultry product
that is the source of the nutrient. Statements of this type would be misleading if the source
of the nutrient is not disclosed because it would create the impression that the meat or poultry
is the source of the substance, which would not be correct. In some situations, however, the feeding
practices employed by the producer would be the reason the substance is present (e.g., feeding
flax seed to cattle and swine can introduce Omega-3 fatty acids to the meat tissue). In this situation,
because there is nothing added to the meat after the animal is slaughtered, the source of the
source of the substance would not need to be declared, although presence of the substance should
be (e.g. “X mg of Omega-3 fatty acids per serving”).
The addition of an FDA regulated food (e.g., vegetable and fish oils such as menhaden oil, tuna
oil, canola oil, or olive oil) to meat or poultry products cannot be done in a way that conflicts
with a FSIS standard of identity or any other Federal regulation. For example, if a processor
wished to add an FDA regulated seasoning that contains caffeine to meat or poultry, it would not
be permitted to do so because under
21 CFR 182.1180,
caffeine is only GRAS for addition to cola-type beverages. In regard to FSIS food standards of
identity, standardized foods such as “Italian Sausage” (9
CFR 319.145) and “Ham, With Natural Juices” (9
CFR 319.104) do not provide for the addition of ingredients such as fish and vegetable oils.
If a Federal establishment wishes to formulate a meat or poultry product with a food that is not
provided for in the standard of identity, the common or usual name of the meat or poultry product
will need to be modified to describe the new food so that consumers can distinguish it from the
traditional product (e.g., “Ham with Natural Juices with Olive Oil” or “Italian Sausage with Menhaden
Oil”).
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Last Modified: September 10, 2009
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