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TOP STORY Amended Prop 65 regulations likely to prompt a significant uptick in litigation Amendments to California's Prop 65—which require firms selling products in the state to provide warnings if their products expose consumers to 900+ chemicals linked to cancer or reproductive toxicity—will likely trigger a sharp rise in litigation as manufacturers struggle to get to grips with the new rules, predict attorneys. Most lawsuits, historically, were filed for failure to provide Prop 65 warnings, but new suits are expected to center on inadequate warning labels. Read more→ UNPA NEWS FSVP training in Sandy, Utah, Sept. 20-21 Seating is limited! Watch the new video: "Five reasons to attend." If you import ingredients for food or dietary supplement use, click on the link above to see the new video and if you should attend this FSMA-based training session. This two-day training provides a certificate issued by FSPCA. NEW! UNPA/Eurofins CBD and Dietary Supplement Symposium Join the UNPA and Eurofins staffs on Oct. 4 at Eurofins' Lafayette, Colo., facility for this one-day symposium discussing the regulatory and legislative status of hemp/CBD products and a deep dive into testing and analytical methods issues. UNPA launches new website! On Wednesday, the association debuted a new website server and a new website. Once fully operational, the new site will offer a host of new features, including an interactive member directory, streamlined event registration, expanded committee and member resources and integration with UNPA’s communications and membership functions. This is in addition to members-only archives, content, presentations and education. We ask for your patience as we continue to upload content and complete site functionality. REGULATORY FDA releases draft guidance on dietary supplements containing live microbials The purpose of this guidance is to advise firms that manufacture, market or distribute dietary supplements of FDA’s intent to exercise enforcement discretion with respect to the declaration of live microbial quantity in colony forming units, in addition to the quantitative amount by-weight declaration required by regulation, within the Supplement Facts label of dietary supplements containing live microbials. FDA’s guidance documents describe current thinking on a topic and should be viewed only as recommendations. Court orders injunction against companies selling products with undisclosed drugs The U.S. District Court for the District of New Jersey entered an order of permanent injunction against S Hackett Marketing LLC. The court order alleges the defendants violated the Food, Drug & Cosmetic Act by selling unapproved and misbranded drugs to U.S. consumers using more than 100 websites. M&A ACTIVITY New Hope Network announces sale of consumer title Delicious Living to Alive Publishing After nearly 40 years as a part of the New Hope Network, Delicious Livingmagazine and deliciousliving.com will be sold to Alive Publishing Group (APG). The company says the deal is more than a business sale; it is the start of a long-term, strategic partnership agreement between New Hope and APG. GLOBAL REGULATORY Is the time nigh? Firms warned of looming changes to China’s cross border e-commerce trade rules China looks set to implement new cross border e-commerce rules in January 2019, according to New Zealand Trade and Enterprise. This is likely to lead to additional regulation and taxes for supplement and functional food firms. Latvia moves to clarify botanical use with draft law notification Latvia has published a draft regulation concerning plants, plant parts and other substances for consumer use, as it seeks to clarify how firms can use these ingredients in food supplements, tea, syrup, and other products. ORGANICS Gov. Wolfe announces six-point plan to cultivate next-generation Pennsylvania farming Pennsylvania Gov. Tom Wolf outlined a six-point plan to strengthen the state’s agriculture industry amid a changing marketplace and new pressures during remarks to industry leaders at Penn State College of Agricultural Sciences. Within the governor’s plan is his vision to make Pennsylvania the nation’s leading organic state. DELIVERY SYSTEMS Can vitamin patches help you gain focus, lose weight or sleep? Experts are skeptical Patches are becoming the next big thing in supplement delivery, as they transmit nutrients directly to the bloodstream through the skin. One menopause-relief patch promises “instant and lasting results all night long.” But these patches might violate FDA rules regarding the marketing of products labeled as supplements that are not orally ingested. OMEGA-3s Pharmacokinetics ought to form basis of evaluating bioavailability claims, expert says Claims of greater bioavailability in the nutraceutical realm are often misapplied or miss the point, according to Nils Hoem, Ph.D., a pharmacologist and chief scientist for Aker Biomarine. The science of EPA and DHA for heart health In the last two years, conclusions among meta-analyses looking at omega-3s and coronary heart disease outcomes have been inconsistent, but