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FDA won’t be hurried to create CBD exceptions amid safety concerns, official says
Published 7 hours ago
Well, what can we say? Not a good sign, IMO.
A top official for the U.S. Food and Drug Administration (FDA) said the agency is concerned that developing a legal exception for supplements containing CBD could send the wrong message, both to companies interested in entering the market and consumers.
Lowell Schiller, the FDA’s principal associate commissioner for policy who is leading a panel investigating CBD as an ingredient in food, beverages and dietary supplements, told a group of nutritionists this week that the agency’s biggest concern is whether CBD is safe to consume in food and supplements, according to nutraceuticals industry trade publication Nutritional Outlook.
Speaking at a conference for the Council for Responsible Nutrition (CRN), Schiller conceded the FDA is getting pressure to move forward with a legal pathway for using CBD as an ingredient.
But he said the agency still does not have enough data to determine whether CBD is safe for long-term use, especially among vulnerable populations.
The CRN was one of several trade organizations that sent a joint letter to Congress in October, asking for legislation to establish CBD as a lawful dietary ingredient by waiving the federal Food, Drug and Cosmetic Act.
Schiller said CBD is not risk-free, pointing to concerns like potential liver toxicity and drug interactions, as well as animal studies indicating risk for the male reproductive system.
“We look at an FDA-regulated product containing CBD the same as we would look at an FDA-regulated product containing any other substances,” he said. “We apply the same tools and authorities and statutory provisions.
“At FDA, we don’t have one set of rules for cannabis-derived substances and another set of rules for other substances. We don’t approach CBD or other cannabis-derived substances with any sort of animus or imposing new burdens.”
Schiller said creating an exception for CBD without adequate safety data could:
Set a dangerous precedent for other unregulated substances in the future.
Encourage more bad actors to enter the market.
Impede the FDA’s ability to identify and address safety violations in the CBD market and send the incorrect message that FDA endorses CBD safety.
He said the agency plans to report on its progress soon. To read the full comments from Schiller’s address, click here. - https://www.nutritionaloutlook.com/regulatory/creating-legal-exception-cbd-supplements-short-full-safety-data-could-set-bad-precedent-says-fda-crn
Absolutely true! I’ve gotten heaps of folks/clients using the 500mg roll-on. I love it and use it for my tight neck muscles 2-3 daily.
jefra: Most excellent overview. I can always count on your deep DD and analytical powers to provide the board with sound and cogent insights. Cheers!
I see that $1 print occurring at 1:01 PM. Isn’t that a AF print?
I hear you. But I’ve also seen major price gauging on products the same cost as CVSI and half the CBD content. Average shopper isn’t savvy
What a major miss with CVSI. I have to say I was perturbed by the poor sales at our big Sprouts Market. At first, they sold out, but then took forever to restock. Once restocked, many other brands with greater shelf presence, more skus and more colorful packaging started out-selling +CBD. One sample doesn’t make for great extrapolation on sales, but in this case, it sure did.
Also, based on talking with supplement department manager, it seemed the CBD TREND starting waning a couple of months ago. Anyone else have insight on this?
Nevertheless, estimates were missed big time, but our company still has no debt, cash in the bank. Unfortunately, the negativity will be spun even more now.
CBD without positive FDA guidance in an Emerging market is going to continue creating choppy waters. Does CVSI have the right ship to stay afloat and navigate until calmer seas?
This Zach’s BS is a complete joke. Why bother if they’re going to add all those disclaimers???
Thanks for taking the time to do this SL!
Here’s my guess: $19,899,999
Excellent article, Jefra. Thanks. CV Sciences is and has been a disrupter, especially with Stuart at the helm.
News alert - USOTC: WEYL
Statement of Changes in Beneficial Ownership (4)
13:07 : Tuesday 15 October 2019
Looks like Suen has been selling more shares!! That's what some here would like you to believe.
Actually, the last few weeks he's purchased 100k shares. vote of confidence????
CBD tops turmeric as top-selling dietary supplement, charting up 333% in natural channels
Published September 26, 2019
CBD rocketed to the best-selling herbal dietary supplement in natural sales channels last year, ousting turmeric as the No. 1 seller, according to a new report from the American Botanical Council.
Sales of CBD products jumped 333% in 2018 in natural- and health-foods sales channels, notching $52.7 million in U.S. sales, the Texas-based industry group reported this week in its 2018 Herb Market Report.
“CBD products have flooded the U.S. marketplace, and sales show no signs of slowing,” the American Botanical Council said.
In 2017, natural sales channels sold some $7.6 million worth of CBD.
However, CBD products have not yet cracked the Top 40 for dietary supplements in mass-market channels such as mainstream grocery and drug stores, the group says. In those mass-market channels, horehound was the top seller in 2018, nearing $147 million in sales. Horehound is a member of the mint family and is commonly found in cough drops and lozenges.
