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    • UNPA Members >
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    • Policies & Endorsements
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        • PCQI
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    • Expert Insights Webinars
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    • 2021 Training Schedule >
      • PCQI Training
      • GMP Inspection Training
      • FSVP Training
    • 2020 DSRS Speakers
    • Industry Calendar of Events
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  • Media
  • For Consumers
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UNPA Digest

FDA official: CBD not a supplement, kratom a ‘violative’ ingredient

6/14/2018

 
TOP STORY
FDA official: CBD not a supplement, kratom a ‘violative’ ingredient
​
During an industry event this week, Robert Durkin, deputy director with FDA's Office of Dietary Supplement Programs, signaled some of his agency's enforcement priorities in targeting certain types of CBD products. FDA’s position has been contested by companies selling CBD in dietary supplements, but to date, no federal court has ruled on the legal status of CBD in supplements or foods. Durkin called another botanical—kratom—a "violative dietary ingredient," saying it is a new dietary ingredient subject to a safety-related, premarket-notification to FDA. Read more→
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UNPA NEWS
FSVPtraining in Sandy, Utah, Sept. 20-21
If you import ingredients for food or dietary supplement use, click on the link above to see if you should attend this FSMA-based training session to ensure regulatory compliance! This two-day training will be held Sept. 20-21 in Sandy, Utah.

Recently posted at unpa.com:
  • NEW! Three presentations from the 2018 UNPA Members' Retreat have been posted to the UNPA YouTube channel for free viewing: cannabis/CBD/hemp and U.S. and global supplement trends.
  • Regulatory Reform: Industry’s Top Ideas for Change, presentation by UNPA’s Larisa Pavlick at the Dietary Supplement Regulatory Summit, May 16
  • FSMA: Why it is important to the Dietary Supplement Industry?, presentation by Larisa Pavlick at USP’s "Tools for GMP Compliance," May 11
  • UNPA OnDemand: Expert Insights: Raw Materials Testing with IR, presented April 19, now available for viewing!(Free registration required)
  • Canadian supplement advertising regulations (Log in)
  • UNPA OnDemand: FSMA and What It Means to You, by Larisa Pavlick (Free registration required)
  • Plus, updated industry events calendar,Member Memos (log in) and UNPA educational archives (log in).

LEGAL
Supreme Court reinstates $148 million award in vitamin C anititrust case against China
The U.S. Supreme Court sided against China on Thursday, throwing out a lower court ruling that had allowed two Chinese vitamin C makers to escape $148 million in damages for violating American antitrust law.

REGULATORY
UNPA leader proposes negative list of ingredients posing safety concerns
In response to the ongoing debate about how to implement the New Dietary Ingredient component of DSHEA, Loren Israelsen, president of UNPA, has proposed developing a list of ingredients posing safety risks in supplements, which he said would be far easier to assemble than an authoritative list of dietary ingredients on the market before October 1994.
 
Quincy Bioscience draws support of dietary supplement industry in advertising fight with FTC
Dietary supplement trade associations claimed in legal briefs that the Federal Trade Commission is once again overstepping its bounds in a lawsuit on appeal involving a product marketed for brain health.

LEGISLATIVE
Grassley amendment could deal a setback to CBD, hemp industry
An amendment to the Farm Bill by Sen. Chuck Grassley, R-Iowa, created last-minute uncertainty over the future legal status of CBD and extracts, as the Senate bill went up for a vote. But the amendment was not discussed before the existing Farm Bill passed the Senate Agriculture Committee with a 20-1 vote. Grassley has said he will try to rouse support for the amendment as the bill heads to the Senate floor. The amendment would exclude from the definition of hemp “derivatives, extracts, cannabinoids, isomers, acids, salts, and or salts of isomers, whether growing or not, of Cannabis sativa L.”

Senators introduce bill to protect state law on marijuana
Sens.Elizabeth Warren, D-Mass., andCory Gardner, R-Colo., introduced a bipartisan bill that would allow states to regulate marijuana without federal interference.Warren and Gardner,who both represent states with legal recreational pot, introduced the Strengthening the Tenth Amendment Through Entrusting States (STATES) Act, as a response to the Trump administration's hard-line stance against the drug.

