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REGULATORY FDA's Tave seeks input on pre-DSHEA list, calls consumer safety top priority Natural Products INSIDER Citing an opportunity for collaboration with industry, the director of FDA’s Office of Dietary Supplement Programs (ODSP), Steven Tave, is seeking help from industry to develop an authoritative list of ingredients exempt from the notification requirement per DSHEA. Tave also recently noted that his top priority is protecting consumers from unsafe products in the market. Read coverage: FDA supplement director seeking collaboration in developing pre-DSHEA list→ FDA dietary supplement chief: ‘Consumer safety’ first priority→ REGULATORY
Industry optimistic in comments on Gottlieb's nomination to head FDANBJ Industry trade associations, including UNPA, are reacting positively on the Trump administration's nomination of Scott Gottlieb, former FDA deputy commissioner in the G.W. Bush administration, as new FDA commissioner. Read more→UNPA NEWS Larisa Pavlick outlines objectives as UNPA's VP, Global Regulatory ComplianceNaturalProductsINSIDER Former FDA Investigator Larisa Pavlick discusses her objectives in her new position at UNPA. Pavlick believes she will be able to help coach members through regulatory challenges and anticipate new challenges in a way that she couldn’t do at FDA. In one of her first efforts, Pavlick will hold atraining session in Provo, Utah,June 27-28, exploring common problems with cGMP compliance. Read more→ UNPA's Israelsen receives AHPA Herbal Insight Award at Expo WestUNPA President Loren Israelsen received the association's 2017 award. His contributions include his role as a founding AHPA member and its VP and general counsel from 1982-1987. Read more→ Register for ICSB, CHPA Dietary Supplements SeminarRegistration is open for the following conferences, both of which are sponsored, in part, by UNPA. UNPA's Larisa Pavlick is speaking at ICSB. International Conference on the Science of Botanicals, April 3-6, Oxford, Miss. CHPA Dietary Supplement Seminar, May 10, NorthBethesda, Md. (UNPA member discount available) Recently posted at unpa.com: 2017 Expo West Members’ Meeting PPT (requires member log in) “New Dietary Ingredients: Enforcement” presentation at 2017 Expo West, by Larisa Pavlick FDA Inspections, Part II by Larisa Pavlick, UNPA VP, Global Regulatory & Compliance (log in) FDA Inspections 101 by Larisa Pavlick, UNPA VP, Global Regulatory & Compliance(log in) The PPT presentations from NDI III: Roadmap to a Viable NDI Policy, UNPA member price: $295 Border Tax Memo by Patricia Knight and Peter Reinecke, UNPA Senior Political Advisors(log in) Plus, updated industry events calendar,Member Memos (log in) and UNPA educational archives(log in).REGULATORY Colorado supplements company ordered to cease operations; FTC partners with Canadian MountiesFDA.gov, FTC.gov A U.S. District judge has entered a consent decree of permanent injunction ordering EonNutra LLC, CDSM LLC and HABW LLC to immediately cease operations until they comply with federal law regarding manufacturing and distribution of unapproved drugs and dietary supplements. FDA determined the company’s products were misbranded and unapproved drugs being marketed with drug claims. To strengthen enforcement of cross-border fraud matters, the FTC has signed a memorandum of understanding to work with the Royal Canadian Mounted Police. FTC said the plan will enhance efforts to share information and conduct joint investigations. Read coverage: Colorado unapproved drug and dietary supplement makers ordered to cease operations for federal violations→ FTC signs memorandum of understanding with Royal Canadian Mounted Police to strengthen enforcement cooperation→REGULATORY FDA public meeting fields concerns on use of ‘healthy’ on productsNewRepublic FDA held a public meeting in Washington D.C. last week related to its efforts to redefine how companies can use the term "healthy" on their products. Among the concerns for the 20-year-old current rule are the standards for overall fat content (vs. individual kinds of fat) and itsomittance of a sugar limit. Read more→M&A ACTIVITY Lion Capital acquires major stake in active nutrition company Grenade HoldingsNutraingredients.com Consumer-focused private equity firm Lion Capital has acquired a majority stake in U.K.-based Grenade Holdings, an active nutrition company. The deal values the company at €83 million. Lion Capital believes Grenade is one of the more innovative players in active nutrition. Read more→FINANCIALS Nature’s Sunshine reports 4.9 percent increase for Q4 2016Nature's Sunshine Products Inc. Nature’s Sunshine Products Inc. reported net sales of $84 million in 4Q2016, up from $80 million for the same quarter in 2015. The company also reported a net loss of $6.7 million from continuing operations, attributable to common shareholders as well as an adjusted EBITDA of $0.6 million. Read more→REGULATORY Good Food Institute petitions FDA for clarity on naming plant-based dairy alternativesFDALawBlog The ongoing debate over how to name plant-based foods is heating up, as the Good Food Institute petitions FDA for more clarity. The petition is in response to the DairyPride Act introduced in January, which proposed an amendment to FDCA, stipulating that a product is misbranded if it uses the name for a dairy product but does not meet the criterion of a particular dairy item. Read more→PRODUCT TRENDS MusclePharm starts natural sports line; Life Extension uses AI for aging products; peptide product ups stem cell growth; probiotic helps balance gut; strain produces natural vitamin B12Nutraceuticals World, Nutraingredients.com, Nutraingredients-usa.com MusclePharm announced the launch of its Natural Series, a line of plant-based, vegan, gluten-free, soy-free, non-GMO products as an natural, organic alternative to traditional sports supplements. Life Extension has introduced ‘senolytics,’ a term to describe its new healthy aging product line called Geroprotect, developed with artificial intelligence technology. Marvin Heuer, M.D., is bringing a new peptide ingredient to the U.S. market that has been researched for a unique property: promoting the growth of bone marrow stem cells. A new probiotic called Biohm from