FDA data indicates improved compliance as more NDINs accepted

​REGULATORY
FDA data indicates improved compliance as more NDINs accepted
Natural Products INSIDER
​Among the companies that submitted new dietary ingredient notifications (NDINs) to federal regulators since 2014, fewer have been rejected, suggesting increased compliance with a safety-related notification requirement in DSHEA. According to data collected by FDA, the percentage of companies that received 'no objection' to their NDINs doubled between 2014 and 2016. UNPA’s Loren Israelsen said the figures indicate progress and suggested that FDA has also gotten better at helping companies navigate the NDI process. Read more→

UNPA NEWS
Only 10 seats left! UNPA's PCQI training in Salt Lake City next week
"Preventive Controls Workshop for Food and Dietary Supplements: PCQI Training for Food and Dietary Supplement Companies," July 17-19, Salt Lake City—very limited seating available.

NEW! Registration now open for UNPA PCQI training in Boulder, Colo.,Aug. 16-18
"Preventive Controls Workshop for Food and Dietary Supplements: PCQI Training for Food and Dietary Supplement Companies," Aug. 16-18, Boulder, Colo. Registration now open!

New Prop 65 insurance policies available
Life Science Risk has unveiled new Proposition 65 liability insurance for dietary supplement/ingredient manufacturers, distributors and formulators, with up to $1 million in coverage caps. View information here or contact Dick Griffin,916.434.8874.

NEW! New UNPA member discounts
See "UNPA Member Discounts" in the right column for new discount offers from NBJ and The Journal of Alternative and Complementary Medicine.

Recently posted at unpa.com:
NEW! "Who's your PCQI? An introduction to PCQI."
NEW! PCQI FAQs
2017 UNPA Members' Retreat coverage, including podcasts from UNPA member executives
UNPA Saves Stark Steering Sign in Sugar House
UNPA endorses the CRN OWL program (log in required)
A new language converter has been installed on a number of pages of the UNPA website. Check it out in the upper left corner!
The presentations and videos from the 2017 UNPA Members' Retreat are now available for viewing/downloading.(log in)
UNPA comments on FDA official's assertion that serious adverse events are going unreported. (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)
Plus, updated industry events calendar,Member Memos (log in) and UNPA educational archives (log in).REGULATORY
FDA warnings still center on ingredient origins, but sports nutrition also a focusNutraingredients-usa.com
Recent warning letters from FDA continued to hone in on provenance of ingredients and demonstrate that the pace of enforcement remains unchanged, despite the Trump administration’s attempts to roll back regulations. Recent warning letters also show an emphasis on sports nutrition products. Read more→M&A ACTIVITY
Lonza finalizes $5.5 billion Capsugel purchaseNutraingredients-usa.com
Swiss-based Lonza has completed its acquisition of Capsugel S.A. from KKR after receiving all the required regulatory approvals. The acquisition aligns with Lonza’s strategy to accelerate growth and deliver value along the health care continuum. Read more→PRODUCT TESTING
Harvard, NCNPR study finds range of monacolin Kin red yeast rice products; Labdoor tests probiotics for kidsNaturalProductsINSIDER, Nutraceuticals World
