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REGULATORY California to list glyphosate as cancer-causing chemical Reuters California’s Office of Environmental Health Hazard Assessment announced it will add glyphosate, an herbicide and active ingredient in Monsanto’s Roundup product, to its list of chemicals known to cause cancer. The listing is the latest legal setback for Monsanto, which has faced increasing litigation over the chemical since WHO declared it as probably carcinogenic in 2015. The company will continue to fight the designation required under Prop 65. Read more→ UNPA NEWS
Register for UNPA's PCQI training in Salt Lake City "Preventive Controls Workshop for Dietary Supplements: PCQI Training for Dietary Supplement Companies," July 17-19, Salt Lake City—very limited seating available. Recently posted at unpa.com: 2017 UNPA Members' Retreat coverage UNPA Saves Stark Steering Sign in Sugar House UNPA endorses the CRN OWL program (log in required) A new language converter has been installed on a number of pages of the UNPA website. Check it out in the upper left corner! The presentations and videos from the 2017 UNPA Members' Retreat are now available for viewing/downloading.(log in) UNPA comments on FDA official's assertion that serious adverse events are going unreported.(log in) FDA updates its FSVP resources with updated fact sheets and guidance document (log in) “Dietary Supplements: State of the Industry,” UNPA presentation at New Hope Network,April 26(log in) Washington Update: FDA User fees; Health Savings Accounts, by Peter Reinecke and Patricia Knight, UNPA Senior Political Advisors (log in) "An Industry Perspective on Botanical Quality & Compliance," presentation at ICSB 2017 by Larisa Pavlick(log in) The PPT presentations from NDI III: Roadmap to a Viable NDI Policy, UNPA member price: $295 Plus, updated industry events calendar,Member Memos (log in) and UNPA educational archives (log in).REGULATORY UNPA’s Pavlick details FSMA requirements for preventive controls personnelNaturalProductsINSIDER The Food Safety Modernization Act (FSMA) requires all food facilities to have a preventive controls qualified individual (PCQI) to maintain a food safety plan. However, many brands in the supplement industry don’t have a qualified individual on staff. In this podcast from last month’s UNPA's Members' Retreat, Larisa Pavlick, VP, global regulatory and compliance for UNPA, discusses FSMA, PCQIs, industry quality initiatives and other details. Read more→REGULATORY FDA pushes forward NDI guidance; standoff over synthetics continuesNaturalProductsINSIDER, Nutraingredients-usa.com It is likely the new dietary ingredient (NDI) draft guidance will be finalized before the end of the year with no modifications, accord to Brian Frisby, general manager, KGK Compliance Advisors, who cites sources inside FDA. In this podcast, Frisby discusses the NDI enforcement and notification best practices. At the same time, experts expect the existing standoff on synthetic botanicals as voiced by FDA in the most recent draft NDI guidance will continue, despite the consensus from industry being that the agency’s position is not rooted in science. Read coverage: Health Insider Podcast #89: Expert said FDA NDI guidance likely to be finalized this year→ Synthetic botanicals standoff likely to continue, despite Georgia fulling→REGULATORY FDA launches site for third-party certifications to expand oversight of imported foodsFDA.gov FDA announced it will launch a website where organizations can apply to be recognized as a third-party accreditation body. The launch of the website will implement the Accredited Third-Party Certification program, a voluntary program established by the Food Safety Modernization Act (FSMA) to expand FDA’s oversight of imported foods. Accredited bodies can conduct third-party audits of foreign food entities. Read more→REGULATORY Industry, FDA mark 10th anniversary of GMPsNaturalProductsINSIDER Thirteen years after the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA)—FDA published final regulations to ensure dietary supplements are manufactured to meet quality standards. FDA and industry leaders, such as UNPA President Loren Israelsen, reflect on the 10-year anniversary, noting the benefits of the regulations, and why some firms continue to fall short of meeting the requirements. Read more→REGULATORY Industry should take NAD influence, referrals seriouslyNaturalProductsINSIDER As a self-regulatory body whose work includes monitoring of dietary supplement advertisements, the National Advertising Division (NAD) wields influence with regulators in Washington. The group works with supplement industry groups to monitor ads, and if a company refuses to cooperate with a NAD investigation or comply with its decisions, the agency may refer the case to FTC, according to FTC official Richard Cleland. FTC takes NAD seriously, noted Ivan Wasserman, of UNPA member Amin Talati Upadhye LLC. Read more→HEALTH POLICY AMA recommends more choline in prenatal supplementsNutraingredients-usa.com The American Medical Association (AMA) now supports an increase of choline in all prenatal supplements to 450 mg/day, according to a resolution passed by the group at its annual meeting earlier this month. The latest NHANES data notes that 90 percent of Americans don’t get enough choline. AMA said that adequate choline is critical for a baby’s brain and spinal development. Read more→SELF REGULATION SIDI workgroup makes last call for comments on protocol--deadline is July 3SIDI Workgroup The SIDI workgroup reminds industry that the open comment period for the Draft SIDI Protocol Version 3.0 ends on July 3.SIDI asks that everyone encourage their colleagues to submit comments. The draft and comment form are available at www.sidiworkgroup.com.MERGERS & ACQUISITIONS Carlyle sells Holland & Barrett; Prinova to buy Lycored premix business; Palagia acquires FMC's omega-3 business; GSK plans to divest MaxiNutritionNutraingredients.com, Nutraingredients-usa.com, Nutraceuticals World, Reuters U.S. private equity firm Carlyle will sell Europe’s largest health and wellness retailer Holland & Barrett to an investment fund controlled by Mikhail Fridman, a Russian billionaire, for €2 billion. Carlyle, which bought the retailer from Nature’s Bounty (now NBTY), is also looking to sell off the other NBTY brands, including Met-RX, Pure Protein and Sundown