GOED Voluntary Monograph Updated & Other News

An update to the GOED Voluntary Monograph, another winning legal battle for Sabinsa and lots of awards and personnel news close 2015’s top happenings.

Greenberg Traurig was named by Law360 as a 2015 winner in its Practice Group of the Year awards, given to firms that came through for clients by sealing the biggest deals and securing wins in high-stakes litigation. Greenberg Traurig was one of four firms recognized in the Food & Beverage category.

Now in its sixth year, the Practice Group of the Year series drew 730 submissions in 2015. A record 184 winners were selected across 30 practice areas for honors, with 80 firms receiving Practice Group of the Year awards.

Along with Greenberg Traurig, the other F&B winners included Gibson Dunn, Patterson Belknap and Winston & Strawn.

With an ongoing focus on omega-3 quality, the Global Organization for EPA and DHA Omega-3s (GOED), published an update to its GOED Voluntary Monograph, which is among the strictest quality standards in the international omega-3 industry. The Monograph is a cornerstone of GOED membership, as GOED members are required to comply with its specifications as a condition of membership. This is the fifth update to the Monograph and it was ratified by a majority of the GOED membership.

The update was undertaken to recognize the industry’s significant growth and the development of many new omega-3 oils and products. For example, the monograph now allows for the inclusion of cod liver oil, and spells out important oxidation testing considerations necessary for flavored oils. While compliance with the Monograph is mandatory for GOED members, it provides valuable direction for the rest of the omega-3 industry as a quality standard.

GOED has also created a set of Guidance Documents to explain differences in oil types and applicable methods. The GOED Voluntary Monograph sets a quality standard for oxidation, environmental contaminants and fatty acid analysis in omega-3 oils, while the new Guidance Documents are designed to help the industry understand other quality parameters specific to unique types of oils and how to select the right methods for analysis.

“The updates to the Monograph should help demonstrate that the industry and GOED members in particular remain focused on quality as a top priority," said Adam Ismail, GOED’s executive director. “The new Technical Guidance documents will provide additional direction to producers and suppliers. They are not meant to establish a separate set of quality standards, but instead give guidance to companies marketing specific types of omega-3 oils."

Sabinsa Corp. successfully concluded a lawsuit against NutriBioLink LLC, filed in the U.S. District Court, New Jersey, on July 30, 2014.

The lawsuit alleged NutriBioLink and Olive Lifesciences Private Ltd. were selling and distributing products that infringed upon Sabinsa’s Curcumin C3 Complex® U.S. Patent 5,861,415 (“the ’415 Patent"), which protects compositions, methods of use and methods of extraction of a nutritional supplement in the United States. Specifically, other companies may not sell imitations of Sabinsa’s unique compositions, nor market it for its antioxidant use, nor use the extraction method developed by Sabinsa and outlined in Sabinsa’s patent.

NutraBioLink agreed to discontinue any and all future sales of curcumin to outside distribution. The proposed final consent judgment stipulated the ’415 Patent is valid, enforceable, and properly issued by the U.S. Patent and Trademark Office.

Previously, lawsuits filed against Prakruthi Products Private Ltd. and HerbaKraft Inc., for Sabinsa’s ’415 patent, were resolved in Sabinsa’s favor.

Marinova has been awarded Australian Nutraceutical Ingredients Company of the Year for 2015, in the Frost & Sullivan Best Practice Awards. Now in their 10^th consecutive year, the awards recognize companies in a variety of regional and global markets, acknowledging companies in areas such as leadership, innovation, customer service and strategic product development.

Nominees for the Best Practice Awards are selected in each category using rigorous measurement-based methodologies. Industry analysts compare market participants and measure performance through in-depth interviews, analysis and extensive secondary research in order to identify best practices in each industry.

Mark Dougan, managing director of Frost & Sullivan (Australia and New Zealand), acknowledged Marinova’s strong overall performance, particularly noting the company’s outstanding research and development (R&D) in collaboration with a number of professional institutions, and excellent customer services.

He also highlighted Marinova’s performance, stating: “As one of the leading companies engaged in the manufacturing and export of high-quality fucoidan products, Marinova is totally committed to the health of its consumers, community, industry and the environment."

