Bipartisan bill would OK CBD in food, supplements

​TOP STORY
Bipartisan bill would OK CBD in food, supplements Legislation was unveiled this week in the U.S. House of Representatives to allow hemp-based CBD to be marketed in dietary supplements and conventional food. The bill, introduced by House Agriculture Committee Chairman Collin Peterson,D-Minn., would explicitly include hemp-derived CBD in the definition of a dietary supplement. It also would create an exception for CBD to a “prohibited act” in Section 301(ll) of the Federal Food, Drug & Cosmetic Act (FDCA), which essentially bars the introduction into interstate commerce of a food (including a dietary supplement ingredient) that was first studied as a pharmaceutical drug. Read more→

​Hemp Extracts/Cannabinoids Committee call rescheduled
The UNPA Hemp Extracts/Cannabinoids Committee update call, which will discuss HR 5587 among a long list of other regulatory activities, has been rescheduled for Tuesday, Jan. 21, at 2pm MST. Call-in: 857.232.0476; code: 828404.

UNPA NEWS

FSVP training, February 11-12 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.

Expo West Members' Meeting set for March 4 in Anaheim 
Members’ Meeting: 8-9am
Open House/Meet & Greet: 9-10am
Plan to join your fellow UNPA members at the association’s annual members' meeting at Natural Products Expo West—the meeting is open to all UNPA members and invited guests, and there is no charge to attend. RSVP here.

Registration now open for annual Dietary Supplement Regulatory Summit, May 27, in Washington 
This fifth annual, one-day summit hosted by UNPA, AHPA, CHPA and CRN provides an intensive deep dive into pressing and topical federal regulatory issues of ultimate importance to the dietary supplement industry. Topics at this year's event include hemp/CBD, DSHEA 2.0, NDI/GRAS and much, much more. UNPA members receive discounted registration using the code AssociationMemberEarlyBird, and early-bird rates run through Feb. 15. Click here for more information.

REGULATORY
FDA grants petition on glucomannan as a dietary fiber Responding to a citizen petition from The Food Lawyers, FDA said it intends to propose that “glucomannan” be added to the definition of dietary fiber.


FDA approves drugs faster than ever but relies on weaker evidence, researchers find FDA has gotten faster at approving new prescription drugs over the past four decades, but the evidence it relies on in making those decisions is getting weaker, according to new research published this week.

FINANCIALS
LifeVantage posts record 2Q preliminary revenue, introduces free shipping in 2020 LifeVantage Corporation announced preliminary revenue for the 2Q20 and six-month period ended Dec. 31, 2019. Preliminary revenue for Q2 was approximately $61 million, while preliminary revenue for the first six months of FY2020 was approximately $117 million. LifeVantage’s introduction of free shipping will provide incremental value to customers and further improve the consumer  experience.
 $580.98 million in sales expected for Nu Skin Enterprises this quarter Equities analysts expect Nu Skin Enterprises to report sales of $581 million for the current quarter, according to Zacks. Three analysts have made estimates for Nu Skin Enterprises’ earnings, with the highest sales estimate coming in at $581.7 million and the lowest estimate coming in at $580 million.

M&A ACTIVITY
Catalent has acquired Italian biologics and oral dose facility from Bristol-Myers Squibb Catalent has completed the purchase of Bristol-Myers Squibb’s biologics, sterile and oral solid-dose product manufacturing and packaging facility in Anagni, Italy, which offers extensive capabilities in aseptic liquid and powder filling for biologics and sterile products across multiple vial sizes.

HEMP/CANNABINOIDS
Court awaits FDA ruling on CBD, stays class action suit Marketers of CBD ensnared in class action litigation could get some temporary relief if courts invoke a doctrine known as “primary jurisdiction."
 High anxiety: Proposed hemp rules worry industry Hemp growers and entrepreneurs, who were joyous a year ago after U.S. lawmakers reclassified the plant as a legal agricultural crop, now are worried their businesses could be crippled if federal policymakers move ahead with draft regulations.

BOTANICALS
New botanical adulterants prevention bulletin reviews evidence of olive oil adulteration and fraud The ABC-AHP-NCNPR Botanical Adulterants Prevention Program announced the publication of a new Botanical Adulterants Prevention Bulletin on olive (Olea europaea) oil. The publication summarizes data on economically motivated substitution of extra-virgin and virgin olive oils with undeclared other vegetable oils or lower-grade olive oils.
 How the Gingko biloba achieves near mortality Trees, like the Ginkgo biloba, can live more than 3,000 years. Now, in the most comprehensive plant-aging study to date, researchers have revealed the molecular mechanisms that allow the ginkgo—and perhaps other trees—to survive so long.

LEGAL
If its adulterated, you may be incarcerated: Criminal liability for FD&C violations FDA has increasingly relied on the Park Doctrine—which states that the government can convict a company executive even if he isn’t aware of a violation of the Food, Drug & Cosmetic Act—to act against supplement brands.

