Based on the official FDA guidance document "LACF/AF – Precursor Questions and Flow". Answer each question to determine whether your product is governed by 21 CFR Part 113, Part 114, or neither.
Official FDA Flow 21 CFR Part 113 & 114 Instant Result
1
Storage
2
USDA
3
Water Activity
4
pH
5
Natural Acid
✓
Result
Question 1
Storage & Distribution Conditions
FDA Guidance — Q.1
Is the product stored, distributed, and retailed under refrigerated or frozen conditions?
This includes products that require continuous cold chain from production through retail. If the product is shelf-stable at room temperature, answer No.
Question 2
USDA Continuous Inspection
FDA Guidance — Q.2
Is the product processed under the continuous inspection of the USDA meat and poultry inspection program?
Such products carry a USDA inspection label. This applies to meat and poultry products regulated by USDA/FSIS under the Federal Meat Inspection Act or Poultry Products Inspection Act.
Question 3
Water Activity (aw)
FDA Guidance — Q.3
Is the water activity (aw) of the finished product less than or equal to 0.85?
Water activity of 0.85 or below inhibits growth of C. botulinum. Must be confirmed by laboratory testing. Examples: dried fruits, jerky, crackers, hard candies, dry spice mixes.
Question 4
Finished Equilibrium pH
FDA Guidance — Q.4
Is the finished equilibrium pH of the product 4.6 or lower?
Finished equilibrium pH is measured after complete acidification and equilibration. pH 4.6 is the critical threshold — C. botulinum cannot produce toxin below this level. Must be confirmed by laboratory testing.
Question 4 — Follow-up
Product Type Exceptions (pH > 4.6)
FDA Guidance — Q.4(a) & 4(b)
Your product has pH > 4.6. Does it fall into either of these special categories?
Certain product types are excluded from 21 CFR Part 113 even with pH > 4.6.
Question 5
Natural Acidity vs. Added Acid
FDA Guidance — Q.5
Is the natural pH of the product 4.6 or lower without any added acid?
This distinguishes naturally acid foods (e.g. citrus juice, most fruit juices, vinegar) from acidified foods where acid is deliberately added to lower the pH of a low-acid ingredient.
Question 5(a)
Low-Acid Ingredients
FDA Guidance — Q.5(a)
Does the product contain any low-acid ingredients?
Low-acid ingredients have a natural pH above 4.6 — for example: vegetables (onions, garlic, peppers), proteins (meat, fish, eggs), starches, dairy, or any ingredient not naturally acidic.
Question 5(b)
Predominant Acid Food Assessment
FDA Guidance — Q.5(b)
Is the product predominantly an acid or acid food that (1) contains only small amounts of low-acid food(s) AND (2) has a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food?
FDA recommends consulting a Process Authority or FDA directly for this evaluation, as "small amounts" and "does not significantly differ" are not defined by exact thresholds.