a closer look suggests much is left to the interpretation of the results. SUPPLY CHAIN Despite some exaggerations, astaxanthin demand growing strongly, expert says A recent market report greatly exaggerates the potential of the astaxanthin market, an expert says, but demand for the ingredient is growing all the same. Demand for Indian frankincense threatened health of slow growing raw material, authors say A recent study cast doubt on the future health of the raw material for Indian frankincense, an increasingly popular botanical. Ginseng pills and ginseng whiskey: Wisconsin growers seek new customers amid trade war Marathon County, Wisc., grows more than 98 percent of all U.S. ginseng, and exports of the herb are an $8-million-per-year industry. But new tariffs with China will raise the price of U.S. ginseng to Chinese consumers by 15 percent. That price hike has already begun to threaten exports. That's where ginseng bourbon comes in, along with ginseng beer, ginseng-extract pills and ginseng herbal energy drinks. Suppliers see uptick in demand for botanical ingredients in beauty-from-within products Botanical teas, tonics, tinctures and more have been used for millennia in various cultures throughout the world, with the goal of maintaining an attractive outward appearance. As new evidence emerges on how these products work, interest and sales are growing. MANUFACTURING BASICS Adverse event reporting requirement for dietary supplements Since December 2007, manufacturers or brand owners—referred to as own-label distributors—of dietary supplement products have been required to report serious adverse events (SAEs) regarding their products. FDA has now established a comprehensive program for serious adverse event reporting of dietary supplements that requires manufacturers to report all SAEs. The end of materials-based manufacturing relationships In a product lifecycle, ingredients and finished products are transferred from one company to another, yet information beyond product development is not often shared. These intelligence gaps accumulate, affecting product development and leading to the brand owner feeling insecure prior to product launch. UNPA MEMBER NEWS USANA’s continued success lands company on Fast 50 list with record sales for 15th consecutive year Global nutritional company USANA was honored for its inclusion in Utah Business Magazine's Fast 50 list. This year marks its the 11th consecutive time on the list. USANA ranked number 37 with record net sales in 2017 totaling $1.047 billion—a 4.1 percent increase from 2016, with 2017 becoming its 15th consecutive year of record sales. Asha Ramesh named new Sabinsa USA CEO Asha Ramesh was promoted to CEO for Sabinsa USA and will join the company’s board of directors. Asha has been with the Sami-Sabinsa Group for more than two decades, most recently as Sabinsa’s VP of business development. She joined the Group 24 years ago as manager of purchasing and special projects at Sabinsa’s parent company, Sami Labs Ltd., in Bangalore, India. MegaFood launches out-of-stock guarantee to support smaller natural channel stores Whole food supplement manufacturer MegaFood is launching an out-of-stock program aimed at helping smaller natural channel retailers compete more effectively in the changing marketplace. LifeScienceRisk releases Prop 65 insurance LifeScienceRisk has developed a first-of-its-kind Proposition 65 insurance coverage for the dietary and herbal products industry. The new policy offers coverage for civil penalties, settlements in lieu of penalties and legal cost incurred by the plaintiff and the advocacy group bringing the notice. ENVIRONMENT Millions risking nutritional deficiencies as CO2 levels rise Increased carbon dioxide levels are now contributing to nutritionally inferior crops, such as rice and wheat, which may lead to increased populations that are deficient in protein and zinc, say researchers from Harvard. INTEGRATIVE MEDICINE Sixth annual Naturopathic Medicine Week planned for October 7-13, 2018 The Institute for Natural Medicine will be engaging in the week-long media push and celebration of naturopathic medicine along with other naturopathic organizations, including the American Association of Naturapathic Physicians and the Naturopathic Medical Student Association. PERSONALIZED MEDICINE Nestlé wants your DNA Nestlé SA, the world’s largest food company, has joined the trend for personalized nutrition with a blend of artificial intelligence, DNA testing and the modern obsession with Instagramming food. The program, begun in aging Japan, could provide the Swiss company with a wealth of data about customers’ wellness and diet. COMMENTARY The rhetoric about what constitutes 'good' evidence has become increasingly polarizing The debate about what constitutes 'good evidence,' always a controversial point, has recently become even more heated, writes complementary medicines consultant Michael Smith. It's now time to reframe the debate and focus on respectful discourse and support of informed decisions, he says. SPORTS NUTRITION Marketing products to female athletes Women want sports nutrition