During the infancy of a new business, it is essential to understand the regulatory requirements and the financial implications of meeting them. The following steps are needed to legally sell your food product in a retail market, along with their associated costs (in BOLD). Keep in mind that these steps do not include costs associated with your facility meeting current Good Manufacturing Practices (cGMP’s) and the adherence to those practices during the production of your product.

1. If you are considering making food products in your home, begin with: Starting a Home-Based Food Business.

2. Request product testing by submitting a request form on the NC State Food Business website. You will be asked to submit a sample for testing to determine the food's compliance with FDA regulations. A testing results letter will be emailed to you. This testing costs $150. If your product is considered acidified and you are not considering co-packing, please continue to Step 3. If your food is defined as acid or exempt, skip to Step 10.

3. If your product is acidified, you will be required by federal law to pass a better process control school, “Acidified Foods Manufacturing School.” The school is intended for and directed at operating supervisors of conventionally canned processing and packaging systems in food processing establishments. It will qualify individuals to be commercial operators of plants producing conventionally canned foods to meet the requirements of the umbrella Good Manufacturing Practice (GMP), the specific GMP for acidified foods (21 CFR Part 114). By definition, an "operating supervisor" is a person present in the plant when the product is processed and packaged. The operating supervisor is responsible for the use of appropriate pH, time, and temperature processes, as well as closure integrity inspections, to render the product safe, and for proper record-keeping and control programs that detect deviations from safe operating procedures. The operating supervisor may be the same person. However, each operation during each hour of plant operation must be under the supervision of a person who has been certified as having satisfactorily completed the approved course of instruction. The school is 100% online and on-demand. The cost is $400, which includes the shipping of the course manual in the continental U.S. The certification does not expire or require continuing education.

4. If you are producing a product using a water bath, you will be asked to process it using a hot fill method that NC State will provide after product and process submission (Step 2).

5. You will need to register your facility as a Canned Food Processing facility with the FDA Form 2541. You should use the Electronic Submission Form FDA 2541. You can find instructions for doing this by searching the internet.

6. If your testing letter indicates you must monitor and record temperature to produce a safe product, you may need to purchase a non-glass thermometer that can be calibrated or a digital thermometer.

7. If your testing letter indicates you must monitor and record pH to produce a safe product, you must purchase a pH meter that can be calibrated. Cost varies widely, but we recommend you do some research and find a reputable brand and appropriate pH buffer solutions for calibration.

8. Once processing you will be required to perform a closure evaluation and keep a record of it. One of the assessments for proper closure is the vacuum level, which can be checked with a gauge. The vacuum gauge costs approximately $110 (optional) and can be purchased from JLW Instruments, Dixie Canner Co., and other retailers.

9. You will need to create an account and register your facility to comply with the Bioterrorism Act.

10. If you choose, you may also have a nutritional facts panel made for your product. This is optional for most small processors; however, many grocery stores require it for sale in their establishments. The cost is $150/product. Use the Online Request Form found on our website.