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TOP STORY FDA releases draft guidance for intentional adulteration rule FDA released the first of three installments of a draft guidance document designed to support compliance with the Intentional Adulteration Rule under the Food Safety Modernization Act. The FSMA final rule on intentional adulteration is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to public health. The remaining two installments are expected to come out later this year. Read more→ UNPA NEWS
FSVP training in Sandy, Utah, Sept. 20-21If you import ingredients for food or dietary supplement use, click on the link above to see if you should attend this FSMA-based training session to ensure regulatory compliance! This two-day training will be held Sept. 20-21 in Sandy, Utah. Just published! The 2Q18 UNPA Asia ReportThe 2Q18 issue of the UNPA Asia Report, a 16-page mini-magazine published in Asiaceutical Insights, distributed in China and Asia, is now available for viewing and downloading. Recently posted at unpa.com:
REGULATORY FDA unveils dietary fibers guidance: Good news for inulin, polydextrose, some gray areas remainLong-awaited guidance from FDA, spelling out which isolated or synthetic non-digestible carbohydrates it believes should be classified as dietary fiber on the Nutrition Facts Panel, brings to an end a period of extended uncertainty for companies supplying widely used ingredients from inulin to polydextrose. FDA announces public meeting to discuss food producedusing animal cell-culture technologyFDA announced it will hold a public meeting to discuss foods produced using animal cell-culture technology on July 12 in College Park, Md. In a statement, FDA noted that these technologies could offer certain new opportunities over conventionally developed food products, but they also note the dynamic space raises many questions. Proposed OEHHA regulation clarifies that cancer warnings are not required for coffee under Prop 65The California Office of Environmental Health Hazard Assessment proposed a new regulation clarifying that cancer warnings are not required for coffee under Proposition 65. The proposed regulation states that drinking coffee does not pose a significant cancer risk, despite the presence of chemicals created during the roasting and brewing process. Tax on weight-loss dietary supplement could restrict consumer accessCRN pushed back on conclusions from a recent study indicating that a 20-percent tax on weight-loss dietary supplements could reduce purchases of “potentially dangerous diet pills” that the study authors say contribute to eating disorders and body dysmorphia in teens.LEGAL U.S. ruling on vitamin C price fixing could exacerbate trade tensions with ChinaA Supreme Court decision on a longstanding vitamin C price-fixing case could further inflame trade tensions with China, according to Scott Steinford, principal of Trust Transparency Consulting and executive director of both the CoQ10 Association and the Natural Algae Astaxanthin Association.M&A ACTIVITY IMCD to acquire E.T. Horn CompanyIMCD, N.V., a Netherlands-based distributor of specialty chemicals and food ingredients, has signed an agreement to acquire 100 percent of the outstanding shares of E.T. Horn Company. According to the companies, Horn aligns well with IMCD's U.S. activities and supports the strategy of offering an organization with national U.S. coverage and dedicated segment expertise. GoodBelly lands $12 million round, led by 301 Inc.NextFoods Inc., the producer of GoodBelly Probiotics, announced the close of a $12 million round of funding led by 301 Inc, the venture arm of General Mills. Previous investor Emil Capital Partners also took part in the round.TRADE U.S., China trade war is bad news for consumersPresident Trump's threat to impose tariffs on an additional$200 billion in Chinese goods, followed by Beijing'sswift vow to retaliate, has jangled investor nerves and elicited concern from a range of industries. But the biggest losers in a full-blown trade war would likely be American consumers.ORGANIC Canada announced deadline for compliance of revised Canadian organic standardsRevised Organic Products Regulations impact certification management and audit standards and permitted substances. Previously certified operators must be able to demonstrate conformity to the new requirements by April 12, 2019.CBD/HEMP/CANNABIS FTC official signals CBD not an enforcement prioritySpeaking during a recent event, FTC official Richard Cleland suggested his employer doesn’t concern itself with the regulatory classification of a substance like CBD. Colorado’s Hemp Food law could serve as a template for other statesSources that lobbied for a hemp foods bill signed in May by Colorado Governor John Hickenlooper said the new law is a landmark achievement and could serve as a template for hemp legislation in other states. Canada legalizes recreational cannabis useCanada's parliament has passed a law legalizing the recreational use of marijuana nationwide, starting in October 2018. The bill controls and regulates how the drug can be grown, distributed and sold.PARTNERHIPS DuPont’s Microbiome Venture membership swells to three with INRA confirmedDuPont Nutrition & Health continue to add to its Microbiome Venture ranks with the French National Institute for Agricultural Research’s (INRA) metagenomics expertise now on board as a member.GLOBAL REGULATORY U.K. government agency warns public to remain vigilant over rogue supplement firmsThe U.K. government has revealed that its research shows that roughly 36,000 "victims" have been duped by "rogue supplement firms" since 2016, cheating them out of an estimated €12.1 million. Swisse on policy: Why regulatory equivalence, not harmonization, may be the best approachIndustry needs to better strive for regulatory equivalence across Asia, and indeed globally, while also educating policymakers that the fast-paced industry can no longer be governed by rules that are 20 or 30 years old. ESSNA: Education key to exposing sports nutrition