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UNPA Digest

FDA sends wave of warning letters regarding COVID-19

3/12/2020

 
TOP STORY
FDA sends wave of warning letters regarding COVID-19 As cases of COVID-19 spread across the globe, U.S. regulatory agencies responded to false product claims surrounding the outbreak with a wave of company warning letters. The agencies jointly issued warnings to the companies—makers of teas, essential oils, tinctures and colloidal silver—and implied in a press release  that the targeted companies had made false or misleading claims about products in connection to the virus outbreak. Meanwhile, Sen. Richard Blumenthal, D-Conn., sent a letter to regulatory agencies demanding more action and noting that the issuance of warning letters to these companies is “insufficient.” Read coverage:
FDA sends wave of warning letters regarding COVID-19→
Senator calls COVID-19 warning letters 'insufficient'→
Senator Richard Blumenthal’s letter→
UNPA NEWS
Dietary Supplement Regulatory Summit postponed; new date and registration details to be announced shortly
This fifth annual, one-day summit hosted by UNPA, AHPA, CHPA, CRN and NPA, scheduled for May 27 in Washington, D.C., has been postponed due to the ongoing coronavirus outbreak. The health and safety of participants is the top concern and focus.The host trade associations are in negotiation with the summit hotel to confirm a new date in Q3 or Q4. Details, including about the status of all registrants, will be forthcoming shortly.

UNPA rescheduled Members' Meeting webinar now available for viewing
The UNPA Expo West Members' Meeting, postponed from its original March 4 date, was held via webinar Wednesday, March 11, and is now available for viewing at the link embedded in the headline--short registration required, and there is no charge to view the webinar. The one-hour session updates UNPA members on coronavirus, supply-chain disruption, hemp/CBD and current regulatory and political topics.


UNPA IN THE NEWS
FDA's new CBD report  recipe for congressional action

FDA report on CBD seen as disappointing recap of status quo

Natural products industry shook by supply chain slowdown


UNPA: WHERE IN THE WORLD?
UNPA's Israelsen participates in TraceGains' coronavirus webinar 
UNPA President Loren Israelsen was a featured speaker for the Feb. 27 webinar sponsored by UNPA member TraceGains, "Coronavirus: How to avoid supply-chain disruptions," to discuss the impact to the ingredient supply chain in China due to the the coronavirus outbreak there. You can view it and download the PPT slides for free here.

​REGULATORY
FDA suspends most foreign facilities' inspections due to coronavirus outbreak As reported during UNPA rescheduled members' meeting webinar, on March 10, FDA announced that due to the COVID-19 outbreak, it was suspending immediately "most" foreign inspections through April. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.  

FDA launches new campaign to help consumers use New Nutrition Facts label FDA launched an initiative to help consumers use the new Nutrition Facts label that appears on packaged foods to maintain healthy dietary practices. The campaign with the tagline "What's in it for you?" aims to reach the general public and also focuses on consumers at increased risk of nutrition-related chronic diseases, including obesity.

FDA studies: ‘Short-chain’ PFAS chemicals more toxic than previously thought Fluorotelomer alcohol—a "forever chemical" used in food packaging and textiles—presents a greater risk to human health than previously estimated. A new study from FDA found that FTOH accumulates in the fat, liver and plasma in rats and stays there for more than one year.

​CORONAVIRUS
Coronavirus crisis: Supplement industry on alert In addition to major business events being postponed around the world, companies have been taking varied approaches about limiting or restricting travel. With heavy reliance on Chinese production facilities for raw materials and ingredients, natural products and dietary supplement companies are also being forced to rethink their predominantly sole-source supply chain.