products formulated just for them and their bodies, leaving brands a huge opportunity to formulate/reformulate and package/repackage products. KRATOM Kratom critic in Colorado: 'We don’t know if it works or what the proof is' Robert Valuck is a professor of pharmacy, epidemiology and family medicine at the University of Colorado Anschutz Medical Campus and the director of the Colorado Consortium for Prescription Drug Abuse Prevention. In the latter role, he's been spending much of his time working on ways to reduce the opioid epidemic. He's also a confirmed kratom doubter. MOU PARTNER NEWS Trust Transparency Center awarded Coconut Coalition of the Americas' management contract Trust Transparency Center announced that it has taken over the management of the Coconut Coalition of the Americas (CCA). CCA is a Washington, D.C.-based not-for-profit (501c6) formed to steward the responsible growth and communications surrounding coconut oil and coconut products. Its membership is comprised of companies across the coconut-products value chain. PROBIOTICS Delivery systems a determining factor in probiotic success, suggests Lumina Intelligence Delivery systems for probiotic supplements will determine probiotic storage, release time and viability through the body, according to recent research with these systems’ ability largely determining product success. New research service offers insights for probiotics manufacturers A new research service offered by William Reed, parent company of NutraIngredients-USA, will offer business insights to probiotics manufactures and brand holders as well as companies in other categories. MARKETING Why brands can’t afford not to advertise on Amazon While still small in comparison to Google and Facebook, the ecommerce giant is on track to become the third largest ad player in the U.S. With each passing day, it’s becoming more clear that brands can’t afford to ignore Amazon. Why,? Because now, more than ever, Amazon is both the beginning and the end of the modern customer’s journey. MARKET RESEARCH Who’s driving the gummy supplement market? Hint: it’s not kids New research from Transparency Market Research estimates that the gummy vitamins market will grow at a compound annual growth rate of 5.2 percent between 2017 and 2025 to reach $4.17 billion. The growth and popularity of gummies can be attributed to their taste and convenience, motivating children and adults alike to take their vitamins. Survey finds consumers skeptical of synthetic supplements and favor labeling on all synthetic vitamins and supplements Trust Transparency Center released the results of a new survey finding that most Americans prefer natural dietary supplements over synthetic and think synthetic supplements should be labeled as such. The survey found that among supplement users and those with an opinion, 83 percent of respondents said synthetic supplements should always be labeled. Why national brands should worry about private label It's been a decade since the recession drove throngs of consumers into the arms of private-label products, but since then, some retailers have turned these house brands into a competitive advantage. A new analysis from research consultancy Magid reveals that the majority of shoppers favor the house brands of Trader Joe’s, Meijer, Aldi, Publix and Costco. More than half of U.K. consumers and a third of the U.S. favor a plastic packaging tax More than half of consumers in the U.K. and a third in the United States are in favor of a tax on all plastic packaging, according to a new survey from Ingredient Communications. RESEARCH Higher lutein linked to higher activity in new systematic review Australian researchers found a positive link between high concentrations of lutein and more physical activity. Whey peptide intake may lead to improved cognitive function in adults: Kirin study Whey peptide consumption may help to improve cognitive function in people who experience a high level of subjective fatigue, according to a study from beverage company Kirin. Marine oil supplement fails to produce beneficial results in non-asthmatic elite runners: RCT Supplementation with a marine-oil lipid extract derived from New Zealand green lipped mussels does not benefit resting pulmonary or muscle function in non-asthmatic elite runners, according to a recent population study from the United States. Innovative study shows medical cannabis is effective in treating a wide range of health conditions Utilizing new mobile application technology, researchers at The University of New Mexico found that medical cannabis provides immediate symptom relief across dozens of health symptoms with relatively minimal negative side effects. Probiotic strain shows body weight benefits for pre-obese adults: RCT Dietary supplementation with the probiotic strain Bifidobacterium breve B-3 may help reduce body fat levels in healthy pre-obese adults, according to a new study from Japan’s Morinaga Milk Industry Co. 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. Search and sign up for a variety of FDA Guidances. Comments are closed.
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