Japan Consumer Affairs Agency Issues Violation for ‘Misleading’ Omega-3 Product(s)
Thank you to Mr. Takeshi Takeda, president of GOED partner Global Nutrition Group (GNG), for providing the following information about a recent issue in Japan concerning Foods with Function Claims. Members can contact GNG directly with additional questions.
On June 30, a corrective order was issued by Japan’s Consumer Affairs Agency (CAA) based on the systematic review (SR) submitted for a Foods with Function Claims (FFC) claim for the reduction of triglycerides by EPA & DHA. The claim was found to be in violation of the Act Against Unjustifiable Premiums and Misleading Representations within the functional food labeling system.
The main point of contention was the recommended daily intake for the reduction of triglycerides by EPA & DHA. In the SR, which was cited as the scientific basis for the relevant notification, it was determined that there were no rational grounds for the recommended daily intake level, as there were both positive and neutral studies regarding its effectiveness. Specifically, the SR found that studies with higher intake levels of EPA and DHA tended to yield more positive results, while studies with lower intake levels showed a mixture of positive and neutral outcomes, and there were more neutral than positive papers. It’s important to note that only this particular SR has been rejected.
The FFC system does not specifically designate who should conduct the SR. The notifier, i.e., stakeholder, can submit its own SR to enable functional labeling, or in many cases, companies receive SRs from raw material manufacturers and use those for their submissions.
In the present case, the selling company (brand owner) received the SR from the raw material manufacturing company, and due to deficiencies in the scientific basis of that SR, they received a corrective order. There are 31 other products (in the case of EPA & DHA) that have used the same SR for their notifications. Consequently, the CAA requested that the submitted documents be reexamined and requested individual reports from the named companies.
As of July 27, there have been seven products that have voluntarily withdrawn their notifications, while another 22 products have not requested a withdrawal of their notifications. It is essential to note that the corrective order issued this time does not necessarily invalidate the effectiveness of EPA & DHA, and there are approximately 200 EPA & DHA products on the market with triglyceride-lowering claims. Rather, it reflects a need for companies to adopt a more rigorous approach to their scientific practices.
In related news, the CAA is reportedly reviewing the methods that companies use to support the science behind their products. According to Mr. Takeda, two violations are under scrutiny — one addresses the issue above and the other challenges the products’ advertising language.
Mr. Takeda offered the following advice to GOED members interested in an FFC.
Firmly understand and follow the FFC notification guidelines.
The guidelines are frequently revised so keep up to date on the latest information.
Read not only the guidelines, but also the Q&A. The Q&A provides specific explanations on points that are difficult to understand from the guidelines alone.
Be sure to represent the science accurately to not mislead consumers.
As further background on Foods with Functions Claims, the CAA created a Guidance for Industry in 2015 when the FFC system was launched.
Member Request for Brand Member Companies: In Which Countries Are Your Products Sold?
GOED member companies should be the preferred choice for consumers, given members’ commitment to the quality and ethics standards outlined in the GOED Monograph. To help consumers and health practitioners know which brands to look for on store shelves or online, GOED has developed a handout that lists all GOED member companies' brands.
Brands featured on the front of the infographic are meant to be country-specific, with the original resource designed for North American target audiences. We also have a resource for the Turkish market (with translation help provided by GOED member Sifar Ilaclari) and would like to design similar handouts for other countries.
To do this, we need information from you! Please email Elana Natker, GOED’s director of consumer and health practitioner communications, with the following information:
Name of company
Name of brand(s) – if different from company
Country or countries where your brands are sold
If you’d be willing to help translate the infographic into your native language
Member Question of the Month
GOED is polling members to better understand what trade shows and regions are important to our members over the next two years. As you know, we host the Omega-3 Resource Center multiple times each year in various countries. Given relaxed travel restrictions and developments in emerging markets, we are evaluating the best trade shows for members' time and resources. Please submit your feedback in this short poll.
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
Member Feedback on Meta's New Threads App
Last month, we asked our members "Is your company on Threads, the new Meta app that competes with Twitter?" With 30 responses from our newsletter and LinkedIn surveys, here is the result:
Reminder: Next Week's Horizon Scan Webinar
Don't forget to register for next week's webinar on the GOED-commissioned “horizon scan” report from sustainable food consultancy Tasting the Future. The webinar will feature highlights of the more than 20 environmental, social and governance trends included in the report and takes place on August 16, 15:00 UTC [click here for your local time zone].