INDUSTRY
Vitafoods Europe, SupplySide East trade shows postponed due to coronavirus Informa has postponed two major upcoming events for the dietary supplements industry: the SupplySide East trade show originally scheduled to take place April 21-22 in Secaucus, N.J., and the Vitafoods Europe tradeshow, originally scheduled for May 12-14 in Switzerland. Newly scheduled dates for the two shows, which are set to take place at the originally scheduled venues: SupplySide East: June 23-24; Vitafoods Europe: September 1-3.
 Gaia finds commitment to traceability resonates with consumer base A commitment to transparency and traceability can have a real ROI when it convinces consumers that a brand aligns with their ideals, said an official with Gaia Herbs.
 Food donations happening in a big way from Expo West 2020 postponement Despite the cancellation of Natural Products Expo West 2020, thousands of boxes of food will still be donated to local families in need. Children's Hunger Fund is continuing to partner with KeHE and New Hope Network to pack the boxes at its Sylmar, Calif., warehouse in a controlled environment.
 Conversation with Kareem Cook: How the natural products industry can better serve people of color As part of a series of interviews with black natural products brand owners, we hear from Naturade co-owner Kareem Cook. An earlier segment of the series discusses the issues with GW "Chef" Chew of Something Better Foods.

CBD/CANNABINOIDS
FDA report on CBD seen as disappointing recap of status quo A report on CBD delivered by FDA Commissioner Stephen Hahn, M.D., was seen by food and dietary supplement industry stakeholders as offering little hope of a timely regulatory solution for the ingredients.
 CBD making headway in pet-care segment According to the 2020 Pet Industry Green Paper by Nielsen and Headset, hemp-based CBD pet products will represent 3 percent to 5 percent of all hemp CBD sales within the U.S. by 2025.
 OPINION: An emerging conundrum—CBD and the regulatory truth CBD is quickly becoming a mainstream byproduct of the cannabis revolution, but a conundrum is developing between the market demand and potential FDA regulatory action.

MEDIA WATCH
3 things experts want you to know about CBD Prevention teamed up with Good Housekeeping and a panel of experts, including UNPA's Larisa Pavlick, to discuss CBD usage, regulations, research and more, during a recent CBD Summit in New York City.

FINANCIALS
Restructuring efforts help Nature's Sunshine show 4Q profit Cost-cutting efforts helped Nature’s Sunshine report a profit even as sales fell in most of its markets.
 UNFI posts 2Q net loss, sales decline United Natural Foods Inc. (UNFI) on Wednesday reported a $30 million 2Q loss on revenue of $6.1 billion, down 0.2 percent. UNFI said adjusted EPS for the quarter ended Feb. 1 was $0.32, compared to adjusted EPS of $0.44 for the same period in FY2019.

M&A ACTIVITY
PepsiCo to acquire energy drink Rockstar for $3.85 billion PepsiCo will acquire Rockstar Energy Beverages as it expands is presence in the fast-growing energy category.

PEOPLE
CHPA appoints John P. Troup, Ph.D., as VP for scientific affairs and dietary supplements The Consumer Healthcare Products Association (CHPA) announced the appointment of John P. Troup, Ph.D., as vice president for scientific affairs and dietary supplements, a new position within CHPA. Troup has wide-ranging experience in the health, nutrition and dietary supplements sectors, including extensive work in clinical and product development, as well as regulatory affairs.

IN MEMORIUM
The Hartman Group reflects on the rich legacy of its visionary founder Harvey Hartman It is with great sadness that we announce the passing of our charismatic founder Harvey Hartman after a courageous battle with cancer. He was 73. Harvey was a larger-than-life presence and guiding force. Those of us who have had the good fortune to know and work with him have lost an inspirational leader and mentor and a dear friend.

RETAIL
82 percent of retailers back replacing UPC with 2D barcode The majority of retailers support a transition from the traditional universal product code (UPC) to a data-rich, two-dimensional (2D) barcode, according to a new study by GS1 U.S.
 Finding a role for brick-and-mortar retailers in personalized nutrition Personalized nutrition is set to transform the sales channel picture for dietary supplements, but the bulk of purchases are expected to happen online–leaving brick-and-mortar retail spaces behind.