PathBiome aims to improve gut health by balancing the fungal and bacterial aspectsof the microbiome. Elsewhere, a probiotic strain that produces high enough levels of natural vitamin B12 to enable an EFSA-approved health claim is the first step toward the category gaining its own claims, according to Winclove, a Dutch probiotic firm, which has developed the strain (Propionibacterium freudenreichii). Read coverage: Muscle Pharm launches natural series→ Life Extension turns to AI program to mine date for ingredients in new product→ Peptide aimed at stem cell genesis debuts on supplement market→ New probiotics meant to balance microbial, fungal communities in the gut→ First steps: Winclove set for probiotics claim with B12 producing bacteria→OMEGA-3s AHA updates recommendation for role of omega-3s in preventing CVDNutritional Outlook The American Heart Association (AHA) is now recommending omega-3 fish oil supplements for secondary prevention of coronary heart disease. This recommendation is a positive update to a previous AHA scientific recommendation that the association published in 2002, which had cautioned that further studies were needed to define the benefits for primary and secondary prevention. Read more→GLOBAL REGULATORY EU Commission revises medical device regulations; changes in EU novel food system to boost efficiencyNutraingredients.com, Nutritional Outlook The EU commission has released revised regulations for marketing of medical devices, simplifying the confusion between foods and medical devices. The updated regulations stripped some products, such as cranberry, of the medical device status but it added to others, such as products containing fiber. The European Union is also making changes to its novel food regulation, which aims to quicken the time to market and boost innovation, with a simpler, clearer and more efficient authorization procedure for novel food ingredients. Read coverage: EU Commission revises outdated medical device regulation→ EU novel food system aims to become faster and better→ UNPA MEMBER NEWS NuSkin appoints Mark Lawrence as CFO; LifeVantage names Charles Wach COO; Sabinsa granted patent for LactoSpore to manage IBS; Shelton receives AHPA awardNuSkin Enterpises Enterprises, Inc., LifeVantage Corporation, Sabinsa Corporation, AHPA NuSkin Enterprises has announced the appointment of Mark Lawrence as Chief Financial Officer effectiveMarch 27, replacing Rich Wood, who will become the new CEO, as previously announced. Lawrence brings a wealth of leadership experience and in-depth knowledge of finance and operations to enhance the senior management team. Read more→ LifeVantage Corp. has announced the appointment of Charles J. Wach as COO, effective March 13. CEO Darren Jensen notes that Wach is an accomplished leader with experience in nutritional supplements, direct selling, online retail and the global food and beverage industries. Read more→ Sabinsa has been granted a U.S. patent on the company's shelf stable probiotic LactoSpore for its use in therapeutic management of Irritable Bowel Syndrome (IBS). The patent claims a method for managing the symptoms associated with IBS, including abdominal pain, bloating, constipation and loose stools, through an orally administered formulation of LactoSpore along with regular treatment. Read more→ Suzanne Shelton, a principal in the Shelton Group, received the American Herbal Products Association 2017 Herbal Hero Award at Natural Products Expo West last week. Shelton was honored for the many contributions she has made to AHPA over her long career, including as the chair of the association’s Communications Committee. Read more→MOU PARTNERS NEWS ABC recognizes Mauritius’ president for work in medicinal plant researchNutraceuticals World The American Botanical Council's 2016 Norman R. Farnsworth Excellence in Botanical Research Award was granted to Her Excellency Ameenah Gurib-Fakim, president of the Republic of Mauritius, recognizing her for outstanding contributions to medicinal plant research. Dr. Gurib-Fakim has led her country as an advocate for African medicinal plants and made valuable contributions to the knowledge about plants growing on Mauritius and surrounding islands in the Indian Ocean. Read more→RESEARCH Absorption varies for plant-extracts; nutrition has less effect on strength; fruit, veg juice slows inflammation; Vit. B protects from pollution; ahiflower boosts immunity; blueberries aid cognitionNutraingredients.com, Nutracenticals World Polyphenols from plant extracts are absorbed into the body at widely different times, with the microbiota playing an important role in significant variation in bioavailability and absorption patterns, warns a new study from Italy and Austria. The effect of dietary supplementation on muscle function in the elderly appears limited, as a U.K. review, including 37 randomized controlled trials, suggests that the combined benefits of exercise and nutrition intervention were ‘less than expected.’ An encapsulated concentrate of fruit and vegetable juice using JuicePlus+ Orchard Garden and Berry Blend may reduce systemic inflammation and improve cholesterol levels in obese people, says a new study inNutrients. Dietary intake of B vitamins might play a role in reducing the impact of air pollution on the epigenome, say researchers from Harvard’s T.H. Chan School of Public Health. A daily dose of ahiflower oil fromBuglossoides arvensismay increase production of the anti-inflammatory cytokine IL-10, says a new study from Canada. Newresearch from Tufts University found that daily consumption of the equivalent of one cup of fresh blueberries, given as 24 g of freeze-dried powder, showed positive changes in cognitive function over a placebo. Read coverage: Variable absorption: Study warns of vast differences in the way plant extracts get into the body→ Nutritional intervention effect on muscle less than expected: Review→ Fruit, veg juice concentrate reduces systemic inflammation in obese people→ Certain B vitamins could protect against air pollution risk→ Study shows ahiflower oil’s anti-inflammatory and immune potential→ Blueberries may improve cognition in older adults→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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