The CBD boom came as sales of other hemp-derived dietary supplements fell by 9.9% in 2018. Hemp supplements such a hempseed oils rich in omega-3 fatty acids are declining in popularity even as CBD is flying off shelves, the group reported.
“The reason for the sales decline is unclear, but it may be due to increased availability of and consumer preference for other plant-based sources of protein and fiber,” the group concluded.
The report does not track sales in cannabis retail channels. The report uses sales data from Nutrition Business Journal and SPINS, a market-tracking firm that specializes in natural and organic products.
Some other takeaways about CBD sales:
Roughly 60% of the CBD products sold in the U.S. natural channel in 2018 were in the form of alcohol-free tinctures, followed by capsules and softgels.
The majority of CBD supplements are marketed for nonspecific health issues, with mood support and sleep the next most-popular uses.
U.S. consumers spent more than $8.8 billion on all herbal dietary supplements in 2018.
Overall sales of herbal supplements in the U.S. have increased each year since 2004.
I have a strongsuspicion that they were served by the law firm representing the investment group Thomas has been talking about. Why else would they suddenly disappear on this board and the Yahoo! board?
Sprouts farmer’s market in my city has been out of CV sciences topicals for almost a month now. I’m not sure why. I keep pressing the manager of the supplement department to follow up with corporate.
Twice I have seen people looking at the other products CBD topical products and have educated them about CBD and then sent them to another health food store to buy CV sciences Oil AND Roll-on. The sad part is that many of these customers are completely ignorant about CBD and they end up buying another brand that’s expensive relative to how much CBD is in it.
Argh!!!!!
Sounds like an easy slam dunk for CV Sciences. Why in the heck is it taking so long???
‘Undeterred’ Prosecutors
The indictments, which come after the government lost two manipulation cases in court, are a good indication that prosecutors are “undeterred and are becoming more, not less, aggressive” in cracking down on market manipulation, said Benjamin Singer, a former head of the Justice Department’s securities fraud unit who is now at O’Melveny & Myers LLP in Washington.
Short and Distort. Seems like the majority of posts on this message board are taking place between the serious sincere longs and the short and distorted crowd. I always question how much naked shorting is actually going on because I don’t understand the mechanism, but I do know without a doubt that ever since Hindenburg came on the short and distorted crowd have been en masse on this and the Yahoo! boards trying to spin a negative perspective on the company. OK is anyone is interested here’s a nice overview of the short and distorted strategy
https://www.investopedia.com/articles/analyst/030102.asp
dabooone:
Oh my God, are you serious? Now that kind of Rumor I can get behind. I’m logging into my brokerage account now and buying all that I possibly can. Hell, Hopefully I have enough time To take a second mortgage out on the Homestead
ap17: I believe the good doctor is referring to PlusCBD capsules but I could be wrong
Not much has been discussed hear about corporate governance compliance. Jefra’s mention of this related to today’s news sent me on a search.
Besides FDA guidelines, compliance plays a major roll in getting listed on Nasdaq.
https://www.sullivanlaw.com/Corporate_Governance_Regulatory_Compliance_Checklist.html
Corporate Governance Regulatory Compliance Checklist
The following is a brief sample of just a few of the areas we explore when conducting a Corporate Governance compliance and best practices review. For more information on the complete audit checklist, or to discuss questions or concerns specific to your organization, please contact Howard Berkenblit.
Board of Directors and their Committees
Do all independent directors meet required criteria?
Are all committees appropriately comprised and functioning effectively?
How does the Board oversee risk management?
Is the Board adequately protected through indemnification and insurance arrangements?
Governance Issues
What should the Company do to address Dodd-Frank rules such as say-on-pay, clawback policies and pay ratio disclosures?
Has the Company set up and monitored required policies such as whistleblower procedures, non-audit service fee approvals and related person transaction approvals?
Are consultants used and overseen appropriately?
Are equity grants properly and timely approved and documented?
Insider Trading/Ethics
Does the Company have an effective policy to prevent insider trading?
Does the Company have a compliant code of ethics and are officers, directors and employees educated about the code?
Disclosure and Reporting Practices
Are the Company’s controls and procedures adequate?
Does the Company assist insiders to ensure timely reporting and avoidance of short-swing profits?
Does the Company’s website have required governance and SEC documents?
jefra: that Wil be the sweetest music to our ears.
Great reference, Wolfie! I forgot about all of those funny commercials.
And look at those white boys PLAY that Funky Music. Great Blast from the Past to accompany some great CVSI news.
Top-of-the-mornin’ to ya’ mate!!
Exactly, Mark! What did you mean by AKA?
