Final defendant pleads guilty in Hawaii liver injuries case; USPLabs to cease operations

​TOP STORY
Final defendant pleads guilty in Hawaii liver injuries case; USPLabs to cease operations Matthew Hebert, the final defendant in the criminal case arising from a spate of liver injuries in Hawaii has pleaded guilty, according to a report in Reuters. The case involved now-defunct sports supplement manufacturer USPLabs and its OxyElite Pro product. The federal government’s case against USPlabs LLC and its co-defendants has been resolved with USPlabs agreeing to cease its business activities within 90 days of entry of the plea agreement and immediately liquidating its inventory. Read coverage:
Final defendant pleads guilty in Hawaii liver injuries case→
USPLabs agrees to cease operations in plea agreement→

UNPA NEWS

REGISTER TODAY! Expert Insights: "Insurance update for hemp/CBD products and companies," March 27, 11am MST
UNPA's newest Expert Insights webinar, "Insurance update for hemp/CBD products and companies," will be held Wednesday, March 27, from 11am - 12 noon MST. The webinar will be led by Michael Garofalo, product development director for LlifeScienceRisk and will provide the latest, post-farm bill news on the insurance market for companies selling hemp and CBD products. Registration for this free webinar is now open via the link above.

The UNPA Retreat is less than a month away! Register today!
UNPA's annual members' retreat, April 30-May 2, in Charleston, S.C., is less than a month away, and the agenda has been posted. Are you registered?

REGULATORY
FDA budget request calls for mandatory premarket product registration The proposed 2020 budget for FDA includes a request for mandatory registration of dietary supplements, as well as decreased funding for research into these products, according to an analysis from UNPA Senior Political Advisors Patricia Knight and Peter Reineke. They noted that FDA would need a new statutory authority to provide the product listing.

Goal of initiative is better tools to predict botanical ingredient safety A new industry/government safety initiative on botanical ingredients will result in better, more predictive tools, according to Stefan Gafner, chief science officer for the American Botanical Council. The new Botanical Safety Consortium was announced in February by FDA, following a year-long effort to develop the plan by industry stakeholders.

NSF International to provide pre-assessment audits to new GRMA standards NSF is now providing interim gap or pre-assessment audits to the recently-developed Global Retailer and Manufacturer Alliance (GRMA) standards, a set of consensus-based GMP auditing standards for manufacturers of dietary supplements, cosmetics and personal care products and over-the-counter drugs, aimed at reducing the number of audits and associated costs of auditing to multiple independent standards. The interim audits offer a way for manufacturers to know where they stand under the new GRMA standards.

LEGAL
Sports nutrition firm’s owners indicted for selling SARMs, prohormones Popular sports nutrition company Blackstone Labs, its co-founders, key employees and manufacturing partners were indicted by a federal grand jury for selling illegal substances, including prohormones (primarily dimethazine, or DMZ), AMP citrate (aka 1,3-Dimethylbutylamine/DMBA) and SARMs (selective androgen receptor modulators), as dietary supplements. The defendants face significant prison time and fines, as well as forfeiture of real estate, automobiles, equipment and already seized funds.

NAI says patent victory is crucial precedent for IP protection A victory for Natural Alternatives International in its beta alanine patent case is being heralded as a huge IP protection precedent in the natural products industry.

California jury finds Roundup caused man’s cancer A San Francisco federal jury unanimously agreed on Tuesday that Roundup caused a man's cancer—a potentially massive blow to the company that produces the glyphosate-based herbicide currently facing hundreds of similar lawsuits. The verdict is the second in the U.S. to find a connection between the herbicide's key ingredient, glyphosate, and the disease.

Chinese supplier arrested at 2017 trade show sentenced to prison An executive of Chinese ingredient supplier Shanghai Waseta International International Trade Co. Ltd., Xu Jia Bao (aka Fred Xu) was sentenced to 18 months in prison for his role in a scheme to sell mislabeled dietary supplements.

M&A ACTIVITY
GNC sells manufacturing arm to IVC Struggling retail giant GNC has formed a partnership with IVC that will result in the company fully owning GNC’s Nutra manufacturing arm by 2023.

ADM further invests in natural citrus offerings with acquisition of Ziegler Group Archer Daniels Midland Company has reached an agreement to acquire the Ziegler Group, a leading European provider of natural citrus flavor ingredients. The agreement comes shortly after ADM completed its addition of U.S.-based citrus flavor provider Florida Chemical.

