UNPA’s Israelsen weighs in on ODIs at FDA meeting; UNPA to host review next week

​REGULATORY
UNPA’s Israelsen weighs in on ODIs at FDA meeting; UNPA to host review next week
Nutraingredients-usa.com, FDA Law BlogFDA’s undertaking to create a master list of old dietary ingredients that could be sold legally in dietary supplementswithout first going through the NDI notification process will likely fall flat, according to UNPA’s Loren Israelsen and other industry trade groups. At an FDApublic meeting this week, Israelsen noted some of the issues that may deter a useful list. Overall, stakeholders suggested the agency should reframe and expand the effort to be more useful. Commentary prior to the meeting noted thatFDA has once again ignored the language of the FD&C Act as amended by DSHEA and is seeking to impose requirements on dietary supplements that have no basis in law. UNPA will host a member conference call next week to review this week's meeting. Read coverage:
An FDA approved list of ‘old dietary ingredients’ may not be possible, or responsible, stakeholders warn→
Note to Commissioner Gottlieb and Congress: FDA has ignored Congressional intent and broken its commitment to Congress to develop NDI policies consistent with the FDC Act as modified by DSHEA→

UNPA NEWS
UNPA now offering expanded menu of onsite training
UNPA has expanded its menu of onsite training to include GMP auditing, mock facilities inspections, as well as PDQI and FSVP training. Learn why this can be a time-saving, cost-effective option for your company.

Recently posted at unpa.com:
NEW! Loren Israelsen's PPT for his presentation at the FDA ODI meeting, Oct. 3, in College Park, Md.(Member log in required)
NEW! The PPT for the UNPA Members' Meeting at the 2017 SupplySide West (log in)
NEW! Larisa Pavlick's 2017 SupplySide West Center Stage presentation on FSMA, including PCQI (log in)
NEW! Nutraingredients-usa.com interview with Larisa Pavlick on FSMA issues, including FSVP (log in)
Washington Update by Patricia Knight and Peter Reinecke, UNPA Senior Political Advisors (log in)
Updated PCQI FAQ
Issues Update conference call (log in)
UNPA announces onsite PCQI training
Synched PPT/audio file ofJim Thomas' Introduction to Synthetic Biology presentation at the 2017 UNPA Members' Retreat (suggest streaming only; file is VERY large)
Plus, updated industry events calendar,Member Memos (log in) and UNPA educational archives (log in).LEGAL
Judge drops FTC suit against Quincy Bioscience over memory claimsNatural Products INSIDER
A federal judge has dismissed a lawsuit filed in New York by state and federal regulators against Quincy Bioscience, the marketer of a dietary supplement, Prevagen, to improve memory in older adults. The case is distinguishable from many other lawsuits filed against companies in the dietary supplement industry. The controversy boiled down to an interpretation of the “Madison Memory Study,” which failed to show any statistically significant results for the study population as a whole, but statistically significant results were identified among certain subgroups. Read more→
NEW! COMMENTARY
Drs. Weil, Maizes note need for better policies on pain and integrative therapiesThe Hill
In response to an article regarding the role of science in the opioid crisis in the New England Journal of Medicine,written by leadership at NIH and the National Institute on Drug Abuse, Drs. Andrew Weil and Victoria Maizes point out that the narrow focus of these agencies is out of step with recommendations of public health organizations. They note the complete omission in the NEJM article of non-pharmacologic treatment and stress the importance and strides of new integrative approaches to these issues. Read more→REGULATORY
HHS report finds weakness in way FDA is protecting food supplyNPR.org
In a new report, the Department of Health and Human Services' Office of Inspector General found “a number of weaknesses in the way that FDA is protecting the food supply.” The FDA often relies on companies to voluntarily correct their violations, and does not follow up in a timely manner, the report says. FDA, for its part, agrees that there are challenges in how it conducts inspections and takes action. Read more→
LEGISLATIVE
House bill to help USDA crack down on fraudulent organic productsLos Alamos Daily Post
New bipartisan legislation introduced by Reps. John Faso, R-N.Y.,and Michelle Lujan Grisham, D-N.M.,seeks to protect the integrity of the organic seal by providing USDA with the resources it needs to upgrade import documentation and technologyand crack down on fraudulent imports. Read more→
BOTANICAL ADULTERATION
New analysis finds widespread adulteration in proprietary TCM productsNutraingredients.com
More than 1,200 adulterants have been found in proprietary Chinese medicines, which are the finished dose form of supposedly all-natural Traditional Chinese Medicines, according to a new analysis published in the British Journal of Clinical Pharmacology. The report documented 404 cases in 487 products containing 1,234 adulterants. Read more→PRODUCT TESTING
Carbon-14 testing emerges as concern over synthetics grows; multi-enzyme blends prompt use of complicated testing proceduresNutritional Outlook, Natural Products INSIDER
Debates on comparative efficacy of natural and synthetic ingredients aside, synthetic analogues can suffer from increased consumer scrutiny in the “wellness” sector. As such, companies are moving into natural, plant-derived ingredients and using sophisticated screening methods to vet the purity and origin of these ingredients. One such tool is carbon-14 analysis, which is used to determine whether ingredients are sourced from petrochemicals or whether they are biobased (plant, animal, or microbial). Meanwhile, companies utilizing enzymes often use testing to dial in the activity level, so they can determine how potent the enzyme is or how much work it can do. For this reason, enzyme potency is measured in activity instead of weight. But when complex products and multi-enzyme blends are manufactured, the methods for testing become more complicated. This article provides a look at some of the issues. Read coverage:
Carbon-14 analysis and dietary supplements→
Common issues with testing enzymes for label claim→
M&A ACTIVITY
MeriCal acquires Global Health Industries to create leader in probioticsMeriCal, Nutraingredients-usa.com
MeriCalLLC, an Anahiem, Calif.-based developer, manufacturerand packager of probiotics and other nutritional supplementsowned by Linden Capital Partners, announced it has signed a definitive agreement to acquireOgden, Utah-based UNPA member Global Health Industries. GHI is best known for its specialized approach toprobiotic manufacturing and packaging, including bacteria, sporesand yeast products.Brian Smith, CEO of MeriCal, says the deal will provide the scale necessary to compete effectively in the growing global probiotic market. Read coverage:
MeriCal acquires Global Health Industries to create leader in probiotics→
MeriCal’s acquisition of GHI will help drive quality and international expansion→
M&A ACTIVITY
KKR closes deal to buy majority ownership of Nature’s Bounty; Lonza buys new clinical manufacturing facilityNutraceuticals World, 4-Traders
The Nature’s Bounty Co.has closed on a transaction with global investment firm KKR, which is now the majority owner of Nature’s Bounty. Effective immediately, consumer healthcare veteran Paul Sturman will assume the role of CEO of Nature’s Bounty, succeeding Steve Cahillane, who was named CEO of Kellogg. Lonza announced that it is acquiring a clinical-stage mammalian manufacturing site in the United States from Shire plc. Financial details of the deal were not disclosed. Read coverage:
Nature’s Bounty Co completes transaction with KKR, names Paul Sturman CEO→
Lonza to acquire a US clinical manufacturing site to support ongoing customer demand→
RETAIL
Whole Foods' Mackey says Amazon deal freed chain from 'whole paycheck' trap; lower prices have competitive impactFood Business News, Thasos Group
Prior to its acquisition, Whole Foods Market was in what John Mackey called a “whole paycheck” trap. At SNAC International’s Executive Leadership Forum earlier this month, he told attendees the Amazon deal would set it free from that reputation. Whether headlines about the deal were hype or not, the promise of reduced prices is attracting shoppers to Whole Foods Market, according to analysis by Thasos, a data intelligence firm. Whole Foods Market foot traffic increased 17 percent the week the natural foods grocer reduced prices and remained elevated at 4 percent year-over-year as of the week ended Sept. 16. Read coverage:
Mackey: Whole Foods set free by Amazon acquisition→
Competitive impact of lower prices at Whole Foods→
GLOBAL REGULATORY
EU agencies highlight adulteration issues; EFSA grants novel food approval for satiety ingredientNutraingredients.com
European authorities have informed the EU of a number of dietary, food and sports supplements that contain either ingredients that exceed permitted levels or unauthorized substances. Specific product recalls are noted in Denmark, Spain and Germany. EFSA has granted a novel food application for the weight loss and metabolism management ingredient hoodia parviflora. The non-endangered, safety-validated ingredient has been approved as a whole food ingredient. Read coverage:
European agencies highlight high levels and banned substances in supplements→
ID Nutra receives EFSA novel food applications for satiety ingredient→

