21 CFR 101.22 governs the labeling of flavoring agents, colorings, and spices in packaged food ingredient lists. It is one of the most practically significant regulations for food and supplement brands because of the widespread use of flavor systems, color additives, and spice blends — and because misuse of the terms "natural flavor" and "artificial flavor" is a frequent source of consumer litigation and FDA warning letters.
Spices: The Collective Term Exception
Under 21 CFR 101.22(a)(2), spices may be declared collectively as "spice," "spices," or "spice and flavor" in the ingredient list without individually naming each component. This is an exception to the general rule that all ingredients must be listed by their common or usual name.
"Spices" under this regulation means: "aromatic vegetable substances in the whole, broken, or ground form, whose significant function in food is seasoning rather than nutritional." The regulation specifies more than 100 qualifying spices including paprika, turmeric, annatto, and saffron. However, these last four qualify as both spices and color additives — when they are used primarily for coloring, they must be declared as color additives, not as spices.
Natural Flavor: The Regulatory Definition
Under 21 CFR 101.22(a)(3), "natural flavor" means a flavoring substance derived from:
Spices, fruit, fruit juice, vegetable, vegetable juice
Edible yeast, herb, bark, bud, root, leaf, or similar plant material
Meat, seafood, poultry, eggs, dairy products, or fermentation products from these sources
Key limit: The substance must be used primarily for flavor rather than for nutrition. A natural flavor must originate from a natural source — it cannot be a synthetically produced chemical, even if chemically identical to a naturally occurring compound.
What "Natural Flavor" Does Not Tell the Consumer
The collective "natural flavors" declaration does not identify:
The actual source of the flavor (fruit vs. animal vs. vegetable)
Whether the source is an allergen (e.g., tree nuts, shellfish used as flavor bases)
The specific chemical compounds used
For allergen disclosure purposes, if a "natural flavor" is derived from a major allergen (e.g., a shellfish-derived flavor enhancer), the allergen source must be disclosed separately under FALCPA requirements — it is not protected by the collective "natural flavors" declaration.
Note: FDA issued guidance in 2023 clarifying that sesame must be declared by name even when used as a flavor, due to its addition to the major food allergen list under the FASTER Act.
Artificial Flavor: The Regulatory Definition
Under 21 CFR 101.22(a)(1), "artificial flavor" means any flavoring substance not derived from the natural sources listed above. Synthetically produced flavor chemicals — even those chemically identical to natural compounds — are artificial flavors under this definition.
A food that contains only natural flavors may be labeled "natural flavor" or "natural flavors." A food that contains any artificial flavor must declare it as "artificial flavor" — and the PDP must bear characterizing statements when artificial flavors are used for characterizing purposes (e.g., "artificially flavored strawberry drink").
When the PDP Must Declare Flavor Type
Under 21 CFR 101.22(i), when a food's characterizing flavor is simulated by flavoring rather than derived from the actual ingredient:
If simulated by artificial flavor only: PDP must state "artificially flavored"
If simulated by both natural and artificial flavors: PDP must state "artificially flavored" or "natural and artificial flavor"
If flavored with natural flavor from the named source (e.g., actual strawberry in a strawberry bar): no qualifier required
This is distinct from the ingredient list declaration — the PDP requirement is about the product's characterizing flavor claim (e.g., "chocolate chip," "lemon," "strawberry").
Color Additives: Individually Named vs. Collective Declaration
Color additives are subject to different rules depending on whether they are certified or exempt (from batch certification):
Certified Color Additives
Synthetic dye-based color additives that require batch certification (FD&C colors) must be declared individually by name in the ingredient list. They cannot be grouped under "coloring" or "artificial color."
Required declaration format: "FD&C Blue No. 1", "Yellow 5", "Red 40" (the full name or the shorter form approved by FDA is acceptable).
Common certified colors: FD&C Blue No. 1 and No. 2, FD&C Green No. 3, FD&C Red No. 3 and No. 40, FD&C Yellow No. 5 and No. 6, Orange B, Citrus Red No. 2.
Exempt Color Additives
Color additives exempt from batch certification — including colors derived from natural sources like beet juice, annatto, turmeric, caramel color, and beta-carotene — may be declared either by their individual name or collectively as "coloring" or "color added."
However, annatto, paprika, and saffron (all of which are both spices and colors) must be declared individually by name when used primarily as colors.
FD&C Yellow No. 5 and Yellow No. 6 — Individual Name Requirement
Under 21 CFR 101.22(k)(1), FD&C Yellow No. 5 (tartrazine) and Yellow No. 6, like all certified color additives, must be declared individually by their specific name in the ingredient list. They cannot be grouped under a collective term such as "artificial colors" or "coloring." The current regulation requires the specific name (e.g., "Yellow 5" or "FD&C Yellow No. 5") to appear in the ingredient statement — this allows consumers with known sensitivity to tartrazine to identify its presence.
Note: A historical requirement for an additional separate declaration statement ("Contains FD&C Yellow No. 5 (tartrazine) as a color additive") outside the ingredient list was removed in subsequent FDA rulemaking. The current requirement under 101.22(k)(1) is satisfied by listing the color by its individual name in the ingredient list.
Dietary Supplement Applications
For dietary supplements, 21 CFR 101.22 applies to flavoring and coloring used in the supplement formulation. Supplement "Other Ingredients" must comply with these declaration rules. Common supplement applications:
Flavored protein powders or gummies: "natural flavors" or "artificial flavors" as applicable
Colored supplement coatings (tablet film coatings): certified colors must be individually named
Botanical extracts with natural color: may qualify as exempt color additives
How Truli Helps with Flavor and Color Declaration Compliance
Natural vs. artificial flavor classification: Truli reviews ingredient documentation to verify that flavor declarations match the actual derivation of flavoring agents
Certified color name check: Truli flags ingredient lists that use collective terms ("artificial color," "coloring") for certified FD&C colors that must be individually named
Yellow 5 individual name check: Truli flags ingredient lists that use collective color terms for FD&C Yellow No. 5 or Yellow No. 6 rather than their required individual names
Allergen-flavor intersection: Truli cross-references "natural flavors" and "artificial flavors" with known allergen sources and flags where the allergen source may need to be declared
Related Regulations
21 CFR Part 101 — FDA food labeling overview
21 CFR 101.4 — Ingredient List — General ingredient declaration rules
FALCPA / FASTER Act Allergen Labeling — Allergen disclosure requirements, including sesame in flavors
21 CFR 101.9 — Nutrition Facts Panel — Nutrition labeling requirements
Frequently Asked Questions
Can we use the term "natural flavors" even if we don't know the exact source?
If the flavoring agent your supplier provides is classified as a natural flavor under 21 CFR 101.22(a)(3) and your supplier has documented that classification, you may use the collective term. However, you remain responsible for ensuring the characterization is accurate, and you need to know if the source is a major allergen.
We use a flavor system that contains both natural and artificial components. How do we declare it?
You must declare "natural and artificial flavors" or "artificial flavors" in the ingredient list. You cannot use "natural flavors" alone if the system contains any artificial flavor components.
Does caramel color need to be individually named?
No — caramel color is an exempt color additive and may be declared as "caramel color" (its individual name, which is also used as a collective descriptor in practice) or as "coloring." It does not need to be listed as a batch-certified FD&C color.
A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
Last updated: April 2026. Reflects 21 CFR 101.22 as of April 2026. Book a demo to see how Truli monitors food label compliance.
