In the U.S. market, structure/function claims are allowed for dietary supplements. FDA review and approval are not required; however, the claim cannot refer to the diagnosis, mitigation, treatment, cure or prevention of disease—these are legally allowed only for pharmaceutical drugs.
For dietary supplements—but not foods—a 30-day post-market notification must be submitted to the FDA notifying them of the claim wording.
Importantly, the claims must be truthful and not misleading!
The Federal Trade Commission is the other major regulatory body that targets health claims. Companies must have scientific substantiation that the amount of long-chain omega-3 fatty acids provided by your product is effective in the population group that is the target of the claim. The FTC can and will send letters asking companies to change marketing language—both on products and online.
Qualified health claims are allowed – but only for DHA and EPA, not every omega-3 out there, in particular ALA—and only for cardiovascular health, not the other benefits alleged in the marketplace from cognitive to visual to joint health. Based on human intervention studies, observational studies or authoritative body reports, the claim can read, “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [Name of the food product] provides [X] grams of EPA and DHA omega-3 fatty acids.”
In addition, the food including DHA and EPA must meet the “low saturated fat” and “low cholesterol” criteria, it must also contain, prior to any nutrient addition, at least 10 percent of the Daily Value for vitamin A, vitamin C, iron, calcium, protein or dietary fiber per the reference amount customarily consumed. Foods can be disqualified if they contain certain levels of total fat, sodium, cholesterol or saturated fat. Supplements should not recommend daily intake exceeding 2g/day of EPA and DHA.
For foods, products can claim: “DHA, an omega-3 fatty acid, supports the normal physical development of the brain, eyes and nerves primarily in children under two years of age.” A quantative statement of DHA in g/serving must appear on the label or in the advertisement for the food.
For dietary supplement Natural Health Products, an extensive listing of permitted claims is listed in the fish oil monograph, including therapeutic claims. The conditions of use must specify the minimum and/or maximum levels of DHA+EPA, DHA:EPA ratio, and maximum permissible daily intakes.
In the European Union, Article 13 Health Claims say that DHA can maintain normal brain function, vision and blood triglyceride levels. EPA and DHA together can maintain normal heart function and blood pressure.
Article 14 health claims say that DHA can contribute to normal visual development of infants up to 12 months of age. In pregnant mothers, DHA contributes to the normal development of the eye of the fetus and breastfed infants, normal brain development of the fetus and breastfed infants.
The European Food Safety Authority assesses health claims. The agency’s criteria includes proper characterization of the food/constituent, the relevance of the claimed effect to human health, and the scientific substantiation of the claimed effect.
Down under, the general-level health claim can say that EPA and DHA (but not omega-3s) can contribute to heart health. The food must contain a minimum of 50mg EPA and DHA combined in a serving of food. And, other than for fish or fish products with no added saturated fatty acids, the food has to contain less than 28 percent saturated fatty acids and trans fats, or less than 5g per 100g saturated fatty acids and trans fats.
Andrea W. Wong, PhD, is senior scientific and regulatory consultant, Food and Nutrition Group, at Intertek Cantox.