Claims: The United States and European Perspective

Overview

In both the United States (U.S.) and the European Union (EU), regulatory frameworks govern the health and nutrition claims made on dietary supplements and functional foods. While both regions aim to ensure consumer protection and truthful marketing, their approaches differ in terms of claim types, substantiation requirements, and approval processes.

United States Regulatory Framework

In the U.S., the Food and Drug Administration (FDA) oversees the regulation of dietary supplement claims. The primary types of claims include:

1. Health Claims: These describe a relationship between a dietary substance and reduced risk of a disease or health-related condition. Health claims require significant scientific agreement and FDA authorization.Jones Day+1Food Safety+1

2. Qualified Health Claims: These are supported by scientific evidence but do not meet the significant scientific agreement standard. They must be accompanied by a disclaimer and are subject to FDA enforcement discretion.

3. Structure/Function Claims: These describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans (e.g., "supports heart health"). They do not require FDA pre-approval but must be substantiated and notified to the FDA within 30 days of marketing.

4. Nutrient Content Claims: These characterize the level of a nutrient in a product (e.g., "high in omega-3 fatty acids"). Such claims are only permitted for nutrients with established Daily Values (DVs).

Omega-3 Fatty Acids in the U.S.

For omega-3 fatty acids like EPA and DHA, the FDA has issued qualified health claims indicating that consuming these fatty acids may reduce the risk of hypertension and coronary heart disease.  However, nutrient content claims such as "high in omega-3 fatty acids" are prohibited unless a DV has been established, which is not the case for EPA and DHA. U.S. Food and Drug Administration+1AquaFeed+1

European Union Regulatory Framework

In the EU, the European Food Safety Authority (EFSA) evaluates health and nutrition claims under Regulation (EC) No 1924/2006. Claims are categorized as:

1. Nutrition Claims: These indicate that a food has particular beneficial nutritional properties due to the energy or nutrients it provides (e.g., "source of omega-3 fatty acids").

2. Health Claims: These suggest a relationship between a food category, a food, or one of its constituents and health. Health claims are further divided into:

   • Article 13 Claims: General function claims based on generally accepted scientific evidence.AquaFeed+4European Food Safety Authority+4Health+4

   • Article 14 Claims: Claims related to the reduction of disease risk and children's development and health.

Omega-3 Fatty Acids in the EU

EFSA has approved several health claims for EPA and DHA, including:

• "EPA and DHA contribute to the normal function of the heart."Puro Omega

• "DHA contributes to the maintenance of normal brain function."Puro Omega+1European Food Safety Authority+1

• "DHA contributes to the maintenance of normal vision."Testa+2European Food Safety Authority+2Puro Omega+2

These claims are authorized when specific daily intake levels are met. 

Comparative Analysis

While both the U.S. and EU require scientific substantiation for health-related claims, the EU's pre-market approval process through EFSA is more stringent, leading to fewer authorized claims. Conversely, the U.S. allows structure/function claims without pre-approval, provided they are truthful and not misleading.

For omega-3 fatty acids, the EU permits specific health claims with defined intake requirements, whereas the U.S. relies more on qualified health claims accompanied by disclaimers.

Conclusion

Navigating the regulatory landscapes of the U.S. and EU requires a thorough understanding of the respective claim types and approval processes. Companies must ensure compliance with regional regulations to market their dietary supplements and functional foods effectively and legally.

References

1. FDA Announces New Qualified Health Claims for EPA and DHA Omega-3 Consumption and Risk of Hypertension and Coronary Heart Disease. Health+3U.S. Food and Drug Administration+3AquaFeed+3

2. Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids. National Law Review+2pfndai.org+2Federal Register+2

3. DHA/EPA Related Health Claims | EFSA. European Food Safety Authority+1EFSA Journal+1

4. Nutrition Claims - European Commission - Food Safety. Food Safety

5. Scientific Opinion on the Substantiation of Health Claims Related to Vitamins, Minerals, and Omega-3 Fatty Acids. EFSA Journal+4European Food Safety Authority+4EFSA Journal+4