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LEGAL Report notes drop in 'natural'-related lawsuits in 2016 New Hope Network FDA’s attempt to define natural may have contributed to the drop in "natural"-related lawsuits in 2016, according to Perkin Coie, a law firm that tracks class action suits. False-labeling lawsuits remain the largest category within class-action food litigation, while "natural" complaints fell by half, according to their data in the Food Litigation Year in Review report. The firm counted 145 lawsuits in 2016, mostly in California and New York. Read more→ UNPA NEWS
Limited seating available for UNPA PCQI training in Boulder, Colo.,Aug. 16-18 "Preventive Controls Workshop for Food and Dietary Supplements: PCQI Training for Food and Dietary Supplement Companies," Aug. 16-18, Boulder, Colo. New Prop 65 insurance policies available LifeScience Risk has unveiled new Proposition 65 liability insurance for dietary supplement/ingredient manufacturers, distributors and formulators, with up to $1 million in coverage caps. View information here or contact Dick Griffin,916.434.8874. NEW! New UNPA member discounts See "UNPA Member Discounts" in the right column for new discount offers from PLMI/Thought Leaders Consortium, NBJ and The Journal of Alternative and Complementary Medicine. Recently posted a tunpa.com: NEW!UNPA announces onsite PCQI training NEW!Synched PPT/audio file of Jim Thomas' Introduction to Synthetic Biology presentation at the 2017 UNPA Members' Retreat (suggest streaming only; file is VERY large) "Who's your PCQI? An introduction to PCQI." PCQI FAQs 2017 UNPA Members' Retreat coverage, including podcasts from UNPA member executives UNPA Saves Stark Steering Sign in Sugar House NEW! Interview with Larisa Pavlick (Nutraceuticals World) UNPA endorses the CRN OWL program (log in required) A new language converter has been installed on a number of pages of the UNPA website. Check it out in the upper left corner! The presentations and videos from the 2017 UNPA Members' Retreat are now available for viewing/downloading.(log in) UNPA comments on FDA official's assertion that serious adverse events are going unreported.(log in) FDA updates its FSVP resources with updated fact sheets and guidance document (log in) Plus, updated industry events calendar,Member Memos (log in) and UNPA educational archives (log in). REGULATORY FDA’s Gottlieb appoints Lauren Silvis as chief of staff The Pink Sheet FDA Commissioner Scott Gottlieb has appointed Lauren Silvis as his chief of staff. Silvis has been acting in the role for a few months, following a two-year stint in a top policy post at the Center for Devices and Radiological Health. There, she helped lead overall development of regulations, guidances and other policies. She was also a point-person for other issues relevant to FDA. Her promotion is part of Gottlieb's ongoing effort to staff top FDA positions with his preferred team. Site requires subscription to read full story. Read more→ M&A ACTIVITY Whole Foods, Amazon deal faces further scrutiny, lawsuits Reuters, Natural Products INSIDER Rep. David Cicilline, D-R.I., who sits on the House antitrust subcommittee, is calling for a closer look at Amazon's acquisition of Whole Foods—its largest buy yet."Amazon’s proposed purchase of Whole Foods could impact neighborhood grocery stores and hardworking consumers across America," he said in a statement. Meanwhile, Whole Foods is also facing a growing number of shareholder lawsuits over the pending acquisition. Robert Berg, a Whole Foods common stock owner,on Friday filed a putative class action lawsuit in Texas federal court, alleging violation of the Securities Exchange Act of 1934. Read coverage: US lawmaker calls for hearing on Amazon’s Whole Foods deal→ Whole Foods hit with second shareholder lawsuit over Amazon Merger→ ORGANIC USDA removes eight substances from approved list for organic production GrowingProduce.com USDA's Agriculture Marketing Service issued the final rule for the ingredients up for sunset review this year. Eight ingredients were removed from the list of approved substances in organic production: lignin sulfonate; furosemide; magnesium carbonate; and the nonorganic forms of chia, dillweed oil, frozen galangal, frozen lemongrass and chipotle chile peppers. The rule also renews the allowance of nonorganic forms of inulin-oligofructose enriched, Turkish bay leaves, and whey protein concentrate on the National List. Read more→ COGNITIVE SUPPORT DSM case illustrates importance of adherence to science for memory claims; top cognition ingredients Nutraingredients-usa.com, Nutraingredients.com Helping consumers maintain healthy cognitive function is one of the goals many supplement formulators, but it is also a target for regulatory enforcement actions. Experts say that the field is fraught with potential pitfalls but note that the DSM case regarding the BrainStrong Adult DHA product provides some guideposts for these challenges. The list of ingredients to address memory, attention and focus, development, mood is growing. This article takes a look at research behind