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REGULATORY FDA publishes adverse events data; industry ponders impact FDA, Natural Products INSIDER, SafetyCall International In an effort to support transparency, FDA, for the first time, is publishing data on adverse events related to cosmetics, food and dietary supplements. The first data released covers the period from 2004 to September 2016, and subsequent data will be published quarterly. The agency hopes the effort will result in more detailed and complete reports and flag possible safety issues more rapidly. But UNPA member SafetyCall notes in a recent commentary: "Though FDA uses the data to flag safety issues or reports that may require further follow-up, it has not verified that the reported events were actually caused by the product in question. In other words, CAERS data does not represent conclusions by the FDA that a product caused a reported event." Read coverage: FDA publishes adverse events on dietary supplements and conventional foods→ FDA now making data available from CFSAN's Adverse Event Reporting System (CAERS)→ CFSAN Adverse Event Reporting System→ (access the 2004-2016 report here) REGULATORY
FTC issues policy to enforce tighter claims on homeopathic medicines Natural Products INSIDER, NPR.org FTC has issued an enforcement policy statement that could cause trouble for homeopathic medicines. The agency has said it will hold safety and efficacy claims for OTC homeopathic drugs to the same standard as products making similar assertions. So, health-related claims must be backed by competent and reliable scientific evidence, which generally includes human clinical trials. Industry manufacturers are not happy with the change, but some companies say they will change their labels to reflect the requirements. Read coverage: FTC: Homeopathy marketing claims are likely misleading without disclaimer→ Time for homeopathic remedies to prove that they work→ ORGANICS USDA publishes draft guidance on calculating organic in multi-ingredient products USDA.gov Given that the USDA organic rule establishes labeling categories based on the percentage of organic in products, a new draft guidance provides further insights on how to calculate the percentage of an organic ingredient in multi-ingredient products. The guidance also provides procedures for calculating organic in single-ingredient products and carbonated beverages and how to exclude water and salt from processed organic products. Comments on the draft are due by Feb. 6, 2017. Read more→ LEGAL Guilty verdict in 5-Hour Energy case may deter counterfeiting Foodnavigator-usa.com The guilty verdict and $20 million penalty in the recent 5-Hour Energy product-counterfeiting case could serve as an important deterrent, according to the plaintiff’s attorney, who represented the brand owner Living Essentials. He noted that though counterfeiting is fairly common, it is rarely prosecuted, making the guilty verdict significant. Read more→ REGULATORY New guidance offers insight on fiber definitions, but prebiotics still vague Nutraingredients-usa.com This article provides some insight on the recently released guidance from FDA on fiber status and what it may mean to marketers of prebiotics, which remain in a regulatory limbo of sorts. The rule has left out a number of products on the market, like inulin, until manufacturers submit petitions to be included in the definition of a dietary fiber.Read more→ MERGERS & ACQUISITIONS Wessanen to buy Biogran for €67 million Nutraingredients.com Dutch health food firm Wessanen has acquired Spanish firm Biogran, a manufacturer and distributor of organic brands. Expected to close this week, the cash deal for €67 million has analysts wondering whether the Dutch firm itself is looking increasingly attractive to investors? Read more→ REGULATORY ABC asks DEA to reconsider ban of kratom American Botanical Council, American Herbal Products Association UNPA MOU Partner the American Botanical Council has submitted comments urging the DEA not to ban kratom, focusing on how the move could restrain research. ABC noted the potential of kratom, especially for symptoms of opiod withdrawal and pain management, and that further research is needed to discover its value, risks and safety issues. Separately, the American Herbal Products Association also reacted to the agency’s plan to place kratom’s two compounds on the Schedule 1 list of drugs, citing issues of precedence and justification. Read coverage: ABC Requests DEA not Proceed with Restrictive Scheduling of Kratom→ AHPA submits comments to DEA on potential impacts of scheduling herbal constituents→ INVESTMENT NEWS Elysium raises $20M for anti-aging pill; Chinese invest in U.S. cannabis sector; U2 members fund biotech startup TechCrunch, Nutraingredients-asia.com, Nutraingredients.com Upon completion of its first clinical trial, Elysium Health has raised a new round of funding. Its first product, Basis, aims to boost levels of NAD+, a protein thought to prevent aging-related decay in cells' mitochondria. A Chinese financial website and private equity fund have made a deal to raise capital from mainland China to invest in U.S. cannabis supplements and functional beverages. Manufacturers of CBD oil are of particular interest. U2 band members Bono and The Edge have been named as major investors in Nuritas, the Irish biotech start-up.Founded in 2014, the company uses artificial intelligence and DNA analysis to scan vast databases to unlock currently wasted peptide sources. Read coverage: Anti-aging pill startup Elysium