FDA Exempts D-Tagatose from Added Sugars Labeling: What It Means for Sugar Reduction in the U.S.

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FDA Exempts D-Tagatose from Added Sugars Labeling

For food and beverage brands developing sugar-reduced products for the U.S. market, D-tagatose added sugars labeling has been one of the most important regulatory questions. The latest FDA position marks a major turning point: D-tagatose may now be excluded from both “Added Sugars” and “Total Sugars” on the U.S. Nutrition Facts label under FDA enforcement discretion, while its caloric value is recognized as 1.5 kcal/g. This gives D-tagatose a much stronger position in reduced-sugar beverages, confectionery, bakery, dairy, nutrition bars, sweetener blends, and tabletop sweeteners.

This update does not mean D-tagatose has become a sugar alcohol, nor does it mean the FDA has issued a final CFR amendment. The correct wording is that the FDA intends to exercise enforcement discretion regarding D-tagatose labeling while it continues to consider how to address sugars that are metabolized differently from traditional sugars.

For manufacturers sourcing bulk D-tagatose, this change is significant. D-tagatose can now be evaluated much more like allulose powder from a U.S. label-positioning perspective, while still offering its own sweetness, browning, bulk, and formulation advantages.

What Is D-Tagatose?

D-tagatose is a rare sugar and low-calorie bulk sweetener. It is a ketohexose monosaccharide with the molecular formula C₆H₁₂O₆ and is structurally related to fructose. It occurs naturally in very small amounts in dairy products and some fruits, but commercial production is usually based on industrial conversion and purification processes.

Unlike high-intensity sweeteners such as stevia, monk fruit extract, sucralose, or acesulfame potassium, D-tagatose provides sugar-like bulk. This makes it useful in formulations where sweetness alone is not enough. In bakery, confectionery, chocolate, dairy, beverages, and nutrition products, formulators often need volume, mouthfeel, browning, moisture control, freezing-point effect, and texture support.

BSH Ingredients supplies bulk food-grade D-tagatose powder for manufacturers that need consistent sweetness, quality documentation, and export support. For product specifications and procurement details, buyers can visit the Bulk D-Tagatose Powder Supplier page. BSH Ingredients also provides a practical guide to D-tagatose applications in food, beverage, and health products, covering uses in beverage, bakery, confectionery, dairy, oral care, and nutrition.

The FDA Update: D-Tagatose May Be Excluded from Added Sugars and Total Sugars

The key FDA update is found in a letter dated November 21, 2025. In that letter, FDA stated that it intends to exercise enforcement discretion with respect to the exclusion of D-tagatose from “Added Sugars” and “Total Sugars” declarations on the Nutrition Facts label. FDA also recognizes D-tagatose’s caloric value as 1.5 calories per gram.

This is important because D-tagatose is chemically a sugar, but it is metabolized differently from traditional sugars such as sucrose, glucose, and fructose. FDA has previously identified allulose, D-tagatose, and isomaltulose as sugars that are metabolized differently than traditional sugars.

In practical terms, this means that when D-tagatose is added to a U.S. food or beverage product, FDA does not intend to object if manufacturers exclude D-tagatose from the grams declared under Total Sugars and Added Sugars, provided the product is otherwise compliant. D-tagatose should still be declared in the ingredient list, and product labels should still be reviewed by qualified regulatory professionals.

Why Added Sugars Labeling Matters for D-Tagatose

Before this FDA update, D-tagatose faced a major commercial barrier. Even though it provides fewer calories than sucrose and has a different metabolic profile, it still had to be declared as added sugar. For U.S. brands, this reduced its value in “reduced sugar,” “no added sugar,” and sugar-reduction reformulation projects.

Consumers increasingly check the Added Sugars line on the Nutrition Facts label. Food brands also use sugar-related label positioning to support product claims and retail differentiation. If a sweetener reduces calories but still increases the Added Sugars number, many brands will hesitate to use it.

This is why the new FDA position is so important. It allows D-tagatose to play a stronger role in:

  • reduced-sugar beverages
  • no-added-sugar confectionery
  • low-calorie bakery products
  • low-glycemic sweetener systems
  • tabletop sweeteners
  • sugar-reduced chocolate
  • dairy and frozen dessert formulations
  • nutrition bars and meal replacement products
  • clean-label sweetener blends

For formulation examples, buyers can review BSH Ingredients’ guide on D-tagatose applications.

