FDA Commissioner Gottlieb advances plan to reorganize inspectors by expertise

​REGULATORY
FDA Commissioner Gottlieb advances plan to reorganize inspectors by expertise
Nutraingredients-usa.com
​A move by newly confirmed FDA Commissioner Scott Gottlieb to reapportion FDA inspectors along lines of expertise has been welcomed as potentially improving the effectiveness of the facilities inspection process. The reorganization has been several years in the making and was reportedly first conceived to help the agency address new responsibilities from FSMA. Read more→

UNPA NEWS
Members'Retreat starts Monday!
Pre-registration ends Friday at 3pm MST for UNPA's 2017 Members' Retreat in Santa Fe, N.M. Register today and learn about housing options at the UNPA website.

Avoid FDA's top 10 GMP violations at UNPA’s GMP training,June 27-28, in Provo, Utah—see intro videonow!
Preview UNPA's June 27-28 GMP training session, taught by Larisa Pavlick, UNPA's VP, Global Regulatory & Compliance, in this short video presentation. Learn more about the program and why you should attend before your next FDA GMP inspection. This course will cover all aspects of the inspection, with a focus on the key elements of quality: identity, purity, strength and composition. VIEW VIDEO→

Register for these upcoming industry events
NEW! UNPA's "Beyond GMPs: Mastering the Key Elements of GMP Quality Before Your Next GMP Inspection or Audit," June 27-28, Provo, Utah

USP Dietary Supplement Stakeholder Forum, June 7, Rockville, Md.

Recently posted at unpa.com:
NEW! FDA updates its FSVP resources with updated fact sheets and guidance document (requires member log in)
“Dietary Supplements: State of the Industry,” UNPA presentation at New Hope Network, April 26 (log in)
Washington Update: FDA User fees; Health Savings Accounts, by Peter Reinecke and Patricia Knight, UNPA Senior Political Advisors (log in)
"An Industry Perspective on Botanical Quality & Compliance," presentation at ICSB 2017 by Larisa Pavlick(log in)
2017 Expo West Members’ Meeting PPT (log in)
“New Dietary Ingredients: Enforcement” presentation at 2017 Expo West by Larisa Pavlick (log in)
The PPT presentations from NDI III: Roadmap to a Viable NDI Policy, UNPA member price: $295
Plus, updated industry events calendar,Member Memos (log in) and UNPA educational archives (log in).FINANCIALS
Nature's Sunshine posts solid Q1 with strong sales in Russia; Vitamin Shoppe cites challenge in sports nutrition; LifeVantage sees shift in tough quarterNature's Sunshine Products, Vitamin Shoppe Inc., LifeVantage Corp.
Network marketing company Nature’s Sunshine Products, which recently celebrated it 45th anniversary, reported 1Q sales of $83.1 million, up 0.8 percent from $82.4 million. The company reported strong growth in Russia and Central and Eastern Europe, where sales increased 19.8 percent. In discussing 1Q17 results,Vitamin Shoppe highlighted ongoing challenges in its sports nutrition business, including falling comparable sales tied to the promotional environment in the sports market. Total comps slipped to a negative 6.3 percent for the first quarter. Reporting a 19.9 percent decrease in revenue for its third quarter 2017,LifeVantage is citing reaccelerating sales growth late in the quarter following a review of international policies and procedures. The shift provides momentum for Q4, according to President and CEO Darren Jenson. Read coverage:
Nature’s Sunshine Products reports first quarter 2017 financial results→
