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4 Things to Know About the FDA’s C BD Guidance

When 2019 began, it was expected to be an incredibly “green” year for the cannabis industry. Canada had just commenced recreational weed sales in October 2018; higher-margin derivative products were expected to hit dispensary shelves in Canada soon thereafter; and President Trump had just signed the farm bill into law, thereby legalizing the industrial production of hemp and hemp-derived cannabidiol (CBD).

Arguably, the greatest excitement surrounded CBD, the nonpsychoactive cannabinoid that’s best known for its perceived medical benefits. Since CBD doesn’t get users high, there’s a considerably broader patient pool for infused products than anything marijuana related. And it also doesn’t hurt that the U.S. population is considerably larger than Canada, providing a juicier opportunity for the CBD industry.

Four vials of cannabinoid-rich liquid lined up on a counter.

IMAGE SOURCE: GETTY IMAGES.

Moreover, with President Trump signing the farm bill into law, it allowed general stores, such as pharmacies and grocers, the opportunity to carry hemp-derived CBD products. In other words, no longer are CBD products carried only in cannabis dispensaries. This more encompassing retail presence should provide a boost to industry sales.

According to the Brightfield Group, U.S. CBD product sales are expected to increase from around a pedestrian $600 million in 2018 to $23.7 billion by 2023. For those of you keeping score at home, this is, indeed, a compound annual growth rate of more than 100% per year over a five-year stretch. This makes CBD a much faster-growing niche than cannabis as a whole.

The FDA lays the hammer down on CBD

And yet, this rapidly growing niche is clouded in worry following a Nov. 25 consumer update from the U.S. Food and Drug Administration (FDA). To quickly summarize the consumer update, the FDA:

  • Noted that CBD has the potential to harm consumers.
  • Pointed out that CBD has the potential to cause side effects that might not immediately be noticed by consumers.
  • Admitted that there are numerous important aspects about CBD that the agency doesn’t know.
A lab researcher in a white coat closely examining a beaker filled with cannabinoid-rich liquid.

IMAGE SOURCE: GW PHARMACEUTICALS.

In particular, the FDA alluded to the only cannabis-derived drug, GW Pharmaceuticals‘ (NASDAQ:GWPH) Epidiolex, as evidence of these bullet points. Despite GW Pharmaceuticals’ lead drug being approved as a treatment for two rare forms of childhood-onset epilepsy in June 2018, Epidiolex was also shown to cause liver injury during clinical studies in some patients. Again, this risk didn’t outweigh the benefits GW Pharmaceuticals’ drug provided in terms of reducing seizure frequency from baseline, but it demonstrates in the eyes of the FDA that CBD doesn’t have a clean bill of health.

This FDA consumer update comes as the agency has been reviewing the compound as an additive to food, beverages, and dietary supplements. The FDA’s findings, based on the update, suggest that the agency is not going to grant companies the ability to add CBD to food, beverages, or dietary supplements at this time. And, as you can imagine, this news wasn’t taken well by Wall Street and investors.

Four things you should know about the FDA’s consumer update on CBD

However, it’s important for investors to understand that this FDA update isn’t as bad as it initially sounds. Here are four important takeaways from the FDA’s CBD guidelines.

1. This move had been telegraphed for months

For starters, the FDA’s consumer update that was critical of CBD’s safety could be seen coming months in advance. Remember, the agency never said it would release concrete guidelines by late summer or early fall. Instead, it only promised to provide an update on the progress it was making in reviewing data and testimony, which it has now done.

Additionally, the FDA hasn’t been shy about cracking down on misleading health claims when it comes to CBD. In July, Curaleaf Holdings (OTC:CURLF), the largest multistate operator in the U.S. by market cap, wound up receiving a warning letter regarding unsubstantiated claims for a variety of CBD products. Even though Curaleaf was quick to respond to these deficiencies, it still wound up costing the company a potentially lucrative distribution deal with CVS Health.

A researcher in a white lab coat making notes on a clipboard in the middle of a hemp farm.

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What Are the Benefits of CBD?

More than 60 percent of CBD users were taking it for anxiety, according to a survey of 5,000 people. Does it help?

By Dawn MacKeen

The CBD industry is flourishing, conservatively projected to hit $16 billion in the United States by 2025. Already, the plant extract is being added to cheeseburgers, toothpicks and breath sprays. More than 60 percent of CBD users have taken it for anxiety, according to a survey of 5,000 people, conducted by the Brightfield Group, a cannabis market research firm.Chronic pain, insomnia and depression follow behind. Kim Kardashian West, for example, turned to the product when “freaking out” over the birth of her fourth baby. The professional golfer Bubba Watson drifts off to sleep with it. And Martha Stewart’s French bulldog partakes, too.


