Weekly Roundup: Aker BioMarine reports strong Q1 2022 results, FDA limits toxic lead in juice

29 Apr 2022 --- This week in nutrition news, Aker BioMarine unveiled revenues of US$56.9 million for its first quarter of 2022, fueled by growth within the Qrill and Superba krill categories. To further reduce exposure to toxic elements in foods, the US Food and Drug Administration (FDA) is taking steps to limit lead in juice products. Meanwhile, a study revealed that calcium supplements have been related to an increased risk of death in elderly populations with heart valve dysfunction.

In brief: Business news
Developer of krill-derived products, Aker BioMarine, reported revenues of US$56.9 million for the first quarter of 2022, up 14% from the same quarter last year. The company’s growth was fueled by the Qrill category, which saw US$17 million in the quarter, up 38% compared to a year ago. Additionally, a study demonstrating the growth and mortality benefits of Qrill Aqua in shrimp diets and separate research confirmed positive effects on growth, health and filet quality of Qrill Aqua in salmonid diets. To add to this, Aker BioMarine experienced growth within the Asia region and Superba Krill sales of US$13 million, which were impacted by high volume sales in Q4 2021. Taking a look into the future, the company targets sales in Superba above US$18 million in Q2 2022. Although there may be seasonal and operational changes from year to year, the company anticipates annual harvesting volumes of 55,000-60,000 tonnes. The harvesting volume this year has been around 25,800 tonnes.

The FDA issued draft guidance for lead in juice, featuring action levels for lead in ready-to-drink apple juice and other juices.The FDA issued draft guidance for lead in juice, featuring action levels for lead in single-strength (ready-to-drink) apple juice and other single-strength juices and juice blends. This is part of the FDA’s broader efforts to reduce exposure to lead, arsenic, mercury and cadmium from foods and advance the goals laid out in the Closer to Zero action plan – the agency’s science-based strategy to decrease toxic element exposure in foods. This draft guidance may lower the risk of adverse health impacts from dietary lead exposure. In detail, the Action Levels for Lead in Juice: Draft Guidance for Industry provides draft action levels of 10 parts per billion (ppb) for lead in single-strength apple juice and 20 ppb for lead in all other single-strength juice types. The FDA estimates that establishing a 10 ppb action level could result in a 46% reduction in exposure to lead from apple juice in children.

In brief: Advertisement regulations
The appellate advertising law body of BBB National Programs, the National Advertising Review Board (NARB), determined that Goli Nutrition’s “Apple Cider Vinegar” gummies product name is not misleading. The advertising at issue had been challenged before BBB National Programs’ National Advertising Division (NAD) by Bragg Live Food Products, a competing manufacturer of an apple cider vinegar product in capsule form. In agreement with NAD, the NARB panel determined that the product name “Apple Cider Vinegar” is not false and noted that Bragg did not submit any consumer research that might have shown that the name alone misleads consumers as to either the amount of apple cider vinegar in the gummies or any health benefits they provide. 

In a separate case handled by NAD, the manufacturer of OmegaVia Fish Oil and OmegaVia EPA dietary supplements, Innovix Pharma’s qualified claims are supported. However, it recommends that some OmegaVia performance claims be dropped. According to NAD, Innovix Pharma can make qualified claims about EPA and DHA supplementation to support heart health and a healthy diet and exercise. However, NAD recommended that the advertiser discontinue the challenged product performance claims and testimonials relating to heart health and triglyceride management. The claims at issue were challenged by Amarin Pharma, the manufacturer of the FDA-approved cardiovascular drug Vascepa. NAD determined that the advertiser did not provide competent and reliable scientific evidence or any studies on its products demonstrating their impact on mood improvement. Therefore it was recommended for these claims to be discontinued.

Cat Media was fined a total of AUD$39,960 (US$28,551) by the TGA for advertising unregistered weight-loss goods.Cat Media was fined a total of AUD$39,960 (US$28,551) for advertising unregistered weight-loss goods. This is the third time the Therapeutic Goods Administration (TGA), part of Australia’s Department of Health issued such notices to Cat Media for this type of advertising. TGA issued the fines for alleged unlawful advertising of three complementary medicines not entered on the Australian Register of Therapeutic Goods (ARTG). The three unapproved products include FatBlaster, FatMagnet, FatBlaster Apple Cider Vinegar & Garcinia Max and FatBlaster Max. Cat Media allegedly advertised the FatBlaster products on the Chinese language section of its website after paying infringement notices for similar alleged unlawful advertisements presented in English. The medicines were not entered on the ARTG. Therapeutic goods not entered on the ARTG cannot be advertised to Australian consumers unless a valid exemption or exclusion applies.

In brief: Announcements
The trade association for the dietary supplement and functional food industry, The Council for Responsible Nutrition (CRN), commented on the recent passing of Senator Orrin Hatch. In partnership with his democratic colleague Senator Tom Harkin, Senator Hatch established the Dietary Supplement Health and Education Act of 1994 (DSHEA). Since its enactment, the supplement market has risen from US$4 billion to US$56 billion. According to CRN, Senator Hatch was a great statesman and a strong advocate for the supplement industry.

In brief: Research and studies
Calcium supplements, commonly given to older people to prevent osteoporosis, have been linked to a higher risk of death among those with aortic valve stenosis, a progressive and potentially fatal condition. According to a study conducted by the Medical University of Vienna, Austria. Calcium supplements seem to worsen the condition, which is the most common form of heart valve disease in adults in the developed world, irrespective of whether or not they are combined with vitamin D, the findings show. The researchers tracked the heart health of 2657 patients (average age 74) with mild to moderate aortic stenosis. Participants were divided into those not taking any supplements, those supplemented with vitamin D alone, and those given calcium, plus or minus vitamin D supplements. More than a third of people in each group developed severe aortic stenosis after five years. Those taking supplements had significantly more diabetes and coronary artery disease than those not taking supplements. They were also more likely to be taking statins, warfarin, and phosphate binders (to limit phosphorus absorption), having had a coronary artery bypass graft and needing kidney dialysis. Aortic stenosis occurs when the aortic valve, the main outflow valve of the heart, stiffens and narrows. The only effective treatment is the replacement of the faulty valve, a procedure known as AVR (aortic valve replacement).

Research found vitamin K2 and vitamin D supplements slow calcium deposits on the aortic valves of older men.A study conducted by four Danish hospitals and published in the American Heart Association journal Circulation strengthened previous research that showed vitamin K2 supplements could slow the progression of aortic stenosis, a narrowing of the valve that controls blood flow from the heart to the rest of the body. The study included 365 male participants who ingested vitamin K2 and vitamin D. The results showed the group taking the supplements experienced slower calcification progression in their coronary arteries. However, it did not slow down the process once it had already begun. Researchers also said because the study only included men, the findings do not apply to women. Research has suggested eating a diet high in vitamin K can benefit heart health.

Japan-based Okinawa Institute of Science and Technology Graduate University (OIST) and Corundum Systems Biology unveiled a research project called MANTA to develop a fully automated system to predict diseases and discover cures by the fiscal year 2024. The comprehensive examination of gut microbes and genomes will help with this. The group will construct a highly automated complete analytic system and conduct multi-omics research on the genome, metabolism-related variables, symbiotic microbes and three years of the first phase. This is part of a larger project to create a system that uses artificial intelligence and robotics to enable autonomous scientific discovery. The first step is to create a completely automated, comprehensive analysis system that includes gut bacteria and other microorganisms. The collaborative lab initiative will enable large-scale human multi-omics research, paving the way for novel health and longevity discoveries.

By Nicole Kerr