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HIGHLIGHTS
  1. Curaleaf Hemp removes non-compliant CBD product health claims from website, social media
  2. CVS Health pulls two Curaleaf CBD products from shelves in seven states
  3. FDA is still working toward establishing hemp-derived CBD regulations

Curaleaf Holdings Inc. said Friday it removed all non-compliant product statements about hemp-based CBD products from its website, responding within days to the U.S. Food and Drug Administration’s (FDA) warning about its unsubstantiated medical claims earlier in the week.

Wakefield, Mass.-based Curaleaf, which trades on the Canadian Securities Exchange and is on track to become the biggest legal cannabis company in the United States, said it removed all online statements in relation to its hemp-based CBD product line deemed non-compliant by the FDA, including the Curaleaf Hemp blog and third-party links.

CVS Health, a major pharmacy chain in the United States, responded by pulling Curaleaf CBD Lotion and CBD Transdermal Patches from its shelves in the seven states where they are sold, CVS spokesman Joe Goode said.

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The move came after the FDA warned Curaleaf last Tuesday for “illegally selling unapproved” cannabidiol (CBD) products with “unsubstantiated” health claims such as relief for anxiety, and treatment for Parkinson’s and Alzheimer’s diseases.

Curaleaf was given 15 business days to comply but did so within the week.

“Our industry needs, wants and appreciates the work the FDA is doing to ensure there is regulation and compliance in the CBD marketplace,” said Curaleaf Chief Executive Joseph Lusardi.

The warning was the latest reputational challenge for the nascent industry that still lacks scientific evidence regarding CBD’s effects on people and pets. While CBD is widely associated with health and well-being, few clinical trials on cannabinoids have been done.

Though hemp-derived CBD was legalized in the United States in late 2018 with the passing of the U.S. Farm Bill, the FDA is still working toward setting new regulations around the ingredient that remains a regulated substance. The FDA plans to update its regulatory pathway plan for CBD this fall.

“We believe the FDA is sincere in wanting to explore new pathways for hemp-derived CBD to be sold legally in the food and supplement markets, while protecting research into future pharmaceutical applications,” said Cowen Washington Research Group in a report on Thursday.

“However, those actions will have to fit under the confines of current law and further legislation will likely be needed to speed up the process. We also doubt that the FDA’s update this fall will provide any regulatory certainty for CBD."

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The law stipulates that CBD extracted from hemp that contains more than 0.3 per cent THC, which is the case with some cultivars, is not permitted. It remains federally illegal to sell CBD extracted from the cannabis plant.

CBD is a non-intoxicating compound found in both hemp and cannabis, and has quickly become a go-to for consumers looking to reduce inflammation, take away pain and ease anxiety in people and pets, among other claims being made by some companies.

“While we think that companies will continue to focus on CBD vapor, topicals, and tinctures, the product offerings are unlikely to make health-based claims in order to stay off the FDA’s radar,” said Vivien Azer, managing director with Cowen.

“Further, though companies are currently selling CBD food and beverage products for interstate commerce (most notably via e-commerce), that could face incremental regulatory headwinds.”

Since recreational cannabis was legalized in Canada in 2018, licensed pot companies have used CBD products to attract new demographics to their products, such as women and the elderly. While industrial hemp products have been legal food products in the country for roughly 20 years, it now falls under the new Cannabis Act that regulates its byproducts such as CBD, which can only be sold by licensed producers and retailers, and is not permitted in items such as pet food and topicals.

Meanwhile in the United States, where several states have legalized cannabis and hemp products including CBD, items such as lotions and beverages featuring this compound have also shot up in popularity.

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The FDA said it continues to be concerned with the proliferation of unapproved products asserting to contain CBD that are marketed for therapeutic or medical uses. An FDA working group aims to find ways for CBD products to be lawfully marketed.

“Selling unapproved products with unsubstantiated therapeutic claims – such as claims that CBD products can treat serious diseases and conditions – can put patients and consumers at risk by leading them to put off important medical care. Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD,” said Acting FDA Commissioner Ned Sharpless when Curaleaf was sent its warning.

The only FDA-approved CBD product to date is Epidiolex, a prescription drug that treats a severe form of childhood epilepsy. The approval of Epidiolex essentially committed the FDA to treating CBD as a pharmaceutical-grade drug, and has put the onus on industry to prove its health benefits.

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