Wholesale/Manufactured Food Program

The Manufactured Foods Program (Wholesale Establishments) is responsible for permitting and inspecting food establishments engaged in the manufacturing, processing, packing, holding or preparing of food for sale or distribution to other businesses.  This food includes food products consisting of or containing hemp extract, which includes CBD or other cannabinoids.

Businesses that typically fall into the wholesale category include: wholesale bakeries, food storage warehouses, bottling plants, canning plants, seafood processors and other food processors. 

Wholesale/Manufactured Food Establishment Permit 

Current Good Manufacturing Practices

All manufactured food establishments are subject to the requirements in Title 21, Part 117 [ 15.7 MB ] , Code of Federal Regulations (CFR), in addition to other applicable regulations depending on the nature of the product.

Acid, Acidified and Low-Acid Canned Foods

Acid foods naturally have a pH below 4.6. Acid foods may include tomatoes, citrus fruits, salsas or sauces made of ingredients that naturally have a pH of 4.6 or below, and other similar products.

Acidified foods are low-acid foods to which acids or acid foods are added to lower the pH to 4.6 or below. Examples include sauces, salsas, juices and other products. Acidified foods are subject to the requirements in 21 CFR 108.25[ ] and 21 CFR 114[ ].

Low-acid canned foods are foods with a pH above 4.6 that are packed in hermetically sealed containers. Low-acid canned foods include shelf-stable canned soups, canned meats and canned vegetables. Low-acid canned foods are not typically produced on a small scale because of the expensive retort (sterilization) equipment and expert heat distribution studies required to manufacture the products. Low-acid canned foods are subject to the requirements in 21 CFR 108.35[ ] and 21 CFR 113[ ].

Acid, acidified and low-acid canned foods are also known as shelf-stable foods. All shelf-stable foods must be evaluated by a food processing authority for proper classification and identification of any critical factors that must be monitored, such as pH and cook time/temperature.

• Acidified and Low-Acid Canned Food Guidance (FDA)
• AFDO List of Food Processing Authorities
• Acidified Foods Training (North Carolina State University)

Bottled Water

Bottlers of drinking water are subject to the requirements in 21 CFR 129[ ] and 21 CFR 165.110[ ].

• Bottled Water Guidance (FDA)
• Bottled Water Testing Requirements [ 219.4 kB ]

Food Safety Modernization Act Preventive Controls for Human Food

The FDA Food Safety Modernization Act (FSMA) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule is now final, and compliance dates for some businesses began in September 2016. 

• Food Safety Plan Builder
• FSMA Final Rule for Preventive Controls for Human Food (FDA)
• Juice HACCP and FSMA
• Low-Acid Canned Foods and FSMA
• Preventive Controls for Human Food Guidance [ 281.5 kB ]
  • Explanation of Preventive Controls for Human Food Guidance [ 90.9 MB ]
• Seafood HACCP and FSMA

Juice Hazard Analysis and Critical Control Points (HACCP)

Juice means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree (21 CFR 120.3). Juice processors who sell or distribute juice products to other businesses are subject to the requirements in 21 CFR 120[ ].

• Juice HACCP Alliance Training Curriculum[ ]
• Juice HACCP Guidance (FDA)
• Juice HACCP Guidance (FDACS) [ 152.3 kB ]

Seafood HACCP

Processors of fish and fishery products are subject to the requirements in 21 CFR 123[ ]. Processing is defined as: handling, storing, preparing, heading, eviscerating, shucking, freezing, changing into different market forms, manufacturing, preserving, packing, labeling, dockside unloading, or holding (21 CFR 123.3).

• Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition – June 2021
• HACCP Sanitation Monitoring Correction [ 264 kB ]
• Seafood HACCP (Florida Sea Grant)
• Seafood HACCP Guidance (FDA)
• Seafood HACCP Guidance (FDACS) [ 306.5 kB ]
• Seafood Network Information Center (Oregon State University)

Presentations