FDA has not issued a formal regulation defining "whole grain" for food labels, but it has published guidance documents — most significantly in 1999 and updated through subsequent industry guidance — establishing what qualifies as a whole grain and how whole grain claims should be made. The 2024 update to the "healthy" nutrient content claim in 21 CFR 101.65 added a whole grain requirement to that specific claim, making the whole grain definition more consequential.

What Is a "Whole Grain"?

Under FDA's guidance, a whole grain consists of all three parts of the grain kernel:

1. Bran — the outer protective layer, containing fiber, B vitamins, and minerals

2. Germ — the embryo of the kernel, containing healthy fats, vitamin E, B vitamins, and antioxidants

3. Endosperm — the starchy interior, the dominant part by weight

Refined grains have the bran and germ removed (leaving only the endosperm), stripping most of the fiber and many nutrients. Enriched grains have some nutrients added back, but not all.

A grain is "whole" only if the bran, germ, and endosperm are all present in the same proportions as in the original intact grain. A product that uses bran and endosperm but not germ is not a whole grain.

Grains That Qualify as Whole Grains

Common whole grains recognized by FDA guidance:

• Whole wheat (including whole wheat flour)

• Whole oats and oatmeal

• Whole grain corn (including whole grain cornmeal and popcorn)

• Brown rice and other whole grain rices

• Whole rye

• Whole grain barley

• Whole grain sorghum

• Whole grain triticale

• Bulgur

• Millet

• Quinoa

• Buckwheat

• Amaranth

Note: Quinoa, buckwheat, and amaranth are technically pseudocereals but are recognized as whole grain ingredients.

What Qualifies for a "Whole Grain" Label Claim

FDA's 1999 guidance established thresholds for different claim levels:

Qualifying for a "Good Source of Whole Grain" or "Made with Whole Grain"

A food that contains at least 8 grams of whole grain per serving qualifies as a "good source of whole grain" — equivalent to the 10–19% DV threshold for other nutrients.

Qualifying for a "High," "Rich in," or "Excellent Source of Whole Grain"

A food that contains at least 16 grams of whole grain per serving qualifies for high/excellent source claims.

"100% Whole Grain" Claims

A food may bear a "100% whole grain" claim only if all grain ingredients are whole grains — no refined grain ingredients are present.

"Whole Grain [Food Name]" as a Statement of Identity

For certain grain foods (whole wheat bread, whole grain pasta), the identity statement itself implies 100% whole grain content. FDA guidance indicates that "whole wheat bread" should be made entirely from whole wheat flour — using a blend of whole wheat and refined flour without additional disclosure may be misleading.

The "51% Whole Grain" Industry Standard

The Whole Grains Council (a food industry association, not a regulatory body) promotes a "51% whole grain" standard — a product may bear the Whole Grain Stamp if it contains at least 51% of its grain ingredients as whole grain. This is an industry certification program, not an FDA requirement. Products bearing the Whole Grain Stamp are using a voluntary certification standard, not an FDA-mandated threshold.

Whole Grain and the 2024 "Healthy" Claim Update

The most significant regulatory development affecting whole grain claims is the 2024 update to 21 CFR 101.65(d) (the "healthy" nutrient content claim definition, effective February 25, 2025). Under the updated definition:

Grain products bearing a "healthy" claim must contain a meaningful amount of whole grain from the grain food group, with at least half of the grain ingredients being whole grains.

This requirement effectively requires grain-based products claiming "healthy" to be predominantly whole grain. A product that uses a token amount of whole grain flour while being primarily refined grain flour cannot claim "healthy."

Whole Grain and Dietary Fiber Claims

Whole grains are typically higher in dietary fiber than refined grains, but the two concepts are not interchangeable for labeling purposes:

• A product can be a "good source of fiber" (21 CFR 101.54) without being whole grain (e.g., a refined grain product with added fiber)

• A product can be "whole grain" without being a "good source of fiber" (some whole grains are lower in fiber than others)

• Both claims can appear on the same product if the relevant thresholds are met

Listing Whole Grain in the Ingredient List

The ingredient list (21 CFR 101.4) must reflect whether grain ingredients are whole or refined:

• "Whole wheat flour" — whole grain

• "Wheat flour" or "enriched wheat flour" — refined grain (not whole)

• "Rolled oats" or "oat flour" — whole grain (oats are almost always processed as whole grain)

• "Corn flour" — may be whole or refined; "whole grain corn flour" specifies whole grain

The presence of "whole" in the ingredient name signals whole grain status. Consumers and auditors read the ingredient list to evaluate whole grain claims against the listed ingredients.

How Truli Helps with Whole Grain Claim Compliance

• Whole grain content calculation: Truli calculates whole grain grams per serving from formula data and verifies whether the amount supports the claimed level ("made with whole grain," "good source," "excellent source," "100% whole grain")

• "Healthy" claim interaction: Truli evaluates grain products bearing "healthy" claims for the whole grain composition requirement under the updated 21 CFR 101.65(d)

• Ingredient list audit: Truli reviews ingredient lists to verify that grain ingredients are listed with appropriate whole/refined designations consistent with the brand's whole grain claims

Related Regulations

• 21 CFR 101.65 — "Healthy" Claim — Updated 2024 definition requiring whole grain in grain products bearing "healthy" claims

• 21 CFR 101.54 — Good Source, High Claims — DV-based thresholds for beneficial nutrient claims applicable to whole grain and fiber

• 21 CFR 101.4 — Ingredient List — How grain ingredients must be declared in the ingredient list

Frequently Asked Questions

Our bread uses 30% whole wheat flour and 70% enriched wheat flour. Can we say "made with whole grains"?
A "made with whole grain" claim is potentially supportable if the product contains at least 8 grams of whole grain per serving and the claim accurately reflects the product's whole grain content. However, if the "30% whole wheat" statement is prominent and the total grain content is mostly refined, the claim may create a misleading impression. A conspicuous disclosure of the actual whole grain content per serving (e.g., "8g whole grain per serving") helps prevent consumer deception.

We want to call our product "whole grain [product name]." Does that mean 100% whole grain?
Using the product's identity statement to imply 100% whole grain (e.g., "Whole Grain Crackers") when the product contains significant refined grain ingredients is likely misleading under FDA's guidance. If your product is not made entirely from whole grain ingredients, avoid using "whole grain" as the primary identity name or clearly disclose the actual whole grain content per serving.

Oats don't say "whole" on the package but I thought oats are always whole grain. Is that true?
Yes — virtually all commercially sold oats (rolled oats, oat flour, steel-cut oats) are whole grain because the oat bran and germ are not typically removed in standard oat milling. The "whole" designation is often implicit for oats even when not stated. However, for labeling clarity and potential claims, using "whole grain oat flour" or "whole rolled oats" in the ingredient list is more transparent.

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. FDA's whole grain guidance has not been updated to a formal regulation. The "healthy" claim update effective February 25, 2025 adds new whole grain requirements for products bearing that claim. Book a demo to see how Truli monitors food label compliance.