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When starting a food business, you must know the regulations for your food product(s). We have compiled a list of FDA website links and resources you may need for your business:

To implement specific provisions of the Bioterrorism Act, the FDA established regulations requiring that food facilities register with the agency.

Food Facility Registration (FFR) provides your facility registration # and PIN.

Registration of Food Facility Website
Food Facility Registration User Guide: Step-by-Step Instructions

A commercial processor shall register with the FDA when first engaging in manufacturing, processing, or packing acidified foods (AF). This is completed by filling out FDA Form 2541.

Section 1: Type of Submission
Section 2: Food Processing Plant Location
Section 3: Preferred Mailing Address
Section 4: Foods Processed at Location
Section 5: Establishment Contact Person

At the end of filling out an electronic form, you will receive:
FCE # is ________ (this number remains with the physical plant location)

Form FDA 2541
Instructions for Electronic Submission Form FDA 2541

A commercial processor engaged in processing an acidified food shall provide the FDA with information, using FDA Form 2541e, on the scheduled processes for each acidified food in each container size.

For each process filing, there will be a unique SID number. The SID consists of (1) the year, month, and day of the month a process filing form is created and (2) a unique sequence number to identify each form when multiple forms are created on the same date.

Form FDA 2541e
Instructions for Electronic Submission Form FDA 2541e

The Food Safety Modernization Act (FSMA), the most sweeping reform of food safety laws in over 70 years, was signed into law on January 4, 2011. FSMA aims to protect public health by focusing on preventing, rather than reacting to, food safety issues. FSMA is administered through the United States Food and Drug Administration (FDA).

Accredited Third-Party Certification
Qualified Facility Attestation – Guidance for Industry
Preventative Controls for Human Food
Preventative Controls Rules FAQs
Q&A Regarding Mandatory Food Recalls – Guidance for Industry

FDA Nutrition Facts Label
On May 20, 2016, the FDA announced the new Nutrition Facts label for packaged foods to reflect scientific information, including the link between diet and chronic diseases such as obesity and heart disease. The new label will make it easier for consumers to make better-informed food choices. FDA published the final rules in the Federal Register on May 27, 2016. The new label already appears on packages even before it is required to be used. Manufacturers with $10 million or more in annual sales must switch to the new label by January 1, 2020; manufacturers with less than $10 million in annual food sales have until January 1, 2021, to comply.

FDA 2016 Nutrition Facts Label Website
Nutrition Facts Panel Industry Guidance

This FDA Labeling guidance has valuable information. The labels in this summary are the older style Nutrition Facts Panels, but the information is still viable.

Written By

Allison Sain, N.C. Cooperative ExtensionAllison SainExtension Associate Call Allison Email Allison Food, Bioprocessing & Nutrition Sciences
NC State Extension, NC State University
Page Last Updated: 2 months ago
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