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21 CFR 101.4 INGREDIENTS

FDA 21 CFR 101.4 Ingredient Statement & Sub-Ingredient Compliance

Format your FDA 21 CFR 101.4 Ingredient List in descending order of predominance by weight with proper sub-ingredient parentheses, chemical preservatives, and 2% threshold rules.

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Quick Guide & Requirements

Under 21 CFR 101.4(a), ingredients must be listed by their common or usual name in descending order of predominance by weight—meaning the ingredient that weighs the most goes first, and the ingredient that weighs the least goes last.

  • Supports multi-component sub-ingredient syntax: `Dark Chocolate Chips (Sugar, Unsweetened Chocolate, Cocoa Butter, Soy Lecithin, Natural Vanilla Extract)`.
  • 2% or less threshold rule helper (`Contains 2 percent or less of: ...`).
  • Automatic integration with the FASTER Act 9-Allergen 'Contains:' statement and Distributor/Manufacturer signature line.

Key FDA 21 CFR 101.4 Ingredient Statement Rules

Rule Topic21 CFR CitationCompliance Requirement
Order of Listing21 CFR 101.4(a)(1)Descending order of predominance by weight at time of formulation
2% or Less Threshold21 CFR 101.4(a)(2)Ingredients present at ≤2% by weight may be listed at the end after 'Contains 2% or less of:'
Compound Sub-Ingredients21 CFR 101.4(b)(2)Declare parent ingredient followed by its sub-ingredients in parentheses in descending weight
Spices & Natural Flavors21 CFR 101.22May be declared collectively as 'Spices' and 'Natural Flavors' unless they are major allergens (e.g., Sesame)
Chemical Preservatives21 CFR 101.22(j)Must state both the common name and function, e.g., 'Potassium Sorbate (to preserve freshness)'

Frequently Asked Questions About Food & Product Labels

Can Sesame be hidden inside 'Spices' or 'Natural Flavors'?

No! Under the FASTER Act and FALCPA (21 U.S.C. 343(w)), if a spice blend or flavoring contains Sesame or any of the 9 major allergens, the allergen must be explicitly declared in the ingredient list or 'Contains:' statement.

Do I have to list added water in the ingredient statement?

Yes, under 21 CFR 101.4(c), water added to a food is an ingredient and must be declared in its descending order of weight unless all added water is subsequently removed during baking or processing.

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