1. (1) Except as set forth in (2), the label for a single ingredient product produced in an establishment under state inspection may be used on that product without prior review from the department.
2. (2) The label for either a single ingredient product bearing special statements and claims as defined in (3) or a multiple ingredient product produced in an establishment under state inspection may not be used on that product unless the establishment has submitted the label for review and the label has been accepted by the department.

3. (3) Special statements and claims are statements, claims, logos, trademarks, and other symbols on labels. Special statements and claims include, but are not limited to, the following:

   1. (a) Those not defined in the U.S. Department of Agriculture Food Safety and Inspection Service’s regulations or Food Standards and Labeling Policy Book. The Code of Federal Regulations is available for review online at www.ecfr.gov, and the Food Standards and Labeling Policy Book is available for review online at www.fsis.usda.gov/sites/default/files/import/Labeling-Policy-Book.pdf. A copy of both documents may be obtained from the department at 301 North Roberts Street, P.O. Box 202001, Helena, Montana 59620-2001;
   2. (b) “Natural” claims, regardless of whether they are defined in the Food Standards and Labeling Policy Book; and
   3. (c) Health claims (including graphic representations of hearts), ingredient and processing method claims (e.g., breed, high-pressure processing), structure-function claims, claims regarding the raising of animals (e.g., “no antibiotics administered,” “grass fed”), organic claims, and instructional or disclaimer statements concerning pathogens (e.g., “for cooking only,” “not tested for E. coli O157:57”).
4. (4) Requests for label review must be submitted on a department-approved label application form containing all required information.
5. (5) Establishments must maintain a copy of all labels used on products that bear the state mark of inspection.

6. (6) The department may grant temporary approval for the use of a label that does not meet all regulatory requirements provided the following conditions are met:

   1. (a) The proposed label would not misrepresent the product.
   2. (b) The use of the label would not present any potential health, safety, or dietary problems to the consumer.
   3. (c) Denial of temporary approval would create undue economic hardship.
   4. (d) Temporary approval would not result in an unfair competitive advantage.
7. (7) Temporary approval under (6) shall not exceed 180 calendar days, provided, however, that the department may extend the temporary approval period when the applicant demonstrates that new circumstances have developed since the original temporary approval was granted and that all the requirements of (6) are met.
8. (8) The department's acceptance of a label is valid for three years from the date the acceptance was issued unless the department provides a shorter time period in its acceptance. Establishments must resubmit labels for renewal after the acceptance period has expired.
9. (9) During the acceptance period, the establishment producing the label must ensure that the label is updated to meet all regulatory requirements following changes to the product formulation, processing procedures, regulation, or other events that may render the label noncompliant with applicable regulations.

Authorizing statute(s): 81-2-102, 81-9-220, MCA

Implementing statute(s): 81-9-220, 81-9-226, 81-9-228, 81-9-234, MCA

History: NEW, 2020 MAR p. 1841, Eff. 10/10/20; AMD, 2025 MAR, Notice No. 2025-302, Eff. 9/27/25.