Breaking News from Last Week: Exploratory Fishing Session Authorized in Peru
The Ministry of Production (PRODUCE), the body that oversees anchovy fishing activities in Peru, authorized an exploratory fishing period of up to 10 days, which began August 3.
The research on omega-3s continues to evolve. Since February 2021, around 5,000 new studies about EPA and DHA omega-3s have been published. The GOED Clinical Study Database (CSD) catalogues and categorizes all studies and using the CSD helps save time searching through the thousands of studies to find articles specific to the question of interest. Please reach out to Kaitlin Roke, PhD, to request a demo or learn more about the CSD.
Production & Supply Chain
GOED member Trident Seafoods has begun building its new processing plant, which will be operational by 2027, in Unalaska’s Captains Bay, Alaska.
Amarin Corporation and Lotus Pharmaceuticals have entered a long-term exclusive partnership to distribute and commercialize Amarin's EPA ethyl ester drug — under the Vazkepa name — across ten countries, including nine in Southeast Asia and South Korea.
Singapore’s Health Sciences Authority is expanding the types of health supplements applicable for voluntary notification, which will now include omega-3 fatty acids.
New Zealand and the European Union have signed a free trade agreement, which will eliminate export tariffs, provide fair treatment for investors, improve market access and reduce compliance requirements to enhance trade efficiency between the two regions. The agreement will come into effect in Q1 2024 pending ratification by both parties.
GOED is offering connections for companies looking for omega-3 related solutions or partners. If you are interested in including an anonymous request, please contact Ashley Becnel.
(New) A company is looking for API fish oil to produce 25 million (1000mg) capsules.
A company is looking for 18:12 fish oil, 33:22 fish oil and a USP-certified and MSC-certified cod liver oil that also contains 5000A and 500D. [Posted 7/31/2023]
French company RetiNov has developed a technology to assess the bioavailability of omega-3 in the retina. It identified a blood biomarker of retinal omega-3 polyunsaturated fatty acid (PUFA) status, which is significantly related to the onset of retinal diseases, such as age-related macular degeneration (AMD), and increased with supplementation in omega-3 PUFAs. This blood biomarker may serve as a practical tool to monitor the adherence to and the efficiency of supplementation interventions. The principle of this technology has been published and the company is looking for collaborators. [Posted 7/10/2023]
Taiwanese health food manufacturer Daiken Biomedical won its third consecutive Grand Gold Quality Award at the 59th Monde Selection for its Fish Oil Concentrate, sourced using oils from GOED member KD Pharma. The Monde Selection is commonly called “the Oscars of the International Food Industry.”
National Geographic recently published an article titled, "Omega-3s are more critical for your health than we thought." The article was written by nutrition expert Jill Weisenberger, who was in the audience during GOED's presentation at the FoodFluence RD event earlier this year.
US company Champion Petfoods introduced a new wet cat food line Acana Premium Pâté, which consists of six recipes, all containing salmon oil to provide omega-3s.
US pet nutrition company Badlands Ranch has released its inaugural pet supplement, Super20. This powder supplement can be used as a food topper and contains several functional ingredients including Deep Sea Omega-3 powder to support the overall well-being of the pet.
GOED member Epax completed the SMETA 4 Pillar audit by supply chain assessment platform Sedex, which is designed to help companies understand standards of labor, health and safety, environmental performance and ethics.
US tuna fishing company Tri Marine has equipped all of its longline tuna vessels operating in the Atlantic Ocean with FlyWire electronic monitoring systems to track their fleet and collect data on vessel performance.
A research study conducted by Oregon State University revealed that despite over four decades of conservation spending amounting to over US$9 billion (€8.2 billion), the stocks of wild salmon and steelhead in the Columbia River Basin have not improved.
Amarin Corporation released its second quarter financial results. Total net revenues amounted to US$80.2 million (€73.32 million), a 15% decrease year-on-year. US$65.2 million (€59.61 million) was net product revenue and US$15 million (€13.7 million) was licensing and royalty revenue.
Canadian plant-based seafood brand Konscious Foods raised $26 million (€24 million) in a seed financing round to expand its business into food service and retail in North America. Its plant-based seafood products are fortified with DHA algal oil.
Seafood certification group the Global Seafood Alliance (GSA) has recruited Steve Disko to its market development team, where he will be representing GSA's Best Aquaculture Practices and Best Seafood Practices certification programs.
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