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Navigating the Omega-3 Regulatory Landscape

<p style="margin: 0in 0in 8pt;">Two key geographies and a global standard-setting body are the focus of recent regulatory developments for eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3s.</p>

The U.S. government is currently reviewing health claims for omega-3s, and selected omega-3s as a priority to review for possible dietary reference intakes.

In Japan, most of the omega-3 products submitted for approved claims under the foods with function claims category are for triglyceride lowering or cognition.

The Codex Alimentarius Commission adopted the fish oil standard during its July 2017 meeting, which will help facilitate international fair-trade practices.

Two key geographies and a global standard-setting body are the focus of recent regulatory developments for eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3s.

United States

Health claims

In November 2013, the Global Organization for EPA and DHA omega-3s (GOED) submitted a petition for an authorized health claim linking EPA and DHA to a reduction in blood pressure in the general population. In August 2014, FDA informed GOED that, based on the agency’s preliminary review, the petition would unlikely meet the standard of significant scientific agreement (SSA). GOED was given the option to have the petition reviewed as a qualified health claim (QHC), and GOED agreed. Since then, FDA has requested a record of nine extensions, the most recent on July 24, 2017. The request was for an additional 90 days, and the new deadline is Oct. 24, 2017. Previously, GOED thought the delay was tied to finalizing the AHRQ’s (Agency for Healthcare Research and Quality) report, “Omega-3 Fatty Acids and Cardiovascular Disease: An Updated Systematic Review,” (Clin Nutr. 2017 May 19. pii: S0261-5614(17)30176-0. DOI: 10.1016/j.clnu.2017.05.015) but that report was published in August 2016. Since GOED’s QHC petition was filed in August 2014, eight QHC petitions have been filed, and FDA has rendered a decision on three of them, including high amylose maize starch, macadamia nuts and soybean oil, so it’s unclear as to what is causing the delay.

Dietary Reference Intakes (DRIs)

In August 2014, EPA and DHA, along with sodium, magnesium and vitamin E, were selected as top priority nutrients for Dietary Reference Intake (DRI) reviews by the United States and Canada, “based on public health and/or policy importance.” Following the announcement of the prioritization of nutrients, the governments decided a workshop on the potential use of chronic disease endpoints in setting DRI values was needed before a DRI review would be undertaken.

In March 2015, the U.S. and Canadian governments held a two-day DRI workshop to evaluate key scientific issues involved in using chronic disease endpoints, such as cardiovascular disease (CVD), for establishing DRIs. The workshop focused on three questions, including: 1) What are the important evidentiary challenges for selecting and using chronic disease endpoints in future DRI reviews? 2) What intake-response models can future DRI committees consider when using chronic disease endpoints? 3) What are the arguments for and against continuing to include chronic disease endpoints in future DRI reviews?

In December 2016, the workshop report, “Options for Basing Dietary Reference Intakes (DRIs) on Chronic Disease Endpoints: Report From a joint U.S./Canadian-Sponsored Working Group” (Am J Clin Nutr 2017;105(Suppl):249S–85S), outlined the range of options identified to answer the three key questions, as well as the strengths and weaknesses of each option. Following the publication of the report, the Committee on the Development of Guiding Principles for the Inclusion of Chronic Disease Endpoints in Future Dietary Reference Intakes was formed and tasked with undertaking a study to assess the options presented in the report, specifically conceptual and methodological challenges identified in the report. The committee’s recommendations and guiding principles were published on Aug. 3 in a report titled “Guiding Principles for Developing Dietary Reference Intakes Based on Chronic Disease” (National Academy of Sciences).

The committee did not recommend against establishing DRIs based on chronic disease endpoints; therefore, it stands to reason future DRI reviews will be based on chronic disease risk reduction. Other than the previously announced DRI review for sodium and potassium, it’s not clear what the next steps are for determining which nutrient(s) will be reviewed next.


In Japan, the Consumer Affairs Agency (CAA) has jurisdiction over the three categories of health claims for foods, including: 1) Foods for Specified Health Uses (FOSHU), 2) Foods with Nutrient Function Claims (FNFC) and 3) Foods with Function Claims. Foods with Function Claims is the newest category (April 1, 2015) of claims, and 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 (i.e., clinical trial or systematic review) is submitted to the CAA at least 60 days prior to the product launch. While nutrients associated with Japanese DRIs are not permitted to use these types of claims, some constituents associated with nutrients with Japanese DRIs are permitted. This means a food whose active ingredient is omega-3 fatty acids cannot be a Food with Function Claims, but when the active ingredient is EPA or DHA, such food can be a Food with Function Claims. 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).

