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 consumer, may be made where the product contains at least 0.3 g (or 0.6 g) alpha-linolenic acid per 100 g and per 100 kcal, or at least 40 mg (or 80 mg) of the sum of eicosapentaenoic acid and docosahexaenoic acid per 100 g and per 100 kcal.

As a consequence of the stringent requirements, the hardest and most sought after claim in the U.S. is a health claim, which must be authorized by the FDA. As a result of the high threshold set by FDA to meet “significant scientific agreement (SSA),” relatively few substances have been authorized to bear a health claim. FDA has determined that evidence to support the level of SSA for omega-3 fatty acids is inadequate, but as shown in Table 1, a qualified health claim is permitted. However, supplement manufacturers’ use of this claim is rare because the FDA-mandated claim language is long and is not persuasive (e.g., a claim might be qualified as “supportive but not conclusive research”) and does not have the assertive qualities needed to promote the product. Therefore the structure/function claim of omega-3 fatty acids support of “heart health” is more widely used. Structure/function claims for brain and eye health are also used in the U.S., without any objections from the FDA to date.

In Europe, health claims are defined as claims that state, suggest or imply that a relationship exists between a food category, a food or one of its components and health. This definition includes:

Health claims related to (a) the role of a nutrient or other substance in growth, development or function of the body; (b) psychological and behavioral functions, or (c) slimming, weight-control, satiety or reduction of available energy (defined in article 13 of Regulation (EC) No 1924/2006 (1) AND
Health claims referring to the reduction of a risk factor in the development of a disease and related to children’s development (defined in article 14 of Regulation (EC) No 1924/2006) (1)

Since 2008, EFSA has been evaluating generic health claim dossiers submitted by companies or national associations. Articles 15 to 18 of Regulation (EC) No 1924/2006 lay down the Community authorization procedure, which consists of different steps involving the national authorities EFSA and European Commission.1 The applicant first has to send the heath claim authorization request to a Member state, which must check the admissibility of the dossier before forwarding it to EFSA. EFSA must evaluate the dossier and give its opinion within five months. If further information is required, one or two months may be added, depending on the type of claim. EFSA opinions are published on its website. For health claims (article 13), the European Commission has to make a final decision in two months if the opinion is positive. In the opposite case (and for health claims defined in article 14), European Commission has to draft a decision, which will be adopted by Comitology with the scrutiny right of the European Parliament. The final goal of European Commission is to draw up a register of health claims authorized after a rigorous scientific assessment. To date, EFSA has already evaluated many dossiers with a majority of negative opinions. A common reason for rejection is use of language suggesting the ingredient reduces symptoms of disease (which is permitted for drugs only) and not risk factors of disease (as permitted by article 14 of Regulation (EC) No 1924/2006). Positive opinions are published on the EFSA website, with suggested wording.[4] EFSA proposals for wording have to be validated by every Member-State as per their culture, their vocabulary, and their linguistic sensitivity.

As shown in Table 1, several health claims for the specific omega 3 fatty acids DHA and EPA have been issued positive opinions by EFSA, including those for normal function of the heart and maintenance of normal blood pressure, triglyceride concentrations, brain function, and vision. A heath claim for vision development in infants also is permitted. The regulations state levels of omega 3 fatty acids that must be present in order to make the claims. The health claims for omega-3 fatty acids in Europe are brief and positive in nature. The common thread of the health claims that have been authorized for omega-3 fatty acids in Europe is use of the words “contributes to the maintenance of normal”. Use of the terms “maintains health of….” is found on many of the structure function claims located on labels for omega-3 fatty acid-containing supplements in the U.S. (available from U.S. National Library of Medicine Dietary Supplements Labels Database). In short, the wording of these claims is more similar to permitted structure function claims than qualified health claims in the U.S. Therefore, although the European system may appear to be more restrictive than the U.S., the case study with omega-3 fatty acids shows that this is not necessarily so. The take home message is that the same claim that is used as a structure/function claim in the U.S. may be permitted as a health claim in Europe, provided that there is substantive evidence supporting the claim at the level of usage and the proper procedures for obtaining the claim are followed.

Table 1. Claims for Omega Fatty Acids in US and in Europe