08.23.23
An article published today in JAMA Cardiology by researchers at University of Texas Southwestern Medical Center called for stricter regulation around structure/function claims present on the labels of fish oil supplements.
The paper gathered data on the health claims and dosages of nearly 3,000 fish oil supplements on the market and found that 73.9% of products possessed at least one health claim.
Health claims, the authors noted, were mostly related to heart health, followed by brain and joint health respectively. Most claims were structure-function claims by nature, while only a small portion were qualified health claims approved by the U.S. Food and Drug Administration (FDA) using the specific language advised by the agency.
“One in five U.S. adults older than 60 years takes fish oil supplements often for heart health despite multiple randomized clinical trials showing no data for cardiovascular benefit for supplement-range doses. Statements on the supplement labels may influence consumer beliefs about health benefits,” the authors wrote.
Across 2,819 unique products, 73.9% made at least one health claim. Of these, 399 (19.2%) used FDA-approved qualified health claims while the rest (1683, 80.8%) made only structure-function claims, which are intended to apply to healthy populations, and 62% of these claims were related to heart health.
The authors noted that there were significant differences in the dosages of EPA, DHA, and total EPA and DHA content in the supplements they tested.
“Results of this cross-sectional study suggest that the majority of fish oil supplement labels make health claims, usually in the form of structure/function claims, that imply a health benefit across a variety of organ systems despite a lack of trial data showing efficacy,” the authors concluded. “Significant heterogeneity exists in the daily dose of EPA+DHA in available supplements, leading to potential variability in safety and efficacy between supplements. Increasing regulation of dietary supplement labeling may be needed to prevent consumer misinformation.”
FDA approved a qualified health claim in 2004 related to omega-3s’ potential to reduce the risk of coronary artery disease. In 2019, the agency announced new qualified health claims related to both hypertension and coronary heart disease.
CRN: Structure Function Claims Have Important Role in Consumer Choice
CRN criticized the report for downplaying the role of structure/function claims in helping healthy individuals choose beneficial products.
While structure/function (S/F) claims are not qualified by FDA, the agency still regulates these claims, and S/F claims have clearly different purposes than Qualified Health Claims (QHCs), noted CRN.
“The report appears to ignore that S/F claims and 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 noted, and therefore, different levels of evidence are required. “While S/F claims might 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.”
“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 regiments 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.”
While there are substantial differences in doses across omega-3s products, CRN said there is a need to recognize the drastic differences in how much EPA or DHA one individual versus another should supplement their diet with.
“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,” CRN concluded.
GOED: Report Downplays Positive Evidence
According to Harry B. Rice, vice president of regulatory and scientific affairs at the Global Organization for EPA and DHA Omega-3s (GOED), the authors’ conclusion that “increasing regulation of dietary supplement labeling may be needed to prevent consumer misinformation” was misguided.
“The authors are clearly unfamiliar with U.S. dietary supplement regulations and how to substantiate structure/function claims,” Rice said.
He noted that the authors limited their scope by focusing only on triglyceride-lowering claims and inappropriately comparing the effects of fish oil supplements to those of pharmaceutical preparations of EPA and DHA, such as Vascepa or Lovaza.
Rice noted that there is sGcientific evidence backing other kinds of structure/function claims related to brain, joint, and eye health.
He said that it wasn’t clear why the authors challenged these claims, or any others – the authors never reported conducting a review of any scientific literature.
“A quick search of GOED’s Clinical Study Database provided confirmation that trial data exists,” Rice said.
Lastly, while there are differences in EPA and DHA dosages from one supplement to the next, Rice noted that there are no regulations requiring a certain level of EPA or DHA to be present in a product in order to make such health claims.
The paper gathered data on the health claims and dosages of nearly 3,000 fish oil supplements on the market and found that 73.9% of products possessed at least one health claim.
Health claims, the authors noted, were mostly related to heart health, followed by brain and joint health respectively. Most claims were structure-function claims by nature, while only a small portion were qualified health claims approved by the U.S. Food and Drug Administration (FDA) using the specific language advised by the agency.
“One in five U.S. adults older than 60 years takes fish oil supplements often for heart health despite multiple randomized clinical trials showing no data for cardiovascular benefit for supplement-range doses. Statements on the supplement labels may influence consumer beliefs about health benefits,” the authors wrote.
Across 2,819 unique products, 73.9% made at least one health claim. Of these, 399 (19.2%) used FDA-approved qualified health claims while the rest (1683, 80.8%) made only structure-function claims, which are intended to apply to healthy populations, and 62% of these claims were related to heart health.
The authors noted that there were significant differences in the dosages of EPA, DHA, and total EPA and DHA content in the supplements they tested.
“Results of this cross-sectional study suggest that the majority of fish oil supplement labels make health claims, usually in the form of structure/function claims, that imply a health benefit across a variety of organ systems despite a lack of trial data showing efficacy,” the authors concluded. “Significant heterogeneity exists in the daily dose of EPA+DHA in available supplements, leading to potential variability in safety and efficacy between supplements. Increasing regulation of dietary supplement labeling may be needed to prevent consumer misinformation.”
FDA approved a qualified health claim in 2004 related to omega-3s’ potential to reduce the risk of coronary artery disease. In 2019, the agency announced new qualified health claims related to both hypertension and coronary heart disease.
CRN: Structure Function Claims Have Important Role in Consumer Choice
CRN criticized the report for downplaying the role of structure/function claims in helping healthy individuals choose beneficial products.
While structure/function (S/F) claims are not qualified by FDA, the agency still regulates these claims, and S/F claims have clearly different purposes than Qualified Health Claims (QHCs), noted CRN.
“The report appears to ignore that S/F claims and 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 noted, and therefore, different levels of evidence are required. “While S/F claims might 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.”
“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 regiments 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.”
While there are substantial differences in doses across omega-3s products, CRN said there is a need to recognize the drastic differences in how much EPA or DHA one individual versus another should supplement their diet with.
“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,” CRN concluded.
GOED: Report Downplays Positive Evidence
According to Harry B. Rice, vice president of regulatory and scientific affairs at the Global Organization for EPA and DHA Omega-3s (GOED), the authors’ conclusion that “increasing regulation of dietary supplement labeling may be needed to prevent consumer misinformation” was misguided.
“The authors are clearly unfamiliar with U.S. dietary supplement regulations and how to substantiate structure/function claims,” Rice said.
He noted that the authors limited their scope by focusing only on triglyceride-lowering claims and inappropriately comparing the effects of fish oil supplements to those of pharmaceutical preparations of EPA and DHA, such as Vascepa or Lovaza.
Rice noted that there is sGcientific evidence backing other kinds of structure/function claims related to brain, joint, and eye health.
He said that it wasn’t clear why the authors challenged these claims, or any others – the authors never reported conducting a review of any scientific literature.
“A quick search of GOED’s Clinical Study Database provided confirmation that trial data exists,” Rice said.
Lastly, while there are differences in EPA and DHA dosages from one supplement to the next, Rice noted that there are no regulations requiring a certain level of EPA or DHA to be present in a product in order to make such health claims.
