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TOP STORY GMP violations for production and quality control still plague supplement makers Natural Products INSIDER In the second part of a series on GMP violations, manufacturers of dietary supplements in the United States are struggling with requirements to establish production and process controls to verify the quality of their products. The production and process controls requirements reflect “the most poorly understood section” of FDA’s 10-year-old cGMPs, according to Vasilios (“Bill”) Frankos, Ph.D., an Herbalife Nutrition executive and former FDA official, who oversaw implementation of the dietary supplement manufacturing regulations after they were adopted in 2007. UNPA’s Larisa Pavlick describes some of the essential cGMP requirements and what FDA wants to see during an audit. Read more→ UNPA NEWS
One week left! Early-bird discount for the 10th Annual UNPA Members' Retreat ends Feb. 16$100 registration savings for the 10th Annual UNPA Members' Retreat, to be held in Park City/Deer Valley, Utah, May 8-10, end Feb. 16. Plan to join us for this year's meeting, with a focus on the business of dietary supplements. Why attend UNPA's FSVP training? See this short video by UNPA's Larisa Pavlick, who will lead the training. Only 12 seats remaining! Sponsorships for the 10th Annual UNPA Members' Retreat are now availableSponsorships for the 10th Annual UNPA Members' Retreat, to be held in Park City/Deer Valley, Utah, May 8-10, are now available. Sponsorships are an effective way to support UNPA, increase your company’s visibility and get your products and services in front of a highly desirable and targeted audience: the UNPA membership. For more information, contact Kira Olsen, 801.474.2572, x107. Recently posted at unpa.com:
FDA commissioner notes scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuseIn a recent statement, FDA Commissioner Scott Gottlieb, M.D., notes the many concerns the agency has related to kratom, but he also recognizes that there is still much that is unknown about the compound, which is why FDA is taking some significant steps to advance the scientific understanding of this product.M&A ACTIVITY Merck consumer health sale at risk after Nestlé pull outThe sale of Merck’s KGaA's consumer health unit is at risk after leading bidder Nestlé left the race for the business after months of negotiations led to an impasse with regard to purchase price.FINANCIALS Amazon’s Whole Foods revenue slightly better than expectedAmazon.com Inc. wowed Wall Street with a record $60.5 billion in sales—an increase of 38 percent—for its 4Q, ended Dec. 31, 2017. Excluding the $1.1 billion favorable impact from year-over-year changes in foreign exchange rates throughout the quarter, net sales increased 36 percent compared with the fourth quarter of 2016. Company officials also said they were pleased with the performance of Whole Foods.Marketing and promotions drive comp sales growth at Natural GrocersNatural Grocers by Vitamin Cottage touted its third consecutive quarter of comparable store sales growth in its first earnings report of 2018, even though it missed profit projections.PARTNERSHIPS Stratum Nutrition to distribute ahiflower in North AmericaNatures Crops International and Stratum Nutrition have entered into a value-added distribution agreement covering the dietary supplement marketplace in North America. The companies said this alliance adds strategic value for both organizations with each offering leading dietary products that address wellness needs in joint and digestive health.Parry Nutraceuticals, Valensa expand microalgae plant through joint venture with Synthite industriesFlorida-based Valensa International announced a joint venture agreement between Valensa’s parent company EID Parry and Synthite Industries Ltd., which expands Valensa’s plans to lead the development and distribution of value-added microalgae extracts for nutraceutical applications. GLOBAL REGULATORY Consumer group report finds inadequate labeling for dietary supplements in PolandQuality control performed on commercially available dietary supplements by the Trade Inspection Authority in Poland has uncovered labeling irregularities that include a lack of ingredient information, daily dosage and warnings.ORGANIC Three new standards approved in the IFOAM family of standardsAt its last meeting in India at the end of 2017, the IFOAM-Organics International World Board approved three new standards into the IFOAM Family of Standards. The newly approved standards include the Biocyclic-Vegan Standard—the first international organic vegan-farming standard; the South African Organic Sector Organization (SAOSO) standard from South Africa; and the Diaoyutai Private Organic Standard from China—a joint private-public brand for organic products in China.APAC MARKET Bumper supplement firm takeovers just the start for Chinese investment into Australian industry: KPMGChinese investment into Australian health firms, including supplement manufacturers, will continue to grow as the country’s healthcare system matures and the population ages, analysts from KPMG are forecasting. U.S.-China research partnership on ginseng sign of increased backing for TCM, sources sayThe funding of a U.S.-China research partnership focusing on ginseng in healthy aging and immunity is a sign of growing investment behind and interest in TCM, according to ABC’s Mark Blumenthal and AHP’s Roy Upton.E-COMMERCE Analyst’s take: Online supplement sales see double-digit growthE-commerce is growing at a rate double that of the supplements industry as a whole. See more in this latest installment of the twice-monthly data discussion from Nutrition Business Journal’s senior analyst Claire Morton.SPORTS NUTRITION Pro sports dietitians find role for NSF’s redesigned mobile app for certified supplementsDietitians working with pro sports teams said NSF’s redesigned mobile app will help athletes stay in compliance by making it easier to choose certified supplements when they are not under team supervision.MEDIA WATCH NPR Podcast on supplements shows industry’s quality message gaining tractionA recent NPR program on dietary supplements was a sign both of how far the industry has come in terms of recognition of its legitimacy and how far it has yet to go.2018 TRENDS 2018 trends to watch for food, drink and dietary supplements: plant-protein, omega-3s, curcumin, caffeine, probiotics and steviaA six-part series on 2018 ingredient trends features:
