Dietary supplement trade associations warn consumers of dangerous substance illegally posing as a dietary supplement
WASHINGTON (Nov. 05, 2018) — The dietary supplement industry today sounded the alarm about the dangers of “phenibut,” a substance being illegally marketed in products fraudulently labeled as dietary supplements. Developed and used as a drug in the former Soviet Union for its supposed brain-enhancing properties, phenibut is not approved as a drug in the United States, nor does it meet the regulatory requirements to be sold in, or as, a dietary supplement. The ingredient should be considered dangerous, and has been associated with potentially serious side effects and great risk for addiction. The responsible dietary supplement industry learned that phenibut has been found in adulterated products fraudulently labeled as dietary supplements and is warning consumers to avoid purchasing any products with this ingredient.
UNPA and TraceGains announce strategic partnership to promote dietary supplement supply-chain quality, integrity and regulatory compliance
SALT LAKE CITY (Oct. 30, 2018) — The United Natural Products Alliance (UNPA), an international association representing more than 100 leading natural products, dietary supplement and scientific and technology and related service companies, and TraceGains, the leading provider of supplier compliance and quality management software for the food, beverage and supplement industries, announced today a strategic partnership designed to increase quality, management and transparency in the global supplement supply chain.
SIDI Work Group Releases Updated Protocol to Help Maintain Dietary Supplement Industry Supply Chain Integrity
—Voluntary ingredient information exchange guidelines streamline
FOR IMMEDIATE RELEASE CONTACTS:
CHPA: Lauren Bloomberg, Lbloomberg@chpa.org, 202.429.3534
CRN: Holly Vogtman, email@example.com, 202.204.7665
UNPA: Frank Lampe, firstname.lastname@example.org, 720.398.8172
WASHINGTON (September 10, 2018) — The dietary supplement industry’s self-regulatory coalition, the SIDI Work Group, today released an updated version of the Standardized Information on Dietary Ingredients (SIDI TM) Protocol. Originally published in 2006, and previously updated in 2008, the newly-released SIDI Protocol provides a standardized format for dietary ingredient suppliers to communicate consistent regulatory and quality information on their ingredients and facilities to inquiring manufacturers. In addition to features that enable enhanced customizability, the newly-released Protocol makes available templates for dietary ingredient datasheets and a site quality overview as companion tools.
“The updated SIDI Protocol helps ensure suppliers and manufacturers can exchange comprehensive ingredient information consistently and reliably,” said Duffy MacKay, N.D., chair of the SIDI Work Group’s executive committee, and senior vice president, scientific & regulatory affairs, Council for Responsible Nutrition (CRN). “Ingredient suppliers recognize the need to provide accurate ingredient information to manufacturers, but a high volume of customer questionnaires asking for the same information in myriad ways can complicate the process. Using the standardized format presented in the SIDI Protocol, dietary supplement ingredient suppliers can proactively deliver information more efficiently, and manufacturers have a trusted framework for requesting the standard data that they need.”
As required by 21 CFR 111, current Good Manufacturing Practices (cGMPs) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, dietary supplement manufacturers must qualify their ingredient suppliers to ensure that specifications for the identity, purity, strength, composition, and limits on potential contaminants for dietary supplements are consistently met to produce quality products. The primary purpose of the SIDI Protocol is to help stakeholders satisfy cGMP requirements by establishing a standard format for communicating crucial information so that a manufacturer can properly assess a supplier’s suitability as a provider of raw materials. To enhance customizability, the updated Protocol also includes additional examples of the type of information that could be offered for dietary ingredients, including safety studies and history of safe use data, and information on sourcing and sustainability.
The SIDI Work Group is a joint initiative of three dietary supplement industry trade associations—the Consumer Healthcare Products Association (CHPA), CRN, and the United Natural Products Alliance (UNPA)—along with dietary supplement ingredient suppliers and finished product manufacturers with an interest in strengthening the industry’s self-regulatory practices.
“The SIDI Work Group’s goal is to provide tools that industry can use to maintain the integrity of the supply chain by helping supplement manufacturers work with quality suppliers and source quality ingredients,” continued Dr. MacKay. “The SIDI Protocol can be adopted across the industry so that companies of any size and budget are operating on an equal playing field, ensuring all stakeholders supply and receive the same level and quality of information. As a result, companies have the tools they need to ensure the products sent to market meet the stringent standards and expectations of regulators—and their consumers.”
The updated SIDI Protocol and accompanying documents are available at www.SIDIworkgroup.com.