GLOBAL REGULATORY
Indecision reigns over current CBD Novel Food status as groups clash with authorities Evidence presented at the Novel Food Commission has triggered a rethink for authorities over the decision to classify cannabidiol (CBD) as a Novel Food.

POLICY
The dangerous food additive that’s not on the label Perchlorate, an additive with an outsized impact on children, was approved by FDA in 2005. The chemical has been linked to disrupted thyroid function, which reduces the production of a hormone necessary for healthy brain development. Now, several environmental and health organizations have been calling on FDA to ban perchlorate in food products.

SPORTS NUTRITION
There are many kinds of sports customers these days: How do brands reach them? If one had to categorize what the new sports nutrition customer is generally like, the description sounds very much like that of the general, overall health and wellness shopper—that is, a consumer seeking strategies to stay healthy throughout life. Illustrating this is the fertile ground for innovation in sports nutrition beverages in 2019, with a number of brands working on new formulations using non-traditional ingredients.

GMOs
The first gene-edited food is now being served Companies big and small have adopted the powerful new gene-editing technologies that are leaving first-generation GMOs, along with their stigma and burdensome regulations, in the dust. They are making products as disparate as climate change-resistant cacao and extra-starchy corn for adhesives and last month Calyxt became the first to commercially debut a gene-edited food, a soybean oil it claims to have made healthier.

Biotechnology: The shadowy overlap between science and nature Biotechnology can help improve a product’s nutritional profile, environmental benefits and culinary performance, but the use of biotechnology is becoming less clear. Rising concerns about genetic engineering—and varying positions regarding disclosure of its use—have led to more questions than answers when it comes to using technology to advance the industry.

PERSONAL CARE
The top beauty brands dominating Amazon Amazon is currently the second-most shopped retailer for beauty products (Walmart being the first). Findings from a recent survey on Amazon’s beauty-industry influence show that a mere 4 percent of beauty brands account for 52.1 percent of all beauty products listed on the site.

INNOVATION
Bacterial biofilms could help probiotics extraction, researchers claim Bacterial biofilms, blamed for allowing the growth of antibiotic-resistant pathogens, are also an effective way to produce a fermented milk product that can deliver hardy probiotics to the digestive tract, according to new research from Zhejiang Gongshang University in China.

PERSONALIZED MEDICINE
Canadian supplement makers launch retail-ready DNA test kit Calgary-based Advanced Orthomolecular Research is jumping into the personalized medicine space with the launch of its MyBlueprint DNA test kit. It will look at 85 of the key gene variations associated with health and disease.

UNPA MEMBER COMPANY NEWS
Standardization is tide that can raise all botanical boats, supplier says Standardization in herbal products will boost consumer acceptance and market uptake, says Sabinsa president Shaheen Majeed, using the company’s Shagandha ashwagandha ingredient as an example.

Thorne launches new at home personalized nutrition tests Thorne introduced its next five at-home health tests for vitamin D, heart health, weight management, testosterone and menopause. The tests, which measure individual biomarkers, uncover health insights, which are converted into a customized plan for what to eat, how to exercise and whether to add nutritional supplements to improve health outcomes.
 NuSkin builds on LATAM growth by expanding into Peru NuSkin has been experiencing sharp growth in its Latin American operation in recent years and recently announced its expansion into the Peru market. The company marked the occasion with an event in the capital city of Lima, where it announced the start of its business there.
 Korean newspaper, Sports Dong, features interview with Shaheen Majeed, president of Sabinsa WorldwideIn this interview with Sabinsa Worldwide President Shaheen Majeed, he discusses Sabinsa Worldwide operations, including its presence in Korea, which is providing a deeper connection to Korean customers in a region where the company sees key opportunities. Majeed also discusses the Sabinsa’s production and distribution systems, technology use and the research-oriented philosophy of the Sami-Sabinsa Group.MOU PARTNER NEWS
AHP releases Lycium (Goji) Berry monograph and therapeutic compendiumThe American Herbal Pharmacopoeia has released a monograph and therapeutic compendium for Lycium (Goji) Berry (Lycium barbarum L., L. chinense Miller). The monograph was a joint effort of AHP and a global network of researchers, who investigated the historical use of the berries in general and medicinal foods, formal medicinal prescriptions, in the practice of traditional Chinese medicine (TCM), as well as Goji’s recent acclaim as an antioxidant-rich tonifier.
 ABC publishes ingredient-specific monograph on BCM-95 (CurcugreenTM) turmeric rhizone/curcumin extractAmerican Botanical Council (ABC) announced the publication of its ingredient-specific monograph on BCM-95 (also marketed as CurcugreenTM), a proprietary, patented extract made from the rhizome of the popular spice and medicinal plant turmeric (Curcuma longa). BCM-95 is a unique preparation of standardized curcuminoids that is blended with the essential oil of turmeric, which, according to the manufacturer, assists in absorption of the preparation and enhances its biological activity and health benefits.
 Aviva Romm, M.D., received ABC Fredi Kronenberg award for excellence in botanicals for women’s healthThe American Botanical Council (ABC) recently presented the second annual ABC Fredi Kronenberg Award for Excellence in Research and Education in Botanicals for Women’s Health to Aviva Romm, M.D., a midwife, herbalist, author and Yale-trained physician who is a recognized expert in botanical medicine.EMPLOYMENT OPPORTUNITIES