Red yeast rice product research published in June, from Harvard Medical School’s Pieter Cohen, M.D., and his colleagues from the University of Mississippi’s NCNPR analyzed red yeast rice supplements and found 26 brands contained monacolin K, a compound FDA has ruled is the same as lovastatin. Amounts of the substance found were wide ranging. In other product testing, Labdoor has unveiled its new rankings for children's probiotics. Products were tested for beneficial bacteria and contaminants and then compared with the latest medical research to provide guidance to consumers and health professionals. Read coverage:
Researchers find range of monacolin K in red yeast rice supplements→
Children’s probiotics tested by Labdoor→GMOs
USDA plans to publish draft GMO labeling rule this fall; comment period endsJuly 17Foodnavigator-usa.com
USDA has announced it will publish a draft of its proposed federal GMO labeling rule in the fall of this year, which will be subject to public comment. Although no compliance date is yet set, the agency says it is working to meet the schedule in order to issue a final rule on the law in July 2018. USDA is accepting comments on GMO labeling through July 17. Comment via a link from the Environmental Working Group. Read more→LEGAL
DEA claims hemp industry suit challenging marijuana ruling illegalNaturalProductsINSIDER
Contending that the Hemp Industry Association and industry stakeholders didn’t have the right to file the lawsuit in the first place, DEA wants to dismiss the suit challenging the marijuana extract rule. DOJ lawyers say the law inflicts no injury on the petitioners but simply adjusts DEA’s administrative methods. Read more→UNPA MEMBER NEWS
Shaheen Majeed to lead Sabinsa WorldWide; Sabinsa concludes patent case with Aegle BiosNutraceuticals World
Shaheen Majeed has been promoted to president of Sabinsa Worldwide, taking over responsibility for manufacturing, marketing, strategies and other operational matters. Most recently, Majeed served as the company’s marketing director, but he has been involved in nearly every aspect of the Sami Labs / Sabinsa Group of companies during his 23 years with the company. In other news, Sabinsa has successfully concluded its patent infringement lawsuit against Aegle Bios Inc., with a final consent judgment filed in U.S. District Court last month. The suit charged Aegle with willful infringement of Sabinsa’s curcumin patent protecting its methods and formulations for tetrahydrocurcuminoids. Read coverage:
Shaheen Majeed named president of Sabinsa Worldwide→
Sabinsa continues to protect Curcumin C3 reduct technology→CRB's Construction Services Group named a top contractor byEngineering News-RecordEngineering News-Record
CRB's Construction Services Group has been ranked 12thamong top contractors in the Industrial sector byEngineering News-Record. ENR releases an annual list of its Top 20 Contractors by market sector. CRB also announced that its Construction Services Group climbed 67 spots to #268 on ENR’s 2017 Top 400 Contractors list. The prestigious list is based on annual construction revenue of the top 400 publicly and privately-held general contractors. The company says the rankings reflect CRB’s commitment to providing fully integrated and best-in-class construction management services to its life sciences and advanced-technology clients. Read more→