Eurofins Bioanalytical Services, part of the broad-service Eurofins Pharma Services Group and a leading provider of bioanalytical testing to the biopharmaceutical industry, announced Vimal Patel joined the company as scientific director for large molecule bioanalysis, based at the company's St. Charles, Missouri facility. Patel will serve as a scientific and technical advisor for clients and internal teams for development, validation and application of assays to ensure compliance with scientific and technical goals and regulatory requirements. He will also drive new technology and services strategy, and lead client development programs with a focus on expanding the large molecule bioanalysis capabilities and customer base.

Patel has held positions of increasing responsibility within the biopharmaceutical industry. After receiving his bachelor’s degree in biology from Cal State Los Angeles, he joined Biosource and then moved to Amgen as a scientist specializing in assay development, automation, new technologies and the application of design of experimentation to improve method transfer and validation. Patel then joined ICON PLC as the director of business development for bioanalytical sciences before joining Eurofins Bioanalytical Services. He has also served in leadership positions in various industry organizations, including the AAPS NBC DOE workshops, and has been an invited speaker at multiple industry events.

ChromaDex Corp. and American Laboratories Inc. (ALI) announced the release of a Fourier Transform Near Infrared (FT-NIR) based identification method for the positive identification of desiccated bovine and porcine glandular tissues used in nutritional product formulations.

ChromaDex developed a FT-NIR algorithm and cluster based analysis model under its ComplyID™ program to individually identify 18 bovine and porcine glands provided by ALI. The model has the ability to find unique spectral differences with each of the 18 glandular materials for proper identification and verification of glandular material.

Frank Jaksch, Jr., CEO and co-founder of ChromaDex, commented, “Compliance with the FDA 21 CFR part 111, the Dietary Supplement cGMPs [current good manufacturing practices], continues to be a critical issue for the industry. Staying in compliance is an ongoing effort for all companies because interpretation and enforcement continues to evolve."

ColinKurtis Advertising announced the release of a new marketing case study for one of the agency’s key accounts. It highlighted the Fibersol brand, a line of soluble dietary fiber ingredients, which is supported by a joint venture (JV) between Archer Daniels Midland Co., Matsutani Chemical Industry Co. Ltd. and Matsutani America Inc. The case study outlined the challenges the JV sales team faced working together to market Fibersol, and highlighted the solution the agency created to optimize the marketing efforts and grow sales.

Colin Kampmier, president, ColinKurtis Advertising said, “The very purpose of marketing is to support sales—but getting the two to truly work together can be challenging for most companies. This is especially true when you consider a large sales team— and in this case, a joint venture with multiple sales teams. We had to find a solution so that everything and everyone was truly working hand-in-hand throughout the entire product sales cycle. The solution we created was a dynamic sales portal. This portal houses everything from product information, tech data and the latest trend information, thus ensuring that the sales team has everything at their fingertips."

ColinKurtis Advertising also added Juanita Hickerson to its staff as a copywriter involved with many of the writing needs for the agency’s key accounts. Her role includes both internal and external communications. She works with the ColinKurtis team to develop materials such as ad headlines, web copy, collateral copy and email blast copy, as well as proofreading.

Hickerson has a bachelor’s degree from Rockford College in Illinois. She was most recently employed by Rock Valley College as a marketing coordinator/copywriter, and prior to that, was with a local advertising agency. She also has experience on the client side with Regis Corp., and has written for a variety of magazines.

SPINS™, a leading information and service provider for the natural and specialty products industry, announced an expansion of its insights offerings through its new partnership with Compellon™, the developer of breakthrough prescriptive analytics that quickly and easily deliver immediate actionable intelligence.

SPINS leverages its extensive SPINSscan proprietary data and product attribution on the Compellon20|20 Platform to quickly and easily create predictors that anticipate outcomes and behaviors in the natural and specialty gourmet markets. The new partnership is a paradigm shift in the way data is leveraged to deliver faster, more accurate answers to how and why consumers are buying health- and wellness-oriented products. The Compellon20|20 software platform uses proprietary machine learning technology to create a novel discovery, modeling and predicting capability unique to the industry. SPINS’ product attribution adds unrivaled insight into label claims, certifications and product positioning.

The joint SPINS and Compellon solutions will launch early next year and will be available to clients as part of SPINS’ SATORI Insights services.