Vitamin Shoppe announced first quarter 2017 results→
LifeVantage announces financial results for third quarter of 2017→REGULATORY
USDA to produce study on tech challenges prior to implementation of GMO labeling ruleNaturalProductsINSIDER
USDA has until the summer of 2018 to adopt a standard governing the mandatory disclosure of bioengineered foods. But the National Bioengineered Food Standard directs that USDA first identify through a study “potential technological challenges that may impact whether consumers would have access to the bioengineering disclosure through electronic or digital disclosure methods." The standard that USDA must adopt is a flexible one—permitting a disclosure through a text, symbol, or electronic or digital link. Read more→GLOBAL REGULATORY
EFSA rejects claims for joint function and sperm DNA damage; EU court rules against maximum vitamin levels; industry calls for nutrient profilesNutraingredients.com
EFSA’s Panel on Dietetic Products, Nutrition and Allergies has rejected two health claims dossiers claiming a link between curcumin and joint function and an extract for sperm DNA damage. European Member States cannot set individual maximum levels for vitamins and minerals unless they are based on international safety data and risk assessments, according to a new ruling from the European Court of Justice. The ruling relates to a French case in which authorities took action against product that exceeded maximum levels in France. An open letter form three leading health and consumer associations and five companies calls for urgent adoption of nutrient profiles in the context of the EU health claims framework. The letter claims that without nutrient profiles, approved nutrition and health claims can be put on any food and non-alcoholic product. Read coverage:
Thumbs down: EFSA panel rejects claims for joint functioning and sperm DNA damage→
European Court rules against France on maximum vitamin levels →
Open letter demands EU-wide nutrient profiles for nutrition and health claims→ORGANIC
Expanded organic research funding bill introduced in House; USDA posts warning about fake organic certificatesOrganic Farming Research Foundation, USDA
State representatives from Maine, Washington and California have introduced a bipartisan bill to support increased funding for organic research. The Organic Agriculture Research Act, which was advocated for by the Organic Farming Research Foundation, will raise funding for USDA's Organic Research and Extension Initiative (OREI) from $20 million to $50 million annually. Meanwhile, USDA has published a strong advisory about falsely representing products as certified USDA organic, which violates the law and federal organic regulations. Noting current activity, it said fraudulent certificates may have been created and used without the knowledge of the operator or the certifying agent named in a certificate. Read coverage:
Bipartisan bill supports increased funding for organic research→
Fraudulent organic certificate→UNPA MEMBER NEWS
OmniActive seeks potential acquisitions; USANA marks 25thanniversary; NuSkin introduces new CFOBusiness World, USANA Health Sciences, NuSkin Enterprises
OmniActive is planning more strategic acquisitions to boost its growing research-focused ingredients supply portfolio. The company acquired Indfrag for an estimated $80 million in January. The Mumbai-based company, backed by private equity invetor Everstone is evaluating targets in the $10 million to $20 million range. Read more→

