If your product is a pickled vegetable, a salsa, a pepper relish, or another shelf-stable food in a jar or bottle, a federal rule may decide how it has to be made. The FDA calls these products acidified foods, and they come with a written process, a filing with the FDA, and trained supervision at the plant. The rule puts that work on "a commercial processor" engaged in the manufacture, processing, or packing of acidified foods. When a co-packer makes your product, confirm in your contract that the plant is registered and whose process filing covers your product. Your job is to know whether the rule may apply and to ask the right questions before you book a run. This post walks through the rule as it is written today, with the section numbers, so you can check every point yourself.
Short answer: if your product is covered, the plant needs a scheduled process set by a qualified person, filed with the FDA for each product in each container size before it is packed. Ask your co-packer who sets that process, whose filing covers your product, and what records you will receive.
Is your product an acidified food?
The definitions are in 21 CFR 114.3. Three of them matter here.
- Acid foods "have a natural pH of 4.6 or below."
- Low-acid foods are foods "other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (a w ) greater than 0.85." The same definition adds: "Tomatoes and tomato products having a finished equilibrium pH less than 4.7 are not classed as low-acid foods." That line covers tomatoes and tomato products themselves. A salsa that also contains onions, peppers, or other low-acid ingredients may still be an acidified food, so have the finished product classified.
- Acidified foods are "low-acid foods to which acid(s) or acid food(s) are added." They have a water activity above 0.85 and "a finished equilibrium pH of 4.6 or below." The rule names beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical fruits, and fish as examples, and says these foods "may be called, or may purport to be, 'pickles' or 'pickled ______.'" Whether your own version starts as a low-acid food depends on its own pH and water activity.
In plain words: a low-acid ingredient that is made safe by adding vinegar, lemon juice, or another acid, and then sold on a shelf, is the core of this rule.
What the rule leaves out
The same definition excludes several products, and this is where founders can guess wrong. The rule does not cover:
- carbonated beverages, jams, jellies, and preserves;
- acid foods, "including such foods as standardized and nonstandardized food dressings and condiment sauces," that contain small amounts of low-acid food and have a finished pH that "does not significantly differ from that of the predominant acid or acid food";
- foods that are "stored, distributed, and retailed under refrigeration."
So a sauce is not automatically an acidified food. Neither is a salsa that is stored, distributed, and retailed under refrigeration. On a plain reading all three have to be true, so a salsa that travels warm and is only displayed in a cooler does not fit that exclusion.
Whether your recipe falls inside or outside the definition depends on its ingredients, its finished pH, its water activity, and how it is stored and distributed. Get that call from a process authority (the expert described in the next section) rather than guessing. And falling outside this rule does not mean no food safety rules apply, so ask about that too.
Exampletwo pepper products. A shelf-stable jar of sliced peppers in vinegar is peppers with acid added, which matches the definition's own examples. A vinegar-based condiment sauce with a small amount of pepper, whose pH sits close to the vinegar's own, may fall under the exclusion. Similar ingredients, possibly a different answer. This is why the classification comes first.
The scheduled process, and who sets it
Every acidified food needs a scheduled process. Section 114.3 defines it as "the process selected by a processor as adequate for use under the conditions of manufacture for a food in achieving and maintaining a food that will not permit the growth of microorganisms having public health significance." It includes "control of pH and other critical factors equivalent to the process established by a competent processing authority."
Section 114.83 says who sets it: "a qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods." The definition of a scheduled process measures it against one "established by a competent processing authority." This post uses "process authority" as shorthand for the qualified person in section 114.83.
Once the process exists, the plant has to follow it. Section 114.80 requires that the product reach "a finished equilibrium pH value of 4.6 or lower" within the time the scheduled process sets, that it be heat treated enough to destroy "the vegetative cells of microorganisms" the rule describes (permitted preservatives may be used in place of heat for microorganisms "of nonhealth significance"), and that the plant test pH frequently and record the results.
Low-acid foods packed in hermetically sealed containers without acidification fall under a different part. For example, 21 CFR 113.83 says scheduled processes for low-acid foods must be set by "qualified persons having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers ..."