Innophos Nutrition Inc., a leading manufacturer and distributor of premium ingredients and blends to the nutritional and natural products industries, and a subsidiary of Innophos Holdings Inc., announced the formation of a scientific advisory board (SAB) comprised of leading scientists in the field of nutrition. The mission of the SAB is to support Innophos Nutrition’s drive for innovation by providing insights, expertise and strategic guidance for product and market developments.

The SAB will be led internally by Alice Hirschel, Ph.D., nutritional science, biochemical and molecular nutrition; graduate of the University of Texas, Austin; hired by Innophos Nutrition in 2015. The initial appointments to Innophos Nutrition’s SAB include:

Tracy Anthony, Ph.D. – Associate professor of nutritional sciences at the department of nutritional sciences, Rutgers, and director of postdoctoral and student programs, New Jersey Institute for Food, Nutrition and Health. Anthony focuses her research on cellular stress responses to amino acid deprivation, environmental stressor effects on the endoplasmic reticulum, and the interface of dietary protein and exercise as relates to weigh control and optimization of lean body mass.

James Fleet, Ph.D. – Distinguished professor, department of nutrition science, Purdue University. He focuses on the role of vitamin D in health, particularly the molecular regulation and genetics of bone and mineral metabolism, as well as the mechanisms of carcinogenesis and cancer prevention.

Michael McIntosh, Ph.D., R.D. – Lucy S. Keker excellence professor, department of nutrition, University of North Carolina – Greensboro. McIntosh’s research focuses on the microbiota-obesity-inflammation triad, hormonal and nutritional regulation of energy metabolism and gene expression in adipocytes.

Neil Shay, Ph.D. – Professor of nutrition and food science, department of food science and technology, Oregon State University. Hos research interests are functional foods and their bioactive components that influence chronic metabolic diseases including obesity, diabetes, heart disease and fatty liver disease.

Christopher Vulpe, M.D., Ph.D. – Professor, physiological sciences, University of Florida, Gainesville. His research focuses on copper and iron metabolism and genomic approaches to identify toxicity pathways in mammals with a focus on metals and metalloids.

The United States Pharmacopeial Convention (USP) announced Salah D. Kivlighn, Ph.D., has assumed the role of senior vice president, strategic marketing and program operations (SMPO). He reports to USP’s chief executive officer, Ronald T. Piervincenzi, and is a member of the organization’s executive team.

A new division in the organizational structure, SMPO will work in direct partnership with USP’s science division, responsible for the technical and scientific development of USP’s quality standards. SMPO will focus on understanding customer needs and specifications, monitoring marketing efficiency and effectiveness and further developing USP’s brand strategy.

“Being able to better understand the unmet and emerging needs of our key stakeholders will enable USP to strengthen its quality-related programs in chemical medicines, biologics, excipients, dietary supplements, food ingredients and healthcare practice," Kivlighn said. The SMPO unit for each of these areas will report to him.

Most recently, Kivlighn was vice president of marketing at Kite Pharma, a company focused on cell-based immuno-oncology. For 8 years, he held global leadership positions in product development and marketing at MedImmune, where he was responsible for regulatory filings; clinical and commercial development; and chemistry, manufacturing and controls (CMC) related to numerous oncology and autoimmunity products. Kivlighn also led marketing teams and initiatives at NABI Biopharmaceuticals and Merck & Co. Inc. related to pipelines, launches and planning for vaccine and cardiovascular products. 

Sabinsa Corp. has promoted Ahmed Khan to the position of national sales manager – USA, effective Jan. 1, 2016. He will be responsible for overseeing sales throughout the United States, as well as ensuring customer satisfaction, and deepening client relationships.

Khan joined Sabinsa's parent company, Sami Labs, in 2004, and was initially involved in sales and marketing. He held several positions, including business development manager—handling the Central Asia region based out of Dubai—and product manager for finished formulations.

He moved to Sabinsa USA in November 2007 and was responsible for the sales in the Western U.S. region, with emphasis on new business development and strategic relationships with customers.

Khan holds a master’s of pharmacy degree with specialization in pharmaceutical marketing and management from Rajiv Gandhi University of Health Sciences, Bangalore, India.