History of D-Tagatose Labeling in the U.S.

Early GRAS Status and Food Use

D-tagatose has a long history of use in food in the United States. FDA GRAS notices have covered D-tagatose for use as a sweetener, flavor enhancer, humectant, texturizer, and stabilizer in various food categories. BSH Ingredients’ guide to D-tagatose FDA GRAS status explains GRN 78, GRN 352, and GRN 977 for buyers evaluating U.S. compliance.

D-tagatose has been used in product categories such as beverages, cereals, chewing gum, baked goods, frozen dairy desserts, candies, meal replacements, and tabletop sweeteners. FDA’s GRAS Notice Inventory also shows that D-tagatose can be used as a nutritive sweetener and other functional ingredient types in multiple food categories.

2016 Nutrition Facts Label Rule: D-Tagatose Still Counted as Sugar

Under FDA’s Nutrition Facts label framework, sugars are generally declared based on their chemical classification. Because D-tagatose is a monosaccharide, it was historically treated as a sugar for labeling purposes, even though it has a lower caloric value and distinct metabolic effects compared with sucrose.

In 2020, FDA opened a discussion on sugars that are metabolized differently than traditional sugars. FDA specifically identified allulose, D-tagatose, and isomaltulose as examples of sugars that may have different physiological effects compared with traditional sugars.

Allulose Received Favorable Labeling Treatment First

Allulose became the best-known example of a rare sugar receiving special FDA label treatment. FDA’s allulose guidance states that the agency intends to exercise enforcement discretion for excluding allulose from Total Sugars and Added Sugars, and for using 0.4 kcal/g when determining calories.

This created an important precedent for D-tagatose. Food companies naturally asked: if allulose can be excluded from Total Sugars and Added Sugars because it is metabolized differently, why should D-tagatose be treated as a traditional added sugar?

For a detailed functional comparison, read BSH Ingredients’ guide: Tagatose vs Allulose: Sweetness, Calories, GI, Uses and Applications.

2018 Bonumose Petition

Bonumose, a U.S.-based rare sugar company, petitioned FDA to reconsider how D-tagatose should be declared on Nutrition Facts labels. The petition focused on the mismatch between D-tagatose’s physiological impact and its traditional added-sugar classification.

This petition became the foundation for several years of regulatory discussion over whether D-tagatose should be treated like traditional sugars or more like allulose.

2022 FDA Response: 1.5 kcal/g Accepted, but Added Sugars Still Required

FDA’s original response, issued in May 2022, did not grant the full exemption Bonumose requested. FDA did not object to using 1.5 kcal/g for D-tagatose when calculating calories, but the agency still required D-tagatose to be declared as Added Sugars. FDA’s later 2023 supplemental response summarized this earlier position.

This was only a partial improvement. From a calorie calculation perspective, it helped. But from a front-of-market and Nutrition Facts positioning perspective, the ingredient still carried a major disadvantage.

2023 Supplemental Response: Added Sugars %DV Relief

On December 14, 2023, FDA issued a supplemental response. The agency stated that it would exercise enforcement discretion if manufacturers adjusted the % Daily Value for Added Sugars based on D-tagatose’s actual caloric value of 1.5 kcal/g.

However, this still did not fully solve the issue. The grams of D-tagatose still appeared under Added Sugars. For many product developers, this was not enough to support no-added-sugar or strong sugar-reduction positioning.

2024 Bonumose Lawsuit and Court Decision

Bonumose challenged FDA’s position in court. A 2024 court document shows the dispute centered on whether FDA’s classification of D-tagatose as an added sugar was consistent with the purpose of added sugar labeling, given D-tagatose’s lower caloric contribution and different physiological profile.

This legal challenge helped advance the discussion and placed greater pressure on the FDA to reassess the labeling of D-tagatose.