M&A ACTIVITY
Molson Coors acquires Clearly Kombucha brand
Denver-based Molson Coors has acquired the maker of Clearly Kombucha. Terms of the deal, which closed June 1, were not disclosed. Clearly Kombucha and its six flavors of non-alcoholic fermented tea beverages will become part of the Tenth and Blake craft and specialty brands owned by Molson Coors, which operates in the U.S. through MillerCoors.

HEALTH CARE
$45 billion saved! Improving adherence to dietary guidelines could save billions in health-related costs
Improving the adherence of American adults to dietary guidelines by 20 percent could save the U.S. a whopping $30-$45 billion every year, according to new analysis presented at Nutrition 18, a recent event hosted by the American Society for Nutrition.

INTERNATIONAL TRADE
Private industry must reassure international partners to help preserve trade
Food and beverage manufacturers and suppliers must actively reassure their partners abroad that they are reliable, even as the U.S. pulls out of key international trade agreements and negotiations around the North American Free Trade Agreement hit the rocks, according to former chief agriculture negotiator Darci Vetter.

FINANCIALS
UNFI reports record net sales in third quarter
3Q net sales reached a record $2.65 billion, up from $2.37 billion for the same quarter a year ago. “These results demonstrate that demand for better-for-you products and UNFI services continues to be strong,” said Steven Spinner, UNFI CEO and chairman, during the quarterly earnings call.


​PHOTO OF THE WEEK

At the NBJ Summit in 2000:(l. to r.) Adam Ismail, chief strategy officer, KD Pharma Group (formerly of GOED); Loren Israelsen, UNPA; Ellen Schutt, executive director, GOED. Photographer unknown.

Photos to share? Send .jpg file with clear ID, when/where taken with photographer ID, if known, to editor@unpa.com.





RETAIL
Amazon, Whole Foods one year on
A year ago this week, the retail world changed when Whole Foods Market CEO John Mackey announced e-commerce behemoth Amazon.com was buying the natural products giant.Here’s a look at how it's doing so far. One of the changes is that Amazon Prime benefits are becoming increasingly available at the point of sale in Whole Foods stores, with the perks now entering stores in 10 more states.

How to level the playing field on Amazon
Amazon tends to be characterized as a level playing field for large and small brands alike, but life is not fair, and neither is Amazon. Marketplace strategist Sam Hager gives insights on how the game is played and what’s important.

Launching brands in the omnichannel age: A discussion between brand holder and retailer
Walter and Chris Robb have different viewpoints when it comes to entering the CPG world. The former Whole Foods co-CEO brings the retailer perspective, while his son Chris covers launching brands.

CBD/HEMP/CANNABIS
CBD retail need-to-knows
Should retailers get in on the "biggest natural product in the history of natural products," or safely see what happens first? Provides insights from retailers, brand holders and legal expertise from UNPA member Greenberg Traurig.

How to label your CBD product correctly
The new world of hemp CBD-containing products is presenting excitement—and much confusion. During this time of uncertainty, New Hope Network wants to see brands labeling their hemp products appropriately in order to strengthen the industry unity. Provides requirements from the New Hope/Expo standards department.

GMOs
The Non-GMO Project may emerge as the big winner from federal GMO-labeling legislation
The Non-GMO Project will only become more relevant as mandatory GMO labeling kicks in, in part because its scope would be so narrow that consumers will simply not be able to assume that anything without a bioengineered label is automatically not GMO, says Executive Director Megan Westgate.

BOTANICALS
NIH launches HerbList mobile app for herbal products
To help consumers navigate information about popular herbs and herbal supplements, the National Institutes of Health’s National Center for Complementary and Integrative Health has launched HerbList—an app for research-based information about the safety and effectiveness of herbal products. Developed by NCCIH and launched through the National Library of Medicine’s app pages, HerbList is available on Apple App Store and Google Play Store.

PROBIOTICS/PREBIOTICS
Personalized prebiotic startup Carbiotix shows early promisein modulating gut bacteria
Early indications from its first six months of service suggest the company’s personalized gut testing and postal prebiotic service achieved almost 100 percent effectiveness in improving gut health, according to the Swedish-based biotechnology firm.

Organic prebiotic ingredient to be produced at Prenexus’s prebiotic manufacturing site in Arizona
Prenexus says that its AmpliVida XOS ingredient will be the first organic prebiotic ingredient produced using an organic-certified manufacturing process. 

