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POLICY Trump budget proposes FDA funding slash, doubling user fees FDA Law Blog This article provides insight to the proposed Trump budget plan, including proposed cuts to discretionary FDA funding by $854 million, but it would make it up (and more) by doubling user-fee funding –a proposal that FDA supports in the agency's own budget justification document. The budget also includes a package of “administrative actions” that are “designed to achieve regulatory efficiency and speed the development of safe and effective medical products.” Read more→ UNPA NEWS
20% savings endMonday for UNPA's GMP Inspection Training: How to Avoid FDA's Top GMP violations,June 27-28, in Provo, Utah—See intro videonow! Preview UNPA's June 27-28 GMP training session, taught by Larisa Pavlick, UNPA's VP, Global Regulatory & Compliance, in this short video presentation. Learn more about the program and why you should attend before your next FDA GMP inspection. This course will cover all aspects of the inspection, with a focus on the key elements of quality: identity, purity, strength and composition. VIEW VIDEO→ Register for this course→ Register for these upcoming industry events UNPA's "GMP Inspection Training: How to Avoid Citations and Prepare for Your Next FDA Inspection," June 27-28, Provo Utah--Save 20% when you register byJune 5! "Preventive Controls Workshop for Dietary Supplements: PCQI Training for Dietary Supplement Companies," July 17-19, Salt Lake City USP Dietary Supplement Stakeholder Forum, June 7, Rockville, Md. Recently posted at unpa.com: NEW! UNPA comments on FDA official's assertion that serious adverse events are going unreported.(requires member 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) 2017 Expo West Members’ Meeting PPT (log in) “New Dietary Ingredients: Enforcement” presentation at 2017 Expo West 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).SYNTHETIC BIOLOGY How biological synthetics will challenge supplementsNew Hope Network A rapid, and some would say “reckless,” rise of synthetic biology now allows virtually any ingredient to be designed and manufactured in a lab. But Jim Thomas of Montreal-based ETC Group, says he expects much of the activity to focus on high-value/low-quantity ingredients that make up so much of the supplement trade.NBJeditor Rick Polito spoke to Thomas at the UNPA Members' Retreat, last week in Santa Fe, N.M., about how synthetic vitamins are different, their level of awareness among consumers and whether development can be stopped or slowed down. Read more→REGULATORY COMPLIANCE Understanding how FDA approaches inspectionscan raise complianceNutraingredients-usa.com Knowing the other team’s game plan can help ensure victory, and this opportunity is open to dietary supplement companies when it comes to GMP compliance, according to UNPA’s Larisa Pavlick, VP of Global Regulatory and Compliance, and a former FDA inspector. Most warning letters, she says, mention some combination of the following: lack of specification, lack of identity tests and deficiencies in manufacturing and batch reduction records. Pavlick notes that a publicly available document is the typical road map for how inspections are conducted, and companies shouldn’t spend time guessing about it. All of these issues will be covered in UNPA's upcoming GMP training in Provo, Utah,June 27-28. Read more→LEGISLATIVE Jarrow challenges FDA position on probiotics in NDI guidanceNutraingredients-usa.com Supplement manufacturer Jarrow Formulas has filed a lengthy comment challenging FDA’s position on probiotics as outlined in the most recent Revised Draft Guidance on New Dietary Ingredients. The comments join similarly weighty comments, noting specific concerns that the guidance seeks to limit what qualifies as a probiotic by restricting the variety of probiotics. The comments note that because the FDA has not defined probiotics is not a reason to limit their development. Read more→ADULTERATION Adulterants programpublishes new guidance on grapefruit seed extractAmerican Botanical Council The nonprofit ABC-AHP-NCNPR Botanical Adulterants Program announced the release of a new Laboratory Guidance Document on grapefruit (Citrus paradisi) seed extract (GFSE). The guidance is the third publication from the program dealing with the adulteration of GFSE. The new guidance is the first-ever detailed review of currently available laboratory analytical methods to identify synthetic antimicrobial compounds in products labeled to contain GFSE. GFSEs, which have no known history of use in traditional herbal medicine, are marketed as dietary supplements with antimicrobial activity and as a natural preservative for personal care and cosmetic products. Read more→LEGAL USP Labs fights DOJ on DSHEA specificsNaturalProductsINSIDER In 2015, the Department of Justice announced a criminal prosecution in Texas as part of a widespread crackdown against unlawful activity in the dietary supplement industry. Now, federal prosecutors and defense attorneys in the