Industry says adverse events study draws faulty conclusions

​ADVERSE EVENT REPORTING
Industry says adverse events study draws faulty conclusions
Nutraingredients-usa.com
​A study, conducted at the Center of Injury Research and Policy at Nationwide Children’s, a hospital in Columbus, Ohio, found a rising tide of reports to poison control centers about dietary supplement exposures. The researchers may have made some faulty conclusions, according to experts familiar with adverse event reporting. They took issue with the study’s methodology and the threatening tone of the press release. Read more→

UNPA NEWS
Limited-time price break for UNPA PCQI training in Boulder, Colo.,Aug. 16-18
NEW! Just announced: An early-bird price break for UNPA's PCQI training,Aug. 16-18,in Boulder, Colo. UNPA members: $995; non-members: $1,295, through Aug. 8. Seating is limited. Details at the website: "Preventive Controls Workshop for Food and Dietary Supplements: PCQI Training for Food and Dietary Supplement Companies." UNPA's Larisa Pavlick was interviewed for this article further explaining PCQI, compliance deadlines and who must have a PCQI on staff.

UNPA Members' Meeting at SSW
NEW! The 2017 Members' Meeting at SSW will be held Wednesday, Sept. 27, from8-9am, at the Mandalay Bay Convention Center, South Seas Ballroom H (Level 3). RSVP here.

UNPA office hours for August
All of UNPA's offices (Utah and Colorado) will be closed on the four Fridays during the month of August. We will respond to your communications and requests promptly.

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.

UNPA member discounts
See "UNPA Member Discounts" in the right column for new discount offers from PLMI/Thought Leaders Consortium, NBJ and The Journal of Alternative and Complementary Medicine.

Recently posted at unpa.com:

