Claims: The United States and European Perspective

In the United States (U.S.), several different types of claims can be made for dietary supplement ingredients (depending on the ingredient and degree of support for the claim). These include Health, Qualified Health, Structure Function, Nutrient Content, or Amount or Percentage of Dietary Ingredient. Health claims and qualified health claims must be approved by the Food and Drug Administration (FDA), while structure/function claims must be supported by clinical evidence, FDA pre-market approval is not required. In Europe, according to European Regulation 1924/2006 on nutrition and health claims,[1] two types of claims are allowed to be made on food supplement (or dietetic) products – nutrition claims and health claims. Each of these claims have to be approved by The European Food Safety Agency (EFSA) and the member states of the European Commission before prior to use. In general, it is believed that it is more difficult to market products sold in Europe with claims because all claims must be approved before use. However, for some dietary ingredients (such as omega fatty acids), EFSA has been more willing to allow certain claims than the FDA.

In the U.S., nutrient content claims can be made for nutrients for which recommended daily allowances (RDAs) or daily values (DVs) have been established by authoritative bodies, such as the IOM.[2] In Europe, nutrition claims mean any claim which states, suggest or implies that a food has particular beneficial nutritional properties (e.g, source of, free of, reduced). Because an RDA or DV has not been established for omega-3 fatty acids, statements implying that supplements provide a certain percentage of the RDA or DV are not permitted on labels of supplements sold in the U.S. (Table 1). An example of a U.S.-compliant claim is an amount or percentage claim such as “contains x grams of omega-3 fatty acids per serving”. Alternatively, dietary supplements may declare the amount of the omega-3 fatty acids EPA and DHA per serving on the “Supplements Facts” panel. However, no numerical value can be placed under the % DV column.  In Europe, nutrition claims for omega 3-fatty acids are permitted.[3] A claim that a food is a source of (or “high in”) omega-3 fatty acids, and any claim likely to have the same meaning for the