2025 FDA Letter: The Major Turning Point

The November 21, 2025 FDA letter is the major turning point. FDA stated that D-tagatose is an eligible noncariogenic sweetener for the dental caries health claim regulation, acknowledged its different effect on glycemic response in certain studies, and recognized its caloric value as 1.5 kcal/g. As a result, FDA stated it intends to exercise enforcement discretion for the exclusion of D-tagatose from Added Sugars and Total Sugars.

Industry media reported this as a major win for D-tagatose in 2026, noting that added sugar labeling had been a major stumbling block for food manufacturers considering tagatose.

Before vs After: D-Tagatose Labeling in the U.S.

Labeling ItemPrevious PositionNew FDA Enforcement Discretion
Calories1.5 kcal/g accepted for calorie calculation1.5 kcal/g recognized
Added SugarsD-tagatose had to be declared as Added SugarsMay be excluded under FDA enforcement discretion
Total SugarsD-tagatose was treated as sugarMay be excluded under FDA enforcement discretion
Ingredient ListD-tagatose must be declaredD-tagatose must still be declared
Total CarbohydrateShould be evaluated based on current labeling rulesShould still be reviewed carefully because the letter focuses on Total Sugars and Added Sugars
Regulatory naturePartial reliefStronger labeling flexibility, but not a final CFR amendment

The most accurate wording is not “FDA final rule” or “FDA formally changed the CFR.” The safer and more professional wording is:

FDA intends to exercise enforcement discretion for excluding D-tagatose from “Added Sugars” and “Total Sugars” on the Nutrition Facts label, while recognizing D-tagatose at 1.5 kcal/g.

D-Tagatose vs Allulose: Similar Labeling Direction, Different Ingredient Profile

D-tagatose and allulose are often compared because both are rare sugars and both are metabolized differently than traditional sugars. However, they are not identical.

ItemD-TagatoseAllulose
Ingredient typeRare sugarRare sugar
Calories for U.S. labeling1.5 kcal/g0.4 kcal/g
SweetnessAround 90% of sucroseAround 70% of sucrose
Added Sugars labelingFDA intends enforcement discretion for exclusionFDA intends enforcement discretion for exclusion
Total Sugars labelingFDA intends enforcement discretion for exclusionFDA intends enforcement discretion for exclusion
Bulk functionalityStrong sugar-like bulk and browningSugar-like bulk, good for many applications
Sugar alcohol?NoNo

Allulose still has a lower calorie value, but D-tagatose may offer stronger sweetness, sugar-like functionality, and useful browning behavior for certain applications. This makes D-tagatose especially attractive for bakery, confectionery, chocolate, and caramel-type products, as well as sweetener blends.

For a deeper comparison, visit BSH Ingredients’ article: Tagatose vs Allulose.

Can D-Tagatose Be Used as a Standalone Sweetener?

Yes. D-tagatose can be used as a standalone sweetener ingredient in the U.S. when the ingredient meets applicable GRAS requirements, and the intended use is covered.

This means D-tagatose is not limited to a small flavor-modifying role. It can be used as a bulk sweetener, tabletop sweetener component, and sugar replacement ingredient in many food and beverage systems. Buyers should still confirm the specific intended use, application level, product category, and label requirements before launch.

For commercial sourcing, BSH Ingredients provides both product and technical support for bulk buyers through its D-Tagatose Powder page and D-Tagatose Powder vs D-Tagatose Liquid guide.

Impact on the D-Tagatose Market

1. Stronger Demand for U.S. Sugar Reduction Projects

The biggest impact is that D-tagatose becomes more attractive for U.S. sugar reduction. Previously, brands could reduce calories but still face an added sugar declaration. Now, D-tagatose can support a cleaner Nutrition Facts profile.

This may increase demand from:

  • beverage companies
  • confectionery manufacturers
  • chocolate brands
  • bakery factories
  • dairy and ice cream brands
  • nutrition bar producers
  • tabletop sweetener brands
  • private label sweetener companies
  • contract manufacturers
  • distributors of functional sweeteners

2. Better Positioning Against Allulose

Allulose has grown quickly partly because of its favorable U.S. labeling treatment. The D-tagatose update narrows the gap. D-tagatose still has more calories than allulose, but it also provides high sweetness and attractive processing properties.

Brands that previously used allulose alone may now consider D-tagatose in blends to improve sweetness, texture, browning, flavor, and cost-performance.