Of the 1,057 products registered, 96 products from 29 companies, including either DHA alone, or the combination of EPA and DHA, have been approved to use claims associated with omega-3s. Most of the claims are for either triglyceride lowering (EPA and DHA combination) or cognition (DHA).

Codex Alimentarius Commission (CAC)

While the CAC is not a regulatory body, often its standards are adopted as regulations, in part or in full, by countries. That makes it important to pay attention to the activity of the CAC.

Nutrient Reference Value (NRV)—Non-Communicable Disease (NCD) EPA and DHA

In November 2015, the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) met and debated, among other issues, the merits of the proposed NRV-NCD for EPA and DHA. Opponents of the proposal said it was premature to establish an NRV-NCD because, among other issues, the relationship between EPA and DHA and mortality from coronary heart disease (CHD) had not been sufficiently characterized. The lack of consensus about the scientific substantiation resulted in many country delegates recommending a third-party review of the science. It was decided that a review would be conducted by the World Health Organization (WHO) Nutrition Guidance Expert Advisory Group (NUGAG) Subgroup on Diet and Health.

In anticipation of the report and discussion at the upcoming CCNFSDU meeting, GOED’s Executive Council on Education and Outreach funded a cardiac death meta-analysis to explore the available randomized controlled trial RCT data on EPA/DHA supplementation and risk for cardiac death (Clin Lipidol. 2017 Aug 2. pii: S1933-2874(17)30395-1. DOI: 10.1016/j.jacl.2017.07.010). The results demonstrate consumption of EPA and DHA reduced the risk of cardiac death by a statistically, not to mention clinically, significant average of 8 percent. Larger effects were seen in subsets of RCTs with EPA and DHA dosages of more than 1 g/d and higher risk populations (i.e., baseline mean or median triglycerides of 150 mg/dL or more, and low-density lipoprotein [LDL] cholesterol of 130 mg/dL or more).

While the WHO’s report has been completed, it hasn’t been released for public review. If the WHO’s review returns similar results to the one commissioned by GOED, the CCNFSDU’s work to adopt an NRV-NCD for EPA and DHA will be easy. Should the results be different, then significant debate on the differences between the two analyses will occur.

Fish Oil Standard

More than eight years after the Delegation of Switzerland first introduced its proposal for new work on a standard for fish oils at the 21st Session of the Codex Committee for Fats and Oils (CCFO), the 40th Session of the Codex Alimentarius Commission adopted the standard during its July 2017 meeting. The adoption of the fish oil standard will help facilitate international fair-trade practices.

While eight-plus years may seem like a long time, consider that the issue of elaborating a standard for marine oils was first introduced almost 48 years ago during the Sixth Session (Nov. 17 to 20, 1969) of the CCFO. Discussions continued at the Seventh (March 25 to 29, 1974), Eighth (Nov. 24 to 28, 1975) and Ninth Sessions (Nov. 28 to Dec. 2, 1977), where the effort was abandoned until 2009—40 years later.

Related to the adoption of the fish oil standard, an amendment for the maximum level of arsenic in edible oils was adopted for fish oils by the CAC as recommended by the 11th Session of the Codex Committee on Contaminants in Foods (CCCF). The maximum level adopted of 0.1 mg/kg is further clarified to consider the maximum level for inorganic arsenic if necessary. By making this accommodation, oils with higher levels of organic arsenic, which is much less toxic than inorganic arsenic, can still be considered Codex compliant, provided the level of inorganic arsenic is less than 0.1 mg/kg. This is particularly important for some high phospholipid oils, which tend to contain higher levels of organic arsenic compared to other oils.

Harry B. Rice, Ph.D., is the vice president of regulatory and scientific affairs for the Global Organization for EPA and DHA Omega-3s (GOED), and the past vice president of the United Natural Products Alliance (UNPA). He has worked in the ingredient, dietary supplement, functional food and consumer packaged goods industries for more than a decade. Among Rice’s responsibilities for GOED are monitoring and reporting on regulatory issues, developing written comments and oral testimony to domestic and international government bodies to advance industry positions on critical health issues, and providing scientific analysis of the growing body of scientific literature. Previously, he spent over six years at Cargill Inc. involved in the development and execution of global regulatory and scientific strategies for a wide range of functional ingredients.

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