case are divided over what’s required to establish that a dietary supplement is unlawful or “adulterated." Lawyers for the defense of USP Labs, distributor of OxyElite Pro, linked to a hepatitis outbreak in Hawaii, suggest that FDA must go through a rulemaking to show a supplement poses a significant risk of illness or injury. Government lawyers counter a rulemaking is not necessary before the DOJ may enforce DSHEA. Read more→GLOBAL REGULATORY EU work on botanical health claims may finally move forwardNutraingredients.com European Commission work to achieve botanical health claims may finally be on track after a seven year delay, with a number of public and industry consultations reaching conclusions. The resulting feedback will form the basis for recommendations expected by year end. Read more→ BUSINESS STRATEGY/FINANCES Investor: Whole Foods' ‘foodie' fans key to turnaroundBloomberg.com Whole Foods Market, facing pressure from restless shareholders after nearly two years of sliding sales, still has cachet in New York and other pockets of the U.S. That unique foodie appeal is key to its turnaround, if CEO John Mackey is able to improve operations, according toCharles Kantor, a managing director at Neuberger Berman, one of the grocery chain’s 10 biggest investors. Read more→SUPPLY CHAIN New Zealand partnership to fast track new ingredientsNutraingredients.com A new collaboration between ingredient supplier Anagenix and Plant & Food Research, a New Zealand Crown Research Institute, will see products based on New Zealand science fast-tracked to the international market. The two organizations have formed The Innovation Cell, using a new business model to launch ingredients into products at an early market stage. Read more→UNPA MEMBER NEWS NOW attributes success to early commitment to valueKOLO TV Thirty-three years of consecutive growth were sparked by a customer complaint at a health food store in 1968, according to Now Foods' CEO Jim Emme. When a customer called then-retailer Elwood Richard, the company’s founder,a "dirty robber" for pricing a particular item higher than a nearby competitor, hedecided to create his own line of products that were affordably priced. Today,NOW Foods doesannual sales of about $400 million. Read more→MARKET RESEARCH Functional foods gain on OTC digestive remedies; plant-based ingredients driving natural beauty growthNutraingredients-usa.com, Fast Company The convergence of Americans’ increasingly sedentary work life and lifestyle and their demand for decadent food is providing an opportunity for digestive supplements and fortified foods to edge out over-the-counter treatments that come with unwanted side effects, according to research from Euromonitor. As more consumersshun chemical-filled cosmetics in favor of plant-based alternatives, opportunity grows for companies in the better-beauty category, and those looking to get into it. The segment is expected to reach sales of $13.2 billion by 2018. Read coverage: Functional foods gain traction as alternatives to OTC digestive aids→ What’s driving the billion-dollar natural beauty movement?→RESEARCH Vitamin D, calcium fight menopausal onset; D in pregnancy reduces kids asthma; ashwagandha aids the brain; chondroitin equals drug for arthritis; K2, policosanol for statin usersNutraingredients.com, Nutraingredients-usa.com, Nutritional Outlook Taking high doses of dietary vitamin D and calcium may be linked to a lower risk of early menopause, as the findings could help in reducing health problems associated with this period, according to a University of Massachusetts analysis. Researchers at King’s College London have found that increased vitamin D supplementation during the second and third trimesters of pregnancy has been shown to benefit the immune system of babies, resulting in decreased development of asthma. Mild cognitive impairment (MCI) is often an early indicator of Alzheimer’s disease. In a study, published in theJournal of Dietary Supplements, researchers found that ashwagandha root may improve memory as well as executive function, attention and information-processing speed in subjects with MCI. High-quality chondroitin sulfate supplementation is as good as a widely prescribed non-steroidal anti-inflammatory drug for the treatment of painful knee osteoarthritis, according to new research from the Annals of Rheumatic Diseases. A policosanol derivative teamed with vitamin K2 was found to be effective in lowering cardiovascular disease risk markers in a large scale study conducted in Serbia. Read coverage: Vitamin D and calcium may reduce onset of early menopause: Study→ Vitamin D during pregnancy could reduce childhood asthma risk: Study→ Ashwagandha root may improve memory and cognitive function in subjects with mild cognitive impairment→ Chondrotin sulfate as good as widely used anti-inflammatory drug for knee osteoarthritis: Study→ Policosoanol fraction, vitamin K combo helps statin users in study→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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