|
REGULATORY FDA prevails in Hi-Tech DMAA case but it may weaken synthetics position Nutraingredients-usa.com A federal district court judge has ruled in favor of FDA in its case against Hi-Tech Pharmaceuticals and its use of DMAA. However, the ruling potentially weakens the agency’s stance on the question of synthetic versions of constituents of botanicals. The agency has attempted to remove all DMAA products from the market for safety concerns. Hi-Tech had claimed the stimulant could be found in geranium. Read more→ ICSB IN REVIEW FDA’s Welch notes agency must adjust to supplement industry; USP: Pesticide regs put botanicals in tough spotNaturalProductsINSIDER, Nutraingredients-usa.com In a presentation at this week’s ICSB conference at Ole Miss, FDA official Cara Welch emphasized the importance of research as her office strives to keep pace with changes in the supplement market. With an exponential increase in the number of products and facilities to track, FDA cannot continue to regulate as it did 22 years ago, she said. This means expanding and adjusting enforcement techniques and priorities. In another presentation, Nadakumara Sarma, director of dietary supplements at USP, noted that quirks of regulation policy regarding pesticides leave botanical ingredients subject to unwarranted seizure. There is a zero tolerance policy even if the same pesticides are allowed at higher levels in foods. Read coverage: Dietary supplement official: FDA can't freeze in time→ Quirks in regulations create nonsensical pesticide limits, USP says→UNPA NEWS High-energy blue light webinar available for viewingUnited Natural Products Association Hear leading experts discuss the dangers of high-energy blue light from digital screens, energy-efficient lighting and the sun, which bombard our eyes daily in this replay of the March 23 Expert Insights webinar, sponsored by OmniActive Technologies. Learn more about this blue light, its sources and ways to combat its effect, including blue-light filtering macular carotenoids. Read more→ Register for these upcoming industry events Ingredient Marketplace, April 18-20, Orlando, Fla., produced by member company Informa Exhibitions. See "UNPA Member Discounts" at right for special offer. Wasatch Scientific Open House, April 19, Murray, Utah. Wasatch is a UNPA member. The Practitioner Channel Forum, April 26-28, San Diego, produced by UNPA member Holistic Primary Care. See "UNPA Member Discounts" at right for special offer. USP Dietary Supplement Stakeholder Forum, May 7, Rockville, Md. CHPA Dietary Supplement Seminar, May 10, N. Bethesda, Md. UNPA is a host of this event, produced by CHPA; Loren Israelsen is speaking. Recently posted at unpa.com: 2017 Expo West Members’ Meeting PPT (requires member log in) “New Dietary Ingredients: Enforcement” presentation at 2017 Expo West, by Larisa Pavlick FDA Inspections, Part II by Larisa Pavlick, UNPA VP, Global Regulatory & Compliance (log in) FDA Inspections 101 by Larisa Pavlick, UNPA VP, Global Regulatory & Compliance(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).QUALITY INITIATIVES GRMA invites help in developing GMP supplement standard; AHPA botanical GMPs ready for field testingNutraceuticals World, Nutraingredients-usa.com As the Global Retailer and Manufacturer Alliance (GRMA) continues developing an ANSI-approved, consensus-based American National Standard for Good Manufacturing Practices (GMPs) in the dietary supplement industry, it plans to publish the first ANSI-approved GMP standard for dietary supplements this spring. It is also encouraging industry participation in the ANSI standard development process. AHPA has issued a version of its botanical GMP document, as several member companies have stepped forward to field test the recommendations. Read coverage: GRMA invites participation in developing GMP standard for dietary supplements→ AHPA’s botanical GMPs document ready for field testing→M&A ACTIVITY Columbia Nutritional acquires Pacific Nutritional; Mylan buys right to Cold-EEZE brandNutraceuticals World Privately owned dietary supplement contract manufacturer Columbia Nutritional in Vancouver, Wash., agreed to acquire its neighbor Pacific Nutritional Inc., also a custom contract manufacturer in Vancouver. Mylan MC has acquired the rights to the Cold-EEZE brand cold remedy line from ProPhase Labs Inc., for $50 million. Read coverage: Columbia Nutritional to Acquire Pacific Nutritional Inc.→ Mylan completes acquisition of Cold-EEZE brand→STATE AG ACTIVITY AG conference panel critical of OxyElite Pro, USPLabs in adulteration caseNaturalProductsINSIDER An industry panel, speaking at the Conference of Western Attorneys General 2017 Chair’s Initiative, in Honolulu, criticized USPLabs and OxyElite Pro in reviewing acase that linked the company's product to a 2013 hepatitis outbreak in Hawaii. Panelists from CRN, UNPA member Cyanotech and USP noted shared concerns about companies that deliberately adulterate products. However, they also noted that other manufacturers are very responsible, but are being characterized as criminals. Read more→DNA TESTING Guelph University launches DNA-testing allianceNutraingredients-usa.com The University of Guelph in Canada is launching the NHP Research Alliance to provide global leadership to advance the use of DNA testing and molecular diagnostics in quality assurance of natural health products. Read more→REGULATORY States need additional funding for FSMA implementationFoodSafetyNews After the release of the preliminary 2018 federal budget proposal,the National Association of State Departments of Agriculture drafted a letter to congressional budget leadership saying state governments need an additional $100 million a year to sufficiently implement the Food Safety Modernization Act, including $40 million for produce safety programs and $40 million for preventive control programs for human food. Read more→MLMs The perils of retail and distribution in ChinaNewHopeNetwork This overview offers the past, present and future perils of international relationship marketing with a focus on China. The article provides profiles of some of the companies