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UNPA Digest

CBD industry hit with nearly a half dozen class-action lawsuits

12/5/2019

 
​TOP STORY
CBD industry hit with nearly a half dozen class-action lawsuits A mounting number of putative class-action lawsuits have been filed in California against marketers of CBD products—including two of the largest companies in the sector based on sales—after FDA reiterated its years-old stance in warning letters and a news release that the compound cannot be lawfully sold in dietary supplements. The agency has taken the explicit position that CBD is a drug only, and is actually illegal in the use of foods, beverages, supplements, and animal products. Read more→
UNPA NEWS

REGISTER TODAY!
Intentional Adulteration training, Jan. 22 in Lehi, Utah
Did you know that you're responsible for having in place a plan to deal with adulteration of your ingredients and finished goods? It's all a part of FDA's Mitigation Strategies to Protect Food Against Intentional Adulteration (referred to as the IA rule), part of the Food Safety Modernization Act. Developed by the Food Safety Preventive Controls Alliance (FSPCA), this intensive, one-day certificate course is the "standardized curriculum" recognized by FDA. Join Ned Mitenius, a 30-year veteran in the food processing industry, who will lead the training. UNPA members receive a $200 discount at registration.

UNPA's FSVP training, February 2020 in Utah 
Do you import ingredients or finished goods? Do you know your obligations under the Foreign Supplier Verification Programs regulation? Join former FDA Investigator and UNPA VP, Global Regulatory & Compliance Larisa Pavlick for this certificate-based training. Click on the title for more information, why you might need to attend and to register.

LEGAL
11th Circuit concludes adulterated supplements are worthless and this economic loss is sufficient to sue The Court of Appeals for the Eleventh Circuit has paved the way for a potential class action against a supplement brand because of the alleged presence of an illegal ingredient, which rendered the product "worthless" and gave the plaintiffs standing to sue.
 Acosta files for chapter 11 to reduce $3 billion debt CPG sales and marketing agency Acosta filed for Chapter 11 bankruptcy in Wilmington, Del., to reduce its $3 billion debt burden. Owned by private equity firm Carlyle Group LP, which also owns Nature's Bounty, since 2014, Acosta is one of the world’s largest grocery brokers, but it has faced hurdles as consumer tastes evolve and marketing priorities change.

REGULATORY
New executive order may impact FTC actions against direct sellers Two executive orders issued in October 2019 may decrease FTC’s ability to regulate industries through informal guidance documents. Because FTC’s regulation of the direct selling industry relies heavily on guidance, the orders are particularly relevant to multilevel markers and direct sellers.
 Ex-FDA chief revisits efforts to modernize food labeling Scott Gottlieb, who led FDA from May 2017 until March 2019, said he and his team aimed to modernize claims that could be permitted on food labels, as well as make it easier for consumers to understand new and different ingredients in today’s foods. He discussed the agency’s efforts to better define commonly used terms like “healthy” and “natural,” as well as to target inappropriate use of what he said are confusing terms, such as “non-GMO.”

HEMP/CANNABINOIDS
Appeals court decision, recent warning letters open door for more CBD suits A recent appellate court decision coupled with a spate of warning letters sets the stage for more class-action lawsuits, like the proposed ones filed against CBD companies in late November.
 Proposed hemp regulations prompt senators to urge USDA to adopt new hemp rules Sparked by proposed USDA regulations that would drastically alter the certification process for industrial hemp, two lawmakers from Oregon want the agency to make several changes before it finalizes rules for the U.S. Domestic Hemp Production Program.
 Just 32 percent of CBD-familiar consumers have purchased products While 70 percent of consumers are now familiar with CBD, only 32 percent of these consumers have purchased CBD products.

BOTANICALS
Climate crisis threatens medicinal plants: HerbalGram report Rapidly warming temperatures, fluctuating precipitation patterns and changing landscapes are all having measurable negative effects on global flora and leading to large-scale disruptions to medicinal and aromatic plants.