charlatansThere is no place in the legitimate sports nutrition world for banned substances, such as methylhexanamine (DMAA), sold by companies that prey on the public’s perceived lack of knowledge, according to the European Specialist Sports Nutrition Alliance, in response to findings from the U.K.’s anti-doping survey.BOTANICALS Equating bitter orange extract with ephedra just 'an old wives tale,' researcher saysA researcher with long experience in p-synephrine, the active ingredient in bitter orange extract, says he’s frustrated with the intransigence of certain authorities, who deem the ingredient unsafe because of a superficial chemical resemblance to the banned substance ephedra. Study highlights progress in turmeric supplement quality, but concerns around synthetic curcumin adulterationA new analysis of 87 different turmeric dietary supplements has highlighted the diversity of available products and the challenges this gives consumers. Concerns were also raised around potential adulteration with synthetic curcumin.PROBIOTICS IPA manufacturing guidelines to drive probiotics companies towards optimal practicesSoon-to-be-released guidelines for contract manufacturing organizations and quality standards from the International Probiotics Association will drive the industry to optimal practice, says IPA’s VP Kevin Mehring of UAS Labs.CERTIFICATIONS CRO launches certification to vet quality of claims validationGlobal Clinicals, a contract research organization based in Los Angeles, has launched a certification that the founder says will help companies differentiate themselves based on the quality of the research that backs the claims they make on their products.E-COMMERCE Supplement subscriptions: Five things you need to know about subscription lawsFrom clear information on how to cancel to sending confirmations that consumers can keep, here are some things to know if you are in the online subscription business.UNPA MEMBER NEWS Omniactive’s specialty botanicals and extracts facility in Hosur, India, receives GMP registration from NSFOmniActive Health Technologies’ Hosur, India, specialty botanicals and extracts division has earned Good Manufacturing Practices registration from NSF International. The plant manufactures natural extracts, including green coffee, valerian, turmeric, green tea, boswellia, fenugreek and guarana, among other ingredients.CLINICAL STUDIES Maximizing investment in clinical researchWhen considering a clinical study, utilizing well-defined approaches can minimize study risks and maximize returns on investment.INNOVATION Could an algorithm personalize caffeine intake and optimize alertness?A new algorithm that works out the ideal caffeine dosage and timing for optimal alertness could form the basis of personalized caffeine consumption guidance. Plasma protein startup adds new study to back its claims for better absorption than normal wheyBlood analysis of participants, who ingested either “plasma-blasted” whey or standard hydrolyzed whey protein isolate, suggests that the former is more bioavailable.PERSONALIZED NUTRITION Nestlé signals personalized nutrition priority in Japan with launch of new DNA testing platformNestlé Japan has announced plans to branch out from the food and beverage business into healthcare, with personalized nutrition and aged care a prominent feature of the shift.MARKET RESEARCH JAMA Pediatrics: A third of children use alternative medicinesOne-third of children under the age of 19 regularly use dietary supplements or alternative medicines, according to anew study published in JAMA Pediatrics,using data from the National Health and Nutrition Examination Survey. Researchers found that multivitamins were the most common supplements, followed by vitamin C, omega-3 fatty acids, vitamin D and melatonin. Responding to the research letter,CRN’s Steve Mister noted that the study is innocuous in its main findings but suspect in its offhanded conclusions. South American consumers are willing to pay more for proteinNearly two-thirds of shoppers in South America are willing to pay extra for a food or beverage productthat is higher in protein, according to a survey commissioned by Arla Food Ingredients.RESEARCH Untapped potential: Mushroom beta-glucans backed for bright functional futureWhile beta-glucans from other food sources are well known, mushrooms may "provide a unique opportunity" for the discovery of novel bioactives with functional food potential, say researchers from the University of Kashmir in India. Higher vitamin D levels associated with lower risk of breast cancerHigher levels of vitamin D were associated with decreased risk of breast cancer, according to an epidemiological study published in the June 15 online issue of PLOS ONE. Adolescent clinical study using affron shows benefts for anxiety, depressive symptomsA new extract obtained from saffron stigmas,affron, by Pharmactive Biotech Products, has recently been clinically shown to improve anxiety and depressive symptoms in youth with mild-to-moderate symptoms. Study demonstrates protein is critical to weight loss and maintenanceThe ability to lose weight and keep it off was the central focus of a health- and wellness-focused collaborative study led by researchers from the University of Colorado Anschutz Medical Campus with support from DuPont Nutrition & Health. The results showed that both groups who were prescribed a high protein, energy-restricted diet lost similar and significant amounts of body weight. Does vitamin D really protect against colorectal cancer?A large international study provides the strongest evidence yet that vitamin D may indeed be protective against colorectal cancer and that a deficiency may increase the risk of this cancer. The findings appeared in the Journal of the National Cancer Institute. Vitamin D deficiency tied to obesityA recent study suggests a possible role for vitamin D in abdominal fat storage and function, according to researchers in the Netherlands.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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