that have been successful in China, including Amway and Herbalife as well as UNPA members NuSKin, dōTERRA and Nature’s Sunshine. Read more→ORGANIC Organic industry has bigger issues than bioponics debateOrganic Produce Network Innovative farmers have figured out how to maintain vigorous populations of microbes using natural fertilizers to cultivate food in containers and other soil-less conditions (sweepingly named bioponics). For the time being, farmers can market this produce as certified organic, if they follow the organic regulations. All this could change as the current administration looks to the 2018 Farm Bill as a chance to dismantle or to denude the NOP, so that it has minimal influence, power or funding. Read more→GLOBAL REGULATORY Indonesian trade group says regulators used inaccurate evidence in omega-3 clampdownNutraingredients-asia.com Indonesian regulators didn’t have the full picture when they slashed the permitted daily limit for omega-3 health claims earlier this year, according to the country’s trade group Asosiasi Pengusaha Suplemen Kesehatan Indonesia. The decision to allow DHA and EPA health claims only for items under 300 mg was based on inaccurate evidence. Read more→INTERNATIONAL MARKETS Australian retailer says industry missing opportunities; Kiwis committed to removing natural products barriers; China takes a long-term commitmentNutraingredients.com, Nutraingredients-asia.com,. Nutraingredients-usa.com The CEO of Australia’s largest independent vitamin retailer, Mr Vitamins, has argued the industry is missing too many opportunities to maximize supplement sales and deliver high-quality customer service. New Zealand’s government is committed to helping natural products and supplement firms meet their export potential by removing barriers to innovation, according to Dr. Nick Smith, the country’s environmental minister. Companies seeking to launch products in China have been told they have to be in it for long haul and make extensive preparations,‘instead of turning up at Shanghai airport and asking trade officials for a list of distributors.’ Read coverage: Supplements retailing: Five factors to focus on to drive sales success—Mr Vitamins CEO→ NZ government backs natural products innovation as exports help offset dairy slump→ Supplement firms seeking success in China: Think big, trademark brands and don’t be too trusting→UNPA MEMBER NEWS Court orders Olive Lifesciences to pay Sabinsa $2.2 million for willfull infringementSabinsa Corporation Sabinsa Corporation, a leader in curcumin for the dietary supplement industry, has prevailed on all counts in its long-running patent infringement lawsuit against Olive Lifesciences Pvt. Ltd. The suit alleges that Olive was selling and distributing products that infringed Sabinsa’s Curcumin C3 Complex® Patent, which protects compositions, methods of use, and methods of extraction noting the company willfully infringed on the protected product. Read more→ Informa launches 'clean label' trade journalINFORMA Exhibitions Informa is now publishingFood Insider Journal,a monthly digital publicationfocused on clean label strategy and formulation. The journal is free to download from the website--as is all of the content--which features audience-related videos, expert columns, infographics and presentations. Read more→MARKET RESEARCH Ease of use, security key in supplement packaging; Americans prefer supplement cold remedies; consumers look for vitamins in functional drinksNutraceuticals World Buying decisions by consumers of vitamins and supplements are driven by security of dispensing close, dosing flexibility and intuitiveness, according to new research from TricorBraun, a manufacturer of nutraceutical packaging. As a result, marketers are looking to supplement packaging to help deliver innovation and ensure brand loyalty. Millennials are more likely to try a natural supplement next time they have a cough and/or cold. In fact a new survey conducted on behalf of Myrtol 300, suggests that 80 percent of Americans are willing to try a natural supplement when dealing with a cold. Similarly, more consumers are looking for functional beverages that support their demanding and fast-paced lifestyles, according to new research from Mintel, with vitamins and minerals (49%) the attribute they say they look for most in their ideal hybrid drink. Read coverage: Consumers look for ease of use, security in supplement packaging→ Survey shows Americans prefer supplements over OTC cold medicines→ Nearly half of Americans look for vitamins, minerals in functional drinks→RESEARCH Calcium supps may equal food; lutein, zeaxanthin boosts brain; elderberry aids blood sugar; blueberries ease stress; probiotics and memory—too soon to sayNewHopeNetwork, Nutraingredients.com, Nutraingredients-asia.com, Nutraingredients-usa.com Post-menopausal women absorbed calcium equally as well from supplements as they did from dairy-rich foods in a small study published in the journalBone Reports. Higher blood levels of lutein and zeaxanthin may be associated with better cognition, memory and executive function, suggests a new study from Ireland. Polyphenolic extracts from elderberry (Sambucus nigra) may increase the uptake of glucose and free fatty acids by muscles and help with blood glucose management, according to a new study from Norway. A blueberry drink a day can help keep stress away, according to a new Korean study, which found blueberry’s antioxidant power improved cognitive performance of adult rats exposed to stress. A recent rodent study published in Molecular Psychiatry indicated that a combination of probiotics may impair memory in healthy animals—conclusions that industry experts say go too far and are at odds with the totality of the evidence. Read coverage: Calcium pills may be good food→ Lutein, zeaxanthin levels linked to better cognitive function: Study→ Study highlights potential blood sugar management activity of elderberry extract→ Blues busters: Study shows blueberry juice antioxidants east stress→ Probiotics and memory: When conclusions can go too far→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.
|