LifeVantage products now available in mainland China through e-commerce websiteMulti-level-marketing wellness firm LifeVantage Corporation announced that starting this month, its products will be available in mainland China through e-commerce. Rend-al-Mondhiry joins Amin TalatiAmin Talati Upadhye welcomes Rend Al-Mondhiry to the firm. Formerly ofthe Council for Responsible Nutrition, she will be senior counsel, resident in the Washington, D.C.. office. “The depth and breadth of Rend’s industry experience and relationshipsare matched by very few,” according toIvan Wasserman, a partner and leader ofthe Washington office. OmniActive expands gingever range and showcases new prototypesOmniActive Health Technologies will be highlighting the latest addition to its ginger ingredient range, Gingever 10 percent powder, expanding its application to tablets, capsules and beverages at the upcoming Engredea 2018 trade show in Anaheim, Calif. 4Life names new general manager of 4Life TaiwanMLM company 4Life has announced that Ivan Huang will be the general manager of 4Life Taiwan. The company says Huang, who has held a variety of industry corporate titles in sales, training, marketing and operations, will be an amazing additional force to support the company’s leaders and distributors in Taiwan. NBJ award winners announced: Sabinsa recognized for supply chain management in IndiaNBJ Editor Rick Polito announced the 2017 NBJ award winners. Among this year’s winners are UNPA member Sabinsa, for building relationships with Indian farmers to ensure a supply chain that’s not only solid but socially responsible.INNOVATION Plant-based melatonin: An alternative to synthetic formsThe origins, purity and the relatively low risk of contamination in plant-based melatonin have opened the door to its use as a nutraceutical compound, Spanish scientists suggest. Arjuna’s amaranth sets green criteria in unearthing nitrate rich extractBotanical specialist Arjuna reveals how a sustainable approach to cultivating a nitrate-rich plant extract is reaping rewards, producing an ingredient that has found uses in energy bars and nutrition powders. SUSTAINABILITY Non-GMO crops now require project verificationLeonardo Academy announced that the ANSI/LEO-4000 American National Standard for Sustainable Agriculture will now require Non-GMO Project Verification for all non-GMO disclosures of agricultural products earning certification under the ANSI/LEO-4000 standard. HOMEOPATHY Industry comments on FDA’s proposed homeopathic regulationsAs the deadline draws near for the FDA decision on how to regulate homeopathic remedies, and an article in the mainstream media reignites the issue, homeopathic agencies and experts are offering guidance to those awaiting the decision.COMMENTARY Keeping trade show marketing legalTrade shows have become ubiquitous in the dietary supplement, food, beverage and cosmetic industries. However, these shows are not a “free for all” for companies to say whatever they want about their products, says attorney Justin Procknow from UNPA member Greenberg Traurig in this commentary. Claims made at trade shows are often under as much, if not more, scrutiny than claims made at retail locations or on the internet.MARKETING Marketing age-related nutrition productsBaby boomers, gen Xers and millennials are key consumer target groups for marketers, and with three different sets of needs and buying propensities, it’s important that brands define their unique selling propositions. The story provides insights for all three groups. Why Amazon’s acquisition of Whole Foods will disrupt the ad industryMost retailers have been feeling the effects of Amazon’s dominance for years, but one industry—consumer packaged goods—has been able to float by largely unaffected by the e-commerce giant. That’s all starting to change, thanks to Amazon’s acquisition of Whole Foods.MARKET RESEARCH A look at how different generations grocery shopMillennials matter, but don't forget about generation X shoppers, who are adventurous and likely to try new flavors and products, and value-focused "silents," who spend the most per person on monthly groceries. Images help people who aren't health conscious make better food choicesHealth-conscious people will choose healthy foods anyway—but visual cues, rather than words, can help those who are less health conscious make better food choices, according to researchers writing in the journal Food Quality and Preference.Adaptogens, CBD and nootropics rise as consumers consider their emotional and mental wellbeingMore products boasting the energy-managing, cognitive-enhancing, and mood-moderating effects of adaptogens, CBD and nootropics will break out in 2018 as consumers continue to seek holistic and preventive ways to manage their mental health, according to trend spotters at SPINS.RESEARCH Compound prevents neurological damage, shows cognitive benefits in mouse model of Alzheimer’s diseaseThe supplement nicotinamide riboside (NR)—a form of vitamin B3—prevented neurological damage and improved cognitive and physical function in a new mouse model of Alzheimer’s disease. The results of the study, conducted by researchers at the National Institute on Aging, part of the National Institutes of Health, suggest a new target for treating Alzheimer’s disease. High doses of vitamin D shown to restore cardiovascular system post heart attackIn a new study published in the International Journal of Nanomedicine, vitamin D3 restored endothelial cells in the human cardiovascular system, which are damaged from conditions such as diabetes, hypertension, heart attack and stroke. Vitamin D a promising solution for inflammatory skin disorder: ReviewVitamin D could be an effective therapeutic treatment for psoriasis and atopic dermatitis patients, say researchers in Qatar. Study finds DHA fish oil concentrate may boost immune systemNew research demonstrates that a high-DHA fish oil concentrate can support healthy immune response in middle-aged obese adults. The study was just published in the Journal of Nutritional Biochemistry.Sunflower oil consumption linked to liver damage in ratsLifelong intake of sunflower oil induced structural changes in the livers of rats, increasing their risk of liver disease in later life, according to a recent study in the Journal of Nutritional Biochemistry. Manipulating gut with probiotics helps restore cognitive function in mice on high fat diet:Thai studyThe consumption of probiotics, prebiotics and synbiotics can improve cognitive function in obese and insulin-resistant individuals by manipulating the gut, say researchers in Thailand.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. Search and sign up for a variety of FDA Guidances. Comments are closed.
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