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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.

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.


BIG Announcement

Dear Valued Clients, Colleagues and Friends,

I’m writing today to inform you of an important change in the structure of One Health WI. As of last Friday, my business partner and I have mutually agreed to part ways. As always, you can count on me to continue to deliver the highest quality products at the best prices, just with a new look and new name! I’m excited to introduce you to: Native Roots Hemp !

As our new company continues to grow, so will our brand with a new look and feel. In the coming weeks you’ll see our online and print presence update with the new logo and information.

Many of you know that I am originally from Algoma, WI and have been very excited to move my family “back to my roots” as we launched our CBD business. We’ve already helped thousands of people across the country to feel better through our quality products and we’re looking forward to having our company’s name and brand signify getting “back to our roots” as well !

As our team at Native Roots Hemp continues to work with my family in Brussels, WI, who are farmers in the hemp industry, as well as our other valued suppliers from the past, rest assured you will continue to receive the highest quality products in the country, as you have since September, 2018.

Thank you for trusting us. You are all like family to our team and we look forward to continuing to partner with you on your wellness journey!

Please join me at the Luxemburg Pharmacy today, August 28th, from 8-2 for FREE samples and to answer any questions you may have.

See you soon!

Warmest regards,

Stacy Deprey-Purper, CEO
Native Roots Hemp
www.NativeRootsHemp.com

CBD Skincare Interest is Rising Fast: What’s the Future of Cannabidiol for Skin Health Look Like?

Since cannabidiol (CBD) was reintroduced as having potential health benefits, the areas that it appears to excel in include pain relief, reduction in anxiousness and attaining a calmer self. The key property in making the previously mentioned benefits a possibility is CBD’s ability to rid inflammation.

As the industry continues to mature, more and more skincare solutions are being infused with CBD and other cannabis’ compounds. With this in mind, curiosity is surely enticed, as consumers now have to assess its true effectiveness.

In a recent post shared by CBD Snapshot, the overall potential of CBD has been explained with respect to skincare. Turns out, it does in fact make a positive difference, however, consumers have been warned to be cautious of their resources.

CBD’s Anti-Inflammatory Properties Creates a Win-win Situation Once Again!
The news outlet referenced a board-certified dermatologist, who argued for the use of CBD for skin health. According to Dr. Jeanette, CBD can be effective in both beauty and skin care because of the very same anti-inflammatory properties that initially helped it to secure a spotlight.

Here’s an extract as to why the latter is so:

“Cannabinoid receptors have been discovered in keratinocytes, or skin cells, and other parts of the skin such as the sebaceous glands, hair follicles, small nerves and immune cells. CBD works on them as part of the skin’s endocannabinoid system.”

Dr. Robert Dellavalle, University of Colorado School of Medicine’s dermatology professor and a co-author of the 2017 study, has noticed how quickly the CBD industry has been developing and is somewhat fearful of consumers’ belief that all skin conditions can be resolved with its use. However, he does not question its general potential, adding that, “I think there’s a lot of promise.”

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