UNPA member companies have posted the following employment opportunities. To include a job posting, email editor@unpa.com.

NEW!Sales Account Executive - Medical, Springfield Mo.,  posted by Ortho Moleucular Products
Sales Account Executive - Medical, Nashville, Tenn.,  posted by Ortho Moleucular Products
Sales Account Executive - Medical, Oklahoma City, Okla., posted by Ortho Moleucular Products
Inside Sales Representative, Woodstock, Ill., posted by Ortho MoleucularProducts
Sales Account Executive - Medical, Orlando, Fla., posted by Ortho Moleucular Products
Sales Account Executive -  Medical, Chicago, posted by Ortho Moleucular Products
Sales Account Executive - Medical, Des Moines, Iowa, posted by Ortho Moleucular Products
Sales Account Executive - Medical, Salt Lake City, posted by Ortho Moleucular Products
Sales Account Executive - Medical, New York, posted by Ortho Moleucular Products

Clinical Product & Program Manager, Lake Barrington, Ill., posted by Ortho Molecular ProductsMARKETING
Rise of e-sports segment pushed nootropic ingredient supplier to market to gamersKyowa Hakko saw value in marketing its branded citicoline, Cognizin, directly to consumers at the recent SXSW Gaming event, which is a gamer-focused offshoot of the popular SXSW event in Austin, Texas. The segment encompasses an audience of  380 million and revenues in North America of $345 million this year.MARKET RESEARCH
Most Amazon brands are duds, not disrupters, study findsAmazon’s greatly feared foray into private-label products isn’t a threat to other businesses in the slightest. Most of these products aren’t attractive to consumers even when the company elevates them in search of results, and the notion that Amazon would be able to use its data to dominate a category is “just a conspiracy theory” according to experts.
 Packaged Facts predicts mashup of beverage trendsCoffee, tea and energy drinks are finding increased sales through unexpected crossover formulations.RESEARCH
Green light for green tea as study links it potency to lower obesity riskThe anti-inflammatory polyphenols found in green tea may be responsible for lowering the risk of obesity, specifically focusing on inflammation that has its origins in the host gut.
 Probiotics supplementation may improve indicators associated with type 2 diabetesSupplementation with the probiotic Lactobacillus casei can improve glycemic index in individuals with type 2 diabetes, according to a new RCT from Iran’s Tabriz University of Medical Sciences.
 Nano encapsulation of peppermint oil delivers antibacterial wound healing prowessPeppermint essential oil (PEO) loaded onto nanostructured lipid carriers may form the basis of a topical formulation for infected wounds as the delivery vehicle may improve PEO bioavailability, according to researchers in Iran.
 Polyphenol-rich spearmint extract may improve attention of young, active subjectsA recent study published in Nutrition Research shows that a polyphenol-rich nootropic spearmint extract called Neumentix by Kemin Human Nutrition and Health supports cognitive performance. Results showed an 11 percent improvement in concentration and sustained attention in subjects taking the spearmint extract.
 Research highlights danger of vitamin B12 deficiencyUsing roundworms, Rice University bio-scientists have found the first direct link between a diet with too little vitamin B12 and an increased risk of infection by two potentially deadly pathogens.
 Study finds calcium and vitamin D essential to osteoporosis managementA new study presented at the 2019 Annual Meeting of the American Academy of Orthopedic Surgeons (AAOS) found that the majority of individuals with osteoporosis do not take adequate calcium and vitamin D supplementation to help reduce the risk of osteoporosis-related fractures.FDA WARNING LETTERS & GUIDANCES
Current FDA enforcement actions and guidancesKeep 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.