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    • UNPA Members >
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    • Policies & Endorsements
    • Education and Training
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      • China Delegation 2018
      • UNPA 2019 Staff Retreat
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        • Monographs
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    • Expert Insights Webinars
    • Education Archive
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    • Member Logos
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    • 2021 Training Schedule >
      • PCQI Training
      • GMP Inspection Training
      • FSVP Training
      • Intentional Audulteration (IA)
    • 2020 DSRS Speakers
    • Industry Calendar of Events
  • Join
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UNPA Digest

FDA acknowledges nearly half of dietary ingredient notices

2/20/2020

 
TOP STORY
FDA acknowledges nearly half of dietary ingredient notices For the second year in a row, FDA acknowledged without objection nearly half of new dietary ingredient notifications (NDINs). The pre-market notifications are a fundamental requirement in the Dietary Supplement Health and Education Act of 1994, aimed to ensure new ingredients are reasonably expected to be safe. Current and former FDA officials were wary to suggest the data foreshadows a long-term trend in an industry, but  the acknowledgement rate does mark an improvement over the historical average. Read more→
UNPA NEWS
IN TWO WEEKS!
RSVP for UNPA's Expo West Members' Meeting, March 4 in Anaheim 
Members’ Meeting: 8-9am
Open House/Meet & Greet: 9-10am
Plan to join your fellow UNPA members at the association’s annual members' meeting at Natural Products Expo West—the meeting is open to all UNPA members and invited guests, and there is no charge to attend. RSVP here.

JUST ANNOUNCED FOR EXPO WEST
Hide & Seek: Surviving the onslaught of hidden GMOs
Join UNPA and four other leading organizations for this update on the threat of genetic engineering to the supplement and food/beverage supply chain, Wednesday, March 4, right after the UNPA Members' Meeting. On the agenda: the threat to 'organic' and 'natural,' new consumer data from the Non-GMO Project, and an industry action plan. No charge to attend. RSVP here.

DISCOUNT EXTENDED TO FEB. 29!
Early-bird discount extended for annual Dietary Supplement Regulatory Summit, May 27, in Washington 
This fifth annual, one-day summit hosted by UNPA, AHPA, CHPA, CRN and NPA provides an intensive deep dive into pressing and topical federal regulatory issues of ultimate importance to the dietary supplement industry. Topics at this year's event include hemp/CBD, DSHEA 2.0, NDI/GRAS and much, much more. UNPA members receive discounted registration using the code AssociationMemberEarlyBird, and early-bird rates now runs through Feb. 29. Click here for more information.

UNPA IN THE NEWS
FDA suspends China inspections in light of COVID-19 outbreak
Feb. 17 | Nutraingredients-usa.com

UNPA: WHERE IN THE WORLD?
UNPA President Loren Israelsen is the featured speaker for a Feb. 20 webinar sponsored by the American Association for Naturopathic Physicians, "Hemp/CBD and the Integrative Practitioner: Lawful But Not Legal."

Larisa Pavlick, VP, Global Regulatory & Compliance, is a panelist on the Feb. 20 "Hemp & CBD: A Regulatory and Standards Update," an educational event sponsored by Naturally Boulder, in Boulder, Colo.

REGULATORY
FDA releases guidance on mitigation strategies to protect food against intentional adulteration This chapter from the Supplemental Draft Guidance, provides an overview of the food defense corrective (FDP) actions mitigation strategy management component and is intended to help companies understand the requirements for food defense corrective actions as a part of their FDP. The agency is accepting comments on the guidance within 120 days.

FDA suspends China inspections in light of COVID-19 outbreak FDA has suspended all inspections at facilities in China, in keeping with a State Department travel advisory, although the agency noted foreign inspections in other areas are continuing, including trips to facilities in other parts of East Asia.

