The Omega-3 Regulatory Landscape: A Quick Update

The global regulatory landscape is an ever-changing road map of claims and regulations that needs to be navigated with precision to successfully market your products on the world stage. What follows is a quick look at what’s new in three key omega-3 markets: the United States, Europe and Japan.

Much on Hold in the U.S.

Compared to other geographies, the United States has not been as progressive and supportive of realizing the public health benefits of the long-chain omega-3s eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). There is neither a dietary reference intake (DRI) nor an FDA-approved health claim that accurately reflects the current state of the science; right now, we are in a holding pattern as we wait for the federal government to go through its due process. The two areas where there was activity in the last year are in the areas of DRIs and health claims.

On July 31, 2013, GOED (Global Organization for EPA and DHA Omega-3s) nominated EPA and DHA for DRI review in response to a call for nominations from Canada and the United States. On Aug. 15, 2014, it was announced that EPA and DHA, along with three other nutrients, had been selected as top priority nutrients for DRI reviews. Prior to the commencement of any DRI review, however, Canada and the United States decided to hold a workshop to discuss chronic disease endpoints for DRIs. That workshop was held on March 10 and 11, 2015. Other than knowing that two or three manuscripts will be published based on the discussions at the workshop, the next steps are unknown. What’s clear, however, is that it will likely be several years before the next DRI review is initiated.

Turning to health claims, the industry has had a qualified health claim since 2004: "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] provides [ ] gram of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat, and cholesterol content.]". However,  the body of scientific evidence supporting the cardiovascular benefits of omega-3s has grown significantly since that time and the industry is extremely interested in having a health claim that reflects the current state of the science.

In November 2013, GOED submitted a health claim petition for EPA and DHA and the reduction of blood pressure in the general population. The petition was based on a meta-analysis of 70 randomized clinical trials and concluded that provision of EPA+DHA reduces systolic blood pressure, while provision of greater than or equal to 2 grams reduces diastolic blood pressure (Miller et al., 2014). In July 2014, FDA informed GOED that, based on the agency’s preliminary review of the health claim petition, it was unlikely to meet the standard of significant scientific agreement (SSA). For this reason, GOED agreed to a qualified health claim (QHC) review. While a decision from FDA was due May 4, 2015, FDA requested a 90-day extension with a new decision date of Aug. 3, 2015. On July 31, 2015, FDA contacted GOED and requested another 90-day extension with a new decision date of Nov. 2, 2015.

EU Is Far More Progressive

Those marketing omega-3-rich oils in the European Union are likely familiar with the numerous claims (nutrition and health) that have been authorized for use. In addition to the allowance of nutrition claims, the European Food Safety Authority (EFSA) has returned more positive opinions for EPA and DHA than any other nutrient. In the EU, health claims are classified as either Article 13 (health claims other than those referring to the reduction of disease risk and to children's development and health) or Article 14 (reduction of disease risk claims (1)(a) and claims referring to children's development and health (1)(b)). Thus far, nine health claims, including six Article 13(1) and three Article 14(1)(b) have been authorized for use.

While nine claims are already approved and in use, there are two newer developments. In October 2014, EFSA delivered a positive opinion on the scientific substantiation for a health claim pursuant to Article 14(1)(b) for “DHA contributes to normal brain development." According to the opinion, in order to bear the claim, foods for children ages 6 to 24 months should provide a daily intake of 100 mg DHA in one or more servings, while foods for children from 2 to 18 years should provide a daily intake of 250 mg DHA in one or more servings. If the panel’s opinion carries through for adoption as is, the claim would stress the importance of DHA for children.

Second, on July 24, 2015, DSM Nutritional Products submitted a dossier for an Article 13.5 health claim for “DHA contributes to improved memory function." The claim is under consideration with the mandate number of M-2015-0165 and question number of EFSA-Q-2015-00456.

New Claim Category Established in Japan

In Japan, the Consumer Affairs Agency (CAA) has jurisdiction over the three categories of health claims for foods, including: Foods with Function Claims, Foods with Nutrient Function Claims and Foods for Specified Health Uses (FOSHU). A new claim category, Foods with Function Claims, was launched April 1, 2015. Foods in this category are permitted to make claims about the health benefit of the finished product or active ingredient if a notification with appropriate scientific substantiation is submitted to the CAA at least 60 days prior to the product launch.

As of Aug. 7, 2015, 67 products have been accepted by the CAA and thus far, one omega-3 claim in this category has been approved for a food with 600 mg EPA and 260 mg DHA from Asahi Food and Healthcare. The approved claim is, “This product contains EPA and DHA. It is reported that EPA and DHA has function to reduce triglyceride and supports the health of people who have high triglyceride level."

Nutrients associated with Japanese DRIs are not permitted to use Foods with Function Claims; however, some constituents associated with nutrients with Japanese DRIs are permitted. For the omega-3 industry, this means if a food’s active ingredient is omega-3 fatty acids, it cannot be a Food with Function Claim, but when the active ingredient is EPA or DHA, such food can be a Food with Function Claim. Despite urging from GOED, Foods with Function Claims cannot be used to market products to individuals with disease, children or expectant mothers (including those who are planning to become pregnant).

Harry B. Rice is the vice president of regulatory and scientific affairs at the Global Organization for EPA and DHA Omega-3s (GOED).