MG America, the U.S. subsidiary of MG2 Bologna, Italy, a supplier of processing and packaging equipment, expanded its filling division through a recently formalized strategic partnership with filling and closing solutions provider COMAS of Florence, Italy. Founded in 1979, COMAS has provided more than 1,500 filling and closing solutions to customers across several countries and most continents. It has delivered more than 70 machines to the United States and North America, and is now aligning with MG America to meet the continued market demand.

MG America will supply COMAS machinery solutions for non-sterile applications for the pharma, nutraceutical and cosmetic market segments, assuming responsibility for all sales, project management and customer service/support. COMAS’ designs incorporate the latest electronic process controls and software systems to meet a wide variety of application speeds, I/O demands and data management necessities. Highlights include: container infeed/outfeed designs for an assortment of container configurations, cleansing and evacuation solutions for container preparation prior to filling, a variety of filling pump and module designs based on the product range the machinery must accommodate, application controls ranging from common sensor options to sophisticated camera systems, and custom solutions—special machine construction for unique container designs or one-of-a-kind applications with distinct requirements and objectives. Capping systems for a wide range of closures are also offered, including induction sealing, screw-capping, pick-and-place insertion and crimp-capping, as well as neck banding and sleeving.

NattoPharma ASA, exclusive supplier of the clinically researched and patented MenaQ7® Vitamin K2 as MK-7, has over the past several years made substantial investments in the research and clinical validation of health benefits derived from Vitamin K2. With this strong foundation of research in place, the company is now transitioning to its next phase. To fully leverage this base of technology, the company will place greater emphasis on global commercialization and growth, and will rebalance these efforts with its traditional focus on R&D. To implement this next phase of its strategy, the company is pleased to announce the following changes to its organization:

Daniel Rosenbaum, who has been serving as COO of NattoPharma for the last year, will assume the role of CEO. Rosenbaum has more than 20 years of experience in global commercial leadership roles within the omega-3, pharmaceutical and specialty chemical industries. Prior to joining the company, he led the pharmaceutical and nutraceutical divisions of FMC Chemical Corp.

Hogne Vik, M.D., who has been serving as CEO of NattoPharma since 2012, will assume the role of chief medical officer. A medical doctor by training, Vik has more than 30 years of experience in medical, pharmaceutical and research industries. As CMO, he will work with the global medical community to increase advocacy of MenaQ7® and will guide the company’s continuing clinical research initiatives.

Kjetil Ramsøy, a certified public accountant, will join the company, effective Jan. 1, 2016, in the role of chief financial officer. Ramsøy comes to NattoPharma from Seabed GeoSolutions, where he served as CFO. Having worked in both Scandinavia and the United States, he brings both global financial and public company experience.

William Sommer joins the company to serve as vice president, global development and regulatory. Previously, he led the global formulations group at FMC Chemical Corp. A chemical engineer by training, Sommer has more than 20 years’ experience working in development, specialty chemical manufacturing and regulated industries.

SternMaid America invested $100,000 in modernizing its warehouse. New high-level racks increased storage capacity fivefold to a total of 1,500 pallet spaces. Additionally, state-of-the-art barcode scanning equipment was installed for computer-aided real-time tracking of goods in storage and processing via an enterprise resource planning (ERP) system.

Pallet barcodes and WiFi-scanning of the movement of all goods allow the company to identify where each individual pallet is at all times. When products are loaded onto a truck, they are scanned for the last time. A delivery note can only be printed if all of the pallets making up the consignment have been recorded. This avoids the risk of incorrect or incomplete loading.

Jan Thoele, executive vice president at SternMaid America, said, “To reduce costs as well as carbon emissions, many of our customers are dispensing with unnecessary shipping of goods and are instead suppling their own customers with raw materials, intermediates and finished products directly from our warehouse. We have therefore enlarged our storage capacity and installed a modern scanning system that enables reliable and fast identification of goods."

The modernized warehouse completes SternMaid America’s comprehensive contract manufacturing services for the compounding of powdered food ingredients and supplements. The company offers everything from expertise in blending and quality control of raw materials to co-packing and logistics.

Locus Traxx Worldwide, involved in real-time temperature and location monitoring of perishable and high-value shipments, made the Food Logistics FL100+ list for the 5th consecutive year. The company was recognized for its dedication and commitment to safeguarding the supply chain and saving customers millions of dollars by mitigating lost loads. SmartTraxx GO products have been shown to make money for their users and provide automated FSMA compliance for the pending Sanitary Transportation of Human and Animal Food regulation.

