Accurate and legal food labeling is crucial for manufacturers, but the criteria for making nutrient content claims, such as calling a product 'high protein,' are not universal. Instead, they are governed by specific regulatory bodies in each market. These bodies, like the Food and Drug Administration (FDA) in the U.S., the European Commission in the EU, and Health Canada, have their own distinct standards for what constitutes a high protein food.
U.S. FDA Requirements for High Protein Claims
In the United States, the Food and Drug Administration (FDA) regulates nutrition content claims on food labels based on a percentage of the Daily Value (DV). For a product to make an 'excellent source' or 'high' protein claim, it must contain 20% or more of the recommended Daily Value for protein per serving. The DV for protein is 50 grams, so a single serving must contain at least 10 grams of protein to qualify.
Protein Quality Matters
Simply having enough protein is not enough for an FDA-compliant claim; the quality of the protein is also a key factor. The FDA requires the use of the Protein Digestibility Corrected Amino Acid Score (PDCAAS) to determine this. The PDCAAS measures both the amino acid profile and the digestibility of the protein, ensuring the body can effectively use it. The corrected protein value is what is used for regulatory calculations, which is why animal proteins like whey and casein often score highly, while some plant-based proteins may have lower scores unless combined effectively.
European Union and UK Regulations
The European Union and the United Kingdom employ a different system for determining a high protein claim, focusing on the proportion of energy derived from protein.
Energy-Based Threshold
For a food to be labeled 'high protein' in the EU, at least 20% of its total energy (calories) must be supplied by protein. This differs significantly from the DV-based approach in the U.S. The calculation is relatively straightforward: one gram of protein provides four calories, so the amount of protein is multiplied by four to get its energy contribution, which is then compared to the product's total energy value. For comparison, a 'source of protein' claim only requires 12% of the energy value to come from protein.
Canadian Food Inspection Agency (CFIA) Standards
Canada has its own set of rules, historically based on the Protein Rating system and now also incorporating the PDCAAS method, aligning it more closely with U.S. standards.
Multiple Assessment Methods
Under Health Canada regulations, food labels can use either the Protein Rating or the PDCAAS to substantiate protein claims. An 'excellent source of protein' claim requires the food to have at least 10g of protein per serving, based on corrected values. This shows a regulatory landscape that is evolving to incorporate more modern scientific assessment methods, such as the PDCAAS.
Global Requirements for a High Protein Claim: A Comparison
| Feature | U.S. (FDA) | European Union & UK | Canada (CFIA) |
|---|---|---|---|
| Primary Metric | % of Daily Value (DV) per serving | % of total energy value | % of Daily Value (DV) or Protein Rating |
| 'High' Claim Threshold | ≥ 20% of DV per serving (10g) | ≥ 20% of total energy value | ≥ 20% of DV per serving (10g) OR based on Protein Rating |
| Protein Quality Test | PDCAAS method required | Not specified in the energy-based metric | Protein Rating or PDCAAS |
| Serving Size Role | Crucial, as calculation is per serving | Not relevant for the energy-based calculation | Crucial for DV-based claims |
What This Means for Food Manufacturers
For food companies, compliance is not just about measuring the quantity of protein; it's about understanding and adhering to the specific regulatory framework of each target market. The choice of which testing method to use and how to present the data on a food label is a complex decision that requires careful consideration of local laws. The differences highlight the need for a global strategy that can adapt to varying legal landscapes. For instance, a product that qualifies as high protein in the EU might not meet the PDCAAS standards for an 'excellent source' claim in the U.S. or Canada.
How to Get Your High Protein Claim Right
To make a valid and legal high protein claim, a food manufacturer should follow these steps:
- Analyze Your Recipe: Determine the precise protein content per serving or 100g/ml.
- Calculate Based on Market: Perform the required calculation (e.g., % of DV for the U.S., % of energy for the EU).
- Assess Protein Quality: If targeting the U.S. or Canada, perform the necessary protein quality testing, such as PDCAAS.
- Consult Regulations: Always cross-reference your findings with the latest regulations from the relevant authority, such as the FDA's Labeling Guide.
- Verify with Experts: Engage with a food labeling consultant or regulatory expert to ensure full compliance before launching a product.
Conclusion: Navigating a Complex Regulatory Landscape
In summary, the specific requirements for a high protein claim are not uniform and depend entirely on the regulatory authority overseeing the market. Whether it's the energy-based system in the EU or the combination of Daily Value and protein quality in the U.S. and Canada, food manufacturers must perform due diligence to ensure their product labels are accurate and compliant. Ignoring these complex, region-specific rules can lead to legal issues and damage brand trust. Consumers benefit from these strict regulations, as they provide clarity and prevent misleading claims about the nutritional content of their food.