ORGANICS
USDA organic flavors required when commercially available The National Organic Program has published a final rule that amends the National List of Allowed and Prohibited Substances. The new ruling requires the use of certified organic flavors whenever they are commercially available.
 Presidential candidates discuss regenerative ag, importance of organic The Organic Farmers Association has received responses from two presidential candidates following its forum, “Combating Climate Change with Organic and Regenerative Agriculture,” held in December, which was attended by Sen. Bernie Sanders. Sen. Elizabeth Warren and Pete Buttigieg have submitted written responses to the questions posed by organic farmers at the event. Sanders has previously identified regenerative ag as a priority in the 2020 race.

ENVIRONMENT
EU commission bans Bayer pesticide tied to harming bees The European Commission has decided not to renew approval for a pesticide linked to harming bees, effectively banning Bayer's insecticide known as thiacloprid.
 Soil and the gut: Two ecosystems with a deep connection Nature is full of parallels and deep interconnections. The gut, or gastrointestinal tract, for example, comprises the mouth, esophagus, stomach, large intestine, and small intestine and is essentially a long tube through which food travels after we consume it. It doesn’t seem like this collection of organs could possibly have a connection to soil, but it does—a deep one. In fact, soil has a microbiome too.

GMOs
New government website meant to clarify GMO regulations does little to answer lingering questions A new website that links information from the EPA, USDA and FDA aims to help consumers understand the ramifications of emerging biotechnology regulations. But it is frustratingly unclear what is and isn't covered by the new GMO labeling laws, and more needs to be revealed in terms of whether or not gene-edited foods will ever be subject to additional regulatory scrutiny.

ADVOCACY
Email no longer works for advocacy efforts Public advocates have one tool they turn to when trying to influence legislators: the grassroots email campaign. It doesn’t work, according to The 2020 Grassroots Influence Pulse, a study conducted by The Showalter Group.

SUSTAINABILITY
The 2020 State of Green Business Report The 13th annual edition of the State of Green Business provides key data and trends to watch in the world of sustainable business. The first half of the report shares the 10 trends sustainable business professionals should be tracking in 2020. The report also offers the State of Green Business Index.

GLOBAL REGULATORY
EFSA warns THC levels in supplements exceed safety limit The European Food Safety Authority warns of consequences to the heart and cardiovascular system as a result of consuming large amounts of hemp products, including supplements, teas and energy drinks.

Bioiberica receives novel food authorization in Brazil The Health Regulatory Agency of the Brazilian Ministry of Health has provided authorization for Bioiberica’s Mobilee as a novel food ingredient. Mobilee is a patented ingredient derived from rooster comb extract that is rich in hyaluronic acid.

RETAIL
H-E-B topples Trader Joe's as America’s favorite grocerDunnhumby has just released its latest Retailer Preference Index, with Texas-based H-E-B leaping into first place, muscling past Trader Joe’s, Amazon and Costco. The new rankings reveal a power surge coming from traditional regional grocers, fueled by exceptional relevance and convenience.

UNPA MEMBER COMPANY NEWS
Rend Al-Mondhiry elevated to partner at Amin Talati Wasserman Amin Talati Wasserman announced that Rend Al-Mondhiry has been elevated to partner of the firm. Rend is well-known and respected and has quickly become a nationally recognized thought leader on the regulation of CBD and other hemp-derived products, as well as on a wide variety of other cutting-edge regulatory issues.

OMEGA-3s
STRENGTH omega-3 trial discontinued The STRENGTH trial for Epanova, omega-3 carboxylic acids, has been discontinued due to its low likelihood of demonstrating a benefit to patients with mixed dyslipidaemia, who are at increased risk of cardiovascular disease, according to AstraZeneca, the manufacturer of Epanova.

SPORTS NUTRITION
Influencer-designed products are set to shake sports nutrition in 2020 Influencer-designed products will be one of the biggest trends in 2020 for sports nutrition and the market is ripe to capitalize on the trend, according to a market analyst.

PREBIOTICS
Sientists create designer prebiotics to disrupt the microbiome health space A team of top scientists leading the way in designer prebiotics, BCD Bioscience, has been selected as one of the most pioneering startups in the microbiome health industry.
 Prebiotics decide gut health and overall wellbeing Studies pointing to prebiotics as the modulators of the microbiome-gut-brain axis could see the non-digestible food ingredient become the basis for preventing the rise in obesity and diabetic cases.
 Prebiotic sales decline but opportunities abound in bars and beverages Prebiotic sales overall are declining, but several specific categories, such as wellness bars, gels and beverages, show great opportunity for prebiotic formulas.

