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Required For Requesting a Temporary Approval |
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Temporary approvals can be granted for a period of up to 180
days for a deficient label. The Labeling Compliance Team can
grant a temporary approval according to certain provisions
indicated in 9 CFR 317.4(f) or 381.132(f). The time granted
for the temporary approval of a deficient label is in order
for the company to take corrective action, e.g., printing
pressure sensitive stickers or printing new labeling.
Applications submitted for temporary approval are evaluated
on a case-by-case basis. Information provided on each copy
of the application should provide sufficient details in
order for the Labeling Compliance Team to make an informed
judgment about the extenuating circumstances. Approval is
granted when the provisions in 9 CFR 317.4(f) or 381.132(f)
are met. It is the responsibility of the company to provide
details regarding the conditions for the temporary approval,
the deficient label and the extenuating circumstances
surrounding the temporary approval request. Applications
without sufficient information are incomplete and will be
returned to the company unapproved.
- When requesting a temporary approval for the first time
The four conditions of 9 CFR 317.4(f)(1) or 381.132(f)(1)
have to be met prior to receiving a temporary approval.
Provide details of all conditions on the application.
- When requesting a temporary approval for the second time
Explain in detail on the application what new circumstances
have occurred since the last temporary approval was granted.
Also, specify the details of the four conditions in 9 CFR
317.4(f)(1) or 381.132(f)(1).
- 9 CFR 317.4 / 381.132
(f)(1)
Consistent with the requirements of this section,
temporary approval for the use of a final label or other
final labeling that may otherwise be deemed deficient in
some particular may be granted by the Food Labeling
Division. Temporary approvals may be granted for a period
not to exceed 180 calendar days, under the following
conditions:
(i) The proposed labeling would not misrepresent the product;
(ii) The use of the labeling would not present any potential health, safety, or dietary problems to the consumer;
(iii) Denial of the request would create undue economic hardship; and
(iv) An unfair competitive advantage would not result from the granting
of the temporary approval.
(2) Extensions of temporary approvals may also be granted by the Food
Labeling Division provided that the applicant demonstrates that new
circumstances, meeting the above criteria, have developed since the original
temporary approval was granted.
- An example of information provided with a request for a temporary label approval:
[The order of predominance for salt and dextrose
has changed. Wheat flour has been added to the filling,
but the product is wrapped in dough. The ingredients
statement already lists flour within the dough sublisting.
The values within the nutrition facts are within the 20%
range. The labeling would not 1) misrepresent the product
because the proposed changes are minor in nature, 2)
present a potential health, safety or dietary threat
since all ingredients are declared within the ingredients
statement, 3) present an unfair competitive advantage
because the changes are minor in nature. Denial of the
request would create an undue economic hardship because
there are 12,000 labels on-hand to use up; the company
has an order to ship in 12 days; and the label is covered
with a continuous vignette that would take several weeks
for the printer to finalize.]
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