Allowable Label Revision: Alcohol Content
Once your label receives TTB approval, you are allowed to change certain items on that label without submitting a new Application for a Certification/Exemption of Label/Bottle Approval, or COLA. One of these changes includes changing the mandatory statement of alcohol content, as long as the change is consistent with the labeled class and type designation, and all other labeling requirements.
For example, you may change the alcohol content of a grape wine labeled with a varietal designation from 13 percent to 15 percent alcohol by volume. However, if the product was designed and labeled as a “table wine”, an alcohol content of 15 percent alcohol by volume would be inconsistent with the rules for use of that designation, so this change would not be permitted.
Similarly, a label bearing a “rum” designation may not be changed to state an alcohol content of less than 40 percent alcohol by volume. The revised alcohol content statement must be consistent with all other mandatory or optional labeling statements.
The complete list of allowable revisions is available in Section V of TTB Form 5100.31.
Food and Drug Administration: Agency Information Collection Activities
 TTB-regulated industries may find these notices of interest.
Proposed Collection; Comment Request; Premarket Tobacco Product Applications and Recordkeeping Requirements
SOURCE: https://www.govinfo.gov/content/pkg/FR-2024-07-16/pdf/2024-15570.pdf
AGENCY: Food and Drug Administration, HHS
ACTION: Notice
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on premarket tobacco product applications and recordkeeping requirements.
DATES: Either electronic or written comments on the collection of information must be submitted to the FDA by September 16, 2024.
Proposed Collection; Comment Request; Substantial Equivalence Reports for Tobacco Products
SOURCE: Federal Register / Vol. 89, No. 136 / Tuesday, July 16, 2024
AGENCY: Food and Drug Administration, HHS
ACTION: Notice
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on substantial equivalence reports for tobacco products.
DATES: Either electronic or written comments on the collection of information must be submitted to the FDA by September 16, 2024.
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