TRENDS
2020 predictions: Staff changes at FDA, CBD, personalization and the microbiome The year is new and lots of people are getting out their crystal balls. Nutraingredients-USA is no exception. Here are the top issues that will impact the dietary supplement industry in the next decade.

PARTNERSHIPS
Bayer and Azitra make deal to develop skin microbiome products Bayer is to enter a joint development agreement with Azitra that uses the skin microbiome as a basis for new skin care products to address a range of skin conditions.
 Jansson and Kaleido Biosciences form gut-focused pact Janssen is to team up with Kaleido Biosciences to explore microbiome-related therapies that focus on healthy gut function to help prevent atopic, immune and metabolic conditions in childhood.
 Nestlé Health Science and Codexis extend gut-disorder partnership Nestlé Health Science and Codexis are to extend a gut health-focused pact that will continue to develop a lead candidate to address the gastrointestinal (GI) disorder phenylketonuria.

DIRECT SALES
Nine years jail for boss of China supplement firm that breached MLM rules A year-long saga involving Chinese direct-selling firm Quanjian has now come to a close with its founder sentenced to jail for nine years.

PERSONALIZED MEDICINE
23andMe sells rights to its first new drug Using the genetic information it collects from customers, testing company 23andMe says it has developed its first drug and that it is selling the rights to the medication to a Spanish pharmaceutical company. It already shares its data with drug makers, including GlaxoSmithKline.

PACKAGING
BPA replacement hinders heart function Bisphenol S (BPS), a replacement for bisphenol A (BPA), can hinder heart function within minutes of a single exposure, according to a new study by the University of Guelph in Ontario and published in the journal Scientific Reports. The study raises concerns about the safety of BPS as a replacement for BPA, which is commonly used in food packaging.
MEDIA WATCH
The kratom debate: Helpful herbal or dangerous drug? Kratom continues to be a hotly debated herb over its purported ability to help opioid addicts recover from substance abuse. FDA warns U.S. consumers that kratom is not fully understood and, therefore, not safe for use; however, propositions to categorize kratom as an illegal substance has led to pushback from advocates and lawmakers that has thus far blocked any type of stricter regulation of the herb.

 APAC MARKET
Aesthetic benefit a prime consideration for Asian women buying sports nutrition Asian women prefer sports nutrition products that claim aesthetic benefits and weight loss more so than female consumers in other parts of the world, according to new insights from Lumina Intelligence.

MARKET RESEARCH
Calcium intake declines among Canadians, study finds A new study has found that calcium intakes have decreased in Canada in recent years as consumers eat less dairy products and use fewer calcium supplements.

2019's biggest ingredient sales trends (positive and negative) for dietary supplements Looking across mainstream and innovation channels, analysts at SPINS see a lot of commonality among top-growing functional ingredients. Those that appeal to both natural and conventional shoppers—protein, collagen, elderberry, magnesium, MCTs, CBD—parallel broader industry trends and provide insight into current consumer wellness priorities.

Retailers must expand online to offline capabilities to capture new era of experience-seeking consumers Consumers are moving across online and offline channels more fluidly, leaving retailers needing to provide a variety of new customer touch points to build engagement and shopper loyalty, according to a report from Edge by Ascential called Future Retail Disruption.

3 ways independent retailers can appeal to millennial shoppers 5WPR Public Relations’ new 2020 Consumer Culture Report sheds some light on how the report’s topline findings will affect independent natural retailers. These consumers find their products in store instead of online, they get product information from media and they will pay a premium if some proceeds go to charity.

RESEARCH
Green tea may contribute to a longer and healthier life Tea consumption is linked to a reduced risk of cardiovascular disease, as well as improvements to health and longevity, especially among consistent, habitual tea drinkers, according to a study published in the European Journal of Preventive Cardiology.

Chinese herbal may be chemoprotective against colorectal cancer The herbal-based supplement berberine reduced the recurrence risk of colorectal adenomas and polypoid lesions after polypectomy vs. placebo, a Chinese randomized trial found.


Polyphenols show promise in shifting microbiome away from obesity statesA new paper by Brazilian researchers elucidates ways in which polyphenols may help shift the gut microbiome away from states associated with obesity and metabolic disorders.


Sestrin protein offers benefits of exercise without actually working outScientists in Michigan explored the impact of sestrin, and their findings suggest that one day it could be used to help reduce muscle decline without the need for exercise.


Meta-analysis supports grape seed extract’s cardiovascular potentialExtracts from the seeds of grapes may significantly improve cholesterol and trigylceride levels and reduce markers of inflammation, according to a new meta-analysis of 15 randomized trials.


Study reveals novel pathway for tocotrienol in neuroprotectionResearch published in the International Journal of Molecular Sciences detailed a novel pathway for tocotrienol-mediated neuroprotection in primary hippocampal neurons. The collaborative study was conducted by a group of researchers from Yale University and the University of Alabama.
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.

Search and sign up for a variety of FDA Guidances.