Supreme Court won't review Amarin complaint over omega-3 supplements

​TOP STORY
Supreme Court won't review Amarin complaint over omega-3 supplements The nation’s highest court has declined to hear a dispute over whether the U.S. International Trade Commission (ITC) should have investigated a complaint brought by a pharmaceutical company over the legality of certain “synthetically produced omega-3 products” promoted as dietary supplements. The Supreme Court on Monday denied Amarin Pharma Inc.’s petition for a writ of certiorari, ending the company’s hopes of compelling the ITC to act on its 2017 complaint. The maker of Vascepa has said it intends to continue to pursue other paths to protect the Vascepa franchise against this class of synthetically produced omega-3 products. Read more→

UNPA NEWS

REGISTER TODAY!
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.

UNPA's FSVP training, 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.

HEMP/CANNABINOIDS
New York law sets stage for strictly regulated market for cannabinoids New York state recently put into place regulations that govern hemp cultivation within its borders. In addition, the new law creates a regulatory framework specific to the trade of cannabinoid extracts and finished goods.

Revised voluntary hemp guidelines set to take effect
Revised guidelines adopted by the U.S. Hemp Authority will take effect in January 2020, marking another effort by the nascent but fast-growing industry to establish credibility with the public through a certification program headed into its second year.
 Attorneys weigh in on CBD lawsuits: A wave of class-action litigation was almost inevitable It was only a matter of time before the plaintiffs bar sought to cash in on the legal uncertainty surrounding cannabidiol, attorneys say. The question is can brands defend themselves against the latest wave of lawsuits, which argue that their products are misbranded and adulterated because CBD is not a legal dietary ingredient.

FINANCIALS
Supermarkets, Whole Foods drive 1Q sales growth at UNFI Sales at United Natural Foods Inc. continued to grow during the 1Q20 with net sales totaling $6 billion for the quarter. UNFI reported sales from former Supervalu customers accounted for $3.1 billion of the $3.1 billion net sales increase while supernatural sales—a category that exclusively includes Whole Foods Market—grew 8.2 percent to $1.1 billion.

M&A ACTIVITY
DCC acquires contract manufacturer Ion Laboratories DCC plc, international sales, marketing and support-services group, has acquired U.S.-based contract manufacturer Ion Laboratories Inc., through DCC Health & Beauty Solutions.
 Kroger divests Lucky’s Market, expands better-for-you private-label line Kroger announced during a portfolio review that it has decided to divest its stake in specialty grocer Lucky’s Market, citing priorities in capital allocation to improve return on investment. Kroger also reported a 3.4-percent, year-over-year sales increase for private label and the launch of  231 new Our Brands items, including a plant-based meat and food line under its Simple Truth brand.
 UNFI enters agreement to sell 13 Shoppers stores United Natural Foods Inc. announced that it has entered into definitive agreements to sell 13 of its 43 Shoppers Food & Pharmacy stores to three separate grocery operators.

PARTNERSHIPS
RB partners with Evolve BioSystems on infant probiotic products The new partnership leverages RB’s national footprint to expand the reach and adoption of Evivo, Evolve BioSystems' infant probiotics, across the United States.
 IFF Health enters strategic partnership with By-Health to develop anti-aging ingredients The formulations will have a special focus on fighting cellular oxidative stress, support of intracellular health, such as of the mitochondria, and telomerase research.

GLOBAL REGULATORY
Bayer fined for unlawful supplement advertising to kids German pharma giant Bayer has been fined by the Hungarian Competition Authority after it ruled the firm breached advertising rules by selling its multivitamin products to children.
 ESSNA unveils its sports nutrition priorities in the wake of EC change of guard The European Specialist Sports Nutrition Alliance has revealed a manifesto in which it looks to match consumers with products that complement balanced diets and support active lifestyles.
 Holland & Barrett’s use of weight-management term banned Content on Holland & Barrett’s website falls foul of The Advertising Standards Authority Guidelines, which deems the retailer’s choice of product categorization cannot apply to its food supplement range.
 Poland adopts vitamin and nutrient supplement limits Polish authorities continue to bring its supplement guidelines up to date with the addition of maximum amounts permitted for vitamins, minerals, caffeine and white mulberry preparations.