In addition to her extensive Board experience, Ms. Graham is a senior marketing executive change agent who directly influenced the success, image and growth of the $3 billion Jack in the Box brand for more than 20 years. As the SVP & Chief Marketing Officer for Jack in the Box for 10 years, she was a pioneer in innovative branding, product development, advertising and digital media. Acknowledged for her strategic thinking, financial acumen, courage and proven results, her strategic vision and business expertise enabled her to effectively reinvent the Jack brand multiple times with franchise partners and executive management. While at Jack in the Box, Ms. Graham delivered one of the most successful national advertising campaigns achieving 10 Effie Awards and several Belding’s and Clio Awards.
CV SCIENCES, APPOINTS TERRI FUNK GRAHAM TO BOARD OF DIRECTORS
Download as PDFAugust 27, 2019
Graham Brings Extensive Fortune 1000 Experience Serving on Boards of Directors and in Senior Leadership Roles
SAN DIEGO, Aug. 27, 2019 (GLOBE NEWSWIRE) -- CV Sciences, Inc. (OTCQB:CVSI) (the “Company”, “CV Sciences”, “our”, “us” or “we”), a preeminent supplier and manufacturer of hemp cannabidiol (CBD) products, today announced that Terri Funk Graham has been appointed to CV Sciences’ Board of Directors effective August 22, 2019.
“Terri brings extensive Fortune 1000 experience serving on Boards of Directors and in senior leadership roles – we are thrilled to welcome her to our Board of Directors,” said Joseph Dowling, Chief Executive Officer of CV Sciences. “Terri’s remarkable leadership has driven stellar results and she will be invaluable to CV Sciences as we continue to expand the business and execute on our global growth strategy.”
Ms. Graham joins the Board of Directors with vast experience serving on the Board of Fortune 1000 companies. She is currently an Independent Board Director for Sprouts Farmers Market Inc., a $5 billion specialty retailer of natural and organic food focusing on health and wellness, where she serves as the Chairperson of the Nominating & Corporate Governance Committee and serves on the Compensation Committee. Ms. Graham is also an Independent Board Director for Lumber Liquidators Inc., a $1 billion specialty retailer of hard-surface flooring, where she serves as the Chairperson of the Nominating & Corporate Governance Committee and a member of the Compensation Committee. She also served on the Hot Topic Inc. and 1-800 Contacts Inc. Boards before these companies were sold to private equity firms.
In addition to her extensive Board experience, Ms. Graham is a senior marketing executive change agent who directly influenced the success, image and growth of the $3 billion Jack in the Box brand for more than 20 years. As the SVP & Chief Marketing Officer for Jack in the Box for 10 years, she was a pioneer in innovative branding, product development, advertising and digital media. Acknowledged for her strategic thinking, financial acumen, courage and proven results, her strategic vision and business expertise enabled her to effectively reinvent the Jack brand multiple times with franchise partners and executive management. While at Jack in the Box, Ms. Graham delivered one of the most successful national advertising campaigns achieving 10 Effie Awards and several Belding’s and Clio Awards.
“I am honored to join CV Sciences’ Board of Directors and welcome the opportunity to play a role in taking this great company to the next level,” said Ms. Graham. “As a pioneer in the industry, CV Sciences is well-positioned in a high growth category with its superior PlusCBD™ Oil brand and a significant opportunity to expand their retail distribution and e-commerce presence. The Company has built a strong team and I look forward to being a part of CV Sciences’ future success.”
Ms. Graham received a B.S. in Business Marketing from San Diego State University and Master’s degree in Business Organization Management from the University of Phoenix.
Hit by Trade War, Tobacco Farmers Turn to Hemp
Rajiv Nanjapla
With President Donald Trump and President Xi Jinping of China not willing to back down, the US-China trade war is intensifying. So far, the United States has imposed tariffs on Chinese products worth $550 billion. In retaliation, China has imposed tariffs on US goods worth $185 billion. In this story, we’ll look at the impact of tariffs and the trade war on tobacco farming and how hemp legalization has come to its rescue.
Effect of the trade war on tobacco farming
In retaliation to Trump’s tariffs, China imposed its first round of tariffs on imports in April 2018. The tariffs on US imports by the Chinese government severely hit the US tobacco industry.
On May 16, the Washington Post reported that the US exported $129 million worth of tobacco from October 2017 to March 2018. However, its exports fell to just $69,000 from October 2018 to March 2019. Apart from these tariffs, the strengthening of the US dollar is increasing the cost of US tobacco. In an effort to mitigate this situation, US tobacco farmers are moving toward hemp farming.
Hemp is also a type of cannabis, which contains less psychoactive THC (tetrahydrocannabinol) and more CBD (cannabidiol). Cannabis has a greater quantity of THC than hemp. Hemp is utilized as a raw material for a variety of products, particularly fabric and food. The CBD extracted from hemp is used for medical applications.
