6. Registration Processes
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6. Registration Processes
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Whisky
USA
This section provides information on any product notification or registration and manufacturing site registration processes.
6.1 Product Notification
General Food
Not required.
Category
Alcoholic drinks
Please refer to Section 4 of this guidebook on labeling requirements for details of the label approval process.
Product
Whisky
Same as "Category" (alcoholic drinks) above.
6.2 Product Registration
General Food
Not required.
Category
Alcoholic drinks
Please refer to Section 4 of this guidebook on labeling requirements for details of the label approval process.
Product
Whisky
Same as "Category" (alcoholic drinks) above.
6.3 Other Notes or Requirements
Product Notification
None.
Product Registration
None.
6.4 Manufacturing Site Registration
General Food
Under the Bioterrorism Act of 2006, all food and beverage domestic and foreign facilities that manufacture, pack, or hold food or beverages meant for consumption in the United States are required to register with the FDA. Registration is done via a web-based application found in the linked reference [1]. There is no fee for registration.
Category
Alcoholic drinks
As mentioned under "General Food" above, the domestic or foreign facility where alcohol sold in the US is produced must be registered with the FDA.
Product
Whisky
Same as "Category" (alcoholic drinks) above.
6.4.1 Standard/Rules for Manufacturing Site
General Food
Compliance with the Food Safety Modernization Act good manufacturing practices and other associated requirements such as the construction and maintenance of a food safety plan is required [2] (see GMP and food safety requirements).
Category
Alcoholic drinks
Same as "General Food" above.
Product
Whisky
Same as "Category" (alcoholic drinks) above.
6.4.2 Other Notes or Requirements for Manufacturing Site Registration
General Food
None.
Category
Alcoholic drinks
None.
Product
Whisky
None.
6.5 References
1. FDA webpage: “Registration of Food Facilities and Other Submissions
https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions
2. 21 CFR PART 117—CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
https://www.ecfr.gov/current/title-21/part-117
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