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  • About
    • UNPA Members >
      • Executive Members
      • Science & Technology Services Members
      • Associate Members
      • Featured Member Profiles
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    • UNPA Staff >
      • National Staff
      • Political Advisors
    • Policies & Endorsements
    • Education and Training
    • Photo Galleries >
      • Members' Retreat 2019
      • China Delegation 2018
      • UNPA 2019 Staff Retreat
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    • Testimonials
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    • UNPA News
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    • Media Releases
    • Member/MOU Partner News
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  • Member Resources
    • Regulatory Resources >
      • GMPs >
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      • FSMA >
        • PCQI
        • FSVP
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      • Labeling/Claims >
        • Nutrition Facts label
      • Guidelines/Best Practices >
        • Monographs
      • Links and Resources
      • Global >
        • Canada
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    • Expert Insights Webinars
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    • UNPA Events & Training >
      • 2021 Training Schedule
    • 2020 DSRS Speakers
    • Industry Calendar of Events
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UNPA Digest

FDA to focus on compliance for new Nutrition Facts, Supplement Facts labels

10/31/2019

 
​TOP STORY
FDA to focus on compliance for new Nutrition Facts, Supplement Facts labels With the deadline for companies to comply with FDA’s new Nutrition Facts and Supplement Facts label rules around the corner, FDA announced that during the first six months following the first compliance deadline—January 1, 2020—it will focus on helping companies meet the new rules, rather than coming out of the gate to immediately enforce the rules. The agency had received strong requests from numerous leading food and supplement industry associations to provide enforcement flexibility as companies work toward compliance. Read more→
UNPA NEWS

NEW! UNPA announces Intentional Adulteration training, Jan. 22 in Lehi, Utah
Did you know that you're responsible for having in place a plan to deal with adulteration of your ingredients and finished goods? It's all a part of FDA's Mitigation Strategies to Protect Food Against Intentional Adulteration (referred to as the IA rule), part of the Food Safety Modernization Act. Developed by the Food Safety Preventive Controls Alliance (FSPCA), this intensive, one-day certificate course is the "standardized curriculum" recognized by FDA. Join Ned Mitenius, a 30-year veteran in the food processing industry, who will lead the training. UNPA members receive a $200 discount at registration.

December GMP training in Provo, Utah
Former FDA Investigator and UNPA's VP, global regulatory & compliance, Larisa Pavlick will lead the training, which will provide everything you need to know to make sure your facilities are fully compliant with 21 CFR Part 111 before your next inspection. The training is scheduled for Dec.4-5 in Provo, Utah. Click the title to learn more about the training and to register.

UNPA's FSVP training set for February 2020 in Utah 
Do you import ingredients or finished goods? Do you know your obligations under the Foreign Supplier Verification Programs regulation? Join former FDA Investigator and UNPA VP, Global Regulatory & Compliance Larisa Pavlick for this certificate-based training. Click on the title for more information, why you might need to attend and to register.

REGULATORY
California probiotics bill clashes with FDA policy In 2019, the California State Assembly presented legislation that was inconsistent with FDA’s current probiotic policy and regulation, causing confusion for industry and consumers.
 FDA releases statement on homeopathics FDA has released a statement regarding its efforts to protect patients from “potentially harmful” homeopathic products, saying these products have the potential to cause significant and even permanent harm if they are poorly manufactured.
 FDA’s limited view on inflammatory claims FDA says general inflammation claims from supplements and foods are illegal because chronic inflammation is a disease state.

FINANCIALS
USANA Health Sciences reports 3Q19 results USANA Health Sciences announced financial results for its fiscal 3Q, noting that net sales were $260.6 million, compared with $296.8 million in the prior-year period, or a 12.2 percent decrease year-over-year. 
 At GNC, net income increases as sales decline slows in third quarter CEO Ken Martindale says the company is in talks to restructure debt by end-of-year, but some speculate the company will go private.

HEMP/CANNABINOIDS
USDA announces interim final rule for U.S. hemp production The publication of an interim final rule paves the way for states and Indian tribes to submit plans to USDA for approval to oversee the production of hemp.
 Mississippi adds to regulatory tangle with warning on CBD products Mississippi state officials have issued a blanket warning to consumers about the dangers of all CBD products sold in the state.