HEMP/CANNABINOIDS
CBD industry faces safety catch 22 U.S. regulators want assurances that CBD is safe before deciding whether to allow the hemp-based compound to be lawfully marketed in dietary supplements. But the agency isn’t willing to review safety information through a traditional regulatory pathway to market because it has determined CBD is excluded from the definition of a dietary supplement.
 Hemp insurance arrives, pushing hemp one step closer to a mainstream crop Although industrial hemp has been legal since the 2018 farm bill, USDA did not offer insurance coverage for the crop until this week. This insurance gives American farmers the opportunity to survive in an unstable market with thin margins, which has prevented a good chunk of them from investing in hemp thus far.

FINANCIALS
China’s direct marketing crackdown hits NuSkin, COVID-19 won't help NuSkin saw year-over-year financials fall by over 10 percent as a result of the continued regulatory pressure in China. The COVID-19 disease outbreak is expected to depress results even further in the coming year.
 Herbalife notches $4.9 billion in annual sales despite hit in China Herbalife reported a 3-percent rise in sales for its full year, recording $4.9 billion in revenue. The increase was achieved even with sharp declines in China, attributable to that country’s regulatory crackdown on multilevel marketing companies.

PARTNERSHIPS
Japan’s Teijin makes first foray into probiotic space with Chr. Hansen partnership Chr. Hansen has sealed a deal to supply probiotic ingredients to Teijin Limited, a Japanese prebiotic firm, for use in functional and health-food applications in its domestic market.
 ChromaDex partners with Persona Nutrition ChromaDex Corp. has launched its flagship cellular health supplement Tru Niagen (nicotinamide riboside) as a product offering in Nestlé Health Science’s personalized nutrition service Persona Nutrition.

GLOBAL REGULATORY
U.K. Food Standards Agency issues CBD industry deadline Cannabidiol (CBD) industry groups have welcomed new regulatory and precautionary advice by U.K. authorities, highlighting its “clear trajectory towards developing a safe and legally compliant CBD industry.”
 CBD industry hits back at FSAI survey findings and 'broad-brush statements' Retailers in the CBD space have expressed frustration at a recent survey from the Food Safety Authority of Ireland, which finds products analyzed breach food law with some posing as potential safety risks for consumers.

MEDIA WATCH
No, it’s not a deep fake. Yes, the language matters There was a moment, back in 2016, when we had a common understanding of the term “fake news.” Three years on—at least in certain circles—the term's definition has been expanded to mean any media you distrust, particularly mainstream media.

TRENDS
Three NBJ insights to help you prepare for Natural Products Expo West Get the scoop on what's fueling growth across three hot categories, hemp/CBD products, non-pill delivery formats and immunity supplements.
 No holds barred: How the nutrition bar market is breaking free from traditional categories The nutrition bar market is witnessing an unprecedented merging of categories and is calling into question all health and wellness stereotypes, revealing ‘fascinating’ macros trends and new product opportunities for the whole food and drink industry to tap into.

RETAIL
Earth Fare and Lucky’s Market: What happens when two big organic grocers collapse? The consensus around the closure of Lucky's Market and Earth Fare appears to be that both were pushed to grow too much, too fast. The demand for organic, healthy fare has never been stronger, and smaller chains can stay in the game by focusing on stocking the newest and most innovative products on the market.

PROBIOTICS
Demand for digestive health provides opportunities for manufacturers New global research shows consumers understand the benefits of probiotics for gut health and are looking for food and beverage products to improve it.
 Poop-eating lab mice affect probiotic research outcomes Researchers have studied a key difference between the microbiome of lab mice and humans caused by rodents’ tendency to eat their own feces, which they say could have wide-ranging implications to numerous research areas.

ORGANIC
Will Michelob’s organic beer really transform American farmland? Michelob Ultra Pure Gold is the first national, certified-organic beer brand, and the company's recent highly publicized campaign stated that each 6-pack sold will help convert six square feet of farmland to facilitate organic barley production and ultimately contribute $1 million to an organic farming fund.

BIOTECH/GMOs
A house divided: Finding common ground in biotech debate—deep dive Biotechnology is accelerating with new genetic engineering techniques and terminology. Regulators have been slow to catch up, and companies are racing to market with new items destined for grocery carts, even as the industry tries to decipher buyers’ mindsets when it comes to food and ingredients intersecting science. Download requires registration.