NEW! UNPA announces onsite PCQI training
NEW! Synched PPT/audio file of Jim Thomas' Introduction to Synthetic Biology presentation at the 2017 UNPA Members' Retreat (suggest streaming only; file is VERY large)
"Who's your PCQI? An introduction to PCQI."
PCQI FAQs
2017 UNPA Members' Retreat coverage, including podcasts from UNPA member executives
UNPA Saves Stark Steering Sign in Sugar House
Interview with Larisa Pavlick (Nutraceuticals World)
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)
Plus, updated industry events calendar,Member Memos (log in) and UNPA educational archives (log in).M&A ACTIVITY
Carlyle Group sells majority stake of Nature’s Bounty to KKRNutraceuticals World
Interest in the dietary supplement industry will likely remain high, with the latest investment news noting the Carlyle Group’s has agreed to sell majority control of The Nature’s Bounty Co. to private equity firm Kohlberg, Kravis, Roberts (KKR). Carlyle will retain a significant stake in the company and partner with KKR to pursue growth opportunities in the segment. Financial terms were not disclosed. Read more→REGULATORY
FDA approves qualified health claim for macadamia nuts and reduced heart disease riskFDA.gov
After a systematic review of the available scientific data, FDA announced its intention to exercise enforcement discretion over the use of a qualified health claim characterizing the relationship between consumption of macadamia nuts and reduced risk of coronary heart disease. The qualified health claim was in response to a petition filed by Royal Hawaiian Macadamia Nut Inc. Read more→REGULATORY
FDA/FTC blog asks consumers to report safety, claimsor labeling issues with supplementsFDA.gov
In a recent FDA blog, officials from FTC and FDA note that both agencies have enforcement programs to protect consumers from false and misleading claims about the safety and benefits of products marketed as dietary supplements. Both agencies, the blog states, have authority over the marketing of these products and urged consumers to report products that didn’t work, have false or misleading claims or cause adverse events. Read more→NDIs
DSHEA did not seek to limit dietary substances to only 'nutritional ingredients'Nutritional Outlook
Attorney Scott Bass, who helped draft the DSHEA law of 1994, says that Congress did not intend “dietary substances” to be limited only to ingredients that are nutritional—and that this should mean that synthetic botanicals and probiotics count as dietary ingredients and be eligible for use in dietary supplements. But the NDI draft guidance could be a big hurdle for these ingredients. As FDA seeks to move forward on the guidance, Bass predicts it may reach out to industry for more dialogue by Fall. Read more→
REGULATORY
Glyphosate's addition to Prop 65 could impact 'natural' labelingNew Hope Network
California recently added the herbicide glyphosate to Proposition 65, legislation that requires businesses to provide warning labels on household products that contain naturally occurring and synthetic chemicals. The addition of the herbicide to its list of carcinogens could have significant impact, according to some industry experts, who believe it could radically influence natural product labeling, including on supplements and certified organic brands. Read more→REGULATORY
Specifics count when it comes to listing botanical ingredients on labelsNutraingredients-usa.com
Making a mistake on an ingredient name can lead to a specific call out on an FDA warning letter, cautions Ivan Wasserman of UNPA member Amin Talati Upadhye. Black Seed Herb Company was recently warned about its notation of galangal in its hoodia product, but what the company means by galangal is unclear. Wasserman notes that being specific is the point of the regulation. Herbs should be identified by their common name as specified in Herbs of Commerce. Read more→MEDIA WATCH
'Why MLM companies fear an honest coversation'The Hill
In a bill sponsored by Rep. John Moolenaar, R-Mich., the multi-level marketing industry and the Direct Selling Association hope to limit regulatory power to prevent MLM companies from operating illegal pyramid schemes, according to this commentary, which is highly critical of the direct sales industry. The author, William Keep of the College of New Jersey, says that if the MLM industry truly believes in the business model, then it should welcome full congressional hearings on the matter. Read more→LEGAL
Gentech executive sentenced to prison for selling DMAA productsNaturalProductsINSIDER
A judge sentenced the president of a dietary supplement company to serve 18 months in prison for introducing misbranded food into interstate commerce. Derek Vest of Gentech Pharmaceutical authorized the use of an amphetamine derivative, DMAA (1,3-Dimethylamine), in various supplements, but he failed to disclose its presence on the product labeling for the tablets. Read more→INVESTMENT
NCN data predicts record year for investment; tech and big food are key deal driversNew Hope Network
Nutrition Capital Network (NCN), an organization that connects investors with high-potential growth companies in the nutrition, health and wellness industry, predicts 2017 will be a record-breaking year for industry acquisitions and investments. Mergers and acquisitions are on pace for 33 percent growth, while financing deals have grown 16 percent in the first six months. Technology and food tech have been top categories for investment the last two years, but will drop off in 2017, while nutrition biotech and ag tech appear to be the new growth engines for 2017. Read coverage:
Top food and beverage transactions for first half of 2017→
Tech and big food among drivers of big investment year→
UNPA MEMBER NEWS
Pharmavite appoints Jeff Boutelle as new CEO, board memberNutraingredients.com
Pharmavite LLC announced Jeff Boutelle as its new CEO and board member, effective Aug. 7. Noriko Tojo, Pharmavite's current CEO, will continue to serve as chair of the board and CEO of Otsuka Medical Devices. The company says Boutelle, who brings extensive CPG and global experience, offers leadership abilities in full alignment with the company’s mission, vision and culture. Read more→

CPS invests in KGK ScienceThe PE Hub Network
KGK Science Inc., a contract research organization (CRO) offering human clinical trials and regulatory services to the health and nutrition industry, has secured an investment from CPS Capital, a Canadian private equity firm. The partnership with CPS will help the London, Ontario-based company pursue strategic growth opportunities. No financial terms were disclosed. Read more→Standard Process promotes innovation with new Center for ExcellenceStandard Process
Standard Process is ushering in a new era of innovation with the opening of its new Center for Excellence in Kannapolias, N.C. The center will be lead by John Troup, Ph.D., the company's VP of clinical science, education and innovation, and will be a focal point for innovation in nutritional therapy for health care professionals developing new solutions in patient care and whole food nutrition. The company also announced a new board leadership team to support the effort and other growth initiatives. Read more→