The Consumer Healthcare Products Association (CHPA) is the 137-year-old trade association representing the leading manufacturers and marketers of over-the-counter (OTC) medicines and dietary supplements. Every dollar spent by consumers on OTC medicines saves the U.S. healthcare system $6-$7, contributing a total of $102 billion in savings each year. CHPA is committed to empowering consumer self-care by preserving and expanding choice and availability of consumer healthcare products. Visit www.chpa.org.
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 150+ dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. Visit www.crnusa.org. Follow us on Twitter @CRN_Supplements, Facebook, and LinkedIn.
The United Natural Products Alliance (UNPA) is an international trade association representing more than 100 leading natural products, dietary supplement, functional food, scientific and technology and related service companies that share a commitment to provide consumers with natural health products of superior quality, benefit and reliability. Founded in Utah in 1992, UNPA was instrumental in the passage of the 1994 Dietary Supplement Health and Education Act (DSHEA) and continues to take a leadership position in legislative and regulatory issues and industry best practices. Visit www.unpa.com.
UNPA announces 10 new member organizations have
joined the expanding alliance
Bifodan, Jigsaw Health, Pharmore Ingredients; ACG North America, Agilent Technologies, Banned Substances Control Group; and FDA Compliance Simplified, Steve Holmes Consulting, Natural Marketing Institute and Ooyen Research swell the ranks of best-in-class UNPA members
SALT LAKE CITY (July 31, 2018) — The United Natural Products Alliance (UNPA), an international association of forward-looking companies dedicated to providing consumers with natural health products of superior quality, benefit and reliability, is pleased to announce the addition of three new executive members, three new science and technology services members and four new associate members to its expanding roster of member organizations within the alliance.
“We warmly welcome these new members companies, who collectively strengthen and broaden the UNPA membership base and reflect a growing understanding that a strong trade association is imperative for the continued growth and successes of the dietary supplement industry,” said Loren Israelsen, UNPA president. “We are already benefitting from and look forward to continued, meaningful contributions from these new members that will help us raise the quality bar for industry and consumers.”
New Executive Members
Bifodan is an innovative and reliable supplier of finished probiotic solutions of high quality and documented stability. Bifodan products are classified and documented as dietary food supplements and its customers are B2B nutritional/dietary supplement distributors, pharmacy chains and drugstores worldwide. www.bifodan.com
Jigsaw Health has been developing science-based dietary supplements with a focus on magnesium, featuring its Sustained Release Technology since 2005. In 2018, MagSRT® was evaluated in the Scottsdale Magnesium Study, a placebo-controlled, human clinical trial of 91 participants, published in the peer-reviewed Journal of the American College of Nutrition. www.jigsawhealth.com
Pharmore Ingredients is an industry leader in supplying high-quality dietary supplement and food ingredients to the human and animal nutrition industries. The company is staffed by a team of industry experts with more than 100 years of combined experience. Pharmore Ingredients focuses on providing joint-care products such as chondroitin, glucosamine, MSM and hyaluronic acid, along with botanicals and B vitamins. www.pharmore.com
New Science and Technology Services Members
ACG North America offers integrated manufacturing solutions for the pharmaceutical industry. Its diverse product range of capsules, films & foils, engineering and inspection systems exceeds the demands of international regulatory requirements. www.acg-world.com
Agilent Technologies is a leader in life sciences, diagnostics and applied chemical markets. The company provides laboratories worldwide with instruments, services, consumables, applications and expertise, enabling customers to gain the insights they seek. www.agilent.com
Banned Substances Control Group offers a complete suite of dietary supplement certification and testing services. BSCG works with supplement brands, ingredient suppliers, manufacturing facilities and individual teams and athletes to ensure the quality of dietary supplement products and ingredients and to protect against contamination with drugs or other agents. www.bscg.org
New Associate Members
FDA Compliance Simplified supports the natural products industry by providing compliance reviews for labels, websites and marketing materials, as well as claim substantiation reviews. www.fdasimplified.com
Steve Holmes Consulting. Steve Holmes is a 40-year veteran of the natural products industry and alternative health care field. He has extensive experience in domestic and international regulatory affairs. He is also a clinical nutritionist, providing evidence-based nutrition counseling to patients at a Southern California medical email@example.com
Natural Marketing Institute is a strategic consulting, market research and business development company specializing in the health and wellness marketplace, with a focus on customized, multi-channel market assessment activities, consumer trend identification, business development, consumer target profiling, market research and strategic plan development. www.nmisolutions.com
Ooyen Research is Carla Ooyen, a market research professional with nine years of industry specific experience, three years of experience in the hemp/cannabis industry and a background in engineering that allow her to tackle strategic business topics in a wide array of industries. firstname.lastname@example.org
MEDIA CONTACT: Frank Lampe, VP, Communications & Industry Relations, 720.398.8172, email@example.com.