CONTRACT MANUFACTURING
Ingredient sourcing has become a critical piece of contract manufacturingNatural Products INSIDER
Ingredient sourcing is a seemingly simple task for contract manufacturers—find the raw materials needed for a formula. The reality, however, is that ingredient sourcing has become an important strategic component of successful contract manufacturing operations. Long gone are the days when companies purchased based on price andrelied on a piece of paper to identify the ingredient. Now, stringent requirements are in place, and sophisticated supply chain systems ensure the supply and the identity and quality of raw materials. Read more→
APAC MARKET
Japan’s older consumers show big brand loyalty; innovators lead growth in APAC supplements marketNutraingredients.com, Nutraingredients-usa.com
Beyond the high regulatory hurdles, supplement and functional food companieslooking to enter the Japanese market with new products tailored to the aging population must overcome high levels of brand loyalty to stand any chance of success, according to Sensing Asia. The market segment does, however, offer plenty of opportunity. Technical advances are having a big impact on the APAC supplement and functional food industry, with the most innovative firms enjoying a major boon as consumer go online for advice and to make purchases, according to Mintel's APAC Trends. Read coverage:
Entering Japan: New supplement and functional food players must entice ‘brand loyal’ older consumers→
AI, chat bots and e-commerce taking APAC’s nutrition industry to next level→
INNOVATION
Coffee ‘waste’ makes attractive addition to antioxidant formulations; nanofiltration recovers polyphenols from blueberriesNutraingredients-usa.com, Nutraingredients.com
Another ‘waste stream’ ingredient is poised to make a splash in the marketplace with the launch of Coffeefruit Pure, a byproduct of coffee production, artisanal coffee production on Hawaii’s Kona Coast. The company says the ingredient has strong antioxidant properties, which could make it an attractive addition to powdered formulations. In other news, use of nanofiltration membranes enable the recovery of substantial amounts of phenolic compounds in waste residues from processed blueberries, according to a recent study in Food and Bioproducts Processing. Read coverage:
Coffee fruit ingredient set to upcycle 15 billion pounds of waste→
Nanofiltration helps recover blueberry polyphenols from residues→
UNPA MEMBER NEWS
Thorne Research breaks ground on new manufacturing, corporate headquartersThorne Research
Thorne Research Inc. celebrated the groundbreaking of its new state-of-the-art manufacturing facility in Berkeley County, S.C. The new facility will serve as the company’s manufacturing center and corporate headquarters complex. Read more→Vitamin Shoppe opens digital platform to serve Chinese consumersNutraceuticals World
Supplement retailer The Vitamin Shoppe opened a digital platform in China, making it the fourth new international market in the last two years. The retailer is partnering with Macy’s China Limited to offer consumers there a mix of private label products, as well as some third-party brands via Alibaba’s online shopping platform, Tmall Global. Read more→