Cyanotech addresses competitive environment with halal certificationNutraingredients-usa.com
Cyanotech continues to move forward with the development of astaxanthin production by achieving halal certification, despite a recent management change. The certification not only recognized the competitive environment in the segment, but also the importance of 1.4 million Muslims consumers in the U.S. The certification will also allow Cyanotech to supply growing markets in Southeast Asia and beyond. Read more→MOU PARTNERS
Bastyr President Mac Powell resignsBastyr University
Bastyr University announced that President Charles (Mac) Powell, Ph.D., has resigned, effective July 31, due to health issues. In a letter from the university's board of trustees, the school also announced that Harlan Patterson, chair of Bastyr’s board of trustees, will assume the role of president on an interim basis while a search for a permanent president is being conducted and will be guiding the university in executing its five-year strategic plan. Read more→CBD
Lawyer claims DEA marijuana extract rule will impact CBD salesNaturalProductsINSIDER
A marijuana extract rule adopted last year by the Drug Enforcement Administration (DEA) has produced adverse consequences for companies selling cannabidiol (CBD), according to lawyer Bob Hoban, who specializes in cannabis law, and has sued DEA. The rule, he said, has scared consumers, discouraged investment and prompted some companies to exit the business. Read more→INDUSTRY AWARDS
NBJpresents business achievement awards at recent SummitNew Hope Network
The Nutrition Business Journal Business Achievement Awards capped the recent NBJ Summit. Among the winners: Ganeden devised a way to put probiotics into more products that make better digestive health accessible; Ribus examined the not-on-the-label excipient components that go into supplements and used innovation and invention to offer clean-label solutions; and Mike Archbold’s departure as CEO of GNC may not have been his choice, but his choices there left a legacy of reform for the whole supplement industry. Read more→MARKET RESEARCH
Millennials support activist lead companies; online supplement sales surge 20 percent driven by brick-and-mortar retailersMediaPost, Nutraceuticals World, Nutraingredients-usa.com
More than half of millennials (51 percent) are more likely to buy from a company led by a CEO, who speaks out on an issue they agree with, according to Weber Shandwick’s second annual survey on American attitudes toward CEO activism.Online sales for vitamins, minerals and supplements surged 20 percent, growing from $2 billion in 2016 to $2.4 billion in 2017, according toTABS Analytics’ 10th Vitamins, Minerals and Supplements Study. Much of the growth is due to the performance of brick-and-mortar retailers' online divisions, which outpaced Amazon and other pure-play outlets in growth. In particular, Walmart’s August acquisition of Jet helped drive the 20 percent increase, aided by an aggressive paid online search strategy. Read coverage:
Millennials favor companies with activist CEOs→
Online sales of vitamins, minerals, supplements surge 20% in $13.5 billion market→
Jet acquisition helps fuel Walmart’s surge in online vitamin sales→RESEARCH
Spirulina protects gut; plant stanols lower LDL; low K2 leads to fracture risk; cannibinoids aid omega-3 effects; protein builds muscleNutraingredients.com, Nutritional Outlook, Nutraingredients-usa.com
Spirulina might help protect against age-related liver inflammation by modifying pathways in the microbiome, say researchers from the Louvain Drug Research Institute in Belgium. Researchers from the University of Helsinki and Helsinki University Hospital are studying the cholesterol-lowering efficacy of a chewable plant stanol ester supplement by Raisio Nutrition and found that daily supplementation lowered LDL cholesterol by 7.6 percent among subjects. New study results recently presented at June’s International Conference on Children’s Bone Health in Germany indicate that children with low vitamin K2 status may be at greater risk of developing low-energy bone fractures. The unpublished study is the first to look at the role of vitamin K in preventing fractures. The anti-inflammatory properties of omega-3 fatty acids may be due to the action of endocannibinoids derived from them, according to a new study from the University of Illinois, which found that EPA and DHA initially metabolized into endocanniboinoids. Elderly men who consumed a whey-protein based, multi-ingredient supplement, including creatine, calcium, vitamin D and omega-3s, increased both muscle strength and lean mass, according to researchers at McMaster University in Canada. Read coverage:
Algal Solution: Could spirulina modify the microbiome to protect against age-related damage?→
Researchers analyze efficacy of chewable plant stanol ester→
Low vitamin K in children may lead to greater risk of fractures, new study shows→
Cannibinoids may be responsible for omega-3 anti-inflammatory effect: Study→