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January 29, 2016
Recent happenings at UNPA, USP and CRN were accompanied by personnel, certification and facility announcements from other industry companies.
UNPA Educational Conference
The United Natural Products Alliance (UNPA) is hosting “The UNPA Raw Materials & Supply Chain Summit," on Feb. 23 and 24 in Salt Lake City. The summit is the second of a three-part series of educational conferences focused on dietary supplement product quality initiatives and a follow-up to UNPA’s November 2015 Analytical Testing Summit, and will include sessions on DNA testing, the Food Safety Modernization Act (FSMA) and information technology (IT) to manage business operations. The summit will offer provide an update on the status and rollout of GNC’s quality standards initiatives, working groups covering botanicals raw material GMPs (good manufacturing practices), an industry product registry database, minimum certification standards and minimum facilities requirements.
Sessions are designed to help senior executives, legal and regulatory staff, QA/QC and R&D experts, and purchasing and marketing teams at dietary supplement companies, analytical labs and raw material suppliers understand the issues and formulate strategies to respond to rapidly changing consumer perceptions and a new manufacturing and production environment.
New Monographs Proposed
The U.S. Pharmacopeial Convention (USP) is proposing new monographs for color and spice additives, and other functional ingredients to be included in its Food Chemicals Codex (FCC). The new monographs are proposed for turmeric oleoresin, anise oil, gamma aminobutyric acid (GABA) and L-carnitine L-tartrate. USP noted these functional ingredients are vulnerable to adulteration and contamination, and are used in a variety of products.
USP seeks comments on the proposed monograph for turmeric oleoresin, particularly as to how it should approach the issue of potential adulteration or contamination of turmeric oleoresin with non-declared colors such as Sudan dyes, including appropriate methods and specifications. The proposed anise oil revision provides test limits for adulteration with Japanese star anise (Illicium anisatum), and an origin labeling requirement. USP also requests comments on how to limit the potential contamination of L-carnitine L-tartrate with D-carnitine, an impurity that lacks the biochemical function of L-carnitine and is reported to be antagonistic to L-carnitine.
Manufacturers and other interested parties are encouraged to comment on the proposed monographs through USP’s FCC Forum, a free, online tool, available for the public to review food ingredients quality standards. The comment period for these new and revised FCC monographs is from Dec. 31, 2015 to March 31, 2016.
Kyowa Hakko USA promoted Leo Cullen to president and CEO, where his responsibilities will include growing the North and South American pharmaceutical, dietary supplement, and cosmetic business areas. Since 2012, he was the company’s executive vice president. Cullen joined Kyowa in 2007 as vice president of sales and marketing. He has over 25 years of experience in the pharmaceutical and nutraceutical ingredient businesses.
D. Christopher Nolte, former director of nutritional sales of Kyowa, is taking the position of vice president of nutritional sales. Nolte joined the company in 2008 and has served as director of sales since 2014. He has over 20 years of nutritional ingredient sales experience.
NP Nutra promoted Eric Guggenheim to director of sales. Guggenheim joined NP Nutra in 2011 as a quality assurance technician developing the company solubility rating system and testing the quality/consistency of ingredients. In June 2013, he transitioned to the position of account manager, quickly advancing to senior account manager within a year.
The Colorado-based organic hemp company CBDRx announced it received USDA Organic Certification for its entire 120-acre hemp crop. CBDRx specializes in the development, cultivation, processing and wholesale distribution of hemp-based cannabidiol (CBD) products for use by the wellness, nutraceutical and pharmaceutical industries. The company grows its USDA Certified Organic hemp in Colorado from proprietary high-CBD, low-tetrahydrocannabinol (THC) broad-spectrum hemp strains that yield high-quality cannabinoid oils.
CBDRx CEO Marc Brannigan stated, "The CBD industry is plagued by products from unidentifiable overseas sources making dubious, unverifiable and false claims. We are understandably proud to be one of the first companies in the United States offering organic CBD products with the high quality, consistency and transparency that this industry demands."
Paragon Laboratories announced it has attained UL Certification for Dietary Supplement GMP (good manufacturing practice) compliance. UL, a global independent safety science company, was founded in 1894, and continues to offer assessment and certification to a broad base of industries, including dietary supplement contract manufacturing.
