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NC State Extension

FDA Quick Links & Resources

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

REGISTRATION OF FOOD FACILITIES
To carry out certain provisions of the Bioterrorism Act, FDA established regulations requiring that food facilities register with FDA.

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

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

ACIDIFIED FACILITY REGISTRATION
A commercial processor, when first engaging in the manufacture, processing, or packing of acidified foods (AF) shall register with FDA. This is completed by filling our Form FDA 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 physical plant location)

Form FDA 2541
Instructions for Electronic Submission Form FDA 2541

FOOD PROCESS FILING FOR ACIDIFIED FOODS
A commercial processor engaged in the processing of an acidified food shall provide FDA with information, using Form FDA 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 that 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

FDA FSMA
The Food Safety Modernization Act (FSMA) is the most sweeping reform of the food safety laws in over 70 years. The FSMA was signed into law by President Obama on January 4, 2011. FSMA aims to protect public health by focusing on prevention of, 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 new 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 is already appearing 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 Course Summary has very useful information. The labels shown in this summary are the older style Nutrition Facts Panels but the information is still viable.