Claims Related to Omega-3 Fatty Acids: Latest Regulatory Developments

Claims made in the labeling and advertising of foods and dietary supplements represent an important means of communicating the benefits of nutritional ingredients to consumers, especially as they take an active role in improving their health and well-being. As omega-3s steadily gain global market share, various jurisdictions continue to follow their own unique regulatory structures in governing permissible claims.

The free report, “Claims Related to Omega-3 Fatty Acids – Latest Regulatory Developments," points out that although there are overlaps, the relevant legislation and guidance documents concerning label claims of omega-3 products reflect significant differences, whether in the United States, the European Union (EU) or Australia/New Zealand.

Co-author Kathy Musa-Veloso, Ph.D., is director of health claims and clinical trials within the food and nutrition group at Intertek Scientific and Regulatory Consultancy. She and colleague Han Youl Lee, a scientific and regulatory analyst in the food and nutrition group, compared the regulatory environments of the aforementioned regions.

When it comes to omega-3 fatty acid claims permissible in the United States, EU and Australia, Nutrient Content Claims may be made for alpha-linolenic acid (ALA) in all three jurisdictions; however, Nutrient Content Claims for eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are permissible only in the EU and Australia.

The United States is unique in that a Qualified Health Claim related to the effects of EPA and DHA in reducing the risk of coronary heart disease (CHD) is permissible under a Letter of Enforcement Discretion; qualifying language is used to convey to the consumer the level of evidence in support of the claim, which is credible but does not meet a rigorous scientific standard. Disease Risk-Reduction Claims are not permissible for EPA and/or DHA in the EU or Australia.

For a detailed analysis of the similarities and differences among these jurisdictions, visit omega3insights.com.