PARTNERSHIPS
Nature's Crops International and Braini LLC announce global ahiflower supply agreement Nature's Crops International has entered into a global supply agreement with Braini LLC for its branded Ahiflower oil (NeurXcel) which will be incorporated into the Braini memory and cognitive health platform slated for launch in December 2019.
 Ashland to distribute Clasado Biosciences Bimuno prebiotics in U.S. Ashland has signed a licensing agreement with Clasado BioSciences to distribute Bimuno, a daily fiber supplement containing galacto-oligosaccharides, which feeds and stimulates the growth of bifidobacteria in the gut, the company says.

DIRECT SELLING
FTC vs. Advocare: A teachable moment for direct selling Attorney Jeffrey A. Babener discusses the landmark settlement between Advocare and FTC, which came with a $150 million fine and lifetime MLM bans for AdvoCare’s CEO and top distributors. He offers some common sense guidelines to create the strongest defense to an MLM program and for promoting anti-pyramid practices aimed at staying off the FTC radar.

DSHEA AT 25
DSHEA’s 25th anniversary: Industry vets, critics respond Exactly 25 years ago—Oct. 25, 1994—President Bill Clinton signed a bill that has enabled the dietary supplement industry to flourish over the last quarter century. Industry veterans, including UNPA’s Loren Israelsen and Patricia Knight, as well as the law's critics, discuss the its impact.

Dietary supplement regulations: Comparing U.S. to Canadian model The 25th anniversary of the Dietary Supplement Health and Education Act of 1994 raises many questions about the pros and cons of the U.S. law.

BOTANICALS
Oregano herb and oil adulteration data summarized in new Botanical Adulterants Prevention Bulletin The ABC-AHP-NCNPR Botanical Adulterants Prevention Program has summarized data on the adulteration of oregano (Origanum vulgare subsp. hirtum; O. onites) and oregano essential oil in a new bulletin.

APAC MARKET
Entering China’s booming probiotics market: The six big challenges to overcome Firms planning to enter China’s probiotics market should take note of six key challenges surrounding the types of ingredients available for use, consumers’ understanding and approved health claims.

RETAIL
Amazon drops $15 monthly fee for Prime members in a bid to drive sales and usage of grocery delivery In an effort to boost sales and attract more users, Amazon has expanded its list of benefits to Prime members and has dropped the $14.99 monthly fee to users of its Amazon Fresh grocery delivery service. Regular patrons of Whole Foods, however, are being angered by scores of the retailer's gig-economy employees referred to as Prime Now shoppers, according to an article in The Wall Street Journal (must subscribe to read the full article).
 Vitamin Shoppe shifts to tech-forward shopping The novel design and offerings at the retailer's latest New Jersey location will serve as a model for future stores.

ORGANICS
Gene editing, celery powder and organic enforcement: A roundup from the NOSB’s fall meeting The National Organic Standards Board recently addressed some of the industry’s critical issues: protecting small-scale organic dairy farmers; strengthening fraud enforcement; and gene editing.
 Faulty study claims switching to organic agriculture increases greenhouse gases A widely covered Nature Communications study indicating that the increased transition to organic agriculture in Wales and England would eventually result in more greenhouse gases fails to acknowledge that production needs can also be fulfilled in the future through reducing food waste and increasing organic yields.
 The elusive goal of no-till organic Organic farmers rely on tillage to control weeds in place of harmful herbicides, but now some experts argue that the organic agriculture movement must give up the till entirely in order to successfully scale up and feed the growing population.

NON-GMOs
Non-GMO month: What does the next decade hold? As the Non-GMO Project marks the 10th Non-GMO Month, project leader Megan Westgate discusses the state of the effort, “blue-dot” consumers, and the food-tech future.

PERSONALIZED MEDICINE
In latest moves, Ancestry and 23andMe aim to change behavior Genetic testing companies have never quite delivered on the health breakthroughs, and combined with privacy concerns about how genetic information might be used against customers, plenty of people have stayed away. But now both 23andMe and Ancestry are announcing new initiatives to address the issues.

CLEAN LABEL
Corporate America has sapped ‘green’ of meaning While “green” is plastered on many a natural-leaning product, the inherent ambiguity of the term means that consumers are often feeling good about their “green” purchases, even if they aren’t actually better for the environment.

UNPA MEMBER COMPANY NEWS
Verdure's maple leaf extract touts skin benefits Verdure Sciences is touting its newly debuted ingredient, with researchers suggesting that the maple leaf extract could be an alternative to Botox.

Colorado hemp industry looks to Latin American markets A Colorado producer of bulk-hemp-derived products, Mile High Labs, backed by an ambitious state government plan, is looking south to new markets in Latin America.

