FDA Reminds Food Facilities to Re-Register by Dec. 31 or Face Import Refusal
The Food and Drug Administration reminded food facilities that the period for biennial registration renewal begins on Oct. 1 and runs through Dec. 31. Under the Food Safety Modernization Act, all domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. are required to register or re-register every two years on even-numbered years. Food facilities that fail to register by Dec. 31 will be subject to import refusal. Facilities may register (here).
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In its reminder, FDA included several guidance documents to assist food facilities with registration:
- Guidance for Industry: What You Need to Know About the Registration of Food Facilities -- Small Entity Compliance Guide (here)
- Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition) (here)
- Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registration (here)
As part of the facility registration process, foreign facilities must also designate a U.S. Agent for their facility and must include that agent’s email address. Pursuant to FSMA, the U.S. Agent will be liable for reinspection fees assessed on foreign facilities. FDA has said that it will not begin invoicing for reinspections until it finalizes its guidance on small business fee reductions.