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M&A ACTIVITY Nutraceutical International acquired for $446 million Nutraingredients-usa.com Long-time supplement player Nutraceutical International will be sold to an affiliate of private equity investor HGCG LLC for $446 million. Under terms of the agreement, stockholders will receive $41.80 in cash for each outstanding share of common stock, which represents a 49 percent premium on its May 19 closing price. During its history, the company has acquired a number of brands, including Solaray, Nature's Life and Natural Bounty. Read more→ UNPA NEWS
Save 20% when you register by June 5! GMP Inspection Training: How to Avoid FDA's Top GMP violations,June 27-28, in Provo, Utah—See intro videonow! Preview UNPA's June 27-28 GMP training session, taught by Larisa Pavlick, UNPA's VP, Global Regulatory & Compliance, in this short video presentation. Learn more about the program and why you should attend before your next FDA GMP inspection. This course will cover all aspects of the inspection, with a focus on the key elements of quality: identity, purity, strength and composition. VIEW VIDEO→ Register for these upcoming industry events UNPA's "GMP Inspection Training: How to Avoid Citations and Prepare for Your Next FDA Inspection," June 27-28, Provo Utah--Save 20% when you register byJune 5! "Preventive Controls Workshop for Dietary Supplements: PCQI Training for Dietary Supplement Companies," July 17-19, Salt Lake City USP Dietary Supplement Stakeholder Forum, June 7, Rockville, Md. Recently posted at unpa.com: NEW!UNPA comments on FDA official's assertion that serious adverse events are going unreported.(requires member log in) FDA updates it sFSVP resources with updated fact sheets and guidance document (log in) “Dietary Supplements: State of the Industry,” UNPA presentation at New Hope Network, April 26 (log in) Washington Update: FDA User fees; Health Savings Accounts, by Peter Reinecke and Patricia Knight, UNPA Senior Political Advisors (log in) "An Industry Perspective on Botanical Quality & Compliance,"presentation at ICSB 2017 by Larisa Pavlick(log in) 2017 Expo West Members’ Meeting PPT (log in) “New Dietary Ingredients: Enforcement” presentation at 2017 Expo West by Larisa Pavlick (log in) The PPT presentations from NDI III: Roadmap to a Viable NDI Policy, UNPA member price: $295 Plus, updated industry events calendar,Member Memos (log in) and UNPA educational archives(log in).LEGISLATION Chaffetz announcesJune 30resignation from CongressDeseret News The dietary supplement industry will lose a strong supporter when Rep. Jason Chaffetz, R-Utah, leaves office on June 30, 18 months before his fifth term ends, to pursue a job in the private sector. The Dietary Supplement Caucus co-chair announced a month ago that he would he not run in 2018 and that he might leave office early for a private sector job. Chaffetz insists the turmoil in Washington wasn't a factor in his decision. Read more→ORGANIC U.S. organic food sales hit record $47 billion in 2016; Trump policies may be dangerous for organicsOrganic Trade Association, New Hope Network The U.S. organic industry remained on an upward climb in 2016 with sales hitting $47 billion and seeing a gain in market share, according to the Organic Trade Association’s 2017 Organic Industry Survey. Sales now represent 5.3 percent of total food sales in the U.S. Meanwhile, new Trump administration policies may fuel a further boon to organics, according to Dave Carter of the National Bison Association, who notes that lifts on environmental restrictions and chemical use could lead to further environmental degradation. Read coverage: Robust organic sector stays on upward climb, posts new records in US sales→ Winter is coming for the organic industry→REGULATORY AHPA urges EPA to revisit botanical pesticide limitsNutraingredients-usa.com The American Herbal Products Association has asked federal regulators to revamp pesticide rules that unfairly impact minor crops that include many botanical commodities. The group noted that its members rely on raw agricultural commodities that are not contaminated by excessive environmental pollutants. Read more→LEGAL Lawsuit says FDA GRAS rule weakens food safety systemNaturalProductsINSIDER In a lawsuit filed this week, consumer advocacy groups are calling an FDA rule unconstitutional, noting that