M&A ACTIVITY
Givaudan snaps up Indena’s nutricosmetics unit as part of ongoing pact Italian botanicals firm Indena is set to sell its nutricosmetics business to Swiss flavors and fragrances specialist Givaudan in a deal that also involves a manufacturing and innovation partnership between the two firms.
 Butterfly acquires a majority stake in clean-nutrition brand Orgain The partnership will reportedly enable Orgain to expand consumer awareness, production innovation and global distribution.

OBITUARIES
South Dakota plane crash victims identified as Idaho direct-selling business executives, family Brothers Jim and Kirk Hansen, founders of Kyäni, which sells health products and nutritional supplements, were killed along with seven other family members in a plane crash near Chamberlain, S.D. Jim, Kirk and their father James, were prominent members of their home community in Idaho Falls, and the family also worked to alleviate hunger over seas and make the world a better place.
 Michael Mooney co-founder of Supernutrition USA passes away Michael Mooney passed away in his home in Portland, Ore., on November 9. Mooney was a leader in nutritional science and a longtime champion for the supplement industry. Michael and his biochemist father, Patrick Mooney, created a not-for-profit vitamin research co-op that led to the development and co-founding in 1977 of SuperNutrition and its state-of-the-art supplements.

GLOBAL REGULATORY
Italian supplement seizure hints at e-commerce issues Italy’s confiscation of supplements worth €400,000 from an express-delivery firm brings into focus inconsistencies in notification procedures required for cross-border food supplement e-trade.
 HMO blend and synthetic chili pepper receive Novel Food approval The European Commission adds to its Novel Foods catalog two Human Milk Oligosaccharides (HMO) and a synthetic chili pepper extract for use in dietary supplements.

APAC MARKET
More FSMPs to come: Nestlé Health Science China opens new production innovation center Nestlé Health Science China has officially inaugurated its product innovation center in Taizhou, Jiangsu province, to beef up the firm’s portfolio of Foods for Special Medical Purposes (FSMPs) in China.

PEOPLE
DSM announces CEO succession plan with Feike Sijbesma to step down next year DSM CEO Feike Sijbesma will step down next year, handing over his responsibilities to Geraldine Matchett and Dimitri de Vreeze as co-CEOs in February.

OMEGA-3s
For your heart, eat fish or take pills? Now there’s a drug equal to eight salmon servings In early November, an advisory panel to FDA voted unanimously to approve expanded use of the prescription drug Vascepa, made from EPA. Vascepa is already approved for use in people with very high levels of triglycerides, but now the drug may soon be approved for use in a much wider group of Americans, including those who’ve had a heart attack, stroke or have Type 2 diabetes.

RETAIL
Vitamin Shoppe adds data-driven, in-store sampling The Vitamin Shoppe is adding interactive, digital kiosks to add data analytics to customer sampling. The first store using the technology from Vengo Labs is in New Jersey, with plans to add at least 10 more stores by the end of the month.

INDUSTRY
Nutritional Outlook's 2019 best in industry award winners In Nutritional Outlook's 2019 Best of the Industry Awards, the publication recognize individuals, groups and companies, whose initiatives today may help shape the state of the dietary supplement and food and beverage industries for years to come.

Leading nutrition organizations unite to champion personalized nutrition The newly formed American Nutrition Association is aiming to close the “nutrition gap” in our culture and healthcare systems through the power of personalized nutrition.

UNPA MEMBER COMPANY NEWS
Sabinsa issues new U.S. patent for LactoSpore based upon research confirming its ability to reverse depression in patients with IBS Sabinsa has been granted a U.S. patent for a method of managing dementia and dementia-related sleep disorders presented as symptoms of major depressive disorder in humans associated with Irritable Bowel Syndrome (IBS) by administering Bacillus coagulans MTCC 5856 (LactoSpore) at a dose of 2 billion colony forming units per day.

SPORTS NUTRITION
UFC and USADA revamp anti-doping policy to better recognize the value of third-party supplement certification The U.S. Anti-Doping Agency and UFC adopted sweeping changes to the UFC Anti-Doping Policy, which now includes a definition of certified supplements to help athletes steer clear of contaminated substances and recognize the value of third-party supplement certification.