3. More Opportunities in Sweetener Blends

D-tagatose can be blended with other sweeteners to balance sweetness, cost, mouthfeel, and label goals. Common blend partners may include:

  • allulose
  • erythritol
  • xylitol
  • stevia extract
  • monk fruit extract
  • soluble fiber
  • inulin
  • sucralose
  • acesulfame potassium
  • isomaltooligosaccharides

BSH Ingredients supplies a wide range of bulk sweeteners, including D-tagatose, allulose, erythritol, xylitol, D-xylose, maltitol, sorbitol, sucralose, stevia, and monk fruit ingredients. The company’s homepage lists D-tagatose powder and other sweetener ingredients among its top products.

4. Stronger Case for Bulk Procurement

If U.S. demand increases, food manufacturers and distributors may need stable bulk supply, consistent quality, and competitive pricing. D-tagatose has historically been more expensive than traditional sugars and some sugar alcohols, but expanded production and supplier competition may improve availability.

For pricing planning, read BSH Ingredients’ D-Tagatose Price Guide 2026, which explains bulk costs, market factors, order volumes, and sourcing considerations.

5. More Regulatory Questions from Buyers

The update will also create more questions from importers, contract manufacturers, and food brands. Buyers will want to know:

  • Is D-tagatose still GRAS?
  • Does it count as added sugar?
  • Does it count as total sugar?
  • How many calories should be used?
  • Can it support no-added-sugar products?
  • Is it allowed in the EU, UK, Canada, Japan, Korea, Australia, and New Zealand?
  • What documents should suppliers provide?

For international market planning, BSH Ingredients has published a Global Regulatory Status of D-Tagatose Ingredients guide covering major regions.

What This Means for Food and Beverage Formulators

The FDA update gives formulators more flexibility. D-tagatose can now be considered for product concepts that previously favored allulose, erythritol, xylitol, stevia, or monk fruit.

Beverages

D-tagatose can be used in reduced-sugar soft drinks, flavored waters, dairy drinks, nutritional beverages, and functional drinks. It provides sweetness and mouthfeel while helping brands reduce traditional sugars.

Bakery

D-tagatose is useful in bakery because it participates in browning reactions. This can help create appealing color and flavor in certain baked goods, although processing conditions may need to be adjusted.

Confectionery

In candies, chocolate, caramels, chewing gum, and gummies, D-tagatose can provide bulk sweetness and improve texture. It may be used alone or blended with polyols and high-intensity sweeteners.

Dairy and Frozen Desserts

D-tagatose may help improve sweetness and mouthfeel in yogurt, ice cream, frozen desserts, and dairy-based nutrition products. It can also support reduced-sugar positioning.

Nutrition Bars and Meal Replacements

Nutrition bars need sweetness, bulk, binding, and texture. D-tagatose can support sugar reduction while maintaining a more sugar-like eating experience than high-intensity sweeteners alone.

Quality and Specification Considerations for Bulk Buyers

Labeling benefits are only useful if the ingredient itself meets quality and compliance requirements. Bulk buyers should evaluate D-tagatose suppliers based on documentation, production control, testing methods, and export experience.

Important purchasing documents include:

  • product specification
  • batch-specific COA
  • SDS or MSDS
  • allergen statement
  • GMO statement
  • country of origin
  • manufacturing flow chart
  • shelf-life statement
  • heavy metal report
  • microbiological report
  • residual solvent statement
  • pesticide residue report, if required
  • Halal certificate
  • Kosher certificate
  • third-party test report
  • packaging details
  • storage conditions
  • regulatory support documents

For China quality standards, BSH Ingredients provides a practical guide to China D-Tagatose Standard QB/T 4613-2013, including product classification, crystalline and liquid tagatose specifications, HPLC assay method, COA requirements, labeling, packaging, transportation, and storage.

For allergen-sensitive products, buyers can also review the D-Tagatose Allergen Statement. According to BSH Ingredients, its D-tagatose does not contain major regulated allergens, is gluten-free, and contains no dairy or residual lactose.

For shelf-life evaluation, BSH Ingredients has also published a D-Tagatose Stability Test Report, which is useful for manufacturers evaluating long-term storage and export requirements.