What the plant files with the FDA
Section 21 CFR 108.25 sets out the paperwork. Its duties fall on "a commercial processor" engaged in "the manufacture, processing, or packing of acidified foods":
| Step | What the rule says | When |
|---|---|---|
| Register the plant | Form FDA 2541, "food canning establishment registration" | "not later than 10 days after first so engaging" |
| File the process | Form FDA 2541e, "for each acidified food in each container size" | "not later than 60 days after registration, and before packing any new product" |
| Supervise | Staff working on acidification, pH control, heat treatment, or other critical factors work under a person who completed a school approved by the FDA Commissioner | Ongoing |
| Keep records | Processing, deviations, pH, and the other records part 114 requires | For 3 years from the date of manufacture |
Three details in that section are easy to miss and matter to a brand:
- Filing is not approval. The rule says filing "does not constitute approval of the information by the Food and Drug Administration." Accepting the filing is not the FDA signing off on the process.
- A new container size is a new filing. Because the filing is per product and per container size, adding an 8 ounce jar next to your 16 ounce jar is not just a packaging change.
- Filed details are kept from public disclosure, not from your co-packer. Filed process information "shall be regarded as trade secrets," and the rule lists quantitative formulas among the information not available for public disclosure, with limited exceptions. That protects against public release by the FDA. It does not replace a confidentiality agreement with the plant that holds the filing.
The section also requires the plant to keep a written recall procedure and to "promptly report" any spoilage, process deviation, or microbial contamination with potential health significance once any of the lot has entered distribution. And every container must carry a code showing the plant, the product, and the year, day, and period it was packed (section 114.80(b)), which is what makes a recall of one lot possible.
Questions to ask your co-packer
Bring these to the first call. They follow the rule above, so a plant that makes acidified foods should be able to answer them. The rule makes the plant answer to the FDA, not to you, so put anything you need to see (filings, pH and processing records, the recall procedure) in your contract.
- Do you treat my product as an acidified food, and who made that call?
- Is your facility registered with the FDA as a food canning establishment, on Form FDA 2541?
- Who will establish the scheduled process for my product, and whose filing will it be under?
- Will the process be filed for every container size I plan to sell, before the first run?
- Who supervises acidification and pH control on my run, and have they completed the required school?
- How often do you test pH during my run, and will I receive copies of the pH and processing records?
- How are containers coded, and what is your recall procedure?
Section 108.25 does not apply to food processed under the continuous inspection of the USDA meat and poultry inspection program (108.25(h)). If your product will be made under USDA Food Safety and Inspection Service inspection, confirm which rules apply with that agency; containing meat alone does not settle it. For anything about your specific recipe, confirm with a qualified process authority and your regulator before you rely on it.
Finding a plant that does this work
Packaging capability matters too. The University of Florida's guide to co-packers puts it plainly: for a hot sauce, "you would need a co-packer who can package liquids into small bottles," and you "might need to know if they can hot fill or are capable of aseptic filling ..."
Our directory lists 81 USDA organic certified co-packers that make sauces and condiments, each with its organic certification checked against the USDA record and a link to the certificate where USDA publishes one. Being listed does not mean a plant makes acidified foods, so ask questions 1 to 5 above. When you contact them, lead with a one-page summary of your product, format, container sizes, and volumes. The free brief builder makes that page, and our guide on questions to ask a co-packer covers the business side of the call: minimums, fees, and contracts.
Sources
- 21 CFR 114.3, Definitions, eCFR, current as of September 30, 2026, read October 2, 2026.
- 21 CFR 114.80, Processes and controls, eCFR, read October 2, 2026.
- 21 CFR 114.83, Establishing scheduled processes, eCFR, read October 2, 2026.
- 21 CFR 113.83, Establishing scheduled processes (low-acid canned foods), eCFR, read October 2, 2026.
- 21 CFR 108.25, Acidified foods, eCFR, read October 2, 2026.
- Finding and Using a Co-packer (FS380), University of Florida IFAS Extension, read October 2, 2026.
- CoPacker Index directory: the count of co-packers listed under sauces and condiments, taken October 2, 2026.
Correction, October 12, 2026: an earlier version said each listing links to its organic certificate. USDA does not publish a certificate link for every facility, so some listings have none. Every listing's organic certification is still checked against the USDA record.