Acidified foods, and what registration means
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If you add vinegar to peppers, garlic or onion to bring the product below pH 4.6, you are almost certainly manufacturing an acidified food, and a specific set of federal requirements attaches to that.
What makes a food acidified
A low-acid ingredient plus an added acid, finishing below 4.6 with a water activity above 0.85. Peppers, garlic, onion and carrot are all low-acid. Vinegar is the added acid. That is most hot sauce.
A food that is naturally below 4.6 on its own is not acidified. A sauce built entirely on fermented mash that reached its acidity biologically sits differently again, and that is a distinction to confirm for your specific process rather than assume from a general description.
What it obliges you to do
Four things, and none is optional.
Register the facility with FDA as a food facility.
File the process for each product, which means submitting the scheduled process established by a process authority.
Complete operator training. Someone supervising production must hold a Better Process Control School certificate or equivalent.
Keep processing records for every batch, and keep them for the period the regulation specifies.
Registration and the process filing
These are two separate things and producers routinely do one and believe they have done both. Facility registration identifies who you are and where you make it. The process filing describes what you make and how you make it safe, product by product.
Change the recipe materially and the filing may need revisiting. A new pepper variety at the same acidity is usually fine; a change in viscosity, particle size or acidification method is the kind of change that alters the process.
What it is not
Say the inconvenient part. A state cottage food exemption does not set any of this aside. Cottage food rules are a state mechanism for certain low-risk foods made in a home kitchen, and acidified foods are generally excluded from them precisely because the hazard is real.
Producers discover this in one of two ways: they ask before they start, or a retailer asks for a process filing number they do not have. The first is a phone call and the second is a listing lost.
Not every hot sauce is one
The definition has two halves, and the second is the one producers never read.
An acidified food is a low-acid food to which acid or an acid food has been added, with a water activity above 0.85 and a finished equilibrium pH of 4.6 or below. Peppers appear by name in the list of examples.
But the same section excludes, from the whole of Part 114, acid foods including condiment sauces that contain small amounts of low-acid food and have a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food. Carbonated beverages, jams, jellies and preserves are excluded outright, and so is anything stored, distributed and sold refrigerated.
Read that against a vinegar-forward sauce. If vinegar is the predominant ingredient and the peppers and garlic are a small part of it, and the finished pH is essentially the pH of the vinegar rather than something the acid had to pull down, the product may be an acid food with small amounts of low-acid food, not an acidified food.
Where the line actually falls
FDA does not define "small amount". There is no percentage in the regulation and none in the guidance. Which means this is not a determination you make by reading; it is a determination a process authority makes for your formula.
The two questions they are answering are how much low-acid material is in it, and whether the finished pH differs meaningfully from the acid you started with. A sauce that is mostly fresh pepper mash with vinegar added to bring it down is squarely an acidified food however low the final number goes. A thin cayenne-and-vinegar sauce may not be.
The consequence is large. An excluded product falls outside the Part 114 production and process control requirements, which is the FCE registration, the process filing and the scheduled process.
Why you still start the same way
You cannot claim the exclusion on your own reading, and the wrong answer here is the expensive kind. So the sequence does not change: send the formula to a process authority, and let their letter tell you which regime you are in.
What changes is what the letter can say. Two outcomes, not one, and the second is more common in this category than the general writing on hot sauce suggests.
And it is per formula. A range where the original is an excluded condiment sauce and the new fruit-and-pepper one is an acidified food is a business running under two regimes at once, which is entirely normal and worth knowing before you build the label and the batch sheet around one of them.