CLIMATE CHANGE
Recent responses to climate change reveal the drivers of species extinction and survival The response of species to climate change is of increasingly urgent importance. This study addresses the specific changes in climate that were associated with recent population extinctions, using data from 538 plant and animal species distributed globally.

PERSONALIZED MEDICINE
IBM uses AI-powered model to predict age from gut microbiome samples Artificial intelligence is now being put to work in microbiome research as researchers use the tool to predict a person’s chronological age based on a microbiome sample.
 New DNA kit yields nutrigenetics report and customizable meal plan After three years of collaboration, research and testing, Mako Medical Laboratories is launching a nutrition-targeted genetic test designed to help consumers better understand what their body needs and what foods should be eaten to optimize performance.

PERSONAL CARE
Tom’s pioneers prebiotics personal care products Step aside, kimchi and kombucha. Tom’s of Maine is out to give Americans a whole new way to befriend bacteria, debuting a line of personal-care products that promote the growth of prebiotics.

UNPA MEMBER COMPANY NEWS
Twinlab recovery story adds chapter with new manufacturing segment Twinlab Consolidation Corp. has entered into a manufacturing agreement with a new contract manufacturer as part of an ongoing effort to rejuvenate the legacy brand. The deal teams Twinlab with Bonn Sante Group, an emerging contract manufacturer in Florida.
 OmniActive’s foundation to be spotlighted at the 'Inside the Bottle' Expo West session Improving Lives Foundation has been selected as a featured case study at Inside the Bottle’s hosted educational working session, Stewarding a Sustainable and Transparent Supplement Industry, taking place on Wednesday, Mar. 4, from 4-5:30 p.m. during this year’s Expo West.

MOU PARTNER NEWS
U.S Hemp Authority Certification Program to hold public session at Expo West The U.S. Hemp Authority Certification Program, the hemp industry’s initiative to provide high standards, best practices and self-regulation for hemp growers, processors, manufacturers and brand owners in the dietary supplement, food/beverage and cosmetic spaces, will be holding a public session to update industry stakeholders on the progress of the effort and solicit members for its Technical and Scientific Committee. The meeting, open to the public, will be held at Natural Products Expo West on March 2, from 6-8 pm, in the Avalon Ballroom at the Anaheim Hilton.
 ABC announces recipients of annual awards for botanical and phytomedicinal research The nonprofit American Botanical Council (ABC) announced that the 2019 ABC Norman R. Farnsworth Excellence in Botanical Research Award has been presented to Professor Rachel Mata, Ph.D., a pharmacist, pharmacognosist and natural products researcher, who has spent most of the past five decades investigating the quality, composition and benefits of Mexican medicinal plants and fungi. The group also announced the 2019 Varro E. Tyler Commercial Investment in Phytomedicinal Research Award will be presented to Napo Pharmaceuticals, a subsidiary of Jaguar Health. Napo specializes in the research, development and production of natural, plant-derived novel therapeutic agents and has successfully developed and commercialized an extract from the sap of the Amazonian tree bark known as dragon’s blood (sangre de drago in Spanish).

MARKET RESEARCH
Research explores how dietary supplements affect work performance A leading expert on public health has called for more research into potential links between food supplements, dietary nutrient density and productivity in the workplace. Adam Drewnowski, professor of epidemiology, conducted a comprehensive review of health-based intervention programs in the workplace and their impact on employee performance. The literature review was supported by IADSA.
 Gen Z drives the future of unattended retail As members of gen Z enter the workforce in greater numbers, their shopping habits are influencing the retail industry in non-traditional ways, including fueling the growth of unattended retail channels, such as cashier-less checkouts and smart vending machines, according to a national study, which polled 2,325 consumers.

RESEARCH
Vitamin D deficiency linked to back pain in postmenopausal women Vitamin D deficiency may lead to greater back pain in postmenopausal women, according to a study published in the journal of The North American Menopause Society.
 'Debunking a myth': RCT shows moringa leaves may lower blood pressure Contrary to public perception in some parts of the world that Moringa oleifera may increase blood pressure, data from a new placebo controlled clinical study indicate that the leaves may actually reduce blood pressure.

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.

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