FDA Quick Links & Resources
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When starting a food business, you must know the regulations pertinent to your food product(s). We have compiled a list of FDA website links and resources you may need for your business:
REGISTRATION OF FOOD FACILITIES
To carry out specific 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.
ACIDIFIED FACILITY REGISTRATION
When first engaging in the manufacture, processing, or packing of acidified foods (AF), a commercial processor shall register with the FDA. 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 physical plant location)
FOOD PROCESS FILING FOR ACIDIFIED FOODS
A commercial processor engaged in processing an acidified food shall provide 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 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
The Food Safety Modernization Act (FSMA), the most sweeping reform of the food safety laws in over 70 years, was signed into law on January 4, 2011. FSMA aims to protect public health by focusing on the 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 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.
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.