LifeVantage appoints Kevin McMurray as general counselLifeVantage Corp.
LifeVantage Corp. has announced the appointment of Kevin McMurray as general counsel. McMurray brings more than 25 years of legal expertise to LifeVantage, where he will be responsible for leading the legal department and serving as counsel to the board of directors, board chair and CEO. McMurray most recently served as assistant general counsel at USANA Health Sciences. Read more→FoodState hires Sara Newmark to direct social responsibility, sustainabilityBusiness Insider
FoodState, creators of MegaFoodand INNATE Responsebrands, is pleased to announce its recent hire of Sara Newmark as its VP of social impact. Newmark will be responsible for all social responsibility and sustainability efforts, as well as industry and regulatory affairs. She joins FoodState from New Chapter, where she was the senior director of sustainability. Read more→Indena teams with Hyris, NHP Research Alliance to develop DNA ID kitsNutraingredients.com
A new collaboration between Indena, Hyris and the NHP Research Alliance will develop DNA authentication test kits for botanicals and related natural health products. The partnership brings together industry and academia expertise in pushing technology used in DNA identification for plant-based ingredients. Indena will provide a standard plant reference material resource that includes the preparation of herbarium vouchers. Read more→

LifeScienceRisk adds chemicals to its Prop 65 coverageNutraingredients-usa.com
LifeScienceRisk has added five new chemicals to its list for coverage in its Proposition 65 insurance for herbal products and dietary supplements. The company has also expanded coverage for the tea industry. Read more→

Tespo to license vitamin-pod technology to manufacturers, including FoodStateNutraingredients-usa,com
Supplement appliance maker Tespo just launched a program, which allows vitamin manufacturers to license its patent-pending, Keurig-like vitamin pods, enabling them to create products compatible with the liquid-vitamin-dispensing system. The first licensee is UNPA member brand Mega Food from FoodState. Read more→
MARKET RESEARCH
Millennial perceptions about supplements to drive market normsNutraingredients-usa.com
Consumers today most associate supplements with powders and beverages rather than capsules, tablets and pills, according to a analysis of social media chatter by market research firm CBD Marketing. The firm notedat a recent SupplySide West sessionthat millennials have become the largest consumer age group of supplements with the strongest buying power, which means their world view will likely dictate the new norm in dietary supplements. Read more→
RESEARCH
Probiotics fight lupus; vitamin D helps asthma patients; bioavailabilty important for polyphenols; pycnogenol aids joints; iron helps low-weight babiesNutraingredients.com, Nutraingredients-usa.com
Probiotic strains found in yogurts may help prevent complications associated with lupus, according to new mouse data from Virginia Tech that reports female mice given Lactobacillus have an altered microbiome and reduced symptoms.Vitamin D supplementation could provide a degree of protection against severe asthma attacks brought on by viral upper-respiratory infections, according to a new review in The Lancet. Overall, supplementation resulted in a 30 percent reduction in asthma attacks requiring treatment with steroids or injections. Health benefits of polyphenols have been examined in a new review from the Instituto de Salud Carlos III in Madrid, in which their impact on gut microbiota was the main focus. They found that benefits were dependent on bioavailability, which is low compared to micro and macronutrients. The potential joint health benefits of pycnogenol, an extract of French Maritime Pine Bark, are linked to its ability to absorb directly into the synovial fluid, according to a new study in patients with osteorarthritis published in Nutrients. Supplementing low birth-weight babies with extra iron may help prevent behavioral problems at school age, suggests researchers at Umeå University in Sweden. Read coverage:
Mouse data links microbiome changes to lupus severity and complications→
Vitamin D supplementation preventing asthma: A precision medicine approach→
Benefit of polyphenols on gut microbiota uncovered in review study→
Pycnopgenol joint health benefits illuminated in unique trial→
Extra iron reduces aggressive behavior in low birth-weight babies→
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→