FDA: Wakefield marijuana company illegally selling unapproved products with unsubstantiated claims

Curaleaf Inc. of Wakefield, the nation’s most valuable marijuana company, is facing potential legal action for illegally selling unapproved products with unsubstantiated claims that they treat everything from cancer and Alzheimer’s disease to opioid withdrawal and pet anxiety, according to the Food and Drug Administration.

In a warning letter sent Monday to Curaleaf president Joseph Lusardi, the FDA said the company’s cannabidiol, or CBD, lotion, pain-relief patch, vape pen, Bido CBD for Pets and other products containing the cannabis extract are “unapproved new drugs sold in violation of” the federal Food, Drug and Cosmetic Act.

The company also used product web pages, its online store and social media to make “unfounded” claims about more than a dozen CBD products, including that CBD has been shown to be effective at treating cancer, Alzheimer’s and Parkinson’s diseases, opioid withdrawal, eating disorders, a variety of mental illnesses and pet anxiety, the FDA said.

“Selling unapproved products with unsubstantiated therapeutic claims … can put patients and consumers at risk by leading them to put off important medical care,” acting FDA Commissioner Dr. Ned Sharpless said in a statement. “Consumers should beware of purchasing or using any such products.”

The FDA requested a response from Curaleaf within 15 working days and said that failure to correct the violations promptly “may result in legal action, including product seizure and injunction.”

In a statement Tuesday, Curaleaf said it 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. We can affirm that nothing in the letter … calls into question the high safety standards of the company’s cultivation and manufacturing processes.”

The company’s share price nevertheless plummeted by more than 14% on Tuesday before closing at $7.40, down 7.2%.

Although the only clinically approved drug containing CBD is Epidiolex, which is used to treat rare forms of childhood epilepsy, there has been a proliferation of unapproved CBD products marketed for medical or therapeutic uses since Congress decriminalized it last year, according to the FDA.

In March, CVS Health Corp. began selling nonintoxicating CBD at more than 800 of its stores as part of a distribution deal with Curaleaf.

Mike DeAngelis, a CVS spokesman, said in an email that the company does not sell any CBD products in Massachusetts.

“Following the FDA’s warning letter to Curaleaf, we will be removing” the only Curaleaf products CVS sells in other states — CBD Lotion and CBD Transdermal Patches — from store shelves, DeAngelis said.

More: FDA: Wakefield marijuana company illegally selling unapproved products with unsubstantiated claims