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Claims: The US vs. the European Perspective (Part 4). Will the FDA permit the same claim?

Updated: May 9

Overview

In both the United States and Europe, regulatory frameworks govern the types of claims that can be made on dietary supplements and functional foods. Understanding the distinctions between jurisdictions is essential for compliant marketing—especially for widely used ingredients like omega-3 fatty acids.


Claim Types in the United States


In the U.S., claims fall into several categories:

  • Health Claims and Qualified Health Claims – must be approved by the Food and Drug Administration (FDA).

  • Structure/Function Claims – do not require FDA approval but must be truthful and substantiated.

  • Nutrient Content Claims – apply to nutrients with established Daily Values (DVs) by authoritative bodies like the Institute of Medicine.


A recent update allows qualified health claims for EPA and DHA omega-3 fatty acids regarding potential benefits in reducing the risk of hypertension and coronary heart disease.


Claim Types in the European Union


Under Regulation (EC) No 1924/2006, only two types of claims are allowed on dietary supplements:

  • Nutrition Claims – e.g., “source of” or “low in”

  • Health Claims – which require rigorous scientific evaluation and approval from both the European Food Safety Authority (EFSA) and the European Commission.


As of 2023, over 260 health claims have been authorized in the EU.


Omega-3 Claims: U.S. vs. EU


U.S. Regulations

  • No %DV can be used for EPA and DHA (since no DV is established).

  • Amounts may be listed (e.g., “contains 500 mg EPA/DHA per serving”).

  • Common Structure/Function Claims include:

    • “Supports heart health”

    • “Supports brain function”

    • “Supports eye health”


These claims must include the standard FDA disclaimer.


EU Regulations


Under EFSA guidance, several approved health claims for omega-3s include:

  • Heart health: “EPA and DHA contribute to the normal function of the heart” (≥250 mg/day).

  • Brain function: “DHA contributes to the maintenance of normal brain function” (≥250 mg/day).

  • Vision: “DHA contributes to the maintenance of normal vision” (≥250 mg/day).

  • Blood pressure: “EPA and DHA contribute to the maintenance of normal blood pressure” (3 g/day) [5][6].


Permitted nutrition claims for omega-3s include:

  • “Source of omega-3”: ≥40 mg EPA+DHA per 100 g and per 100 kcal

  • “High in omega-3”: ≥80 mg EPA+DHA per 100 g and per 100 kcal


Key Takeaway


While European claims undergo more rigorous pre-approval, they often result in short, assertive, and positive marketing language. In contrast, the U.S. allows broader Structure/Function Claims but restricts Health Claims with qualifying language that may dilute marketing impact.


Surprisingly, the same claim—such as “supports heart health”—might be used as a Structure/Function Claim in the U.S. and a Health Claim in the EU, provided regulatory requirements and scientific evidence are met.


References

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