Health inks at least $20 million in series B funding→ Chinese partnership seeks to raise funds for US cannabis supplement sector→ Bono and The Edge find what they’re looking for in Biotech startup Nuritas→ PROBIOTICS IPA paper evaluates state of probiotic science and metabolic syndrome Nutraingredients.com Metabolic disorders including hypertension, dyslipidemia, obesity and diabetes reflect a complex tangle of interfaces with the microbiota representing only one part of the multiple factors at play, according to a new paper on probiotics and metabolic syndrome from the International Association of Probiotics.The paper provides an overview of the current science on probiotics and metabolic disorders. Read more→ INNOVATION Digital data show nutrient influence on gut; Chinese stabilize anthocyanins; company ups bioavailability of CoQ10 Nutraingredients.com, Nutraingredients-usa.com The behavior of gut bacteria has been recreated digitally in computer simulations that model metabolic processes taking place and explain how they affect the health of the human host. The digital tool, known as AGORA, uses data to create computer models that mimic the metabolism found in the GI tract and can help explain how diet influences the microbiome. Loading anthocyanins into chitosan nanoparticles could help improve their stability in functional drinks, according to researchers from the Anhul Agricultural University in China. New Zealand-based MitoQ, a company whose products are based on a special form of CoQ10, is taking a different tack on the bioavailability of CoQ10 with an electrostatic penetration system to deliver the antioxidant to the mitochondria. Read coverage: Digitized gut bacteria sheds new light on nutrient influence→ Nanoencapsulation stabilizes anthocynanins for food and beverage use, China researchers reveal→ Accumulating science boosts MitoQ as it launches product for new indications→ AYURVEDA Swiss create framework for Ayurvedic practitioner approval The Economic TImes Last year, the Swiss government became the first Western country to recognize and sanction Ayurvedic medicine and therapy. Now, it's working on creating a framework for approving medical practitioners and medicines that can be sold.The Indo-Swiss Ayurveda Foundation has given Swiss authorities a list of 450 formulations that will be included in curriculum for examinations and held for medical practitioners there. Read more→ MARKET RESEARCH Pew Research shows most Americans are mixed on GMOs; personalization tops NNB’s trends for 2017 PewInternet.org, Nutraceuticals World Fifty-five percent of Americans consider organic produce to be better for health than conventionally grown produce, according to a new Pew survey, and that number jumps among consumers who say they care about GMO issues. However, almost half of Americans say they don't care much or at all about the issue of genetically modified foods. A small group of Americans—6 percent, by Pew's data, and perhaps manycore natural products consumers—both care a great deal about GM food issues and say their own eating style is focused on being healthy and nutritious. Personalization is the key growth opportunity in foods and beverages in New Nutrition Business’ annual report "10 Key Trends in Food, Nutrition and Health for 2017." The rise of the trend stems from consumers taking control and a desire to feel more empowered and confident to create their own healthy eating patterns. Read coverage: The new food fights: US public divides over food science→ Personalized nutrition represents the next big growth opportunity→ RESEARCH Yeast aids probiotics; gut bacteria may cause yo-yo effect; Parkinson’s linked to gut; resveratrol tied to metabolism, brain; DHA ups sperm health; herbs improve blood sugar Nutraingredients.com, Nutraingredients-usa.com The components of yeast cell walls could be a viable protective coating for probiotics in functional foods, suggest researchers in a paper published in Food Research International. Rapid post-diet weight gain, often referred to as yo-yo dieting, could be a result of obesogenic gut bacteria, which remain even after weight loss, say researchers in Israel, who hope their findings could help to stop weight gain after dieting. Parkinson’s disease may begin in the gut, according to scientists at the California Institute of Technology. The findings suggest that probiotics may be a potential therapy for the disease. Supplements of resveratrol may improve energy metabolism, cell signaling pathways and neurotransmission in monkeys eating a high sugar and fat Western diet, says a new study from two Kentucky universities. Researchers have found that supplements of the omega-3 fatty acid DHA may reduce the amount of DNA damage in sperm, in findings from a new randomized, double-blind, placebo-controlled, parallel-group study from Spain. Compounds extracted from the herbs purslane and tindora appear to reduce blood sugar levels, according to a study at the University of Applied Sciences in Austria, which looked at the plants’ insulin-like activity in improving glucose uptake. Read coverage: Probiotics protection: Yeast wall compound improves survival in food products→ ‘Yo-yo diet’ weight gain may be caused by gut bacteria→ Does Parkinson’s start in the gut? Study reinforces gut-brain link→ Resveratrol shows metabolic and brain signaling benefits: Study→ DHA supplements may boost semen and sperm quality: RCT→ Herb extracts may have insulin-like properties to aid diabetics: Study→ Comments are closed.
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