Naturals. Food ingredients giant Prinova is accelerating its global expansion strategy with the acquisition of Lycored's premix business. Lycored, in turn, will expedite its move toward concentration in its carotenoid and encapsulation businesses. FMC corporation is selling its Epax omega-3 business to Pelagia AS, a producer of pelagic fish and marine protein and oils. Sources say Emma Walmsley, GSK’s new CEO, has plans to divest the MaxiNutrition brand, which makes protein bars, drinks and powders. GSKbought the business in 2010 to complement GSK's Lucozade sports drink, but it sold that brand in 2013. Read coverage: Russian billionaire buys Holland & Barrett for a healthy €2 billion→ Prinova expands it global manufacturing with acquisition of Lycored’s premix business→ FMC Corporation to sell omega-3 business to Pelagia AS→ GSK’s new CEO aims to divest sports nutrition brand: Sources→PRODUCT TESTING ConsumerLab test finds some magnesium products contaminated, mislabeledNutraceuticals World In a recent review of clinical evidence and testing of popular magnesium products, Consumer Lab found that four products contained less magnesium than claimed, took too long to break apart in disintegration testing, were contaminated with lead and/or were improperly labeled. Analysis also found that tablets made with a particular form of magnesium were unstable, absorbing so much water from the air as to become wet, which could damage nearby supplements. Read more→BOTANICALS African database catalogs regional bioactive compoundsNutraingredients.com A database of natural products isolated from native organisms of Northern Africa is now available online as its creators look to categorize the region’s untapped repository of bioactive compounds. Read more→UNPA MEMBER NEWS PLT launches liquid-stable caffeine; Verdure's Longvida shows neuroprotective effects; Indena forms DNA testing partnership; NSF details harmful ingredientsPLT Health Solutions, Inc. PLT Health Solutions, Inc. is launching a new liquid-stable, extended release caffeine ingredient aimed at the 2- to 4-ounce beverage or 'shot' market. The new ingredient is the third entry based on zümXRTargeted Release Caffeine technology. All zümXR ingredients feature state-of-the-art delivery system technology drawn from the pharmaceutical industry that represents what the company calls a significant step forward from conventional caffeine-coating technologies. Read more→ Verdure Sciences Researchers at Central Michigan University have found that Longvida Optimized Curcumin from Verdure Sciences outperformed 95-percent curcumin extract in all tested parameters. The study found that the ingredient, developed by Verdure and an elite group of university neuroscientists at UCLA, showed greater permeability, decreased reactive oxygen species (ROS) production and prevented apoptic death. Read more→ Indena S.p.A. Indena S.p.A. has announced a new DNA testing partnership with London-based biotechnology company Hyris Ltd. The agreement gives Indena a minority share in Hyris and preferential access to Hyris’s DNA-analysis technologies, including its proprietary bCUBE portable laboratory device. The platform will allow companies to jointly develop identification methods for the genomic identification of botanical species. Read more→ NSF International Many manufacturers use NSF certification to show consumers that their dietary supplements don’t contain harmful ingredients. Some non-certified products, however, may include ingredients that could hurt you. One of the top 12 ingredients to avoid is DMBA, a synthetic stimulant that has been masquerading as geranium and can cause increased heart rates, heart attacks and worse. NSF offers details on 11 others.Read more→ MARKET RESEARCH New trends in the burgeoning European sports nutrition marketNutraingredients.com The sports and health nutrition segment is booming in Western Europe as more consumers look for a healthy lifestyle, according to market research. Finland, the U.K. and Sweden are the biggest sports nutrition markets per capita, with U.K. the fastest growing region, as retail sales jump 14 percent in 2017. Mintel notes the importance of active seniors to the segment. Read more→RESEARCH Cattle stick boosts memory; K2 for hemodialysis patients; omega-3s aid joint health; Probiotics help respiratory health; Magnesium for depressionNutraingredients.com, Nutraceuticals World A botanical extract, known as cattle stick (Carpolobia lutea), offers possibilities in preserving memory and learning abilities, according to a new study from the University of Nottingham. Four-week supplementation with vitamin K2 MK-7 from Nattopharma significantly improved vascular calcification in hemodialysis patients, according to a new study from Lebanon. Regular consumption of omega-3 rich fish could reduce symptoms of rheumatoid arthritis, according to new data from Brigham and Women's Hospital and Harvard Medical School. Despite widespread interest in improving athletes’ health and performance with probiotics, the reduction of URTI’s has received substantial confirmatory evidence, according to a new review published in the Journal of Sport and Health Science.Magnesium appears to reduce symptoms of depression and anxiety, according to a new study from the University of Vermont looking at magnesium’s effects on depression for the first time. Read coverage: Botanical extract offers anti-inflammatory potential in tackling Alzheimer’s→ Clinical trial confirms need for vitamin K2 in hemodialysis patients→ Omega-3 and arthritis: Study finds link between fish consumption and joint disorder→ Can probiotics help respiratory illnesses in athletes?→ Study finds magnesium may ease depression symptoms→ETC. Dr. Andrew Weil: People are taking too many drugsNew York TImes Best known for popularizing the concept of integrative medicine, Andrew Weil, M.D., discusses his new book,Mind Over Meds: Know when drugs are necessary, when alternatives are better—and when to let your body heal on its own. Weil talks about how doctors are contributing to the overuse of drugs, why many of us should not be taking statins to lower cholesterol, and why he says many of the medicines and herbs we buy at pharmacies and supermarkets may be harming our health. Read more→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. Read more→ Comments are closed.
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