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TOP STORY FDA's FSMA enforcement delay: impact to industry Nutraingredients-usa.com, Project NOSH FDA announced last week that it will not actively enforce certain areas of the Food Safety Modernization Act (FSMA). FDA said it decided to make changes after receiving feedback about the complexity of complying with some of the act’s rules. The new guidance summarizes that the agency will use discretion when enforcing specific provisions in four FSMA rules, including the Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food rule, and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule. Read coverage: FDA to delay enforcement on four FSMA rules→ What FSMA changes mean for CPG→ UNPA NEWS
Registration now open for UNPA FSVP training, Feb. 28-March 1, in Sandy, UtahThis course is designed to help participants understand the role of food importers under the new Foreign Supplier Verification Programs (FSVP) rule, part of the Food Safety Modernization Act (FSMA). Foods covered under the new rule include dietary ingredients, raw materials used in dietary supplements and natural products marketed with a Nutrtion Facts panel as a food product. The course will focus on the expectations of the new rule and will explain the requirements of importers. Many importers are already outside of compliance with this law, published in 2015. Only 27 seats available! Sponsorships for 2018 UNPA Retreat are now availableSponsorships for the 2018 UNPA Members' Retreat, to be held in Park City/Deer Valley, Utah, May 8-10, are now available. Sponsorships are an effective way to support UNPA, increase your company’s visibility and get your products and services in front of a highly desirable and targeted audience: the UNPA membership. For more information, contact Kira Olsen, 801.474.2572, x107. Recently posted at unpa.com:
FDA disallows medical food positioning on osteoarthritis productFDA has branded one of medical food specialist Primus Pharmaceuticals’ products as an unapproved new drug and has stipulated a recall based on what it called life-threatening safety concerns. What FDA's new definition of dietary fiber means for the food industryThe rule includes numerous updates, like the introduction of a regulatory definition for “dietary fiber” and an increase of its daily reference value (DRV) from 25 to 28 g. Many food manufacturers will need to adjust the fiber DRV listed on their labeling to comply with these changes, so it is prudent to understand what the regulations entail. Justice Department issues memo on marijuana enforcement/Deputy AG Rod Rosenstein discusses rule of lawThe Department of Justice has issued a memo on federal marijuana enforcement policy announcing a return to the rule of law and the rescission of previous guidance documents. In a recent speech, Deputy Attorney General Rod Rosenstein discussed the importance of the rule of law and how the American constitutional structure promotes it. Sessions opens door for stepped up cannabis enforcement; effect on CBD sphere unclearA move announced by U.S. Attorney General Jeff Sessions to allow federal prosecutors to pursue marijuana enforcement cases further unsettles the regulatory underpinning for those companies seeking to use hemp derivatives for nutritional products.MLMs Avon expanding into health and wellness with supplement lineEspira is a new line of supplements from beauty brand Avon. It includes products for sleep, energy, metabolism and food cravings, as well as a plant-based protein powder.M&A ACTIVITY Firmenich to acquire organic flavor companySwiss-based flavors and fragrance firm Firmenich S.A. has entered into an agreement to acquire Natural Flavors Inc., based in Newark, N.J., a manufacturer of flavors that are USDA certified as organic. Terms of the acquisition were not announced. Private investment firm LeBaronBrown Industries acquires majority interest in AICThe firm acquired a majority interest in Massachusetts-based American International Chemical Inc. for an undisclosed sum. The company’s portfolio of ingredients ranges from botanicals to carotenoids and fibers.GLOBAL REGULATORY Novel silicon gains EFSA approval for food supplement useThe European Food and Safety Authority has authorized the use of Orthosilicic acid-vanillin complex as a safe source of silicon for food supplements. Panel gives companies two weeks to submit data for India’s new ingredients listSupplement and functional food manufacturers have two weeks to submit scientific data to get 34 ingredients currently used in products—including kale powder, plant-sourced vitamin D and kiwi extract—on India’s approved list.RETAIL Whole Foods places new merchandising limits on suppliersSmall vendors are already feeling the effects of Amazon’s acquisition of Whole Foods Market, which is reportedly requiring vendors to work with Daymon, a retail strategy firm, on all in-store demos, inventory and displays. The retailer is requiring suppliers that sell more than $300,000 of goods per year to discount their products to fund this new program. Kroger fuels growth of Simple TruthKroger announced the expansion of its Simple Truth private brandand launch of its largest-everprivate brand sales promotion, featuring savings on thousands of Simple Truth and Simple Truth Organic items.The company said third-quarter sales of Simple Truth products grew 19 percent, generating $16 billion in 2016. Sprouts boosts expansion of CarolinasSprouts Farmers Market said it will expand to the fast-growing Charlotte, N.C., market in April, followed by its first South Carolina location in June.OMEGA-3s Adam Ismail announces departure from GOEDAdam Ismail, the executive director of GOED since 2007, has decided to take a new position outside of the association. In a statement to GOED members, he said the new role will still be within the omega-3 industry.Innovating on sustainability and whole foods in omegasCompanies expand targeted nutrients beyond fats (and sources beyond fish) as they build a sustainable omega market.APAC MARKET The analyst’s take: Supplement sales in ChinaNutrition Business Journal’s senior analyst Claire Morton provides insight on China's supplements market: complex and ripe with opportunity.BOTANICALS Endocannabinoid claims, climate change, adulteration progess: What to look for in 2018Climate change, enthusiasm about the endocannabinoid system and the emergence of a Mexican blood-sugar-control ingredient are among