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.
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 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 鈥 such as claims that CBD products can treat serious diseases and conditions 鈥 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)
The most valuable marijuana company in the U.S. is under fire for how it鈥檚 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)
鈥淭oday鈥檚 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,鈥 said Dr. Ned Sharpless, acting FDA commissioner. 鈥淐onsumers should beware of purchasing or using any such [CBD] products.鈥 (Martin, 7/23)
In other news from the FDA 鈥
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鈥檚 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 鈥渘ew information regarding the application,鈥 according to an agency statement. (Feuerstein, 7/23)
