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Hello. This is Jeff White with the Food Safety and Inspection
Service. And, today we’ll talk about generic label approval which
involves a final label that can be used on a product without
having to get specific authorization from FSIS. With me today is
Mark Reo to explain more about generic labels.
Mark, can you give us some information concerning generic label
Sure. I’d like to begin by mentioning that FSIS streamlined the
label approval process in 1996. As a result, the generic label
approval process now allows establishments to use certain labels
without having to get specific approval from the agency. This
labeling is not required to be submitted to FSIS for approval. It
is considered to be approved under the labeling regulations, and
therefore, may be applied to a product in accordance with the
agency’s prior label approval system.
What type of labels are eligible to be generically approved?
There are actually several types of labels that are eligible. For
example, labeling for single-ingredient products, such as beef
steaks, lamb chops, chicken legs and turkey breasts, that don’t
bear any special claims, guarantees or foreign language qualifies
for a generic label approval.
What is a special claim that would keep a label from being
generically approved, and can you give some examples?
Sure. A special claim would be a statement, text or ad copy that
is added to the label that makes a statement about the product.
For example, some special claims are quality claims such as “all
natural.” There are also nutrient claims and health claims, and
negative claims. An example of a negative claim would be “raised
without antibiotics.” There are geographical origin claims, such
as “Long Island duck” and other special claims using terms like
Are there any other labels that are generically approved?
Yes, there are several more. For example, labels for containers of
products sold under contract specifications to federal government
agencies and that are not offered for sale to the general public
are considered to be generically approved. The contract
specifications would have to include specific labeling
requirements. These specifications would need to be made available
to the FSIS inspector-in- charge. An example of this would be
products produced for military contracts.
Another category of generically approvable labeling would be that
for products not intended for human food, provided the label
complies with the regulations.
That’s interesting. There seem to be several categories of
products on which a generically approved label can be used. Have
you listed them all?
No, there are actually several others. Meat inspection legends and
poultry inspection legends that comply with the labeling
regulations in Parts 312.2 and 381.96 are generically approved for
the establishments where they are applied to products that the
And there is labeling for consumer test products that are not
intended for sale.
Another generic label category is labeling for products that are
subject to a standard of identity. The standard may be in the
regulation, or the product may be defined in the food standards
labeling policy book. Some examples are pork sausage, beef stew
and turkey ham from the regulation or burrito and chicken wraps in
the policy book.
That’s quite a list of categories where a generically approvable
label would apply. What if a company has already submitted a label
to FSIS for approval and wants to make a minor change, would that
also be considered a generically approvable label?
Yes, labeling that was previously approved by FSIS as a sketch
labeling would be generically approved, provided the final label
was approved without any modifications. There’s a list of
modifications that can be made to a previously approved label
without a company having to resubmit the label for a new sketch
approval. Changes such as the deletion of the word “new,” or the
addition, deletion or change of recipe suggestions for the
product, are a couple of examples of changes that don’t require
resubmission of a label.
Thank you Mark for this brief overview on the generic label
approval process. It seems like there’s a lot of information to
know about this topic.
Yes there is. We get a lot of questions about generic labeling and
FSIS has several sources available for those who have questions.
For example, many commonly asked questions and answers are posted
on the FSIS Web site which I would encourage listeners to visit. The web site address is www.fsis.usda.gov.
If you type labeling in the search field you’ll find not only the
commonly asked questions and answers but information on submitting
applications, regulatory requirements, forms to submit for label
sketches and more.
FSIS also has a web-based feature,
askFSIS, that’s available 24 hours a day to help answer
technical and policy questions. Listeners can also call FSIS
at 202-205-0279 if they have labeling questions.
Thank you for listening in today and remember to visit the
FSIS web site www.fsis.usda.gov for more information on
generic labeling and other FSIS information.
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