Will probiotics ever live up to the hype?
The future of microbial medicine isn’t simply about haphazard probiotics. It’s about an “ecological type of thinking,” according to Ed Yong, science journalist and author of the book “I Contain Multitudes: The Microbes Within Us and a Grander View of Life.”

FUNCTIONAL BEVERAGES
Market overview: Functional beverage innovation
Consumers are gravitating toward beverages with functional benefits—and fortunately, new ingredients and technological achievements have advanced the offerings. The article includes comments and insights from UNPA members Applied Food Sciences and KGK Science.

ANIMAL NUTRITION
Infographic: Animal nutrition update
As consumers continue to embrace their companion animals as family members, the attributes they value in human nutrition products carry over to purchases for pets, too.

PERSONALIZED MEDICINE
How Fitbit is trying to transform medicine and itself
Physical and even mental health is a growing focus for Fitbit as it tries to fill the revenue gap left by a stalled business in fitness trackers. Now Fitbit is directing much of its time, money, and strategy toward presenting the value of its devices, services and data to healthcare providers, such as hospitals.

APAC MARKET
How institutional reform will impact ingredient space
Changes to the Food Supervision Department in China will have an effect on enterprises doing business in China and sourcing ingredients.

Healthy Aging Summit: Aging population presents opportunities for innovative food firms
Asia Pacific’s rapidly aging population will drive significant opportunities for the region’s food and nutrition industry, according to keynote speakers on day one of the inaugural Healthy Aging Summit in Singapore.

Australian and New Zealand industry not convinced over wave of Chinese investment, say exclusive survey results
Ongoing major acquisitions of Australian nutrition and supplement firms have received a lukewarm response Down Under, according to an annual Nutraingredients survey.

GLOBAL MARKETS
Latin America is the fastest-growing market for probiotics with Brazil, Mexico leading the way
Latin America is one of the largest opportunities for probiotic-fortified foods and beverages, but consumer education is a challenge to the growing market, according to a new white paper from Kerry called “A Global Look at the Digestive Health and Probiotic Market.”

MARKET RESEARCH
Study: Purpose now rivals cost, quality for attracting, retaining, engaging consumers
Nearly 80 percent of respondents in a survey of 1,000 American adults say they’re more loyal to and more likely to recommend companies that are purpose-driven. More than three-quarters said it’s no longer enough for companies to make money; they should be making a positive impact on the world, too. When it came to purchasing decisions, quality remained the top factor for these consumers, but cost and purpose followed closely behind.

Collagen sales are skyrocketing from supplements to food
From the looks of things, the health and wellness industry is having no trouble convincing Americans to take their collagen. Sales of supplements touting the structural protein as a primary functional ingredient were up an astounding 33.8 percent in the U.S., hitting $46.6 million, in the 52 weeks ending February 25, 2018, per research from SPINS.

RESEARCH
High vitamin D levels linked to lower cholesterol in children
There is a link between higher serum vitamin D levels and lower plasma cholesterol levels in primary school children, according to research from the University of Eastern Finland and published in the Journal of Clinical Endocrinology and Metabolism.

There’s building evidence on nutrition’s role in reducing the risk of dementia
Nutritional steps for heart disease prevention are well known. Now it’s time to do the same for reducing the risk of dementia, argued researchers during a nutrition conference in Boston.

Even after heat processing beta-glucan in an RTD may reduce severity of colds in marathon runners
A clinical research lab tested the efficacy of a beverage containing the branded beta-glucan Wellmune and suggested that it may help reduce severity of colds.

Non-animal chondroitin sulfate ingredient supports joint health, according to a new unpublished study
A non-animal chondroitin sulfate ingredient from Gnosis S.p.A (Milan), Mythocondro, may be effective in reducing the symptoms of moderate knee osteoarthritis. The ingredient reduced subjects’ knee pain and improved knee function over placebo, according to the study from the University of Pavia in Italy.

Study links vitamin K2 deficiency in children and bone health
A new study on K2 deficiency in children. published in Nutrients,notes that the epidemiological evidence indicates a disturbing growth in the number of cases of low-energy fractures in healthy children and adolescents. There are multiple risk factors that may contribute to this growing health concern, and among the leading considerations are deficient or insufficient nutrition and nutrients, including calcium, vitamin D and vitamin K. In the study, Vitamin K2, particularly MK-7, is highlighted and differentiated from vitamin K1 in maintaining calcium.

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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