AUGUST 23, 2023
WASHINGTON – The Council for Responsible Nutrition (CRN), the leading trade association representing the dietary supplement and functional food industry, provides its perspective on the JAMA Cardiology report on fish oil health claims that was released today.
The JAMA Cardiology report suggests that most fish oil supplement labels make claims about health benefits without trial data to support their efficacy. The report criticizes dietary supplement companies’ use of structure/function (S/F) claims specifically—a type of claim permitted for dietary supplements and regulated by FDA—and suggests these claims are inferior to FDA-reviewed qualified health claims. The report appears to ignore, however, that S/F claims and Qualified Health Claims (QHCs) serve different purposes—one to provide general non-disease specific health information to consumers and the latter are permitted to discuss the relationship between a nutrient and disease risk. CRN notes that S/F claims still must be supported by scientific evidence, however, the type of evidence required is different from the evidence required to support QHC claims that discuss disease risk. While S/F claims may not have the same level of scientific substantiation as qualified health claims, they still require evidence to support their validity and provide consumers with valuable health information.
Claims on existing product labeling reflect researched health benefits associated with these ingredients. For example, according to NIH’s Office of Dietary Supplements: “…fish oil and other [long-chain] omega-3 supplements lower triglyceride levels and might reduce the risk of some cardiovascular endpoints, especially among people with low dietary omega-3 intakes.” Additionally, existing labeling, as the authors point out, carry the appropriate legal disclaimers regarding the limitations of those claims.
“The call for ‘additional regulation of dietary supplement labeling’ is both predictable and unsupported by the research,” said Steve Mister, President and CEO of CRN. “Consumers should always discuss their supplement regimens with their healthcare providers, but there is nothing in this study that should persuade consumers to change their omega-3 regimens for better health. Ultimately, this study demonstrates an amazing lack of understanding of the many different reasons why consumers choose to use supplements for better health.”
And, as the JAMA Cardiology report also references, in 2004, and again in 2019, the FDA additionally allowed QHCs regarding health benefits associated with coronary heart disease and high blood pressure, respectively, for conventional foods and dietary supplements that contain EPA and DHA.
The report highlights variability in the daily doses of EPA and DHA across different fish oil supplements. However, it's important to recognize that individual nutritional needs vary, and people consume different amounts of omega-3 fatty acids in their diets. Not all consumers require the same dosage, or take fish oil supplements for the same reasons, and the presence of various dosage options allows consumers to choose a supplement that aligns with their specific needs, dietary habits, and based upon the advice of their health care practitioner.
Lastly, the study suggests that increasing regulation of dietary supplement labeling is necessary to prevent consumer misinformation. Yet, the current regulations permitting structure/function claims provide consumers with the information they need to make informed choices. CRN believes that any attempt to limit the diversity of claims and dosages available to consumers would only hinder their ability to choose supplements that align with their personal preferences and needs.
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 200+ dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. Follow us on Twitter @CRN_Supplements and LinkedIn.