What are the requirements for high protein labels?

October 27, 2025 •

5 min read

According to the FDA, for a food to be labeled "high in protein" in the U.S., it must contain 20% or more of the Daily Value (DV) for protein per serving. This standard varies significantly depending on the regulatory body, and understanding these requirements for high protein labels is crucial for both manufacturers and consumers navigating the marketplace.

Quick Summary

This guide details the specific requirements for making a 'high protein' claim on food products in the U.S. and E.U., covering FDA Daily Value percentages and protein quality assessments like PDCAAS, as well as the E.U.'s energy-based criteria.

Key Points

U.S. FDA Standard: For a "high protein" or "excellent source" claim, a food must provide 20% or more of the Daily Value (DV) per serving.
E.U. Standard: A "high protein" claim requires that at least 20% of the food's total energy (calories) comes from protein.
Protein Quality Matters (U.S.): In the U.S., the Protein Digestibility-Corrected Amino Acid Score (PDCAAS) is used to validate claims, ensuring protein is both plentiful and high-quality.
Mandatory Labeling: If a protein claim is made on a U.S. product, the %DV for protein must be listed on the Nutrition Facts panel.
Source vs. High: The U.S. distinguishes between a "good source" (10-19% DV) and an "excellent source" (20%+ DV), while the E.U. has a "source" (12%+ energy) and "high" (20%+ energy) classification.
Labeling Transparency: For consumers, checking the Nutrition Facts panel and understanding regional standards is critical for interpreting protein claims accurately.
Plant-Based Considerations: Manufacturers using plant proteins may need to combine different sources to achieve a complete amino acid profile and meet quality standards for labeling claims.

Navigating Global Regulations for High Protein Labels

The regulations governing "high protein" claims are not universal; they differ based on the country or region. For food manufacturers and consumers alike, understanding these varied standards is key to interpreting nutritional information accurately. The primary regulatory bodies with distinct approaches are the U.S. Food and Drug Administration (FDA) and the European Commission (EU).

U.S. FDA Requirements

In the United States, the Food and Drug Administration regulates nutrient content claims, including those for protein. The standard is based on a percentage of the Daily Value (DV) for protein, which is set at 50 grams for a 2,000-calorie daily diet. The claims are tied to a specific Reference Amount Customarily Consumed (RACC), or serving size.

Excellent Source: To be labeled an "excellent source of protein," a food must contain 20% or more of the DV per RACC. This translates to 10 grams of protein per serving, based on the 50g DV. This is often equated with the "high protein" claim.
Good Source: A "good source of protein" claim requires the food to contain between 10% and 19% of the DV per RACC, which is 5 to 9.5 grams of protein per serving.
Mandatory Labeling: If a protein claim is made, the manufacturer must include the % Daily Value for protein on the Nutrition Facts panel. For products intended for infants and children under four, or for products where protein quality is low, the %DV is also mandatory, regardless of a claim.

E.U. and U.K. Requirements

In contrast to the U.S. system, the European Union and the United Kingdom base their protein claims on the food's total energy value, not a fixed daily value. This means the protein content is assessed relative to the product's caloric density.

High Protein: A "high protein" claim can be made if at least 20% of the food's total energy (calories) is provided by protein.
Source of Protein: A less stringent claim of being a "source of protein" can be made if at least 12% of the food's total energy value comes from protein.

The Importance of Protein Quality

Beyond simply meeting a quantity threshold, the quality of the protein can also be a factor, particularly in North America. Regulatory frameworks like those in the U.S. and Canada use protein quality assessment methods to validate claims, especially for plant-based proteins.

PDCAAS Method: The U.S. FDA requires the use of the Protein Digestibility-Corrected Amino Acid Score (PDCAAS) for validating protein content claims and establishing the %DV. This method considers both the amino acid profile of a protein source and its digestibility. For a product to claim it is an "excellent source" of protein, its protein content must meet the 20% DV threshold based on its PDCAAS-corrected value.
Challenges with Plant Proteins: Plant-based proteins often have lower digestibility and may lack sufficient amounts of certain essential amino acids, resulting in a lower PDCAAS score compared to animal proteins. Manufacturers often need to use complementary protein blends to meet these quality standards for claims.