itweakens the integrity of America’s food safety system. Adopted in August 2016, the final rule clarifies criteria in FDA regulations for when the use of a substance in food is not subject to premarket approval because it is generally recognized as safe (GRAS). Read more→REGULATORY Industry groups react to FDA reorganizationNaturalProductsINSIDER Industry groups are showing support for FDA's effort to reorganize its work force, saying it may bring more consistency in cGMP inspections. UNPA’s Larisa Pavlick, a former FDA investigator, said she believes the realignment will ultimately be positive but cautioned that in the short-term, FDA still faces high turnover and a long lead time to train investigators. Read more→LEGISLATION Scientists, researchers urge HHS, FDA to not delay in Nutrition Facts overhaulWisconsin Gazette As food industry trade groups lobby to delay the implementation of the new Nutrition Facts Labels until 2021, more than 40 scientists and researchers wrote a letter asking HHS Secretary Tom Price and FDA Commissioner Scott Gottlieb to stick to the July 2018 compliance date. Read more→GLOBAL REGULATORY EFSA leaves vitamin K levels alone; industry questions Belgium’s nutrient levels; Italy ups DRVs to align with EFSANutraingredients.com A new scientific opinion from the European Food Safety Authority (EFSA) has maintained existing guidance on adequate intake levels for vitamin K. Following review of evidence and stakeholder comments, EFSA confirmed the DRVs will remain at the same level that they were initially set at almost 25 years ago. Industry is questioning Belgium’s recent amendments to a decree setting minimum and maximum levels for four nutrients, caffeine, lutein, lycopene and red yeast rice. Industry watchers note that proposed levels fall well below established EFSA safety data. Italian authorities have increased maximum levels for vitamin D, vitamin B12 and vitamin K to be in line with opinions from EFSA’s guidance. The announcement follows the recent ECJ ruling that said member states cannot set individual maximum levels unless based on international safety and risk assessment data. Read coverage: UPDATE: EFSA maintains guidance on vitamin K→ Belgium drafts supplement guidance for four nutrients, but is it right?→ Mutual recognition: Italy increases maximum vitamin levels in line with EFSA→MEDIA WATCH Harvard’s Cohen says supplements are more dangerous than some processed foodsBusinessInsider On the back of many supplement bottles are two words that strike fear in the heart of industry critic, Harvard Assistant Professor of Medicine Pieter Cohen: “Proprietary Blend.” Cohen believes that this language allows supplement makers to not list the product ingredients. The risks, he said, can be serious. Read more→LEGISLATION Bill requiring cost-benefit analysis on regulations sparks debateNutraingredients-usa.com Advocacy groups are reacting strongly to a bill sponsored by Sen. Rob Portman, R-Ohio, that would require a cost-benefit analysis on every new federal regulation. The Regulatory Accountability Act is a bipartisan effort to increase agility and competitiveness of different industries. Consumer groups say the bill would undermine food safety measures and force government to apply cold financial calculus to every decision. Read more→GMOs Canada votes down GMO labeling; Mintel study: generations avoid GMOsFoodnavigator-usa.com, Packaging Digest The Canadian Parliament voted against mandatory labeling of genetically modified foods in a vote in the House of Commons this week. Defeated by a significant margin, the bill sparked debate in parliament, with some noting the term “genetically modified” was not defined and others arguing that the wording was too vague. Consumers today don't avoid GMOs as much as they do artificial flavors, sweeteners and preservatives, but around one-third of millennials and baby boomersare actively avoiding genetically modifiedfoods, according to new Mintel research. The research also showed higher consumer perceptions of taste, quality and trustworthiness with products that featurea GMO-free claim.Read coverage: GMO labeling bill defeated in Canadian parliament→ Canada: House of Commons to vote on GMO labeling bill→ GMO labeling remains a front panel issue for brands→UNPA MEMBER NEWS Indena’s authentication program raises quality, traceability standards; study