Warning letter to Utah firm highlights contract manufacturing, FSMA questions
A warning letter sent to Biotek Inc., of Layton, Utah, by FDA lists various GMP violations, including a lack of allergen warnings, something that will only accelerate as FSMA implementation goes into full swing. UNPA’s Larisa Pavlick, VP, global regulatory and compliance, notes that supplement companies must identify and control for allergens as a part of their preventive programs. Read more→
PCQI training in Lehi, Utah, June 5-7It's the last scheduled UNPA PCQI training of 2018! Registration is open for the June 5-7 training in Lehi, Utah, which meets FDA's PCQI training requirements. Learn who must comply, course agenda and additional information at the UNPA website.
UNPA Asia Report: Building lab capacity to ensure product safety, quality and efficacyThe nature of dietary supplement product development is more complex than ever. In a recent UNPA Asia Report, a profile of UNPA member company Waters Corp. outlines the importance of state-of-the-art analytical technologies for drug discovery, quality control of raw materials, and verification of label claims.
UNPA Expert Insights webinar: Raw Material Testing with IR/Heavy Metal TestingNEW! Join Douglas Townsend as he discussesthe principles behind Fourier transform infrared spectroscopy and how to build robust methods for raw material identification of simple and complex substances. The infrared spectroscopy solution is simple to implement, easy to use and powerful enough to keep up with changing regulatory environments and the dynamic world of raw material sourcing.Sponsored by PerkinElmer.
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DSM petitions FDA to allow simpler vitamin names on packDSM Nutritional Products filed a citizen petition with FDA, suggesting an amendment to allow brands to use simpler vitamin names on pack instead of chemical nomenclature, in an effort to appease consumers looking for recognizable ingredients.POLICY
Trump’s proposed tariffs hit CoQ10, some vitaminsSome dietary supplement ingredients have landed on President Donald Trump’s list of tariffs on imported Chinese goods. They include CoQ10 and vitamins E, B2 and B12.
Chinese tariff on American ginseng definitely concerning, Wisconsin farmer saysNearly all of the ginseng grown in the U.S. is shipped to China — and almost all of it is grown in Marathon County, Wis., a county that went for President Trump in 2016. One farmer there is calling the tariff very concerning.M&A ACTIVITY
Bayer, Monsanto deal said to clear U.S. justice hurdlesThe Justice Department will allow Bayer AG to acquire Monsanto for more than $60 billion, once the companies sell off some assets, according to a report in the Wall Street Journal. The deal will make it the world’s biggest supplier of pesticides and seeds for farmers.
Natoli acquires Carlisle Precision Machining encapsulationMissouri-based Natoli Engineering Co. said that its acquisition of Carlisle Precision Machining will expand its refurbishment services and enable it to provide its customers with a wider range of custom encapsulation solutions.
Florida court dismisses class action that hinged on NDI status of ingredientA Florida court has dismissed a class-action lawsuit predicated on the presence of an illegal ingredient, DMBA, in weight-loss products. The court didn’t buy the argument that the plaintiffs had been harmed by not knowing the ingredient's impaired regulatory status at the time.ORGANIC
USDA defies advisors, allows carrageenan to keep organic labelThe U.S. Department of Agriculture has decided that organic food companies can keep using an emulsifier called carrageenan in foods, such as ice cream and high-protein drinks, despite a vote by the National Organic Standards Board to ban the ingredient.
Rebel farmers create new organic food labelThe Real Organic Project, a rebellious group of about 15 farmers and scientists from around the country, are creating the standards for an additional organic certification program that would indicate that a plant had been grown in soil, among other policies.MLMs
Thai direct sales industry forecasts 5-percent growthThe Thai Direct Selling Association (TDSA) forecasts the direct sales business this year in Thailand to expand by 5 percent from last year’s figure. The positive growth projection is in line with the trend of economic recovery and the increasing purchasing power from an aging society and health-conscious consumers.GLOBAL REGULATORY
Dutch researchers urge vigilance on pregnancy supplementsWith the use of dietary supplements gaining popularity in pregnant women, researchers warn that current regulations may not take into account longer-term safety and health considerations for the child, adding updated regulations and nutrivigilance schemes could be useful.PRODUCT TESTING
Potency testing could be the supplement industry's next scandalPotency testing for finished products is a regulatory gray area—but meeting label claims is still a requirement. Supplement brands that don't test could chip away at the industry claim of responsibility and self-regulation.
