The Food Program at the North Carolina Department of Agriculture & Consumer Services (NCDA&CS) oversees many processed, packaged food products for sale within the state, and actively partners with the Food and Drug Administration (FDA) to enforce state-adopted federal regulations with an ultimate goal of producing safe foods and protecting public health.

Webinar Highlights

Food Program Goals

• #1: Prevent foodborne illnesses and protect public health
  • Ensures food products are safe, wholesome and properly labeled
  • Program helps prevent adulterated and misbranded foods in the marketplace

Food Regulation

• In 2011, Food Safety Modernization Act (FSMA) amended the existing Federal Food, Drug & Cosmetic Act (FD&C Act); it shifted the focus from responding to foodborne illnesses to preventing them.
• Human food facilities registered with the FDA must implement a written plan that identifies food safety hazards and outlines appropriate preventive controls.

  • Which facilities must register with FDA?

    • If the annual monetary value of sales of food products directly to businesses (wholesale) exceeds the annual monetary value of sales of food products to consumers (retail), then that food firm must register.
    • Looking for more information on Food Facility registration? Visit NC State Extension’s publication!
• In 2015 FDA published the final rule – “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food”
  also known as: 21CFR117. It includes the following subparts:
  • Subpart A          General Provisions
  • Subpart B         Current Good Manufacturing Practice
  • Subpart C         Hazard Analysis and Risk-Based Preventive Controls
  • Subpart D         Modified Requirements
  • Subpart E          Withdrawal of a Qualified Facility Exemption
  • Subpart F          Requirements Applying to Records That Must Be Established and Maintained
  • Subpart G         Supply-Chain Program

Food and Drug Protection Division Inspection Areas

1. Retail & wholesale food operations: Subpart B (GMP) of 21CFR117 applies to all retail and wholesale operations. Some or all subparts of 21CFR117 may apply to wholesale operations.
   1. Depending on the type of the product, additional regulations may apply.
   2. Establishing risk-based preventive controls enables a proactive & systematic approach to food safety.
   3. Ingredients should come from approved suppliers to ensure a safe and wholesome finished product.
   4. Commercial food facilities must have a separate hand-washing sink in addition to utility sinks preferably in the processing area.
   5. Low-risk & high-risk foods can be made and sold in-state or out-of-state, including online sales.
   6. No commercial grade appliances or equipment needed. However, equipment must be in a good working order and not pose any food safety risks.
2. Seafood and juice, wholesale operations: Must be HACCP trained for their product
   1. As an example, a wholesale seafood company must be trained in Seafood HACCP principles, not just a general HACCP training.
   2. For more information about Seafood HACCP training through NC State Extension, visit here.
3. Shelf stable products: Some products can require additional evaluation for food safety. This is typically with new or novel food items or items that are manufactured in such a way to no longer require refrigeration.
   1. Low-acid canned foods and acidified foods will have additional regulatory requirements.
4. Ice cream, butter and cheese: These products are inspected by the Food Program and require licensing through NC Department of Agriculture & Consumer Sciences.
   1. Licenses are renewed annually, every July.
5. Milk: Also known as Grade A Dairy, NCDA&CS’s Food program has an entire Grade A team that exclusively handles these products in North Carolina.
   1. Raw milk haulers are given a test and require licensing prior to hauling milk.
   2. The sale of raw milk for human consumption is prohibited in North Carolina.

Responsibilities for Making or Selling Food in North Carolina

Food Entrepreneurs

• Applies to any new food manufacturer, processor, re-packer or owner of a distribution center selling foods for retail or wholesale market.
  • Established operations should contact the Compliance Office prior to introducing new food products to the market to investigate if additional regulations or inspection is required.
• Contact the Food Compliance Office to discuss product(s), regulations, labeling, inspection process and inspector information.
• Read and understand regulations, complete required trainings (if applicable), confirm your operational set-up, prepare labels and schedule your first inspection.

Preparing for Your Inspection

• When you call the Food Compliance Office, be ready to share information about your product(s), ingredients, process, how you intend to sell or distribute your product & the processing facility address.
  • You may be asked to email a complete list of proposed products and their ingredients as well as the process flow.
• After the discussion, the Food Compliance Officer will send an email with the regulations, inspector information & any required additional steps.
• When your set-up is ready call the Food Inspector at least 2 weeks in advance and schedule your first inspection.
• After your first inspection, the Food Program will automatically enroll you into their routine inspection program and you will receive inspections in regular intervals, as long as your company is in business.
  • If you move to a new facility or production location, contact the Food Compliance Office to schedule an initial inspection at your new facility.

Farmers Market Managers, Shared Kitchen Managers or Retail Stores

• Any company that is looking to have a company retail at their space or retail food products for a company should confirm the inspection status of the vendors; either request a copy of the Observation Sheet & Notice of Inspection issued by an Inspector or contact the Food Compliance Office.
• North Carolina Department of Agriculture does not have state registration requirements for manufacturing or selling foods. This does not exclude other business requirements such as, gaining a tax ID, or holding a business license.

  • What about out-of-state companies?

    • Food manufacturers are subject to the regulations and policies of their own state. If permitted for interstate commerce and the company is in compliance with their state regulations, they can sell products in North Carolina.
• Those overseeing a shared-use kitchen facility, an incubator kitchen or any other type of commercial kitchen must contact the Food Compliance Office & request an inspection.
  • All manufacturers & re-packers renting such facilities must also be inspected individually for their food operation.

Food Program Contacts

Located in Raleigh at the Steve Troxler Agricultural Sciences Center

4400 Reedy Creek Road, Raleigh, NC

Webinar hosted on April 19, 2024

“This work was supported by the intramural research program of the U.S. Department of Agriculture, National Institute of Food and Agriculture, Food Safety Outreach Program 1030908. The findings and conclusions in this preliminary publication have not been formally disseminated by the US Department of Agriculture and should not be construed to represent any agency determination or policy.”