What This FDA Update Does Not Mean

This update is powerful, but it should not be overstated.

It does not mean:

  • D-tagatose is a sugar alcohol.
  • D-tagatose is zero-calorie.
  • D-tagatose can be removed from the ingredient list.
  • Every product containing D-tagatose automatically qualifies for “no added sugar.”
  • FDA has issued a final rule amending the CFR.
  • Brands can make disease treatment claims.
  • U.S. labeling rules automatically apply in the EU, UK, Canada, or other markets.

D-tagatose remains a rare sugar and nutritive sweetener. It should still be used under appropriate regulatory, formulation, and labeling review.

About BSH Ingredients

BSH Ingredients is a leading bulk D-tagatose supplier in China, supporting global manufacturers with food-grade D-tagatose powder, sweetener blends, and related bulk sweetener ingredients. The company supplies D-tagatose for beverages, confectionery, bakery, dairy, nutrition products, tabletop sweeteners, and reduced-sugar formulations.

As a professional sweetener ingredient supplier, BSH Ingredients supports B2B buyers with:

  • bulk D-tagatose powder supply
  • food-grade quality control
  • batch-specific COA
  • HPLC assay testing
  • product specification
  • custom packaging
  • export documentation
  • regulatory support documents
  • free sample evaluation
  • wholesale quotation for bulk orders
  • technical support for sweetener formulations

BSH Ingredients also provides related technical resources for buyers, including:

If you are developing reduced-sugar beverages, confectionery, bakery, dairy products, nutritional foods, or tabletop sweeteners for the U.S. market, BSH Ingredients can help you evaluate the right D-tagatose specification, packaging, documentation, and supply plan.

Frequently Asked Questions About D-Tagatose Added Sugars Labeling

Does D-tagatose count as added sugar in the U.S.?

FDA’s November 21, 2025 letter states that the agency intends to exercise enforcement discretion for excluding D-tagatose from “Added Sugars” on the Nutrition Facts label.

Does D-tagatose count as total sugar?

FDA also stated that it intends to exercise enforcement discretion for excluding D-tagatose from “Total Sugars” on the Nutrition Facts label.

How many calories does D-tagatose have?

FDA recognizes D-tagatose’s caloric value as 1.5 kcal/g. This is lower than traditional sugars, which are generally calculated at 4 kcal/g.

Is D-tagatose the same as allulose?

No. D-tagatose and allulose are both rare sugars, but they are different ingredients. Allulose is recognized at 0.4 kcal/g for U.S. labeling, while D-tagatose is recognized at 1.5 kcal/g. FDA allows allulose to be excluded from Total Sugars and Added Sugars under enforcement discretion, and now FDA has taken a similar enforcement discretion position for D-tagatose.

Is D-tagatose a sugar alcohol?

No. D-tagatose is not a sugar alcohol. It is a rare sugar. Sugar alcohols include erythritol, xylitol, sorbitol, maltitol, mannitol, and isomalt.

Can D-tagatose be used as a standalone sweetener?

Yes. D-tagatose can be used as a standalone sweetener ingredient when the ingredient meets GRAS requirements and the intended use is covered. It can also be used in sweetener blends with allulose, erythritol, stevia, monk fruit, xylitol, and other sweeteners.

Does D-tagatose still need to appear in the ingredient list?

Yes. The FDA letter relates to Nutrition Facts declarations for Total Sugars and Added Sugars. It does not remove the requirement to declare D-tagatose in the ingredient list.

Can a product with D-tagatose claim “no added sugar”?

Possibly, but it depends on the full formula and label review. If D-tagatose is the only sweetening ingredient and no other added sugars are used, the new FDA position may support stronger no-added-sugar positioning. However, final claims should be reviewed by a regulatory professional.

Is the FDA D-tagatose update a final rule?

No. It is an FDA enforcement discretion letter, not a final CFR amendment. The distinction is important for regulatory accuracy.

What is the biggest impact of the FDA update?

The biggest impact is that D-tagatose becomes much more attractive for U.S. sugar reduction. It can now support reduced-sugar and no-added-sugar product development without automatically increasing the Added Sugars line on the Nutrition Facts label.