Sprouts Farmers Market ramps up store openingsSprouts currently operates almost 300 stores in 16 states. The planned expansion will bring the grocer into three new states: South Carolina, Pennsylvania and Washington. The company said it plans to open 16 stores by the close of the 2018 first half and to expand its market area to 19 states by the year’s end.
Natural Grocers grows presence in OregonMoving ahead with its expansion, Natural Grocers by Vitamin Cottage plans to open its fifth Portland-area store and 11th in Oregon on April 18.UNPA MEMBER NEWS
Lonza opens next-gen cell-gene therapy manufacturing facilityLonza is opening the world’s largest dedicated cell-and-gene-therapy facility, built in anticipation of rising demand from developers of cell and gene therapies—what it calls the next era in medicine—and with the mission of enabling them to deliver these types of treatments to patients around the world more quickly and efficiently. The state-of-the-art facility will be located in the greater Houston area.
USANA expanding to four new marketsUSANA, the Cellular Nutrition Company, is proud to announce the official opening date of its four new European markets as of June 20, 2018. Since 1992, USANA has grown into to a global health and wellness leader, and the company looks to cement its place in the industry with the upcoming European expansion. The new markets—Romania, Germany, Italy, and Spain—will increase USANA's global footprint to 24 markets worldwide.
Verdure Sciences adopts pomegranate through ABCs Adopt- an-Herb programVerdure Sciences’ adoption of pomegranate supports the American Botanical Council’s extensive HerbMedPro database,ensuring that this essential educational resource remains up to date for researchers,health professionals, industry, students, consumers and other members of the herbal and dietary supplements community.
New egg yolk sports supplement line Yolked gets NSF Certified for SportA new sports nutrition product line made out of fertilized egg yolk by Myos Rens Technology received the Certified for Sport certification from global testing firm NSF International.
Clean label on the rise in sports nutrition supplementsSports supplement users are now looking for everything from the absence of banned substances and artificial ingredients to non-GMO, organic, sustainable and vegetarian formulations.PERSONALIZED MEDICINE
New investment will help Nutrino uncover trends, marketing breaks based on personalized nutritionAnnouncing a successful series A fundraise of $8 milliion, nutrition-related data services and analytics firm Nutrino wants to build “the world’s largest and most adaptable nutrition insights platform,” in part to help manufacturers track trends, test product ideas and understand the competitive landscape.RESEARCH
Low folate and B12 linked to severity of fatty liver diseaseTwo key B vitamins may be linked to the progression of liver fibrosis in non-alcoholic fatty liver disease, say researchers from Israel.
Vitamin D supplementation may improve eczema symptoms, researchers sayReviewing existing studies looking at vitamin D functions in skin physiology, Qatari researchers found mounting evidence that ingesting vitamin D may help improve skin inflammatory symptoms.
Better bioavailabilty: Novel curcumin formulation could overcome absorption issuesThe use of a gamma-cyclodextrin formulation in curcumin supplements could provide a boost to bioavailability, according to researchers from the University of New South Wales, who reported a 39-fold improvement vs. standardized unformulated curcumin.
Clinical trial supports assimilation of magnesium from Jigsaw Health’s MagSRTDaily supplementation with MagSRT improved serum magnesium levels by 22 percent and reduced magnesium deficiency symptoms by 63 percent, according to a recent clinical trial published in the Journal of the American College of Nutrition.
Study links astaxanthin and sesamin supplement to reduced mental fatigueThe combination of astaxanthin and sesamin may help promote recovery from mental and physical fatigue, according to a study from Tohoku University in Sendai, Japan.
Anthocyanins from berries linked to possible cancer treatmentNaturally occurring pigments in berries, also known as anthocyanins, increase the function of the sirtuin six enzyme in cancer cells, a new study from the University of Eastern Finland shows. The regulation of this enzyme could open up new avenues for cancer treatment.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.
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