[This is an interim policy statement and may be withdrawn or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 claims area.]
This policy documents that factual statements of the amount of
omega-3 fatty acids per serving expressed either as the number
of milligrams per serving or the number of grams per serving on
labeling are acceptable. Similar factual statements regarding
the amount of omega-6 fatty acids as well as the types of both
omega-3 and omega-6 fatty acids (e.g., conjugated linoleic acid
(CLA)) in a serving of a meat or poultry product will also be
permitted. However, claims or implied claims regarding these
components will not be permitted.
FSIS is aware that the increasing interest in making nutrient
content claims regarding omega-3 fatty acid content or factual
statements of the number of milligrams of omega-3 fatty acids
has been increasing in the past several years. However, the
nutrition labeling regulations in Title 9, Code of Federal
Regulations (9 CFR), Subpart B, Section 317.300 – 317.400, for
meat products, and Subpart Y, Sections 381.400 – 381.500, for
poultry products, clearly state that claims that, expressly or
by implication, characterize the amount of a nutrient in the
product, may not be made on the labeling of a meat or poultry
product unless the claim is made in accordance with the
nutrition labeling regulations. Therefore, without regulations
defining such claims, the labeling of meat and poultry products
with express omega-3 fatty acid claims, including, but not
limited to, “Good Source of Omega-3 Fatty Acids,” and “Excellent
Source of Omega-3 Fatty Acids,” cannot be approved.
Similarly, labeling for meat and poultry products that bear
claims that imply that the level of omega-3 fatty acids in a
product is high or place significance on a specific level of
Omega-3 Fatty Acids, including, but not limited to, “Contains X
grams Omega-3 Fatty Acids,” “More than X grams of Omega-3 Fatty
Acids,” and “Fortified with X grams of Omega-3 Fatty Acids,”
cannot be approved. (“Contains” and “provides” are synonyms for
“good source” claims). Similarly, trademarked uses of such
phrases on labeling cannot be approved with the exception of the
use of a company name in the signature line of a product label,
provided that the signature line is normally placed and is not
given undue prominence, which prominence would cause the use of
the company name to be a false or misleading claim.
Historically, FSIS has permitted a factual statement on the
number of grams of omega-3 fatty acids per serving on the
labeling of meat and poultry products, provided that nutrition
information was included on the labeling, data on the omega-3
fatty acid content was provided, and the product was not
fortified to provide the omega-3 fatty acid content. The factual
statements that have been approved have stated the number of
grams of omega-3 fatty acids per serving rounded to the one
tenth gram, e.g., “0.4 grams Omega-3 Fatty Acids per serving.”
The decision to only provide for factual statements declaring
the grams of omega-3 fatty acids was based on discussions with
other federal agencies and the Canadian Nutrition Labeling
regulations which provides for the declaration of the number of
grams of omega-3 fatty acids within the Canadian nutrition facts
panel.
There is a growing interest in making factual statements based
on the number of milligrams per serving, as opposed to the
number of grams, which is the unit required for other fat
declarations. This interest is possibly due to the desire to
include such factual information on the labeling of products
with smaller reference amounts where the level of omega-3 fatty
acids per serving fall below 0.1grams per serving. After further
evaluation of labeling requests about factual statements of the
level of omega-3 fatty acids per serving based on milligrams per
serving instead of grams per serving, and consulting with the
Food and Drug Administration (FDA), Office of Nutritional
Products, Labeling, and Dietary Supplements, FSIS has concluded
that such declarations are not false or misleading . FDA also
has no objection to factual statements about the level of
omega-3 fatty acids declared in either grams or milligrams per
serving. Therefore, FSIS believes that factual statements of the
amount of omega-3 fatty acids per serving expressed either as
the number of milligrams per serving or the number of grams per
serving on labeling are acceptable. In addition, companies
wishing to state the number of grams of omega-3 fatty acids per
serving may declare the grams to the nearest one thousandth
gram, e.g., “0.125 grams omega-3 fatty acids per serving.”
Similar factual statements regarding the amount of omega-6 fatty
acids as well as the types of both omega-3 and omega-6 fatty
acids (e.g., conjugated linoleic acid (CLA)) in a serving of a
meat or poultry product will also be permitted.
Lastly, consistent with the Agency’s regulations about generic
label approval, all labels bearing special statements about the
level of omega-3 fatty acids should be sent to the Agency’s
Labeling and Consumer Protection Staff for evaluation and
approval before use.
For additional information about FSIS labeling policies and
programs, review the FSIS Web Site at:
https://webarchive.library.unt.edu/eot2008/20090117150215/http://www.fsis.usda.gov/About_FSIS/labeling_&_ consumer
_protection/index.asp
or contact the Labeling and Consumer Protection Staff at
202-205-0279 or 202-205-0623.
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