Cannabidiol, or CBD,is the lesser-known child of the cannabis sativaplant; its more famous sibling, tetrahydrocannabinol, or THC, is the active ingredient in pot that catapults users’ “high.” With roots in Central Asia, the plant is believed to have been first used medicinally — or for rituals — around 750 B.C., though there are other estimates too.

Cannabidiol and THC are just two of the plant’s more than 100 cannabinoids. THC is psychoactive, and CBD may or may not be, which is a matter of debate. THC can increase anxiety; it is not clear what effect CBD is having, if any, in reducing it. THC can lead to addiction and cravings; CBD is being studied to help those in recovery.

Cannabis containing 0.3 percent or less of THC is hemp. Although last year’s Farm Bill legalized hemp under federal law, it also preserved the Food and Drug Administration’s oversight of products derived from cannabis.


CBD is advertised as providing relief for anxiety, depression and post-traumatic stress disorder. It is also marketed to promote sleep. Part of CBD’s popularity is that it purports to be “nonpsychoactive,” and that consumers can reap health benefits from the plant without the high (or the midnight pizza munchies).

Just as hemp seedlings are sprouting up across the United States, so is the marketing. From oils and nasal sprays to lollipops and suppositories, it seems no place is too sacred for CBD. “It’s the monster that has taken over the room,” Dr. Brad Ingram, an associate professor of pediatrics at the University of Mississippi Medical Center, said about all the wild uses for CBD now. He is leading a clinical trial into administering CBD to children and teenagers with drug-resistant epilepsy.

 

How Mainstream Media Botched the Vape Lung Story

David Bienenstock

In 1989, a mysterious figure known as Dr. Lunglife sent High Times a set of detailed instructions for transforming a handful of easily obtained equipment into a low cost vaporizer. He included a guide to making a highly potent cannabis concentrate that optimized the contraption’s effectiveness.

Soon thereafter, the magazine published a letter to the editor from K.O. of Clarksville, Mississippi:

Just thought I’d let you know I built one of Dr. Lunglife’s vaporizers. Tell the good doctor that it has worked well for me. Now if I can just get a really long extension cord for the Hash Bash in Ann Arbor.

30 years of user data on vaping

Clearly, many cannabis enthusiasts must have started experimenting with vaporization around this same time.

Commercial products required a little more time to make it to market. The first Volcano vaporizer, made by Storz & Bickel, appeared in the US in 2003. The first pen-size vaporizers appeared around 2006. Cannabis vape pens hit the American scene starting around 2010.

That gives us—at the very least—a solid three decades of anecdotal user data to work with when evaluating any potential harms involved.

So when a rash of people started getting seriously or even fatally ill after using vape pens earlier this year, it was obvious that something other than cannabis must be the culprit. The overwhelming number of cases of VAPI, vaping associated pulmonary injury, have been attributed to counterfeit products produced and distributed illegally without any regulatory oversight whatsoever.

Tainted illegal THC pens are suspect

At Leafly, our reporting team tracked these dangerous counterfeit pens from production to sale. We found a supply chain operating wholly outside the law and with a blatant disregard for public health. Theories on what’s causing VAPI range from dangerous additives to poorly manufactured pens, or possibly some combination of the two. No evidence has emerged to show THC, CBD, or any other cannabinoid is to blame.

 

 

 

Why CBG (Cannabigerol) Is One Of The Most Expensive Cannabinoids To Produce

As CBD continues to explode in popularity, brands are beginning to take notice. Innovative companies are already beginning to offer products centered around one of the other 100+ cannabinoids found in the plant.

One of those cannabinoids is Cannabigerol, or CBG. First discovered by researchers in the 1960’s, CBG is the precursor from which all other cannabinoids are synthesized, which is why it’s often referred to as the “mother” or “stem cell” of cannabinoids. This unique property imbues CBG with enormous therapeutic promise, making it a subject of great interest for researchers and consumers alike.

“It’s definitely gaining momentum,” says James Rowland, CEO of Steve’s Goods, a Colorado based brand that specializes in producing CBG goods. “We have personally administered CBG to thousands of people at over 50 events. It’s the most requested product on our website and we provide education to thousands of receptive people both in person and online every month.”

CBG (Cannabigerol) being made

CBG (Cannabigerol) being made PHOTOS COURTESY OF STEVE’S GOODS

The US government is also keen on learning more about CBG. In 2018 The National Center for Complementary and Integrative Health (NCCIH) announced an intent to research minor cannabinoids including CBG that could help manage pain. Today In: Lifestyle

So how exactly does CBG work?

“CBG works by interacting with the endocannabinoid system (ECS). Together, CB1 and CB2 receptors regulate neurohormones which actively affect physiological processes including mood, metabolism, pain response, and appetite,” begins Derek Du Chesne, Chief Growth Officer at EcoGen Laboratories. “When cannabinoids like CBG interact with these receptors, it activates a response and produces physiological changes.”

 

 

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