What documents should buyers request before purchasing bulk D-tagatose?

Buyers should request product specification, batch COA, SDS/MSDS, allergen statement, GMO statement, country of origin, shelf-life statement, manufacturing flow chart, heavy metal report, microbiological report, residual solvent statement, and regulatory support documents.

Where can I buy bulk D-tagatose powder?

BSH Ingredients is a leading bulk D-tagatose supplier in China. Buyers can request specifications, samples, COA, packaging details, and wholesale pricing through the BSH Ingredients Bulk D-Tagatose Powder page.

Conclusion

FDA’s D-tagatose labeling update is one of the most important developments for rare sugar sweeteners in the U.S. market. For years, D-tagatose had strong technical potential but faced a major labeling barrier because it had to be declared as Added Sugars. With FDA now intending to exercise enforcement discretion for excluding D-tagatose from both Added Sugars and Total Sugars, D-tagatose becomes much more attractive for U.S. sugar reduction.

This does not make D-tagatose identical to allulose, and it does not make D-tagatose a sugar alcohol. However, it gives food and beverage manufacturers a stronger reason to evaluate D-tagatose in reduced-sugar, no-added-sugar, low-calorie, and clean-label sweetener systems.

For brands developing beverages, confectionery, bakery, dairy, nutrition bars, tabletop sweeteners, and functional foods, D-tagatose now offers a stronger balance of sugar-like taste, bulk functionality, lower calories, and improved U.S. Nutrition Facts label positioning.

References

  • U.S. Food and Drug Administration. (2025, November 21). Letter to Edwin O. Rogers, Bonumose, Inc., regarding enforcement discretion for D-tagatose labeling. U.S. Food and Drug Administration.
  • U.S. Food and Drug Administration. (2023, December 14). FDA issues supplemental response on the labeling of D-tagatose on the Nutrition Facts label. U.S. Food and Drug Administration. (U.S. Food and Drug Administration)
  • U.S. Food and Drug Administration. (2020, October). Guidance for industry: The declaration of allulose and calories from allulose on Nutrition and Supplement Facts labels. U.S. Food and Drug Administration. (U.S. Food and Drug Administration)
  • U.S. Food and Drug Administration. (2020, December 17). FDA seeks input on nutrition labeling for certain sugars and issues final guidance on allulose. U.S. Food and Drug Administration. (U.S. Food and Drug Administration)
  • U.S. Food and Drug Administration. (2026). GRN No. 977: D-tagatose produced via novel enzymatic cascade. GRAS Notice Inventory. U.S. Food and Drug Administration. (FDA HFP App External)
  • U.S. Food and Drug Administration. (2026). GRN No. 78: D-Tagatose. GRAS Notice Inventory. U.S. Food and Drug Administration. (FDA HFP App External)
  • U.S. Food and Drug Administration. (2024, February 21). Response letter to petition for a qualified health claim for D-tagatose and reduced risk of type 2 diabetes: Docket No. FDA-2022-Q-0051. U.S. Food and Drug Administration. (U.S. Food and Drug Administration)
  • Food and Drug Administration. (2016, May 27). Food labeling: Revision of the Nutrition and Supplement Facts labels. Federal Register, 81(103), 33742–33999. (Federal Register)
  • Food and Drug Administration. (2020, October 19). Sugars that are metabolized differently than traditional sugars. Federal Register, 85(202), 66335–66338. (Federal Register)
  • Office of the Federal Register. (2026). 21 C.F.R. § 101.80: Health claims: Dietary noncariogenic carbohydrate sweeteners and dental caries. Electronic Code of Federal Regulations. Retrieved July 9, 2026. (eCFR)
  • United States District Court for the District of Columbia. (2024, August 28). Bonumose, Inc. v. United States Food and Drug Administration: Memorandum opinion, Case No. 1:23-cv-00645-RDM. GovInfo. (GovInfo)
  • Watson, E. (2026, April 10). FDA exempts tagatose from added sugar labeling. AgFunderNews. (AgFunderNews)
  • Keller and Heckman LLP. (2022, May 24). FDA denies request to exempt D-tagatose from added sugar labeling. The Daily Intake. (The Daily Intake)

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