Avoiding Common Errors On Label Applications – Providing Translations of Foreign Text
One of the most common problems we encounter when reviewing applications for label approval (COLAs) are labels that contain foreign text without a translation provided on the application. On many labels for imported products, the mandatory label information appears in English, as required by TTB regulations. However, often other label text, such as an explanation of the production process, the history of the manufacturer, or a description of how the product tastes, is not in English.
Foreign text on a label is subject to all the same rules that apply to English text. The most efficient way for TTB to ensure foreign text is not misleading or prohibited, and that it doesn’t conflict with mandatory label information, is for the applicant to provide a translation.
Department of Health and Human Services: Food and Drug Administration
 TTB-regulated industries may find this notice of interest.
SOURCE: Federal Register / Vol. 88, No. 33 / Friday, February 17, 2023
AGENCY: Food and Drug Administration, HHS
ACTION: Petition for rulemaking
SUMMARY: The Food and Drug Administration (FDA) is announcing it has filed a petition, submitted by Center for Science in the Public Interest, et al., proposing that FDA repeal the color additive regulations providing for the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs.
DATES: The color additive petition was filed on November 15, 2022. Either electronic or written comments must be submitted by April 18, 2023.
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