Issue of FSVP compliance is coming to a head as FDA issues first warning letter

TOP STORY
Issue of FSVP compliance is coming to a head as FDA issues first warning letter Facilities that are subject to FSMA inspection are struggling with the Foreign Supplier Verification provision of the law, according to new data. The issue is coming to a head with the first FDA warning letter for an FSVP failure.  Read more→

UNPA NEWS
UNPA to host annual member meeting at SupplySide West, Oct. 17
Hear the latest insights and news from the UNPA team at the annual SupplySide West Members' Meeting, Oct. 17, from 8-9am with a one-hour member meet-and greet to follow starting at 9am. Room location TBD. There is no charge to attend. See you there!

Access UNPA's analysis of CBD comments to FDA
The Aug. 22 UNPA webinar, a review and analysis of the comments submitted to FDA on cannabis and CBD by UNPA President Loren Israelsen, is now available for OnDemand viewing at the link embedded in the above title.

UNPA team leads podcast discussions on hemp and CBD
UNPA's Loren Israelsen recently discussed  the status of hemp and CBD in conversation with TraceGains' CEO Gary Nowacki. Listen to the podcast, "CBD: Fad or Trend?" here. In another posdcast, UNPA's Frank Lampe discussed the state of hemp/CBD regulation in conversation with Pete Thornton of Chatanooga, Tenn.-based Landrace Biosciences, A GMP-certified, bulk CBD product manufacturer. The interview series, geared for the hemp industry, is called, "Call Me Cannabinoids." Listen to it here.

REGULATORY
FDA wins appeal over DMAA dietary supplements A decision by the U.S. Court of Appeals for the Eleventh Circuit marked a victory for FDA and a loss for supplement manufacturer Hi-Tech Pharmaceuticals over the legality of an ingredient in dietary supplements, but the case may not be over.

​New facts panels aim to make Americans healthier Information is power, and FDA hopes its impending roll-out of new Nutrition Facts panels for foods and beverages, as well as Supplements Facts panels for supplements, will make Americans more aware of the nutritional profile of the products they consume.

LEGAL
Dietary supplement company Basic Reset shut down by federal judge A federal judge ordered a Middle Tennessee distribution company to shut down on Tuesday after prosecutors accused the business of blurring the line between proven medicine and dietary supplements with no scientifically backed use.

M&A ACTIVITY
NOW acquires high-potency vitamin brand SuperNutrition NOW has acquired family-owned, high-potency multivitamin company SuperNutrition to expand its line and increase distribution worldwide through a growing network of international distributors.

Kaneka takes control of AB Biotics after concluding takeover bid AB Biotics is now in the ownership of Kaneka Europe after the Japanese company confirmed the completion of a takeover bid as the majority stakeholder of the Spanish probiotics specialist.

Nestlé Health Science acquires personalized nutrition company Persona Nestlé Health Science is expanding into personalized nutrition with the acquisition of Persona, a personalized vitamin business, which will operate under the Nestlé Health Science’s North American-based Atrium Professional Brands.

INDUSTRY
NPA files for bankruptcy citing losses, burdensome arbitration award The Natural Product Association filed for Chapter 11 bankruptcy in mid-August, noting it has suffered through six straight years of losses, according to a Reuters report on the filing.

SPORTS NUTRITION
Longtime sports nutrition player Ultimate Nutrition vanishes overnight Employees of sports nutrition company Ultimate Nutrition were greeted with news of the company’s closing and locked doors at the company’s Connecticut headquarters.

FINANCIALS
Nutrition Capital Network deal download August 2019 Healthy snacking, supplements and natural food and beverage deals were popular in August.

PARTNERSHIPS
Chr. Hansen, Lonza joint venture BacThera receives antitrust  approvals Chr. Hansen Holding A/S and Lonza AG announced that they have received the necessary approvals from antitrust regulators to establish BacThera–a 50/50 joint venture in the emerging market for live biotherapeutic products.

HEMP/CBD
An advance beyond CBD: Geocann launches CBG formulations Colorado-based Geocann has launched two CBG (cannabigerol) formulations, optimizing absorption and bioavailability by utilizing the VESIsorb drug-delivery system, the company says.

Sleep supplement sales growth spikes 12 percent thanks to hemp CBD Sleep-support supplement sales have been dwindling since 2015, but growth spiked above 12 percent in 2018 with the influx of hemp/CBD formulations targeting healthy sleep.

Nation’s largest hemp processing plant opens in Colorado Colorado City, a town of fewer than 2,500 in southern Colorado, will soon be home to up to 50 million pounds of hemp, now that a massive hemp-processing facility is open for business.

Certified seed shortage means hemp crops exhibit wide range of phytochemistry The high variability of hemp plants now being grown in North America means claims of standardization should be taken with a grain of salt, says botanical expert Eleanor Kuntz, founder and CEO of LeafWorks.

