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    • UNPA Members >
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        • Nutrition Facts label
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    • 2020 DSRS Speakers
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UNPA Digest

FDA targets unsafe supplements with SARMS

11/2/2017

 
​REGULATORY
FDA targets unsafe supplements with SARMS
Natural Products INSIDER The Food and Drug Administration this week has warned of bodybuilding products with potentially unsafe ingredients, known as selective androgen receptor modulators, or SARMs. Recent warning letters show FDA is targeting companies selling ostarine and other SARMs in products marketed as dietary supplements. FDA sent warning letters to three companies allegedly selling products containing SARMs but labeled as dietary supplements and cautioned that the products are unapproved drugs that have not been reviewed for safety and effectiveness. Read more→
UNPA NEWS
Limited seating left for PCQI training in Salt Lake City, Dec. 6-8
Due to demand, UNPA has added an additional instructor and 15 more seats to its 2.5-day Preventive Controls Qualified Individual (PCQI) training, Dec. 6-8, in downtown Salt Lake City. $200 discount for UNPA members. Learn more, including who must be trained, and why it's a very good idea for many other companies to have a PCQI on staff, at the UNPA website.

NEW! UNPA's Larisa Pavlick to conduct FSMA workshop at 2018 GOED Exchange
UNPA’s Larisa Pavlick will present a pre-conference workshop entitled “The Food Safety Modernization Act and What It Means to You," at the 2018 GOED Exchange The workshop, which is free for GOED Exchange attendees, will cover two of the key rules affecting the industry including the Preventive Controls for Human Food rule and the Foreign Supplier Verification Program. The presentation will also introduce the requirements for a Food Safety Plan specific to the omega-3 industry industry and walk through the expectations of the FDA. See "UNPA MEMBER DISCOUNTS" to the right for discounted registration information.

Recently posted at unpa.com:
NEW! ITC dismisses Amarin omega-3 complaint (Member log in required)
NEW! FDA proposes dropping ‘authorized’ health claim for soy protein and reduced risk of heart disease (log in)
FTC Update:President nominates two for FTC; third nomination likely soon (log in)
About naturopathic medicine and link to frequently asked questions
Larisa Pavlick's PPT presentation at the 2017 Rocky Mountain Dietary Supplement Forum, Oct. 10,in Boulder, Colo.: "FDA Top 10 Citations & Potential Solutions" (Log in)
Loren Israelsen's PPT for his presentation at the FDA ODI meeting, Oct. 3, in College Park, Md. (Log in)
The PPT for the UNPA Members' Meeting at the 2017 SupplySide West (log in)
Updated PCQI FAQ
Plus, updated industry events calendar,Member Memos (log in) and UNPA educational archives (log in).

REGULATORY
Hi-Tech’s suppliers among companies indicted for mislabeled DMAA shipments
Natural Products INSIDER
Four Chinese companies and several of their employees were indicted by a Dallas grand jury for charges related to the intended sale of mislabeled DMAA (1,3-dimethylamylamine), including fraud, smuggling and obstruction. Jared Wheat, president of Hi-Tech Pharmaceuticals Inc., acknowledged thattwo of those arrested were among his company’s suppliers. Read more→

REGULATORY
FDA’s Ostroff says collaboration with industry will be critical for modernization program
​
Nutraingredients-usa,com
Partnerships with industry and other stakeholders are a key part of helping FDA keep up with a rapidly changing marketplace, according to FDA official Stephen Ostroff, M.D., who spoke to industry at the recent CRN conference. Ostroff said FDA is executing on a 10-year strategic plan to modernize its operations, which has been prompted in part by the growth of the dietary supplements industry. Read more→

REGULATORY
Injunction of supplement maker underscores importance of allergen control under FSMANutraingredients-usa.com
Long Island dietary supplement manufacturer Riddhi USA Inc. has been shut down by FDA following numerous and repeated violations of GMP standards and labeling laws. Among the labeling violations: the use of soy lecithin in a product with no ingredients listed and thus failing to declare soy as an allergen. The recent injunction reinforces again the duty companies have to detect, declare and control allergens. This responsibility will only accelerate with the implementation of FSMA rules, according to UNPA’s Larisa Pavlick, VP of global regulatory and compliance. Read coverage:
FDA shuts down NY supplement firm→
Controlling for allergens more urgent under FSMA, expert says→

