The US FDA has started the initial review of a petition received from GOED, asking the agency to allow a new authorized health claim about the benefits of omega 3’s.
The petition, filed by the Global Organization for EPA and DHA Omega-3s (GOED) (Ref. 1), calls for an authorized health claim regarding the relationship between the consumption of EPA and DHA – the two fatty acids in fish oil – and a reduction in blood pressure.
Hypertension impacts almost a billion people worldwide, and because it puts stress on the blood vessels, can lead to heart disease and stroke. High blood pressure is often called “the silent killer,” because many sufferers aren’t even aware they have it.
According to the petition, a meta-analysis of 70 randomized studies found that supplementing with omega-3 fatty acids significantly reduced blood pressure – and may be more effective than reducing sodium or alcohol and equally effective as increasing exercise. (Ref. 2)
Those with existing high blood pressure saw the best results, though those at risk of developing hypertension also benefitted from omega-3 supplements.
“Overall, available evidence indicates that provision of EPA and DHA reduces systolic blood pressure, while provision of less than 2 grams reduces diastolic blood pressure,” wrote researchers from the Center for Epidemiology, Biostatistics, and Computational Biology at Exponent, Inc., who headed the study.
Previous studies had shown a link between omega-3s and lower blood pressure, but the research has been limited in scope and has included food sources. The current study – which appeared in March in the American Journal of Hypertension – focused on supplements, and cast a wider net while analyzing data published over the last two years.
Researchers found that compared to a placebo, supplements containing both DHA and EPA significantly reduced both systolic and diastolic blood pressures, reducing the risk of disease.
The American Heart Association previously acknowledged that omega-3 fatty acids can help lower blood pressure, and the group recommends eating at least two servings of fatty fish a week. (Ref. 3)
The results were welcomed – but not unexpected – by longtime proponents of the health benefits of Omega-3 fatty acids.
“Results from this study build on a wealth of prior data indicating that EPA plus DHA intake reduced the risk of cardiovascular events,” said Adam Ismail, executive director of GEOD. “It is now well-established that EPA and DHA reduce triglycerides and blood pressure and even highly critical meta-analyses have found that they reduce cardiac death risk by 9 percent.” (Ref. 4)
The FDA received the petition on April 24 and now has 100 days to either file for a comprehensive review of the request – which would include a review of all 70 studies including in the March research - or deny it. A denial could come as official action from the FDA or a lack of action from the group during the 100-day time period.
If the petition is submitted for review, the FDA will publish proposed regulations for the requested use of the health claim in the Federal Register and will announce the availability of the petition for public review. If the petition goes to review, a final ruling from the FDA will come within 270 days, although the review period could be extended.
The petition was initially submitted in November, but the FDA required additional information, which it received and acknowledged on April 24.
The 100-day decision period ends on Aug. 1. You can read more about the GOED petition here.
GOED is the leading industry organization representing omega 3’s. It is GOED’s mission to research the health benefits of omega 3 DHA & EPA, promote the health benefits and promote the highest standards throughout the industry.
Xtend-Life Natural Products is a member of GOED, and we fully support GOED’s efforts to promote the health benefits of omega 3’s and the highest standards in the industry.
For further information on Xtend-Life’s Omega3 products, please click here.
1. GOED website: http://www.goedomega3.com
2. American Journal of Hypertension - A Meta-Analysis of Randomized Controlled Trials
3. American Heart Association - Fish and Omega-3 Fatty Acids
4. NUTRA Ingredients-USA