“Developments in the software and technology sector are generating new opportunities for growers, food manufacturers, grocery retailers and the many logistics providers that support them," noted Lara L. Sowinski, editor-in-chief at Food Logistics. “Moreover, cloud-based solutions and mobile connectivity are helping create tools that are more flexible, affordable and responsive, making software and technology even more valuable to those in the global food supply chain."

The honor followed a number of Locus Traxx Worldwide achievements in 2015, including United Fresh’s Food Safety Product of the Year Award, IoT Evolution’s Product of the Year Award, Supply and Demand Chain’s Green Award, Driscoll’s 2015 Cold Chain Champion of the Year and being named a 2015 GrowFL Company to Watch.

Canbank Venture Capital Fund Ltd. (CVCFL) through its Fifth Fund viz., Emerging India Growth Fund has invested Rs.250 million by way of equity shares and convertibles for a minority stake in M/s Bioneeds India Private Limited (Bioneeds).

The total expansion program will lead to the addition of 120,000 sq. ft. of facility space, of which 55,000 sq. ft. will be added immediately. This will result in a total 230,000 sq. ft. facility consisting of biopharma discovery labs (molecular biology, cell culture, upstream and downstream, DPD, bioanalytical and quality control/QC labs) and NEC discovery labs (chemistry, DMPK, safety pharmacology, bioanalytical and canine facility), as well as the additional manpower of 75 scientists. With this expansion, Bioneeds will be offering a full range of discovery, development and regulatory services to pharma, biotech, medical device and agrochemical companies.

“We are a first-generation business, built primarily on high-quality work by our well-qualified scientific staff. Our high-growth to date has been funded by internal accruals and borrowings," said Dr. S.N. Vinaya Babu, Bioneeds. “We have been actively looking for funds to strengthen our balance sheet and also expand our services. The funds from CVCFL shall be deployed to build additional vivarium and discovery labs with state-of-the-art equipment … We aim to be counted among the best Global CROs offering a complete range of services."

Effective Dec. 17, 2015, Azelis Group (Azelis) and KODA Distribution Group (KDG) announced that the deal to acquire U.S.-based KDG is complete and has closed following regulatory clearance. KDG is now called Azelis Americas and is led by Frank Bergonzi, CEO, president, and a member of the Azelis board of directors. Bergonzi reports to Hans Joachim Müller, CEO Azelis.

Azelis Americas will continue to operate in the United States and Canada using its existing business model and go-to-market strategy. Its local brands will be maintained and co-branded with the Azelis visual identity, thereby emphasizing its local focus on absolute customer service, now backed by a global structure. Specialty markets are also aligned across the group.

“Although we are now a much larger organization with a better-balanced geographical footprint, the overarching rationale of the acquisition was the revenue synergies that exist between KDG and Azelis, which we aim to exploit," Müller said. “Going forward we will be focusing on generating fast-paced organic growth by extending our lateral value chain offering to the specific markets we serve. Moreover, we also will selectively pursue acquisition opportunities to complement our portfolio. We are now well positioned in North America and in Europe, and have built a sizeable and fast-growing presence in Asia. We will continue to expand and invest for future profitable growth, as we become a truly global player in specialty chemicals."

In total, the new company will have more than 30 application laboratories worldwide covering food & health, personal care, pharma, homecare & industrial cleaning and case (coatings, adhesives, sealants and elastomers).

FONA International, family-owned creator and manufacturer of complete flavor solutions, has been named a National Best & Brightest in Wellness winner by the National Association of Business Resources (NABR). Already an overall 2015 National Best and Brightest Company to Work For, FONA's focus on employee wellness garnered further recognition.

To win National Best & Brightest in Wellness, FONA was evaluated by SynBella, a wellness systems firm, and examined for wellness program effectiveness. Metrics include participation, incentives, benefits and programs, leadership, employee input, culture and environment.

The award celebrates companies that are making businesses more healthy, the lives of their employees better and the community a healthier to place to live. FONA's commitment to employee health and well-being includes programs and benefits such as generous company-paid health insurance, an on-site fitness room, free yoga and massages, summer hours, an employee garden and monthly lunches.