shows role of curcumin in bone densityNutraingredients-usa.com, Nutraingredients.com Indena is introducing a new authentication program that will raise the bar for quality and traceability. The program includes a unique herbarium, a new “DNA tested” seal and access to a handheld genomic technology for botanical ID testing. In other Indena news, a recent pilot study backed by the company suggests that a curcumin-based supplement could be helpful in maintaining a healthy level of bone density. The research, published in theEuropean Review for Medical and Pharmacological Sciences, tested the safety and efficacy of an oral supplement containing Indena’s bioavailable curcumin formulation Meriva. Read coverage: Indena’s DNA authentication program raises the bar for quality and traceability→ Curcumin may play a role in maintaining bone density: Pilot study→dōTERRA named 'Best in State' for merchandising and consumer servicesdōTERRA International Essential oils companydōTERRA recently received the Best in State award from Utah for merchandising and consumer services. It marks the third consecutive year that the company has been recognized as one of Utah’s top companies and a standard bearer in essential oils. The annual awards recognize organizations for innovating and improving quality of life in Utah. Read more→INNOVATION Neurosurgeon launches liquid brain supplement; new amino acid ingredient touted to promote muscle growthNutraingredients.com A neurosurgeon at the University of Illinois at Chicago has launched an MCT-based liquid supplement called VitaMind, containing what founders call the four pillars of fundamental healthy cognition, citicholine, Cereboost, triglycerides from coconut MCT oil and omega-3s from fish oil. Meanwhile, an amino acid ingredient first developed to help burn victims battle muscle wasting is now debuting on the dietary supplement market. Called Reginator, the ingredient, from Zanda LLC, is a patented blend of amino acids at a ratio to stimulate muscle growth without movement. Read coverage: Chicago-based VitaMind launches liquid multivitamin for the brain→ Developer debuts patented ingredient line with blend based on ideal ratio of amino acids→MARKET RESEARCH IFIC research finds that older Americans differ in opinions about nutritionNew Hope Network In a recent surveyof more than 1,000 consumers, the International Food Information Council Foundationfound that baby boomers and older Americans—the country's fastest-growing demographic—diverge significantly from other groups when it comesto food and nutrition attitudes and decisions. Read more→RESEARCH SDA, ALA for cognition; PQQ may prevent osteoporosis; probiotics support immunity; theanin aids liver; low D linked to retinopathyNutraingredients.com, Nutritional Outlook, Nutraingredients-asia.com, Nutraingredients-usa.com A study from the University of Illinois, Urbana-Champaign, has linked three long-chain fatty acids, including ALA and SDA, to the health of a structure in the brain and the effect on ‘fluid intelligence’ in older subjects. A new animal study in the American Journal of Translational Research suggests pyrroloquinoline quinone (PQQ) supplementation may stimulate osteoblastic bone formation and inhibit osteoclastic bone resorption. Researchers in Austria now suggest that a blend of six probiotic strains may beneficially affect tryptophan-kynurenine metabolism in athletes and reduce incidence of upper respiratory tract infections.Theanine, an amino acid present in the tea plant, can potentially be used to treat liver injury and boost immunity, according to a new review from China. There is a statistically significant link between diabetic retinopathy and vitamin D deficiency, according to a new meta-analysis of studies on more than 10,000 diabetic patients in several countries. Read coverage: Study links SDA, ALA to cognitive support for health of region in cerebral cortex→ PQQ may prevent osteoporosis, testosterone deficiency: Animal study→ Multi-species probiotics may support immune health in athletes→ Theanine: How a tea amino acid could help fight liver disease→ Possible link between vitamin D deficiency and diabetic retinopathy: meta-analysis→FDA WARNING LETTERS & GUIDANCES Current FDA enforcement actions and guidancesKeep 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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