APAC MARKET
Better quality: China adds new requirements to product labeling and health food raw materials filling Health food firms selling to China will need to adhere to more product labeling requirements in January 2020, and new guidelines for raw-material-filling process will kick in from next month.

RETAIL
GNC announces Brazil expansion with new partner Banco de Franquias GNC Holdings Inc. announced its partnership with BFG Brasil Comercial de Vitaminas LTDA, a professional retail operator, to help expand the company’s presence in Brazil.

Thrive Market embraces glyphosate-residue-free certification Online natural products retailer Thrive Market has teamed up with The Detox Project to ask suppliers--where applicable--to go through the Glyphosate Residue Free certification process.DSHEA AT 25

How Congress revolutionized the supplement industry Patricia Knight, former chief of staff to retired Sen. Orrin Hatch, and now a senior political advisor for UNPA, reflects on the forces that led to DSHEA.

COMMENTARY
Trade war fuels adulteration fears The fever pitch of U.S.-China trade wars could turn up the heat on adulteration issues in the dietary supplements industry, but American Botanical Council founder Mark Blumenthal says the issue must be viewed in a wider context. 

PROBIOTICS
How can probiotic brands tap into growing consumer demands As probiotic players see the popularity of specific probiotic categories rise, Lumina Intelligence’s Market Analyst Emer Mackle delves into brand strategy fundamentals.

E-COMMERCE
Amazon has ceded control of its site. The result: Thousands of banned, unsafe or mislabeled products Amazon is struggling to police its site as third-party sellers continue to offer subpar, and often dangerous, products, and recent lawsuits resulting from this lack of authority underscore the fact that America’s tech giants “have lost control of their massive platforms—or decline to control them.”

Amazon and counterfeiting: How widespread is the problem for dietary supplements With so much third-party reseller activity over dietary supplements happening on Amazon.com, it’s almost expected that some of that activity will be at the hands of bad actors, such as those selling counterfeit products.

GLOBAL REGULATORY
Italy updates labeling rules on curcumin extract use in supplements Italy’s Ministry of Health updated its rules governing the use of plant preparations and extracts from the Curcuma genus in response to a hepatitis outbreak linked to curcumin-based supplements.

POLICY
Here are the biggest agriculture issues in the upcoming election Farm policy can be confusing: Big food monopolies, climate change innovation and land access are just some of the things voters should look for in their chosen candidate’s platform before heading to the polls.

World Health Organization calls for reduction of plastic pollution Following the release of an analysis of current research related to microplastics in drinking water, the World Health Organization has called for further assessment of microplastics in the environment and their potential impacts on human health.

UNPA MEMBER COMPANY NEWS
Sabinsa opens new office in Poland Sabinsa announced the opening of a warehousing, sales and distribution office in Poland, which will serve customers in the growing East European, Eastern Block and CIS countries.

BDS Analytics raises $10 million in funding BDS Analytics, a Boulder, Colo.-based provider of cannabis market intelligence and consumer research solutions, held an initial closing of $7million in a new $10 million financing round.

Tracegains wins endorsement as official supply chain partner for SupplySide West Informa Markets has endorsed TraceGains, a leader in cloud-based compliance, quality and new-product-development software for the CPG industry, as the official Supply Chain Automation Partner of SupplySide West and Food Ingredients North America, set for Oct. 15-19 in Las Vegas.

MARKETING
Innova Market Insights: The appeal of holistic nutrition across generations Holistic nutrition, which supports both physical and emotional wellbeing, is resonating with all generations from gen Z to boomers in slightly nuanced ways, according to new research from Innova Market Insights.

RESEARCH
RCT supports eggshell membrane’s joint health benefits The water-soluble, chicken-eggshell-membrane ingredient BiovaFlex may help support joint health and function, says a new study published in the Journal of Medicinal Food.

Vitamin D deficiency linked to adolescent aggression Vitamin D deficiency in childhood could be linked to aggressive behavior, as well as anxious and depressive moods in adolescence, according to a study of school children in Columbia.

New study supports muscle benefits of GABA supplementation Oral gamma-aminobutyric acid (GABA) supplementation may enhance the benefits of whey protein for building lean mass, suggests a study from Japan.

Omega-3 supplements have little or no effect on risk of type 2 diabetes, say researchers Omega-3 supplements should not be encouraged to help tackle diabetes, argued University of East Anglia researchers after a systematic review that found no benefit of the supplement.

Chr. Hansen-funded probiotic study points to boosts in immune health A study funded by Chr. Hansen reveals the benefits probiotic consumption has on flu-like sickness, as the study results indicate a daily regimen may be justified for particular at-risk populations, such as children.

Curcumin may protect against muscle damage, soreness after exercise Supplementation with curcumin may reduce muscle damage and soreness without impacting the ‘natural inflammatory response,’ says a study from Mississippi State University.

FDA WARNING LETTERS & GUIDANCES
Current FDA enforcement actions and guidances Keep 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.

Search and sign up for a variety of FDA Guidances.