VITAMIN DEFICIENCIES
Nutrition expert urges action on vitamin D deficiency in younger populations A leading nutritionist is calling for greater awareness of vitamin D deficiency in younger healthy populations that are becoming susceptible to an increased diabetes risk as a result.

CROP DIVERSITY
Raiders of the lost crops: Scientists race against time to save genetic diversity More than 100 scientists in 24 countries have banded together to collect wild relatives of popular domestic crops in The Crop Trust Project, which aims to make sure that such varieties are available in seed form regardless of whether climate change decimates them in their natural habitats so as to preserve genetic diversity for the future.

PACKAGING
Brands confront plastic problem Reducing packaging and using environmentally friendly materials is a growing consumer demand and a complex challenge many natural products brands are working hard to meet. The efforts come in the nick of time, as issues surrounding the highly mobile per- and polyfluroalkyl chemicals (PFAs) in food packaging prompt states like Maine and Washington to pass legislation banning such products.

MARKETING
Five B2B marketing trends to watch in 2020 B2B decision makers are a lot younger than they used to be and do at least 12 searches online before engaging with a website. This article provides a few ways to get their attention and market your business more successfully in 2020.

How brands can navigate boycotts, outrage Consumers are increasingly prone to put their money where their mouths are when company executives do things they don’t agree with. In order to navigate backlash, companies need “to know who they are, and who their core stakeholders are, and what those stakeholders believe in,” according to Kellogg Insight.

MARKET RESEARCH
Brand authenticity, transparency outweigh sustainability The most important values for brand selection among U.S. adults are authenticity/transparency, far outweighing sustainability, community involvement and political/cultural advocacy, according to a new survey from Blis.

Survey of Hispanic millennials indicates strong preference for natural health remedies Most Hispanic millennials (87 percent) are interested in natural remedies, such as changes in diet to prevent and/or manage type 2 diabetes without medication, if possible, according to a survey from Aguacates Frescos - Saborea Uno Hoy, the Hass Avocado Board’s science-based program.

Nielsen: Which sustainability attributes matter most to consumers Consumers are increasingly factoring in a product's sustainability attributes into their purchasing behavior, and 73 percent of consumers surveyed by Nielsen say they are willing to change their consumption habits to reduce their environmental impact.

RESEARCH
Astaxanthin: How much is too much? A safety review A recent study evaluating maximum safe daily intake of astaxanthin found no safety concerns with natural astaxanthin supplementation, but because synthetic astaxanthin is chemically different than natural astaxanthin and has few studies, these results are not transferable to synthetic astaxanthin.  

China’s yingyangbao improves weight, height and anemia amongst young children The consumption of yingyangbao among infants and young children living in rural China has improved their weight and height, according to a meta-analysis.

Probiotic combination shows immune health benefits for children in daycare A combination of two Lactobacillus strains may reduce the severity of runny nose and may reduce absences from daycare, according to a new study from Swedish probiotic firm Probi.

Taiyo study supports L-theanine for cognitive benefits Supplements containing L-theanine from tea may boost measures of cognitive function such as verbal fluency and executive function, compared to placebo, in healthy adults, suggests a new study from Taiyo.

Vitamin K2 as MK-7 supports nitric oxide dependent endothelial function An animal study recently published in Vascular Pharmacology found that vitamin K2 as MK-7 (MenaQ7 from Nattopharma) boosts nitric oxide (NO) to improve NO-dependent endothelial function.

Lycopene from Sibelius Natural Products may support male reproductive health A study recently published in the European Journal of Nutrition found that a proprietary lycopene extract from U.K.-based Sibelius Natural Products may support male reproductive health.

Personalized treatment with omega-3s might help children with ADHD Omega-3 supplements could improve the attention spans of some children, who have been diagnosed with attention deficit hyperactivity disorder, a new study shows—but only if the children are deficient in omega-3 polyunsaturated fatty acids levels, particularly EPA and DHA.

​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.

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