According to Jay Kaufman, president of Paragon Laboratories, the new certification is just one of the many investments in third-party certification the company has pursued in more than 45 years in the industry.
AstaReal Inc. announced its parent company, Fuji Chemical Industries Co. Ltd., is expanding its line of kosher products. On Jan. 7, 2016, Fuji received its kosher certificate from the certifying body, KLBD (London Beth Din Kashrut Division), listing AstaReal® P2AF (2-percent cold water dispersible powder) as one of the certified products. It is geared toward tableting, two-piece hard capsules and powder premixes for beverage formats.
Joe Kuncewitch, AstaReal’s national sales manager, said, “AstaReal is once again showing our commitment to providing the most certified natural astaxanthin available to our customers." The company is exclusively dedicated to the production, research and marketing of natural astaxanthin from the microalgae Haematococcus pluvialis.
CRN Membership Expansion
The Council for Responsible Nutrition (CRN), a leading trade association for the dietary supplement and functional food industry, announced the addition of seven new voting member companies to CRN’s membership roster. The companies are Bodybuilding.com, Helios CORP., The Honest Company Inc., RIBUS Inc., KD Pharma, NRG Innovations LLC and Seppic Inc.
“We’re thrilled to start off the New Year by welcoming these new companies as CRN members," said Steve Mister, president and CEO, CRN. “It’s an exciting time for the industry, and as our membership continues to grow to new record levels, the addition of these new companies helps strengthen our association to ensure our voice is heard. More than ever, CRN is reflecting the breadth of this vibrant industry. We truly look forward to working with them."
Bodybuilding.com is one of the world’s largest online fitness sites, with more than 1 million daily visitors and 9,500,000 total members. It offers customers an extensive selection of bodybuilding articles, exercises, workouts, supplements and fitness friends. Its online community features guidance from personal trainers, nutritionists and supplement experts, positioning itself as personal trainer, nutritionist, supplement expert, lifting partner and support group.
Helios CORP. is a science-based company that develops nutritional ingredients backed by human clinical studies. The end-use customer will utilize these studies to maximize structure-function claims, thus enhancing the ability to commercialize product and stay in compliance with federal regulations.
The Honest Company is a leading lifestyle brand with a mission to inspire and empower people to live a healthy and happy life. The company’s growing portfolio of more than 100 products addresses the ever-growing category needs of baby, personal care, home care, vitamins, supplements and more. Launched in 2012, The Honest Company now has a presence across the United States and Canada online and in more than 4,000 leading retail locations.
Founded in 1992, RIBUS supplies natural and organic ingredients to food, nutrition and pet companies globally. Utilizing its patented technology, RIBUS is committed to being a leading supplier of high-quality specialty rice ingredients, helping producers provide “clean" consumer-friendly labels.
Founded more than a quarter century ago in Germany, KD Pharma patented the Super Critical Fluid process used to extract and purify omega-3 compounds. Today, the company employs a full repertoire of state-of-the-art purification technologies, providing the flexibility to tailor-make omega-3 concentrates with purity as high as 99 percent. The oils are produced in a GMP manufacturing facility for both the pharmaceutical and nutritional industries.
NRG Innovations is a privately held U.S.-based company focused on the manufacturing and commercialization of dietary supplements in “gem" format. The company’s primary brand of supplements, Energems, is the first in its line of chocolate-gem dietary supplements.
For more than 70 years, Seppic, a subsidiary of the Air Liquide Group based in Paris, has designed and supplied innovative specialty ingredients—both excipients and actives—for the cosmetic, pharmaceutical and nutrition markets. The company has more than 600 employees in 14 countries, with U.S. offices in New Jersey.
To access CRN’s complete list of member companies, visit the association’s website.
MTC Industries Inc. announced the completion of one of its key development plans, a brand-new, in-house research and testing laboratory. Construction began in 2015, and currently the lab has full instruments and equipment to conduct quality control (QC), product development and research projects. Raw material QC and product development are the main functions. MTC can conduct physical testing, ID testing, micro testing and chemical testing for all in-stock/pre-shipment ingredients following GMP guidelines.
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