M&A ACTIVITY
Frutarom buys Enzymotec for $168 million; Cargill to purchase maker of EpiCor
​
Nutraingredients.com, Nutraingredients-usa.com
Israeli flavor and fine ingredients firm Frutarom is now the owner of nutritional ingredient specialist Enzymotec in a $168 million deal for the remaining 81 percent of the company’s shares. The deal is Frutarom’s ninth acquisition this year. Cargill, meanwhile, has moved to purchase the parent company of Embria, makers of EpiCor, an immune health ingredient. The deal is thought to be part of an effort by Cargill to diversify from commodity markets that are high in supply and low in profits. Read coverage:
Enzymotec on board in Frutarom’s $168M natural and infant nutrition investment→
Cargill adds EpiCor to ingredient stable→

FINANCIALS
Lonza touts performance, on track Capsugel integration; social media drives USANA results in China; GNC CEO optimistic about turnaround
Nutraceuticals World, Nutraingredients-usa.com, Whole Foods Magazine
Lonza reported continued strong performance and confirmed its full-year 2017 guidance on a standalone basis in its recent Q3 update. The company says its focus is now on the successful integration of Capsugel in order to realize expected synergies and further boost its ambition to become the leading integrated service provider for the pharma and healthcare industries. Network marketing firm USANA Health Sciences is riding strong sales growth in North Asia driven by social media IT investment.GNC Holdings'new CEO Ken Martindale expressed optimism about a turnaround with unique products and services in the pipeline for 2018 and the ability to market them better. He reported Q3 same store sales up 1.3 percent in company-owned stores, but net income at less than half of what it was last year.
Read coverage:
Lonza reports strong third quarter, Capsugel integration on track→
Social media investment helps drive USANA results in China→
GNC shows Q3 profit with new model→

GLOBAL REGULATORY
Australia seeks companies to try ‘third-way’ claim; U.K. cracks down on claims for turmeric, vitamin A
Nutraingredients-asia.com, Nutraingredients.com
The first wave of supplement firms wanting to make Australia’s 'game-changing' new health claims will be able to register their interest by the end of this year. The new claim has been dubbed a "third-way" option, sitting between the current low-risk medicine classification and higher-level registered pharma medicines. A raft of British firms continue to test the boundaries of U.K. supplement advertising as the Advertising Standards Authority takes action over health claims used to market joint health and weight loss products. Read coverage:
First supplement firms sought for Australia’s new game-changing health claims→
ASA rules turmeric, vitamin A claims overstep advertising code→

INNOVATION
Technology allows 3D printing of food with defined criteria
Nutraingredient.com
Personalized nutrition using a natural, calorie-free fiber to create nutritionally enhanced foods on demand is revolutionary, according to the makers of a 3D printing platform. The Israeli-based firm Yissum says its technology is designed to print 3D food according to a pre-defined criteria and could service particular populations, such as athletes and the elderly. Read more→

GMOs
Shoppers still confused about GMOs in food
Forbes.com
In a poll conducted by the Michigan State University College of Natural Resource’s Food@MSU program, one-third of respondents didn’t realize that non-GMO foods contain genes, and almost half think they don’t consume GMOs, or don’t know if they do. A similar study by the University of Florida and Purdue University found that respondents were willing to pay 35 cents more for a box of granola bars labeled “Non-GMO Project” but only 9 cents more for a box labeled “USDA Organic.” Read more→

UNPA MEMBER NEWS
Botanical Liaisons helps verify PLT Health’s RhodioLife ingredient
PLT Health Solutions
Botanical Liaisons LLC and NaturPro Scientific LLC have jointly completed a successful ingredient identity verification program for Rhodio Life Rhodiola roseaL.—which is marketed in the United States by PLT Health Solutions Inc.Verification of Rhodio Life identity was motivated by concerns raised by ABC’s October publication of an adulterants bulletin on Rhodiola rosea.The verification was based on a comprehensive set of criteria, including supplier verification, chain of custody review and identity testing using HPLC and DNA testing. Read more→

Indena's Meriva curcumin shown to provide gut protection, heat relief
Nutraingredients.com
Curcumin-based supplementation may be helpful in protecting the gut during bouts of endurance-based exercise as researchers also observed a reduction in core temperature and heart rate. The results, achieved with Indena’s Meriva curcumin supplements, also found an improved ability to maintain body temperature at a prescribed level in spite of heat stress brought on by treadmill exercise. Read more→

Sabinsa’s curcumin C3 complex plus aspirin helps cancer therapy
Natural Products INSIDER
Researchers at Rutgers have provided the first evidence of chemopreventive effect of a low-dose combination of aspirin and Sabinsa’s Curcumin C3 Complex in the treatment of colitis-accelerated colon cancer. There has been concern about the potential of gastrointestinal bleeding with aspirin. In this new animal study, researchers discovered that co-administration of Curcumin C3 Complex and aspirin helps to lower the dose of aspirin by 50 percent, rendering this therapy feasible without adverse effects. Read more→