the things that will characterize the botanical industry, according to ABC founder Mark Blumenthal. The 'Shroom Boom: Will trendy medicinal mushrooms go mainstream in 2018?Medicinal mushrooms long used in Asian cultures for boosting immunity, energy and overall health are now infiltrating the American mainstream market, with experts estimating that the market will exceed $50 billion in the next six years. Botanical adulterants program changes nameThe American Botanical Council (ABC) announced a change in the name of the ABC-AHP-NCNPR Botanical Adulterants Program. Effective immediately, the program will be known as the ABC-AHP-NCNPR Botanical Adulterants Prevention Program. The new name incorporates "prevention" to emphasize the program's goal and purpose.ORGANIC Organic Center responds to op-ed ‘Avoiding GMOs isn’t just anti-science, it’s immoral’In his op-ed published in the Washington Post, Mitch Daniels would have you believe that scientific research finds only benefits and no downsides to genetically engineered crops. The reality is not so.GMOs Interagency task force on rural prosperity omits organics in recommendations to improve prosperityThe U.S. Department of Agriculture (USDA) released itsRural Prosperity Task Force, a summary of recommendations to help improve life in rural America. The report urges acceptance of biotech products. However, organics was not included among the recommendations. These are not your father’s GMOsThe U.S. Department of Agriculture has concluded that new plants utilizing gene editing—often referred to as "GMO 2.0"—are not “regulated articles.” The reason is a legal loophole: USDA regulations apply only to GMOs constructed using plant pathogens such as bacteria, or their DNA.UNPA MEMBER NEWS Thorne continues push on testing front with deal to develop AI bioinformatics platformPractitioner channel specialist Thorne Research has teamed with two bioinformatics experts to found Pillar Health with a plan to create an artificial intelligence wellness platform that will provide an integrated molecular portrait and customized recommendations for individual health. Thorne adds training firm as sports nutrition partnerThorne Research has upped it game in sports nutrition via a partnership with training firm ALTIS. Amin Talati expands in Washington D.C. with addition of advertising, marketing attorneyAs a new partner, Katie Bond brings years of experience at leading law firms, where she has become the go-to attorney for many of world’s most innovative food, nutritional supplement, drug and cosmetic companies. NOW celebrates 50 years by saying thanks with $500,000 instant win gameThe company is saying “thank you” to everyone who has made NOW a trusted partner in their wellness journey by launching the “Celebrate NOW” Instant-Win Game, where consumers will have a chance to win 50 $10,000 cash prizes. Sabinsa launches video ‘Quality Ingredients: The power of relationships’Bringing quality ingredients to market is about source and science, but ultimately comes down to relationships with all stakeholders. Sabinsa’s commitments are evident here. Nature’s Way launches new single herb powder lineNature's Way Brands has introduced a new line of Single Herb Powders made with premium, dried herbs. The full line includes three herbal powders, selected for their unique health properties: Standardized Turmeric Powder to support joint health; Beet (Beta vulgaris) Root Powder, containing sugars and starches that make it a source of energy; and Activated Coconut Charcoal Powder for internal cleansing.INNOVATION New sugar replacer could be a game changerThe developers of HEYLO, a patented combination of acacia fiber and stevia promising to "blow rivals out of the water" in the sugar-replacement stakes, say the ingredient could actually be a game changer.Swallowable sensors could revolutionize understanding of nutrition’s impact on gut healthA breakthrough swallowable capsule could revolutionize understanding of the gut microbiome, and the role nutrition can play in modulating it.MARKET RESEARCH Eight ingredient surprises of 2017Over the past 12 months, the supplements industry has witnessed sizable shifts in which health-and-wellness ingredients are hot, which are not and which are just waiting to be discovered, according to researchers at SPINS, who point to ingredients for which 2017 sales data tells a deeper story. Takes a look a protein, bee products and Nigella seed, among others. Food values, technological innovations and savvy consumers fuel U.S. nutrition trendsFood waste, digital and online innovations, and consumer values are expected to drive some of the major food and nutrition trends in 2018, according to the International Food Information Council (IFIC) Foundation.RESEARCH Higher prenatal choline intake could improve brain function in infantsAccording to research recently conducted at Cornell University, pregnant women need two times more choline than currently recommended, particularly in the last trimester, to achieve optimal cognitive benefits for their children. Multivitamin plus omega-3s may be safe, economical and effective means of lowering diabetes riskPeople at high risk of developing diabetes may benefit from combined supplementation with multivitamins with omega-3s, according to a new study from researchers in Canada. Long-term melatonin supplementation could benefit those with high cholesterol: Iran reviewSupplementation with sufficient melatonin for at least eight weeks may lower cholesterol levels, researchers in Iran say. Omega-3s and heart rate: Meta-analysis provides strong clinical evidence for benefitsData from 51 randomized controlled trials support theability of omega-3s EPA and DHA to reduce heart rate, report researchers from Soochow University (China) and DSM Nutritional Products. High dose vitamin D: The remedy for stiff arteriesLarge doses of vitamin D could rapidly reduce arterial stiffness, according to a new study in Plos One. Study examines carotenoid concentrations and risk for diabetes mellitus, diabetes retinopathySerum β-carotene and α-carotene have been found to be associated in protection from diabetes mellitus (DM) and diabetes retinopathy (DR) respectively, according to a new cross-sectional study published in Current Molecular Medicine.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. Search and sign up for a variety of FDA Guidances. Comments are closed.
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