USANA announces appointment of Timothy Wood to board USANA Health Sciences announced the appointment to its board of directors of Timothy Wood, Ph.D., who joins the board as an independent director and brings more than 30 years of experience in scientific research and development.

Awards recognize Sami-Sabinsa innovation excellence The Sami-Sabinsa Group along with founder, Chairman and Managing Director Muhammed Majeed, Ph.D., were honored by the Associated Chambers of Commerce & Industry of India, an organization of more than 400 Chambers of Commerce and Trade Associations, with the mission to impact policy and legislation to foster balanced economic, industrial and social development.

ANIMAL COMPANIONS
Consumers spend $74 billion annually on pets "Pet parenting" is reshaping the landscape for the consumer packaged goods and retail industries, according to a report, Pet industry Study 2019, which puts  pet owners spending at upwards of $74 billion annually.

UNPA MOU PARTNER NEWS
Len Monheit named CEO of Trust Transparency Center Trust Transparency Center has promoted Len Monheit to chief executive officer, effective immediately. Monheit previously served as the organization's managing partner and brings more than two decades of industry experience and thought leadership to the position.

Oxford botanical conference calls for abstracts, opens for registration The 20th annual Oxford International Conference on the Science of Botanicals is now accepting abstract submissions. The event is held March 30-April 2, 2020, in Oxford, Miss.

MARKET RESEARCH
Analyst's take: Supplement raw material market reaches $6.3 billion The supplement raw material and ingredient market is a $6.3 billion industry unto itself, with growth of 5.9 percent in 2018, just behind the 6-percent growth of the consumer supplement market.

MARKETING
The great American love affair: B2B sales and marketing Almost all companies think their sales and marketing teams work well together, but 66 percent of those who say they are well aligned and 66 percent of those who feel they are very well aligned show negative performance and pipeline growth, according to a new benchmarking study by LeadMD and Drift.

Global B2B firms say it’s tough producing content The need for content is paralyzing B2B teams as they struggle to compete in multiple channels and markets, according to a new study from inRiver, a provider of product merchandising and management services, conducted by Savanta.

The power of influencer marketing: IZEA and IRI can pinpoint influencers’ direct impact on sales Influencers have become a crucial element of the content-marketing tool box for CPG brands, and with the recent launch of InfluenceImpact by IRI and IZEA Worldwide, brands and marketers can now measure the direct impact influencer campaigns have on the sales of a particular SKU or product line.

Fix what’s broken: gen Z wants brands that tackle guns, gays, the planet Brands are going to have to get gutsier about purpose if they expect to hang on to gen Z consumers, according to the latest Porter Novelli/Cone Gen Z Purpose Study, which shows that while gen Z may be tender in age, they’re increasingly focused on fixing what’s broken. And they expect the companies they buy from to do the same.

RESEARCH
Pharmako delivery system boosts omega-3 absorption six fold The oral absorption of omega-3 fatty acids can be significantly boosted using the AquaCelle self-emulsifying drug delivery system, without requiring a high-fat meal, says a new study published in the European Journal of Nutrition.

Probiotics and cranberry supplement very promising for recurrent UTIs A probiotic and cranberry supplement can significantly reduce recurrent urinary tract infections in premenopausal women, as well as shorten the duration of infections and reduce the need for antibiotic treatment, according to a study published in the journal Expert Review of Anti-infective Therapy.

Coffee bean extracts alleviate inflammation Researchers are using coffee bean leftovers to study their role in alleviating chronic disease.

Vitamin D deficiency linked to poor muscle function in older adults Low vitamin D levels are an important determinant of skeletal muscle function of adults age 60 and older, warn Irish researchers, calling for more action to tackle deficiency.

Vitamin B3 overdose report pinpoints cause of eyesight loss Eye experts have discovered that severe vision loss from a self-prescribed high dose of niacin (Vitamin B3) is linked to injury of a specific cell type in a patient's eye.

Shirota strain shows immune inflammation benefits for marathon runners Consumption of Lactobacillus casei Shirota (the Yakult strain) for 30 days prior to running a marathon may help modulate immune and inflammatory response after the race, says a new study from Brazil.

ETC.
Is a diet that’s healthy for us also better for the planet? Most of the time, yes In a vast new analysis published in the “Proceedings of the National Academy of Sciences,” researchers at the University of Minnesota looked at the health and environmental impacts of 15 different food groups, including nuts, fruits, vegetables, red meat, dairy, eggs, fish, olive oil, legumes and sugar-sweetened beverages, finding that foods that promote good health also tended to be better for the planet—and vice versa.

​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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