Curaleaf Holdings, Inc. Receives FDA Warning Letter for Unsubstantiated CBD Health Claims, Products Removed from CVS

Hot on the heels of their recent acquisition of Grassroots, the Food and Drug Administration has issued a warning letter to Curaleaf for allegedly “illegally selling” CBD products with “unsubstantiated claims” that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety.

Curaleaf Holdings, Inc. (CSE: CURA) (OTCQX: CURLF) (“Curaleaf”) is a leading vertically integrated multi-state cannabis operator in the United States. It is a high-growth cannabis company with a national brand known for quality, trust and reliability. The company is positioned in highly populated, limited license states, and currently operates in 12 states with 48 dispensaries, 13 cultivation sites and 12 processing sites. Curaleaf has the executive expertise and research and development capabilities to provide leading service, selection, and accessibility across the medical and adult-use markets, as well as in the CBD category through its Curaleaf Hemp brand and Bido brand for pets.

While the agency is considering opening up new pathways for CBD products to enter the market as its popularity grows, the FDA has said it will continue to take action against companies making “egregious” health claims.

“As we examine potential regulatory pathways for the lawful marketing of products containing cannabis and cannabis-derived compounds like CBD, protecting and promoting public health remains our top priority,” acting FDA Commissioner Ned Sharpless said in a statement. He continued, “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.”

The FDA has issued roughly two dozen warning letters to companies for allegedly making unproven health claims about CBD products. This one against Curaleaf is notable because the company is a leading player in the booming CBD industry.

The FDA said Curaleaf made “unfounded claims about more than a dozen different CBD products” on its product webpages, online store and social media websites. Some of the claims it highlighted include “CBD has been demonstrated to have properties that counteract the growth of [and/or] spread of cancer” and “CBD has been linked to the effective treatment of Alzheimer’s disease ….”

“Today’s action demonstrates that the agency stands firm in its commitment to continue monitoring the marketplace and protecting the public health by taking action as needed against companies that deceive consumers and put them at risk by illegally selling products marketed for therapeutic uses for which they are not approved, such as those claiming to treat cancer or Alzheimer’s disease,” Sharpless said.

Curaleaf has 15 days to respond to the FDA’s concerns. Failure to correct the violations could result in legal action, such as product seizure or injunction, the agency said.

A Curaleaf spokeswoman said its legal counsel is currently reviewing the letter and the company will respond within the FDA-mandated time frame. “We intend to work collaboratively with FDA to address the issues in the letter,” the spokeswoman said. “Curaleaf is fully committed to complying with FDA requirements for all of the products that it markets.”

Curaleaf subsequently issued the following statement in response regarding its CBD product marketing:

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 will respond to the FDA letter within the required 15 working days. 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. Curaleaf CBD products are all derived from hemp and meet the requirements of the Farm Bill.

In the wake of the letter from the FDA, CVS has stated that they will be removing all Curaleaf products named by the FDA from its offering with no plans of adding the brand or products back.

The products named in the letter include CBD oil, which Curaleaf said can treat anxiety, depression, post-traumatic stress disorder, schizophrenia, chronic pain from fibromyalgia, slipped spinal disks, eating disorders and addiction, among many other conditions. They also include CBD disposable vape pens and CBD tincture. The claims were made on the company’s website and in social media postings on Facebook and Twitter.