omega-3s, Phosphytidyl Serene, B vitamins, vitamin E, Lutein, citicholine, and L-theanine, among others. Read coverage: Strict adherence to science backing only way to avoid memory claim pitfalls, experts say→ The top ingredients for cognition, focus, mood→ GLOBAL REGULATORY TGA notes broad support for third path to market; EC urges Spain to end unfair practices for imported food supplements Nutraingredients-asia.com, Nutraingredients.com The Australian Therapeutic Goods Authority says there is broad support for plans to introduce a third level of health claims for supplements. The current two-tiered system allows low risk products on the market without a pre-market assessment from the Australian Register of Therapeutic Goods, while higher-risk medicines must be assessed for quality, safety and efficacy. The European Commission has threatened to take Spain to the European Court of Justice to ensure free movement of food supplements. The agency sent an opinion to Spain urging it to end discriminatory practices that have one standard for Spanish companies to launch a product and a more costly, detailed program for products from other EU countries. Read coverage: Broad support for new ‘third way’ supplements health claims in Australia: TGA→ EC urges Spain to remove discriminatory practices for imported food supplements→ BOTANICALS Herbal formulations too often ignore principles of traditional medicine Nutraingredients.com Finding a place for ingredients from the traditional medical systems, such as Traditional Chinese Medicine or Ayurveda, in the modern marketplace can be a difficult exercise, with formulators only paying lip-service to the principles that underlie these ingredients. Experts in the segment weigh in, including Ezra Behar, a scientific advisory board member of the American Botanical Council, Roy Upton of American Herbal Pharmacopeia and Beth Lambert of Herbalist and Alchemist. Read more→ PROBIOTICS Thinking ‘bigger picture’ may help scientists better understand the complexity of the microbiome Nutraingredients-usa.com A more holistic, environmental view of the human gut microbiome is taking shape among researchers, but confounding factors complicate the task of fully elucidating this via tenable study designs. Scientists are now starting to look at how the environment and food can impact the microbiome. Read more→ MARINE MATERIALS STANDARDS Revisions to marine supply standards help enhance supply credibility Nutraingredients.com The aim of a revised IFFO Global Standard for Responsible Supply RS, version 2.0,is to ensure relevance and credibility of the marine raw material standard, which up to now has mainly seen use in the salmon farming sector.The amendments include a revision of the scoring methodology for fisheries, introduction of criteria for GMPs and social and environmental parameters for fishmeal and fish oil factory workers. Read more→ UNPA MEMBER NEWS NuSkin partners with NCN to cultivate ideas; study supports Indena's boswellia; Sabinsa publishes book on BioPerine;Whole Foods magazine launches product platform Nutraceuticals World, Nutraingredients.com, Sabinsa Corp., Whole Foods Magazine Nu Skin Enterprises and Nutrition Capital Network (NCN) are inviting companies, entrepreneurs and nutrition industry visionaries to apply to present their product ideas in front of top Nu Skin executives at its 2017 North American Innovation Partnering Meeting. Nu Skin has strong interest in cultivating the flow of new ideas through the introduction of novel products, ingredient and technology solutions into the company’s existing product lines and creation of line extensions. Read more→ A new proprietary method to deliver the Indian botanical extract Boswellia serrata, also known as frankincense, could boost bioavailability and help manage the symptoms of irritable bowel syndrome, according to a study from Indena. The method centers on a lecithin-based delivery form of boswellia to improve plant absorption, penetration across biological membranes and bioavailability. Read more→ Sabinsa has just published a book on the company’s patented black pepper extract, BioPerine, which is widely used to enhance the bioavailability of other nutrients as well as for its thermo-nutrient properties. The book,BioPerine - Nature’s Own Super Nutrient, was written by several of the company’s scientists, including Muhammad Majeed, founder of Sabinsa Corp. Read more→ WholeFoods Magazine is partnering with ConnectMii, a video meeting technology provider, to create VirtualMart, a new interactive platform to make it easy for retailers to learn about new products in all natural products categories without leaving their store. Starting in September, retailers can have one-on-one meetings in real-time using the platform, designed to make it more efficient for retailers to find new products and get the business-to-business meetings they need. Read more→ MARKET RESEARCH NFM’s Annual Market Overview reports top-level retail sales, highlights supplements sector New Hope Network Among the highlights from this year’s Natural Foods Merchandiser’s 2017 Market Overview