UNPA / UNPA and Healthnotes create partnership to promote Vitature supply-chain management software; July 10 webinar scheduled
Software helps companies manage cGMP and FSMA compliance, streamline claims and certifications documentation;July 10 webinar to explore compliance challenges and solutions
SALT LAKE CITY(June 25, 2018) — The United Natural Products Alliance (UNPA) and Portland, Ore.-based Healthnotes have signed a commercial partnership memorandum of understanding to promote Vitature®, a comprehensive software solution for dietary supplement brand holders, contract manufacturers, ingredient suppliers and importers.
Vitature is a cloud-based, software-as-a-service compliance platform designed specifically for the dietary supplement industry. Many supplement manufacturers rely on outdated or inadequate technology to request, track and transparently manage increasingly complex sets of data and documents required by various regulations, including the Food Safety Modernization Act (FSMA). Vitature helps manufacturers accelerate the process of qualifying vendors, create and share material specs and manage label compliance, including scientific support for structure/function claims.
Vitature provides many benefits and cost savings by automating communications and data sharing required by manufacturers to qualify suppliers and materials, using an industry-approved protocol (SIDI), while providing compliance reports and business insights for executives, auditors and customers.
“As the supplement industry works toward full regulatory compliance under the Dietary Supplement Health and Education Act (DSHEA), and more recently, various provisions of FSMA, we’ve seen frustration with the costs and complexity associated with record-keeping requirements, as well as the number of external audits,” said Loren Israelsen, UNPA president. “Vitature is a smart, efficient and cost-effective answer to tackle these regulatory compliance issues. We see Vitature as a viable way for all companies in the supplement space to solve these technical issues and are pleased to partner with Healthnotes to support its adoption by industry.”
“UNPA and Healthnotes both support a common mission to provide more awareness, education and technology within the dietary supplement industry to support compliance, quality and overall transparency in the supply chain,” said Skye Lininger, D.C., CEO of Healthnotes. “We are pleased to partner with UNPA in this effort.”
One company reaping the rewards of the Vitature software is Chandler, Ariz.-based Arizona Nutritional Supplements (ANS), which adopted Vitature in September 2017 to help manage supplier qualification and provide real-time compliance insight across the organization.
“As a contract manufacturer with a growing business, we realized that we needed to scale the way we were qualifying suppliers and managing regulatory information,” said Tom Dubinski, vice president of quality systems at ANS. “We needed a more efficient way to manage regulatory compliance, and having a central repository with automated workflow that manages our raw-material compliance documentation and collaboration with suppliers has greatly improved our ability to serve our customers and improve our regulatory audit preparation.”
Dubinski added that Vitature allows the entire ANS team to manage and store FSMA- and DSHEA-required data—as well as certification documentation for label claims, such as organic and GMO-free—from its suppliers for all of its SKUs, in one place, allowing the company to reduce costs with faster time to market for new products.
A3:30-minute Vitature demonstration video from Healthnotes for manufacturers is available for immediate viewing, as is a 2:45-minute video for ingredient suppliers.
UNPA and Healthnotes will conduct a live, one-hour webinar on the challenges of managing regulatory and supply-chain compliance, transparency, consumer expectations and technology on Tuesday, July 10, from 2-3pm MDT. The webinar is free and open to all companies interested in learning about the solutions that Vitature can bring to these supply-chain-based issues. The webinar will be recorded for on-demand viewing after July 10 from the UNPA and Healthnotes websites. Register for the webinar here.
Healthnotes Inc. is a leading provider of ingredient education and compliance software technology for the natural health products industry. It provides solutions for the dietary supplement industry via Vitature and its Aisle7 products. For 20 years, its solutions have been used in retail stores and online for training, consumer-decision support, regulatory compliance and product development. Vitature is the cloud-based platform that digitizes and standardizes the data, documentation and processes needed for material compliance, eliminating regulatory risk for manufacturers and suppliers and speeding up their time to market. For more information, visit www.healthnotes.com.
Frank Lampe, VP, Communications & Industry Relations, 720.398.8172, firstname.lastname@example.org
Michelle Woolfolk, Director of Product Marketing, Healthnotes, 503.234.4092 x4520, email@example.com
SOURCE: The United Natural Products Alliance, www.unpa.com