Salt Lake City-based cellular nutrition company USANA Health Sciences celebrated its 25thanniversary at its annual Asia Pacific Convention in Singapore, which boasted record attendance and momentum. The company is excited about the record-breaking growth in the region and noted its continued mission to produce the highest quality supplements in the world. Read more→

To introduce its newly appointed Chief Financial Officer Mark Lawrence, NuSkin Enterprises offers a Q&A with the 20-year veteran of corporate operations and finance, who most recently served as head of finance for Amazon-Lab126. Lawrence answers questions on the meaning of success, daily activities to achieve success, his definition of innovation, as well as striking an appropriate balance between personal and professional life. Read more→OMEGA-3s
New omega-3 studies provide ‘leap’ in understandingNutraingredients.com
EPA and DHA omega-3 fatty acids both drive anti-inflammatory gene expression, while DHA is better at lowering triglycerides and decreasing inflammatory markers, according to recent studies published in three different journals that are said to be a “leap forward” in our understanding of these nutrients. The research marks a shift toward well-designed intervention studies that will tease out true benefits for EPA and DHA supplementation. Read more→INDUSTRY ASSOCIATIONS
IADSA expands reach with new association members from Turkey and ColumbiaNutraceuticals World
IADSA, the international organization for the food/dietary supplements sector, has expanded its representation with the addition of two new member associations from Turkey and Colombia. The new additions will bring IADSA members to 42 associations representing 32 countries, including UNPA. Read more→INNOVATION
Mazza recognized for clean, solvent-free extraction methodNutraceuticals World
Mazza Innovation is gaining increasing attention in dietary supplement circles with its technology offering an environmentally friendly, solvent-free way of extracting compounds, such as polyphenols, alkaloids, glycocides and specialty carbohydrates. The first product launched with the company’s PhytoClean seal was the recently launched Mediterranean Whole Food Blend by Life Extension. Read more→PERSONALIZED MEDICINE
How will genetic testing impact consumers choice for food and supplements?New Hope Network
As genetic testing expands into a mail-order industry, it’s getting easier for consumers to learn about their ancestry, inherited traits and individual health risks. Prof. Joel Eissenberg, Ph.D., a biochemistry and molecular biology professor at the University of St. Louis, helps us understand how new tools are arming consumers with health information that may inform their food and supplement choices. Read more→MARKET RESEARCH
U.S. supplement sales to reach $18.3 billion in 2020; consumers sketchy on microbiome details; IFIC study notes high nutrient confusion; high demand prompts Down Under innovationPRNewswire, Nutraceuticals World, New Hope Network,
Nutraingredients-usa.com
In a new study,Nutritional Supplements in the U.S., 7th Edition, from Research and Markets, positive consumers trends, such as demand for condition- specific supplements, digestive health products and to maintain cognitive function, will drive the sector for the next few years. The report predicts sales will reach $18.3 billion by 2020, with an ongoing CAGR of 6.2 percent. More than half of nutritional supplement users in the U.S. are aware of their gut microbiome, but nearly three in four say they don’t really know what it does, according to a new study from Embria Health Sciences using Qualtric enterprise research platform. The study of 1,000 supplement users indicated consumer knowledge about the microbiome is far from complete. In the International Food Information Council Foundation's annual survey, consumers demonstrated a lack understanding of health benefits associated with particular nutrients and a reliance on non-health factors like price, form and number of ingredients to determine if a food is healthy. Innovation is booming in Australia and New Zealand’s vitamins and dietary supplements sector with companies rolling out scores of new products over the past five years, according to new research from Mintel. Read coverage:
Nutritional Supplements Market in the U.S. 2016-2020:Supplement sales expected to reach $18.3 billion by 2020→
Most supplement users aware of gut microbiome, but understanding limited→
IFIC Survey: Nutrition confusion abounds→
Supplement brands clamour to meet demand for health and convenience in Australia, NZ, with NPD boom→RESEARCH
Cranberry reduces UTIs; lycopene, lutein supplements protect skin from UV damage; beta glucan aids seniors; vitamin D not linked to allergies; omega-3, prebiotics help fight Parkinson'ssymptomsNutraingredients.com, Nutritional Outlook
A daily intake of cranberries may significantly reduce the risk of recurrent urinary tract infection (rUTI) in generally healthy women, says a new meta-analysis of seven randomized controlled trials from scientists at Tufts University, Biofortis Research and UCLA. A study recently published in the British Journal of Dermatology shows that both a lycopene-rich tomato nutrient complex and lutein may protect skin against UVA/B and UVA1 radiation at a molecular level. Supplementation with beta-glucan both protected elderly subjects against upper respiratory tract infections (URTIs) and reduced the duration of any URTIs that did occur, according to a human clinical trial soon to be published in the journal Nutrition.Supplementation with vitamin D is unlikely to reduce the risk of asthma, atopic dermatitis or allergies, according to a new genetic study from the Lady Davis Institute in Canada. A recent study, published in the journal Frontiers in Aging Neuroscience, has demonstrated how dietary interventions with omega-3, prebioticsand other nutrients can help improve motor functions and cognition after the onset of Parkinson's disease in mice. Read coverage:
Cranberry effective against recurrent UTIs: Meta-analysis→
Lycopene and lutein supplements may protect skin against solar damage→
Beta glucan supports senior immune health: New study→
Genetic study suggests vitamin D not linked to asthma or dermatitis→
Parkinson’s Disease and diet: Nutritional intervention reveals clear therapeutic benefits→ETC.
Do influencers have responsibility for the products they push?New York Times
In the wake of a recent Twitterstorm about the appropriateness of the use of social media influencers, such as Kendall Jenner and Bella Habid, in advertisements and on magazine covers, theTimesponders whether there is a growing downside to the upside of being an influencer. The question is timely given the recent warning letters from FTC reminding companies and celebrities about the necessary disclosure for endorsements. We may be on the cusp of a new era in influencer culture. Read more→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→