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:
FDA Registrations & Acidified Filings
Registration of Food Facilities
To implement specific provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), the FDA established regulations requiring that food facilities register with the agency. Food Facility Registration (FFR) provides the facility registration # and PIN. This is completed within the FDA Industry Systems. During the FFR process, or during an update to a facility’s FFR submission, you can identify your facility as an Acidified Food Processor under Section 9a.
Registration of Food Facilities
Food Facility Registration User Guide: Step-by-Step Instructions for Registration
Acidified Facility Registration
Under FDA regulations (21 CFR 108.25(c)(1)), any commercial processor starting to make, process, or pack acidified foods must register their facility. This registration requires submitting the company's name, main business office, specific facility locations, the manufacturing methods used, and a list of the foods processed at each site.
Acidified Establishment Registration provides the Food Canning Establishment (FCE) number, this number remains with physical plant location. The electronic AF/LACF registration system in FURLS becomes available to you if your registration in the FFR system identifies your facility as an Acidified Food Processor.
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
Food Process Filing for Acidified Method
Under FDA regulations (21 CFR 108.25(c)(2)), any commercial processor must register the acidified food on a scheduled process for 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.
FDA Form 2541e (Food Process Filing for Acidified Method)
Instructions for Electronic Submission of Form FDA 2541e (Food Process Filing for Acidified Method)
FDA Food Safety Modernization Act
Signed into law in early 2011, the Food Safety Modernization Act (FSMA) is the biggest update to US food safety laws in over 70 years. Managed by the FDA, FSMA aims to protect public health by stopping food safety problems before they happen, rather than just reacting to them.
Accredited Third-Party Certification
Qualified Facility Attestation - Guidance for Industry
Preventative Controls for Human Food
Preventive Controls Rules FAQs
Q&A Regarding Mandatory Food Recalls - Guidance for Industry
FDA Labeling
The FDA Labeling Guidance has valuable information. The labels in this summary are the older style Nutrition Facts Panels, but the information is still viable.
FDA 2016 Nutrition Facts Label Website
Nutrition Facts Panel Industry Guidance
Other Federal Resources
U.S. Food and Drug Administration
Guidance on rules and regulations from the FDA.
U.S. Department of Agriculture
Information on laws, regulations, marketing, trade, and more.
U.S. Environmental Protection Agency
Small farm/small business information.
U.S. Small Business Administration
Provides planners, services, tools, and local resources for small businesses.
Minority Business Development Agency
Bureau of Industry and Security - Export Administration
Economic Development Administration
National Technical Information Service
Internal Revenue Service
Tax information for businesses.
Social Security Administration
Business services are available online.
U.S. Patent and Trademark Office
Information on filing for patents and trademarks.
U.S. Copyright Office
Information on copyright law, licensing, and more.
U.S. Postal Service
Business services are available from the postal service.
U.S. Trade and Development Agency
Information on trade in developing countries.