GLOBAL REGULATORY
COVID-19: China, Vietnam, Australia and Singapore caution against fraudulent health claims Authorities from a raft of countries have stepped out to caution against the advertising of health supplements that claim to prevent or treat the novel coronavirus.
 CBD sector warms to U.K. 2021 novel foods deadline British, European and international CBD players are throwing millions of euros at EU novel food dossiers to meet the U.K.’s recently issued 2021 sector ultimatum to clean up its actor or clear off the market.

UNPA MEMBER COMPANY NEWS
OmniActive's Improving Lives Foundation, a case study in ethical business OmniActive Health Technology is dedicated to improving the lives and well-being of those throughout its value chain. Through its corporate social responsibility initiative, the Improving Lives Foundation, OmniActive works with farming communities at the very beginning of the supply chain to reduce treatable eye and vision problems, treat nutrition-related diseases, empower women, improve sanitation and hygiene and educate farmers.

OMEGA-3s
GOED reacts to recent research and headlines on EPA and DHA The Global Organization for EPA and DHA (GOED) believes the way in which two simultaneously released studies were publicized downplayed recent clinical affirmations supporting cardiovascular health benefits provided by fish oil supplementation.

PERSONALIZED NUTRITION
 Data-driven entrepreneur takes personalized nutrition up an interactivity notch A data entrepreneur fascinated by health and longevity has created an ultra-interactive personalized health tracking service fit for a future where consumers want as much access to their health data as they do their bank accounts.

INNOVATION
Intergalactic plant crop ideal as dietary supplement for space missions Cultivation of space-grown lettuce on board the International Space Station could be a viable dietary supplement for astronauts, potentially replacing processed, pre-packaged space rations, a study shows.

MOU PARTNER NEWS
Mary L. Hardy, M.D., awarded ABC’s Fredi Kronenberg Excellence in Research and Education in botanicals for women’s health award The American Botanical Council (ABC) announced that the 2019 Fredi Kronenberg Excellence in Research and Education in Botanicals for Women’s Health Award will be presented to Mary L. Hardy, MD. Hardy is board certified in internal medicine, specializes in botanical and integrative medicine and is a leader in integrative oncology. In a second award, ABC  will present its 2019 James A. Duke Excellence in Botanical Literature Award  to Flora of the Voynich Codex: An Exploration of Aztec Plants, co-authored by Arthur O. Tucker, Ph.D., and Jules Janick, Ph.D., and published by Springer.

MARKETING
Gen Z’s favorite social media platform? None of the above New research from Kantar reveals that while this generation is more active than any other age group on social media, their favorite social haunts aren’t YouTube, Facebook, Snap or TikTok. They are most at home in the private and creative world of video games.
 The B2B comfort zone: Email is still the best for sending content Don’t discount the old channels—such as email. That’s the main takeaway from B2B Content Consumption Trends, a study by Centerline Digital. Email is the top B2B content vehicle and the best at producing leads and revenue, the study reports, sourcing other research.
 What’s a tribe and why does it matter for digital marketing? Find out how to get past the social media algorithms and connect with your brand's audience.

RESEARCH
MSM shows strong promise in ingestible beauty, even at low dosage A new study into a supplement usually taken for its anti-inflammatory benefits, has reaffirmed its effectiveness in reducing visual signs of skin aging, even at a dose as low as 1 gram per day.
 Amino acid found in protein sources linked to cardiovascular disease Cleveland Clinic researchers have identified an amino acid found in plant- and animal-based protein sources, like meat, beans and soy, that is linked to the development of cardiovascular disease, including heart attack, stroke and death.
 Study explains how prebiotics improve sleep and reduce stress Specific fibers known as prebiotics can improve sleep and enhance stress resiliency by influencing the metabolites produced by gut bacteria, according to a new University of Colorado study.
 DolCas tackles liver and vascular health with botanical extracts A new clinical study published in the Journal of Traditional and Complementary Medicine suggests branded botanical ingredient Bergacyn is effective in providing liver support.
 Indoor athletes at risk of vitamin D deficiency College athletes participating in indoor sports may be vitamin D deficient, which poses a risk for injury or poor performance, according to a study from George Mason University and the Mayo Clinic Health System Sports Medicine Research.
​
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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