FDA allulose rules

U.S. allulose labeling is confusing because the regulation, FDA enforcement policy, and front-of-package nutrient-content rules do not do the same job.

The core framework is:

• 21 C.F.R. § 101.9(c)(6)(ii) defines Total Sugars as the sum of all free mono- and disaccharides;
• allulose is a monosaccharide;
• FDA's 2020 guidance says the agency will exercise enforcement discretion allowing allulose to be excluded from Total Sugars and Added Sugars declarations;
• allulose still belongs in Total Carbohydrate;
• FDA permits 0.4 calories per gram for label calculations;
• separate rules in § 101.60(c) govern sugar-free and no-added-sugar claims.

That structure is the legal background for the current lawsuits.

Rule 1: Total Sugars has a structural definition

21 C.F.R. § 101.9(c)(6)(ii) defines Total Sugars as all free mono- and disaccharides.

The definition is based on chemical structure.

Allulose is a monosaccharide.

That is why the Seventh Circuit held in Franco v. Chobani that allulose falls within the definition.

Rule 2: FDA permits allulose to be excluded from Total Sugars

FDA's 2020 guidance says the agency intends to exercise enforcement discretion so manufacturers can exclude allulose from the amount declared as Total Sugars.

That does not mean the regulatory definition disappeared.

It means FDA announced how it intends to enforce the declaration requirement while recognizing allulose's different physiological effects.

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Rule 3: FDA also permits exclusion from Added Sugars

The same guidance allows allulose to be excluded from the amount declared as Added Sugars.

Again, that is an enforcement-discretion policy.

It should not be paraphrased as a blanket statement that "FDA says allulose is not sugar."

Rule 4: allulose remains in Total Carbohydrate

FDA does not give allulose the same exclusion from Total Carbohydrate.

That creates a label where allulose can contribute to Total Carbohydrate while being omitted from Total Sugars and Added Sugars under current enforcement policy.

Rule 5: FDA permits 0.4 calories per gram

FDA permits manufacturers to use 0.4 kcal/g when calculating calories from allulose for the Nutrition Facts label.

That reflects allulose's different metabolic characteristics compared with traditional sugars.

Rule 6: "Sugar Free" and "Zero Sugar" are separately regulated claims

21 C.F.R. § 101.60(c)(1) governs statements such as:

• Sugar Free;
• No Sugar;
• Zero Sugar;
• Without Sugar;
• Sugarless;
• similar claims.

The provision ties these claims to the regulatory definition of sugars and includes a quantitative threshold and other conditions.

That cross-reference is what made § 101.9's definition central in Franco.

Rule 7: "No Added Sugar" is a different regulatory question

Section 101.60(c)(2) separately governs statements such as:

• No Added Sugar;
• Without Added Sugar;
• No Sugar Added.

The rule focuses on whether sugars or relevant sugar-containing ingredients were added during processing and includes additional conditions.

This is why newer allulose cases involving KIND, Special K, Magic Spoon, Trader Joe's and other products cannot simply be summarized as copies of Franco.

What the litigation data shows

The cases we track show that the distinction among claim types is not theoretical.

Verified cases are tagged across several normalized claim families, including:

• Zero Sugar;
• 0g Sugar;
• Sugar Free;
• No Added Sugar;
• Zero Added Sugar;
• No Sugar Added;
• 0g Added Sugar;
• 0g Total Sugars.

One case can have more than one tag.

The distribution shows which label theories are actually appearing in litigation. It does not mean every type faces the same legal standard.

Why the Nutrition Facts panel and front-label claim can diverge

A manufacturer may rely on FDA's enforcement discretion when calculating Total Sugars and Added Sugars inside the Nutrition Facts box.

A plaintiff may separately challenge a large "Zero Sugar" or "Sugar Free" statement on another part of the package.

Those issues are related, but they are not identical.

This is the single most important distinction for understanding the allulose litigation.

Guidance versus regulation

FDA guidance describes the agency's current thinking and enforcement approach.

A regulation is legally different.

The Seventh Circuit in Franco treated FDA's allulose guidance as an enforcement position rather than an amendment to the regulatory definition.

That is why the plaintiffs could rely on the existing text of the regulation despite FDA's more flexible Nutrition Facts policy.

Could FDA change the legal landscape?

Yes.

FDA could undertake rulemaking or issue new authoritative policy that changes how allulose is treated.

Any material change should trigger a site-wide review of:

• this page;
• the Franco page;
• the main lawsuit page;
• claim-family explainers;
• case-page analysis.

Regulatory updates should never be silently applied to old editorial copy.

Quick reference

Sources cited in this guide (4)

• 21 C.F.R. § 101.9
• 21 C.F.R. § 101.60
• FDA allulose guidance
• Franco v. Chobani, LLC