Verdure celebrates 20th anniversary; Pomella gains self-affirmed GRAS
Natural Products INSIDER
Verdure Sciences celebrated its 20-year anniversary and unveiled details of on a new corporate campus during the SupplySide West show in Las Vegas. Next year, Verdure will be in a new seven-acre corporate campus including office, laboratory, product development, greenhouse and warehouse spaces. The company has also attained self-affirmed GRAS status for its pomegranate extract Pomella, demonstrating its commitment to prove safety and efficacy for it branded ingredients. Read coverage:
Verdure Sciences 20th birthday and new campus→
Pomegranate extract ingredient Pomella get self-affirmed GRAS→

CRB ranked in top 4 among pharma contractors by Engineering News Record
CRB
Engineering News Record recently released its annual ranking of the top U.S.-based contractors for 2017, ranking CRB as fourth among pharmaceutical contractors based on annual revenue. The ranking shows a rise of four spots from 2016 for CRB's Construction Services Group. Its growth can be attributed to robust project work for pharmaceutical clients across the U.S. Read more→

HEMP
Report: Colorado, Kentucky lead states in hemp production
New Hope Network
Led by Colorado with 7,500 acres in the ground, and Kentucky's 3,000 acres, hemp acreage has doubled in the last year as states are getting in on the promise and potential of industrial and nutritional hemp, according to the 2017 U.S. Hemp Crop Report.The report documents state-by-state progress of hemp legislation passed in 2017, acreage of hemp grown and identifies states with active hemp pilot farming programs. Read more→

MOU PARTNER NEWS
ABC celebrates 30 years of service in botanicals, herbal medicine
Herbalgram
The American Botanical Council begins its 30th year of service this month, providing reliable, science-based information on the responsible use of herbs, medicinal plants, other beneficial botanicals, essential oils, fungi and related materials. The independent nonprofit has members in countries around the globe, has received numerous awards and is recognized as a thought leader and innovator in the field of botanicals and herbal medicine. Read more→

MARKET RESEARCH
Beauty consumers see value in natural, organic; Amazon now a key player in health, wellness; product innovations to drive growth in APAC supplements
Cosmetic Design, Natural Products INSIDER, Nutraingredients-asia.com
According to research by the Benchmarking Company, beauty consumers perceive value in natural and organic ingredients and are willing to pay a premium for them. A new report from One Click Retail found Amazon is now a key player in the health and wellness market and will only get larger as consumer perception of a healthy lifestyle continues to evolve in the U.S. Membership services, snack-style products and interactive packaging will help drive Asia Pacific’s supplement sales to $56 billion by 2022, a $10 billion increase over 2016, according to research firm Euromonitor. Read coverage:
California’s SCC Suppliers Day keynote explores how beauty consumers define natural→
Amazon now a key player in the health and wellness market→
Three key innovations that will help APAC’s supplement sector grow by $10 billionin five years→

RESEARCH
Glyphosate consumption on the rise; mixed results in Alzheimers trial; probiotics aid weight loss; strain supports liver, kidney; unmetabolised folic acid lowers absorption
Consumer Reports, Nutraingredients.com, Nutraingredients-usa.com
People are now more exposed to glyphosate than in the 1990s, according to a new study published in JAMA. In the most recent samples, 70 percent of people had glyphosate concentrations above the detection limit. Daily consumption of a drink containing a specific combination of essential fatty acids, vitamins and other nutrients does not improve key markers of Alzheimer’s progression, but may aid everyday cognitive performance, according to a two-year clinical study from the University of Eastern Finland. Probiotic supplementation with various strains of Lactobacillu shave been shown to induce a small but statistically significant weight loss in the obese and overweight, according to a new review and meta-analysis lead by researchers in Norway. Scientist in Serbia have found that diabetic lab rats orally administered with the Lactobacillus paraplantarum BGCG11 saw a reduced level of DNA damage in the liver and kidney compared to control rats that didn’t receive probiotics. Unmetabolised folic acid (UMFA) may reduce the uptake of the bioactive form of the vitamin, suggests recent research in the Journal of Cardiovascular Pharmacology. Read coverage:
We may be consuming more glyphosate than ever before→
Major EU funded Alzheimer’s trial reveals mixed results for daily nutrition drink→
Probiotics backed for weight-loss benefits: Meta-analysis→
ProbioticL. paraplantarummay reduce diabetes induced liver and kidney damage in rats→
Too much synthetic folic acid may interfere with absorption of bioactive folate, warns study→

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