Processing Technologies International LLC (PTi), a global manufacturer of high-performance sheet extrusion machinery, announced a $10 million plant expansion at its Aurora, Illinois headquarters in response to growing demand for its sheet extrusion equipment. The company will add 40,000 sq. ft. of space, nearly doubling its net manufacturing capacity while increasing office space to 20,000 sq. ft.

Groundbreaking is slated for March 2016, and the new space is expected to be fully operational by October 2016. An integral part of the expansion is a 15,000 sq. ft. technology development center that will be dedicated to product development and process trials for customers on production-scale systems. This space will accommodate up to three different systems, including the patented high-vacuum twin-screw extruder (HVTSE^®)* dryer-less technology, a conventional multi-layer (barrier) system, and a third system with newly patented sheet extrusion technology that will be released soon. All demonstration systems will feature winders for producing roll stock. *HVTSE Technology by Bandera

Huber Carbonates LLC, a subsidiary of J.M. Huber Corp., announced it is substantially increasing capacity at its ground calcium carbonate (GCC) operation in Marble Hill, Georgia.

“Huber has a long-term, multi-stage plan to increase capacity in ground calcium carbonate, driven by customer demand and new product sales," said Matt O’Brien, vice president and general manager of Huber’s GCC business.

The continuous investments in GCC will position Huber to continue supporting its customers’ growth strategies with increased capacity for both medium-fine and fine ground products. “This expansion—coupled with the recent expansion of our Quincy, Illinois, GCC facility—is already in motion and targeted for completion in 2016," said Rick Zwingelberg, operations director for Huber’s GCC business. “We continue to be well-positioned to meet the growing needs of our customers in a number of markets."

Ingredient News

Shanghai, China-based ECA HealthCare Inc. obtained self-affirmed GRAS (generally recognized as safe) for its phosphatidylserine (PS) products, including soy origin BioPS™, Sunflower origin SunPS™ and marine fish origin DHAPS™.

Under provisions of FDA’s Federal Food, Drug and Cosmetic Act (FD&C), ECA’s PS products were submitted for review by a panel of experts to examine all aspects of process and production. After a comprehensive evaluation of research studies and toxicology data, the panel concluded ECA’s PS products are safe for use as ingredients in a variety of products, including beverages, confectionery products, dietary supplements and nutritional bars.

ECA has been developing and supplying innovative ingredients for dietary supplements to the global market since 2007; now with self-affirmed GRAS obtained on PS products, ECA is able to supply innovative ingredients to the food industry.

FutureCeuticals announced the addition of Coffeeberry® Energy Organic Coffee Caffeine to the Coffeeberry brand coffee fruit product family. Intentionally designed to retain healthy natural coffee nutrients from the whole coffee fruit, Coffeeberry Energy delivers standardized levels of natural coffee caffeine. Made exclusively from carefully selected premium Arabica whole coffee cherries, it provides chlorogenic acids, organic acids and trigonelline.

FutureCeuticals also received Non-GMO Project Certification and Verification of NeuroFactor™, its patented and clinically researched neuroprotein support ingredient. The Coffeeberry® brand product is made from the whole fruit (including the bean) of the coffee plant, Coffea Arabica.

Frutarom Health BU is offering AB-Fortis^®, a patented encapsulated iron system that’s an option for vegans/vegetarians, as well as women of childbearing years. The clean label, GMO-free, all-natural ingredient has a high iron content and can be formulated into a full range of food and beverage applications.

AB-Fortis^® is produced by a patented process to provide stable encapsulation with minimal release of free iron into the food matrix. The spherical gelation of ferric saccharate by calcium alginate results in an encapsulated iron salt with a high (40 percent) iron content. Its excellent suitability for food matrices and consumer acceptability was recently demonstrated in a successful bakery product targeted to children and launched in Spain by a market leader in this segment.

“This microencapsulated iron ingredient allows fortification without changing appearance, palatability or flavor of foods," said Wouter Haazen, product manager for Frutarom Health. “AB-Fortis is stable under high pressures and temperatures, staying intact during processing. Further, it is highly bioavailable, as shown by a recent human clinical study."

AB-Fortis is produced by AB-Biotics Co. SA, Spain, and marketed exclusively by Frutarom BU Health, Switzerland.