The Agricultural Act of 2014 had allowed growing industrial hemp for research. Later, with the passage of the 2018 Farm Bill in December 2018, hemp was legalized across the United States. The legalization of hemp at the federal level has allowed farmers to take crop insurance on it, as well as having the ability to transport hemp across state lines.
Growth in the US hemp industry
Currently, only 11 states in the US have legalized cannabis for use by adults, while 33 states have legalized cannabis for medicinal purposes. However, the US cannabis market is already the largest in the world, and multiple companies are seeking to enter this burgeoning market. BDS Analytics and Arcview Market Research have projected the US CBD market to exceed $20 billion by 2024.
To expand its hemp business in the US, Tilray (TLRY) acquired Manitoba Harvest, a hemp food manufacturer, in February. Also, the company introduced a portfolio of hemp-extracted products in the second quarter.
In March, Canopy Growth (WEED)(CGC) had acquired hemp enterprise AgriNextUSA. In January, the company announced that it would build a hemp production facility in New York.
Aurora Cannabis (ACB) has partnered with the UFC to conduct clinical trials on the usage of CBD by elite athletes. These results could be used for developing hemp-derived CBD products for athletes.
Cannabis legalization and the 2020 presidential election
With the 2020 presidential election heating up in the US, the legalization of cannabis is a hot topic. The current Democratic candidates are united on the legalization of cannabis.
The prominent nominees who support legalization include Kamala Harris, Bernie Sanders, Pete Buttigieg, and Andrew Yang. For President Trump’s views on cannabis legalization, please read President Trump: Is Marijuana Legalization a Key Weapon?
Cannabis sector performance
This year, the cannabis sector has underperformed the broader equity market. The Horizons Marijuana Life Sciences Index ETF has returned 1.2% year-to-date, and the S&P 500 Index has increased 13.6%.
Looking at individual stocks, Tilray and Canopy Growth have lost 59.9% and 9.5%, respectively, of their stock value year-to-date.
In the first and second quarters of 2019, Tilray reported an increase in its net losses. Also, the company reported higher-than-expected losses in the second quarter, leading to a fall in its stock price. However, Tilray is focusing on capturing the US hemp vape market. For more information on this market, please read Tilray on Vape, FDA, and the US Market.
On August 15, Canopy Growth reported a dismal first quarter of fiscal 2020. The company missed its top-line and bottom-line expectations, leading to a fall in the company’s stock price. However, Bruce Linton, the company’s former CEO, is optimistic about the company’s initiatives and is buying more shares. For more on that story, please read Canopy Growth: Bruce Linton Is Buying, Should You?
This year, Aurora Cannabis has outperformed its peers by returning 10.9%. Its management’s better-than-expected guidance for the fourth quarter and the recent acquisition of Hempco Food and Fiber has led to an increase in Aurora’s stock price.
Yes, enjoy the ride. And I would absolutely be shocked if we saw $.25 anytime Over the next month. But I’ll take it if it comes
I overlooked that link.
Still, a lot needs to happen before we even come close to them applying to Nasdaq. And don't forget, there are huge costs in applying to uplist.
Good news nevertheless. Just gonna take time.
Was just yesterday thinking about Buying another 50k shares. Without news to support today’s volume move, SP Will settle back down and I’ll get another opportunity to accumulate. Been holding for years now. And just quite content to hold another year or two
Jefra: I called a couple of local Vitamin Shoppe retailers and asked which CBD products they carry. Right now all they have is SpaRoom brand. Strangely, their roll-on says CBD on it yet the ingredients or no where on the back label does it say CBD.
https://www.vitaminshoppe.com/p/roll-on-cbd-oil-1-fl-oz/unx0078
It's JUST a HEMP SEED OIL!! How do they get away with saying CBD? I guess because there's some small amount of CBD in all Hemp Seed Oil.
Strange!
I'm going to contact Corporate and ask them why they carry a product that actually doesn't have CBD added to it?
jefra: I had the same thoughts this morning
This is truly fantastic news and is a harbinger of more big box retailers inking distribution deals with CVSI. Long and Strong with the #1 brand in the US.
Nice! And who was Vice President and Chief Operating Officer of Pfizer Vaccine Research and Development??
Our Chairman of the Board and Chair of the Predictive Scientific Advisory Board, John Sorrentino!!
Thomas:
You said: “I personally took this picture and the other pictures.”
Might I ask what the purpose of that meeting was with NASDAQ if not as a preparation for actual listing and eventual ringing of the bell?
Maz: I was thinking the exact same thing this morning about their reason for releasing the photo without a NR. It’s called “Entrapment!” I, too, was thoroughly disgusted AND angry after yesterday’s manipulative close. And it takes a lot to get me angry.
Thanks jefra!! Love your clarity. You should consider becoming a WS analyst! Just being cheeky!!
“Just the facts, ma’am, just the facts!” Sergeant Joe Friday of Dragnet fame.