Marijuana Company Gets Warning From FDA Over Unproven Health Claims That Could Prevent People From Seeking Care
The FDA has issued similar warning letters to smaller businesses, but the warning against Curaleaf is the first since the agency began studying how it regulates CBD. The agency plans to report in the fall on its regulatory approach after holding a public hearing and receiving nearly 4,500 comments.
The Associated Press:
FDA Warns Top Marijuana Company For Making CBD Health Claims
U.S. regulators warned a leading marijuana company for making unproven health claims about CBD, the trendy ingredient that's turning up in lotions, foods and pet treats. The Food and Drug Administration announced Tuesday it warned Curaleaf Inc., of Wakefield, Massachusetts, for illegally selling unapproved products. Curaleaf's claims could lead people to delay medical care for serious conditions like cancer, the agency said. (7/23)
The Hill:
FDA Warns Company Against Making 'Unsubstantiated Claims' About CBD
The FDA also said the promises of some products, like helping treat cancer, could lead people to delay medical care for serious conditions. "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," acting FDA Commissioner Ned Sharpless said in a statement. (Rodrigo, 7/23)
Bloomberg:
FDA Targets Curaleaf (CURLF) In Crackdown On CBD Marketing
The most valuable marijuana company in the U.S. is under fire for how it’s marketing and selling CBD, the trendy cannabis extract now sold at national retailers. The Food and Drug Administration sent Curaleaf Holdings Inc. President Joseph Lusardi a letter dated Monday warning the company its lotion, pain-relief patch, tincture and disposable vape pen are considered drugs because they claim to treat conditions like pain, anxiety and ADHD, according to language on its website and social media pages. (Edney and Giammona, 7/23)
Boston Globe:
FDA Warns Curaleaf To Stop Marketing CBD With Unfounded Claims
“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,” said Dr. Ned Sharpless, acting FDA commissioner. “Consumers should beware of purchasing or using any such [CBD] products.” (Martin, 7/23)
In other news from the FDA —
Stat:
FDA Cancels Panel Review Of Intra-Cellular's Lead Drug, Shares Tumble
Shares of Intra-Cellular Therapies (ITCI) fell sharply Tuesday afternoon after the Food and Drug Administration canceled an advisory committee meeting scheduled for next week to review the company’s lead drug, seeking approval as a new schizophrenia treatment. The meeting of outside experts was set to review the Intra-Cellular drug lumateperone on July 31. FDA canceled the meeting, however, citing “new information regarding the application,” according to an agency statement. (Feuerstein, 7/23)