Comparison: U.S. vs. E.U. Protein Labeling


Feature	United States (FDA)	European Union (EC)
Basis for Claim	Percentage of Daily Value (DV) per serving (RACC).	Percentage of total energy (calories) from protein.
"High Protein" Threshold	20% or more of the 50g DV per RACC (10+ grams).	At least 20% of the food's energy value must come from protein.
"Source of Protein" Threshold	10% to 19% of the 50g DV per RACC (5-9.5 grams).	At least 12% of the food's energy value must come from protein.
Protein Quality	Assessed using the Protein Digestibility-Corrected Amino Acid Score (PDCAAS) for claims.	Not explicitly tied to claims, but a good amino acid profile is crucial for overall quality.
Mandatory %DV Label	Required on the Nutrition Facts panel if a protein claim is made.	Not required for the "high protein" claim, but nutrition labeling is still mandatory.

Creating High-Protein Products and Avoiding Misleading Labels

For food producers, formulating a product to meet high-protein requirements involves more than just adding protein powder. Considerations include the type of protein, the product's overall formulation, and target market regulations. For consumers, awareness of these rules is the best defense against misleading claims.

Best Practices for Manufacturers

Know Your Market: Design products and labels with the target country's specific regulations in mind. A product labeled "high protein" in the U.S. might not qualify for the same claim in the E.U. due to differing caloric density standards.
Use Complementary Proteins: If using plant-based proteins, consider combining them to create a complete amino acid profile and increase the PDCAAS score, making it easier to qualify for a claim in the U.S..
Test and Validate: Before launching a product, conduct laboratory testing to confirm its protein content and, if necessary, protein quality. This ensures compliance and substantiates any claims made on the packaging.
Clear Labeling: Ensure all required information, such as the %DV in the U.S. when a claim is made, is prominently and accurately displayed. For comparative claims, like "more protein," state the specific difference clearly.

The Consumer's Guide to High-Protein Claims

Check the Fine Print: Don't just rely on front-of-package claims. Turn the package over and examine the Nutrition Facts panel. For U.S. products with a protein claim, verify that the %DV for protein is listed and is at least 20%.
Consider the Energy: For products sold in the E.U. or U.K., think about the context of the claim. A food might be 20% protein by energy, but if it is very high in calories overall, the protein intake might not be as significant as it appears.
Look for Ingredient Variety: A variety of protein sources (e.g., combining beans and grains) often indicates a more complete amino acid profile. A product relying on a single, incomplete protein source might be lower in quality despite meeting the quantity requirements.
Question the Claim: If a claim seems too good to be true, it might be. Be critical of marketing language, as different regions and companies may interpret claims in varying ways.

Conclusion

Ultimately, understanding what are the requirements for high protein labels is essential for both those producing food and those consuming it. From the DV-based system of the FDA to the energy-value criteria of the European Commission, the rules are specific and require careful adherence to avoid misleading consumers. By focusing on both protein quantity and quality, manufacturers can build trust, while educated consumers can make more informed dietary choices. A clear, compliant label is the foundation of transparency in the food industry.

For more detailed regulatory information, refer to the official U.S. FDA website.

Frequently Asked Questions

In the U.S., a 'good source' of protein contains 10-19% of the Daily Value (DV) per serving, while an 'excellent source' (equivalent to 'high protein') contains 20% or more of the DV per serving.

The EU's standard for a 'high protein' claim is based on the food's energy content; at least 20% of the product's total energy value must come from protein. The U.S. standard is based on a fixed Daily Value percentage per serving.

Yes, particularly in the U.S. The FDA uses the Protein Digestibility-Corrected Amino Acid Score (PDCAAS) to validate protein claims, assessing both the amount and quality of the protein. This is especially important for plant-based products.

No, it is only mandatory to list the % Daily Value for protein if a protein claim is made on the packaging. It is also required for products intended for infants and young children.

PDCAAS stands for Protein Digestibility-Corrected Amino Acid Score. It's a method used by the U.S. FDA to evaluate protein quality, taking into account both the amino acid profile and digestibility. A higher score means better quality protein for human nutrition.

Yes, as long as the product meets the protein requirements for the respective region. The fat content and protein claim are independent requirements. For example, a low-fat cottage cheese can also be legitimately labeled 'high protein' if it meets the necessary standards.

The core regulations for 'high protein' claims are the same, but the protein quality assessment (like PDCAAS in the U.S.) may be more challenging for plant-based proteins, which can be less digestible or have incomplete amino acid profiles.