FDA Warns Curaleaf About Marketing of CBD Products

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is warning a large cannabis company to stop making unsubstantiated claims that its products can treat chronic pain, cancer, opioid withdrawal and other medical conditions.

An FDA warning letter was sent to Curaleaf, a Massachusetts-based company that sells cannabidiol (CBD) products online and in stores, and operates dispensaries in a dozen states. CVS Health responded to the FDA letter by pulling some Curaleaf products off its store shelves.

“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,” acting FDA Commissioner Ned Sharpless, MD, said in a statement. “Consumers should beware of purchasing or using any such products.”

Curaleaf, which claims to be the largest cannabis operator in the United States, makes an extensive line of CBD lotions, creams, oils and skin patches.

It recently began marketing a line of CBD products for pets to treat pain, spasms, anxiety and inflammation in animals.

The FDA’s warning letter to Curaleaf cited a number of unapproved marketing claims made by the company online and in social media, including:

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  • “CBD was effective in killing human breast cancer cells.”

  • “CBD has been linked to the effective treatment of Alzheimer’s disease…”

  • “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”

  • “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”

  • “CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety … ADHD.”

The FDA gave Curaleaf 15 working days to respond. Failure to correct the violations could result in legal action, including seizure of the company’s products.

“Curaleaf is committed to the highest standards of quality and compliance, and will work collaboratively with the FDA to resolve all issues addressed in the agency's letter,” the company said in a statement.

“Compliance is a top priority for Curaleaf and the Company is fully committed to complying with FDA requirements for all of the products that it markets. We can affirm that nothing in the letter raises any issues concerning the quality and consistency of any Curaleaf product or calls into question the high safety standards of the Company's cultivation and manufacturing processes.”

CBD Products Loosely Regulated

Unlike prescription drugs approved by the FDA, the manufacturing process for CBD products is not subject to FDA review, and there has been no FDA evaluation of their effectiveness, proper dosage, how they could interact with drugs, or whether they have side effects.

Despite the lack of regulatory oversight, there has been explosive growth for CBD companies and their products are starting to appear in mainstream stores. In March, CVS Pharmacy and Walgreens started selling CBD lotions, tinctures, edibles and lozenges — including some made by Curaleaf.

“The only Curaleaf products we are selling are its CBD lotion and CBD transdermal patches,” CVS said in a statement. “Following the FDA’s warning letter to Curaleaf, we will be removing these items from our CBD offering.”  

The FDA sent similar warning letters to three cannabis operators in April. Until now, the enforcement actions have been sporadic and only targeted small companies.

“We will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law through actions like those the FDA is taking today. At the same time, we also recognize the potential opportunities and significant interest in drug and other consumer products containing CBD,” said FDA Principal Deputy Commissioner Amy Abernethy, MD.

“We understand this is an important national issue with public health impact and of interest to American hemp farmers and many other stakeholders. The agency has a well-established pathway for drug development and drug approvals, and we remain committed to evaluating the agency’s regulatory policies related to other types of CBD products.”

The FDA held a public hearing on the issue in May, and opened a docket for public comments to obtain scientific data about the safety, manufacturing, quality, marketing, labeling and sale of CBD products. Nearly 4,500 comments were received. The agency plans to report on its progress this fall.

This week Curaleaf announced it will acquire GR Companies, a large cannabis retailer, in a cash and stock deal valued at $875 million. Curaleaf said the purchase solidifies it’s position as “the world's largest cannabis company by revenue and the largest in the U.S. across key operating metrics.”

CVS Begins Selling Cannabis Products

By Pat Anson, PNN Editor

You may not be able to get your opioid prescription filled at a CVS pharmacy, but you can stock up on medical marijuana. The nation’s largest drug store chain has begun selling cannabis-based products in eight states, despite lingering concerns about their effectiveness and legal status.

The move was announced by cannabis retailer Curaleaf Holdings, which carries a line of cannabis lotions, tinctures, edibles and lozenges that CVS started carrying in its stores last week. The CBD products are being sold over-the-counter without a prescription.

(Update: Walgreens has also announced plans to sell CBD products in 1,500 of its stores.)

CBD stands for cannabidiol, a chemical compound in marijuana that does not produce euphoria but is believed to reduce symptoms of chronic pain and other health conditions.  

“We have partnered with CBD product manufacturers that are complying with applicable laws and that meet CVS’s high standards for quality,” a CVS spokesman said in an email to MarketWatch.  

CVS said that it was selling CBD products in Alabama, California, Colorado, Illinois, Indiana, Kentucky, Maryland and Tennessee. Curaleaf executives said CVS would eventually carry its products in 800 stores in ten states.

“We’re going to walk slowly, but this is something we think our customers will be looking for,” CVS Health CEO Larry Merlo told CNBC.

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‘Treated Like Criminal’ at CVS

The move is somewhat puzzling for CVS, which was one of the first pharmacy chains to crackdown on opioid prescriptions due to concerns about addiction and overdose. In 2017, CVS began restricting initial opioid prescriptions to 7 days’ supply and aligned its polices with the CDC opioid guideline.

Pain sufferers now complain they’re treated like drug addicts by CVS pharmacists.

“I submit to monthly drug tests and do everything I am supposed to do and I am treated like a criminal at the doctor and CVS pharmacy. My two pills a day barely touches the pain, but I need to work,” one patient recently told us.

“Some pharmacies, such as CVS, have taken it upon themselves to deny my prescriptions that I have been having filled there for 15 years. They first took it upon themselves to adjust my dosage. I didn’t realize that pharmacist were allowed to change a prescription,” said another patient.

“Why does CVS, a drug store that sells NSAIDs without restriction, have control of how I treat my patient?” asked one practitioner.

Although most Americans now support the use of medical marijuana and it is legal in dozens of states, the safety, effectiveness and legality of CBD is still very much up in the air.  Marijuana remains classified as a Schedule I controlled substance by the DEA, alongside heroin and LSD.

“Societies have jumped far, far ahead of science,” Dr. Margaret Haney, a professor of neurobiology at Columbia University Medical Center, told NBC News. “So it’s showing up in lotions and pretty much any form of product one can use. There’s a lot of different ways one could use CBD, but the ways we have studied CBD is much more limited.”

According to MarketWatch, Curaleaf only list its shares on the Canadian Securities Exchange because major exchanges in the U.S. and Canada will not list shares of marijuana companies due to their hazy legal status.