New Systematic Review and Meta-Analysis on Omega-3s and Bleeding Published
Paper highlights the fact that there is no association between EPA and DHA intake and bleeding risk.
A systematic review and meta-analysis of 11 randomized clinical trials (RCTs) has been published in the well-respected Journal of the American Heart Association. The conclusion of this peer-reviewed paper is, “Omega‐3 polyunsaturated fatty acids were not associated with increased bleeding risk, including fatal and central nervous system events, when compared with control.”
As background, GOED has worked for many years to inform members and healthcare professionals about the misconception that EPA+DHA intake increases the risk of bleeding. Most recently, at the 2023 ISSFAL Congress, GOED presented the findings of its systematic review of bleeding events across 78 EPA+DHA interventional studies, which concluded that there is a lack of evidence connecting EPA+DHA intake and bleeding events across RCTs. We considered working on a full meta-analysis on the subject, but then learned about this impending publication. We do plan to submit an editorial for publication that will summarize the results from our systematic review and reference the results from the current publication.
These combined results demonstrate that there is no relationship between increased EPA+DHA intake and bleeding events. In addition, findings from observational studies report no increased risk for clinically meaningful bleeding with the use of omega-3 supplements, even when combined with anti-coagulant or anti-platelet drugs. While the publication reports that intake of high-dose EPA-only pharmaceuticals was associated with an increased relative risk of bleeding events, it’s important to point out that there was only a small increase in absolute risk. This finding was discussed extensively when the US Food and Drug Administration (FDA) met in 2019 and allowed a label expansion for Amarin’s Vascepa omega-3 pharmaceutical (see November 15, 2019 Breaking News).
European Commission Provides Further MOH Information
As a follow-up to our 28 June 2024 News Alert on the MOAH draft regulation, GOED would like to inform members that we received an email from the European Commission (EC) that was sent to participants in the January 18 Stakeholder Forum. The purpose of the email was to share an FAQ document addressing general stakeholder comments (not related to specific industries), and to inform stakeholders that “commodity specific comments and data will be further discussed in the coming months, in order to come to a revised draft of the proposal.” This then needs to be approved by the Member States.
In addition, in contrast to what GOED reported previously, the email also stated that a vote on the draft regulation will not be scheduled until quarter 1 of 2025 at the earliest. The proposed effective date remains 1 January 2026.
Please note that GOED does not analyze or make any representation of accuracy for the Omega-3 News items. This is simply a compilation of news articles found on the internet that are relevant to the EPA and DHA business.
Highlights
GOED Schedules Webinar on Entering the Chinese Market
GOED is pleased to announce a new webinar for GOED members on the topic of "Selling Into the Chinese Market: What You Need to Know." The 30-minute webinar will take place on Tuesday, July 23rd at 10:00 am EDT/4:00 pm CEST and is designed to help you learn what you need to know about customs clearance, regulations and registrations, technical specifications, documentation and more. The webinar is free for all GOED members and the recording will be shared after the event takes place.
Speaking of China, on this month's Communications Committee call, GOED partner Pattern will give a presentation on e-commerce trends in China and marketplace strategy, as well as share a case study on last month's 6/18 shopping festival. The call takes place on Tuesday, July 16, at 15:00 UTC (click here for your time zone).
The Peruvian Ministry of Production (PRODUCE) has authorized the start of the Peruvian anchoveta fishing season in the southern part of the country. The season began on July 1 and the established quota is 251,000 metric tons. The season continues until December 31, 2024 or until the entire quota is caught.
The Compositional Guideline for DHA-rich oil derived from microalgae Schizochytrium sp. was updated as of 24 June 2024 to align the ‘Acceptance criteria’ for ‘Nitrogen’ between the onlineversions, with both versions now reading ‘≤ 0.02%.’ Last May GOED sent aletter to Australia’s Therapeutic Goods Administration (TGA) and requested the change.
Irish brand Revive Active has achieved Friend of the Sea certification for its omega-3 product Omega Active.
GOED is offering connections for companies looking for omega-3 related solutions or partners. If you want to include an anonymous request, please contactAshley Becnel
(New) A pharmaceutical company in Dubai is looking for fish oil with the following specs: EPA min 18%, DHA min 12%, total omega-3 min 35%, mixed natural tocopherol (as antioxidant) min 1 mg/g.
One of GOED's Clinical Study Database (CSD) Research Award Winners, Nada Abuknesha, presented her research at the recent American Society for Nutrition conference. Her presentation, "The Seizure Amelioration Effect of Omega-3 EPA and DHA Fatty Acid Supplementation on Patients With Drug Resistant Epilepsy: A Scoping Review Using the GOED Clinical Study Database," was included in the Poster and Poster Theater Flash Session.
A new pet food formula for senior dogs was launched by Japanese pet food manufacturer Mishwan. The product contains green shelled mussel for its omega-3 content.
Nature Made brand supplements from GOED member Pharmavite were once again named as a #1 Pharmacist Recommended Brand in the US by Pharmacy Times magazine.
GOED partner Women in Nutraceuticals has launched an awards program to honor those in the industry who champion gender equity, drive research innovations and excel in mentorship within the nutraceutical sector. Winners will be announced at this year's SupplySide West event.
.png?upscale=true&width=1120&upscale=true&name=Omega-3%20News%20(1).png)