report, supplement sales grew 5 percent in 2016, with top sales in herbal and homeopathic products, curcumin and, of course, CBD. The report also noted that as the natural and organic market matures, growth slows overall and for independent natural retailers. See the review of top-level numbers from the 2017 survey in this infographic and download the complete report. Read coverage: Supplement upside, committed shoppers drive sales→ Market Overview: Sizing up 2016 organic and natural products retail sales→ MOU PARTNER NEWS Jiaherb adopts rhodiola in ABC’s Adopt-an-Herb Program American Botanical Council The American Botanical Council (ABC) is pleased to recognize the adoption of rhodiola (Rhodiola rosea) by Jiaherb Inc., a manufacturer and supplier of natural and botanical ingredients, based in Pine Brook, N.J., through its Adopt-an-Herb Program. With the adoption, Jiaherb helps ABC expand its nonprofit educational mission and keep its unique HerbMedPro database updated with the latest scientific and clinical research on this traditionally used medicinal plant. Read more→ PERSONALIZED NUTRITION / INNOVATION Personalized nutrition company uses AI to address potential interactions Nutraingredients-usa.com With 70 supplement offerings and an algorithm developed and supported by medical advisors, startup Vitamin Packs believes it can get very personal within the personalized nutrition space. Founder of the Seattle-based company, Jason Brown, sees the main differentiator as the company’s artificial intelligence, programmed with an algorithm that considers potential interactions with medications the patient is taking. Read more→ MARKET RESEARCH Interest in protein may put pressure on sports nutrition; immunity for seniors has huge potential in Asia; energy, sports marketers target video gamers Nutraingredients.com, Nutraingredients-asia.com, Nutraingredients-usa.com More than 70 percent of U.K.-based users of sports nutrition would like to see an industry-wide certification that ensures the quality of ingredients, according to new Mintel data that also suggests a blurring of lines between traditional sports nutrition products and ‘on trend’ high-protein foods.Immunity boosting health products for older adults have massive untapped potential in Asia, especially China, where less than 1 percent of new launches in the past five years have been created for those over 55. Energy and sports drink companies have heavily invested in marketing towards the video gaming community, a space which the cognitive supplement space may benefit from, according to category experts. Research firm Packaged Facts said marketers are starting to recruit celebrities from the video-game world to help position their products for cognitive performance. Read coverage: Is growing consumer scrutiny and mainstream protein putting sports nutrition under pressure→ Immunity boosting supplements: Why products for older adults have huge untapped potential for APAC→ Video gamers, e-athletes emerge as cognitive supplement target audience→ RESEARCH Carnitine may prevent autism; calcium absorption key to thwarting superbug; iron may lower heart attack risk; finding the link between gut and heart health; red clover, probiotic mix for menopauseChron.com, Nutraingredients.com, Nutraingredients-usa.com, Nutraingredients-usa.com Researchers at Baylor College of Medicine suspect that a body’s lack of the amino acid carnitine might be involved in triggering mild cases of autism. They suggest that 10 percent to 20 percent of all cases might have a common mechanism in a new paper published in the journal Bio Essays. Improving calcium absorption in the gut may be vital in reducing the risk of catching a ‘superbug’ that kills thousands of people per year, researchers writing in PLOS Pathogens suggested.Iron supplementation may be a low-cost approach in reducing the risk of heart disease, as a study from Imperial College U.K. identifies low levels as a risk factor for one of the leading causes of death worldwide. People with heart failure have been found to have less gut bacteria diversity and lack certain important species groups. So are changes in our microbiome causing heart disease, or vice versa? A new analysis from Germany attempts to answer that question. The fermented form of isoflavone and probiotic-rich red clover is effective in halting the accelerated bone loss and associated symptoms seen in menopausal women, according to a Danish study. Read coverage: Baylor: Carnitine may prevent some autism→ Superbug may depend on calcium to multiply→ Does iron supplementation promise lower heart attack risk?→ Cause or consequence: Investigating the ling between gut bacteria and heart health→ Potent red clover, isoflavone probiotic mix combine to ease menopausal signs: Study→ FDA WARNING LETTERS & GUIDANCES Current FDA enforcement actions and guidances Keep up to date on FDA’s current enforcement actions, including general warning letters, recall information and GMP compliance issues, with this link to FDA's website. Read more→ Comments are closed.
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