Study shows OmniActive’s Lutemax 2020 protects visual health; OmniActive announces Asian expansion plansNew Hope Network, Nutraingredients-asia.com
The macular carotenoids lutein and zeaxanthin may protect eyes from prolonged use of digital screens, according to a new study conducted with Lutemax 2020 ingredient from OmniActive Health Technologies. It is the first study to examine the effectof macular carotenoids supplementation to protect visual health and performance, reduce eye strain and fatigue and improve sleep quality, during prolonged exposure to blue light emitting from digital screens. OmniActive also has signaled its intention to aggressively expand across the Asia Pacific region, with new plans to open an office in Singapore and increase its business in the region from 5 percent to 30 percent in the next five years. Read coverage:
Eye strain from reading screens all day? Natural help is here: Study→
OmniActive targets six fold increase in APAC business, continues acquisition hunt→PEOPLE NEWS
Len Monheit joins Trust Transparency ConsultingTrust Transparency Consulting
Trust Transparency Consulting has announced the addition of Len Monheit as its co-managing partner. Monheit joins the company from William Reed Business Media, where he served as general manager for North America. He will lead Trust Transparency’s single- ingredient trade association program. Company website→GLOBAL REGULATORY
Italian decree could make Belfrit list of botanicals EU law; TGA to oversee supplement ad complaintsNutraingredients.com, Nutraingredients-asia.com
Italy has published a final decree which could bring a consolidated ‘Belfrit list’ of botanicals into full European law as early as this autumn. In Australia, the Therapeutic Goods Administration has announced it will become the sole overseer of complaints about supplement advertising starting next year. The current system has been deemed too complex for consumers and business to navigate. Read coverage:
Italy set to put Belfrit into law with final botanicals list and degree→
Australian regulator to take sole control of supplements advertising complaints regime→
BOTANICAL INNOVATION
Australia funds partnership to develop native botanicals for indigenous groupsNutraingredients-asia.com
The nutritional profile and bioactive compounds of Aboriginal food plants will be assessed as part of a major research partnership between the University of Adelaide and The ORANA Foundation to support development of the Australian native food industry. Funded with a grant from the South Australian government, the partnership aims to research and cultivate native ingredients for the benefit of indigenous communities. Read more→INNOVATION
Scientists debut fermentation process to produce natural red food colorsNutraingredients-usa.com
Microbes can convert sugar into the red anthocyanin pigments found in fruits via a fermentation process that – when perfected – could prove to be much more efficient than extracting commercial quantities of these pigments from plants, claim researchers at Rensselaer Polytechnic Institute in New York. Read more→MARKETING
Understanding Gen Z consumers; new age of digital discounting is hereMediaPost
With 84.7 million kids born between 1996 and 2010, there is no doubt that Gen Z will have enormous spending power. Learn ways to better serve this high-spending demographic. The days of clipping coupons in the kitchen are over as methods for coupon usage moves into the digital age. According to the recent Coupon Intelligence Report, consumers who prefer to receive discounts on their smart phone or mobile device have increased 33 percent since 2016. And retailers are jumping in to make it easier. Read coverage:
How to get Generation Z to jump onto your brand→
Couponing in the digital age→MARKET RESEARCH
Millennials break health myths; China's probiotics market soaring; microbiome segment to triple; choline bolsters eye health categoryForbes, Nutraingredients.com, NaturalProductsINSIDER
The millennial shift toward taking their health into their own hands has ushered in an era of innovation in wellness—take Fitbit and the rise of natural foods as evidence. According to a study from Communispace, less than two-thirds of millennials see a primary care doctor.The probiotics sector is forecast to soar by 23 percent in China by 2020 and even greater long-term growth beckons if the industry unites to better educate consumers and regulators, according to International Probiotics Association director George Paraskevakos. The global microbiome market is forecast to nearly triple in size to $500 million by 2022, according to a new market report from EU venture capitalist company Seventure Partners. The study pinpoints France, the U.S. and Israel as market leaders. The eye health segment appears to be undergoing a solid resurgence over the past few years as data from Innova Market Insights notes that “vision" claims more than doubled from 2015 to 2016, and remain on pace for 2017. Choline will bolster the space as awareness grows that optimal eye health starts early in life. Read coverage:
Millennials are breaking health myths at a rapid pace: Here’s how→
WATCH: Probiotics in China: The market is set to explode→
Global microbiome market to triple by 2022, with France a primary driver→
Choline builds better vision→RESEARCH
Vitamin D guidance outdated?; D results mixed for heart; good diet better than antioxidants for eyes; protein aids bone health; K2 boosts athletesNutraingredients.com, Nutraingredients-asia.com, Nutraingredients-usa.com
Research from the U.K. suggests that vitamin D3 is twice as effective as D2 on raising levels of the nutrient in the body. A controversy remains over the links between vitamin D and heart disease, according to a new review from the Emory University School of Medicine in Atlanta. Scientists from the University of Auckland in New Zealand have found that antioxidants in supplement form are not as effective as a nutrient-rich diet to improve eye-health disease, with some evidence suggesting supplements may even worsen existing conditions. There’s more to protein than just muscle gains. Reviewing existing literature, researchers propose that taking more than the daily recommended allowance may support bone health. Supplements of vitamin K2 may boost output of the heart by 12 percent in male and female athletes, according to a new study published in Alternative Therapies in Health and Medicine. Read coverage:
Time to change vitamin D guidelines?→
Vitamin D good for the heart or not?→
Eye health and vitamins: Supplement intake can increase degeneration, review reveals→
Protein intake above recommended levels may benefit bone health, study says→
Vitamin K2 may be beneficial for athletic training: 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→