OMEGA-3s
GOED published its annual global EPA and DHA omega3 market report The Global Organization for EPA and DHA Omega-3s (GOED) has published the 2017-2018 edition of its annual Global EPA and DHA Omega-3 Ingredient Market Report. Top-line data from the report shows that the total volume of omega-3 ingredients in 2018 increased 2.3 percent to 111,210 metric tons from 108,757 metric tons in 2017. The GOED report estimates the value of the market at $1.38 billion. The report also breaks down numbers for sources that appear in the market in specific forms.

PROBIOTICS
Could probiotics help save the bees and global food systems? A “BioPatty” containing probiotics could help boost the immune systems of honey bees, which could help protect colonies from collapse and maintain bees' valuable role as pollinators of crops globally, new research suggests.

MICROBIOME
Long-term data on diet microbiome-interactions needed, warn researchers Our knowledge of how dietary changes impact our gut microbiome in the long term is limited by a lack of long-term studies and interventions with multiple sample-time points and follow-ups, according to researchers in the journal Nutrients.

UNPA COMPANY MEMBER NEWS
doTERRA partners with Tour of Utah and Utah Jazz doTERRA has teamed up with Larry H. Miller Sports & Entertainment to create a partnership that emphasizes community-based events and supports women’s empowerment activities. As part of the multi-year relationship, doTERRA will be a stage-presenting sponsor of the Tour of Utah professional cycling race beginning in 2020. doTERRA will also sponsor the Utah Jazz’s annual spring seminar designed for female high school students.

PERSONALIZED MEDICINE
Centenarians and their microbiota: Metabolites and personalization ripe for further exploration The crucial role of microbiota metabolites, and the potential for new technology to create personalized solutions based on scientists understanding of them, has been highlighted by a leading academic from Japan.

PERSONAL CARE
Environmental Working Group: Cosmetics and personal care products exist in a regulatory black hole This week, the watchdog organization implored the House Committee on Energy and Commerce to increase FDA's authority in the personal care sphere.

MARKETING
Can big brands survive the next 10 years? It depends, say Rabobank analysts While iconic brands are currently losing the tug of war with niche startups for consumer engagement and spending, how they play the game in the next 10 years will dictate whether they can regain ground or become obsolete, according to senior analysts from Rabobank.

MARKET RESEARCH
Global supplement sales expected to grow 5.6 percent in 2019 Supplement sales across the world are projected to reach $135.5 billion this year, and Asia's collective market share is quickly catching up to the U.S, according to NBJ data.

Clean label is the future of sports nutrition … but what does that mean? Clean label is an ethos, a consumer demand for transparency, sustainability and responsibility and sports nutrition currently suffers from a negative perception when it comes to these demands, according to Mintel.

Mintel identifies global food and drink trends over next 10 years Three key trends will shape the global food, drink and foodservice industries over the next 10 years, according to Mintel. The firm suggests that successful companies will have to improve the planet’s health; that technology will enable personalized approaches to physical and mental health; and that consumer trust in food technology will strengthen as these tools help save the food supply.

RESEARCH
Saffron extract may be beneficial adjunct to antidepressants In an eight-week, randomized, double-blind, placebo-controlled study published in the Journal of Psychopharmacology, 160 subjects currently taking antidepressants were randomized to receive either placebo or the saffron extract and results showed that subjects taking the saffron extract experienced a significant, 41-percent decrease of depressive symptoms, compared to placebo (21 percent).

Mushroom mycelium and fermented substrate support immune health A peer-reviewed study in BMC Complementary and Alternative Medicine suggests that the filament-like roots in mushroom as well as the layer it's grown on offer immune-enhancing benefits.

Protein consumption beyond recommended has little benefits Eating more protein daily than what is recommended has little benefit, unless a patient is actively losing weight by cutting calories or strength training to build more lean muscle mass, according to a new study published in the journal Advances in Nutrition.

Pre-term supplementation does not raise developmental risks Nutrient supplementation in small babies does not raise the risk of developmental and metabolic conditions later in life, according to a review from the University of Auckland.

Eggshell membrane cuts osteoarthritis knee discomfort in large-scale clinical trial Eggshell membrane could be the key ingredient to help the sufferers of knee pain and stiffness associated with osteorarthritis, a condition suffered by nearly one in four U.S. adults.

Probiotics may provide relief for infants with colic Supplementing an infant with Bifidobacterium animalis subsp. lactis BB‐12 may help with the management of colic, says a new clinical trial.

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.