FDA demands to remove mention of therapeutic properties from products of another manufacturer of CBD products
Since 2015, the FDA has sent 47 warning letters to 21 manufacturers of CBD products, prohibiting the use in the description of language related to the therapeutic effect of hemp products on human or pet health.
On the pages of the profile electronic publication of Ukrainian hemp breeders, incidents of state structures of the USA , Great Britain , as well as other countries related to the mismatch of marking / description of CBD products with their real therapeutic capabilities have been repeatedly described . The reasons why “the FDA doubts the therapeutic properties of cannabidiol extract ” were indicated . This publication once again demonstrates that US regulatory authorities do not lose sight of the situation in this area and require another manufacturer of cannabinoid products to remove information in the description that the drug has a number of therapeutic properties.
Federal Drug Enforcement Authorities have officially warned one of the largest companies in the United States that manufactures CBD products that the company's products do not comply with current US law.
The U.S. Food and Drug Administration (FDA) has warned Curaleaf, a vertically integrated legal hemp production company based in Wakefield, Massachusetts. The FDA accused Curaleaf of selling unapproved products containing CBD via the worldwide Internet with unreasonable medical evidence that its products treat cancer, Alzheimer's disease, contribute to ending opioid dependence, pain, anxiety in people and pets, as well as alleviating conditions a number of other serious, including chronic, diseases.
“Curaleaf adheres to the highest standards of quality and compliance and will work together with the FDA to resolve all issues addressed in the agency’s letter ... within the required 15 business days,” the company said in response to the FDA’s letter. "Compliance is Curaleaf's top priority, and the company is fully committed to FDA compliance for all the products it sells."
Commentary of the Ukrainian Technical Hemp Association
In March 2019, Curaleaf signed a distribution agreement with the CVS pharmacy chain to initiate sales of hemp products, including lotions and transdermal patches, in 800 stores in 10 states. Immediately after Curaleaf management received a letter, the company's share price fell by more than 14%. The fall came after a rise in stock prices last week after Curaleaf announced that it was acquiring Grassroots, a vertically integrated cannabis company, in order to gain a foothold in the Midwest market.
The FDA has a history of sending alerts to CBD companies that indicate illegal medical indications on product labels. The FDA's letter to Curaleaf is the first one sent after May 31. In a recent fan letter dated April, the FDA and the Federal Trade Commission (FTC) cautioned three companies against unfounded statements about the medical performance of their products.
Since 2015, the FDA has sent 47 warning letters to 21 manufacturers of CBD products, prohibiting the use in the description of language related to the therapeutic effect of hemp products on human or pet health. Companies that receive FDA warning letters have 15 business days to notify the agency in writing of actions taken to correct violations and prevent new cases. Ignored letters can lead to lawsuits, including the confiscation of such goods.