American FDA lashes out at companies marketing CBD as a miracle cure
Since the legalization of cannabis for medical and recreational purposes in some states, there has been an array of products on the market. In states that have not legalized marijuana, the 2018 Farm Bill is operative. The Farm Bill allows for the legalization of hemp, but the hemp must not contain more than 0.3% THC. CBD is legal because if it is made from the hemp, it should contain less than 0.3% THC. Therefore, it is non- psychoactive. As a result, many products on the market now claim to be CBD derivatives from hemp.
Many companies have even gone to the extent to make false claims about the health benefits that can be derived from their products. However, the FDA has issued several warnings against practices such as these. Cannabis is still illegal under federal law in the United States, and so the FDA has the mandate to regulate products to ensure the safety of the public.
Curaleaf warned by FDA
For example, the FDA has issued a warning letter to Curaleaf, a cannabis company that sells CBD products such as CBD lotion, CBD tincture, and CBD transdermal patches. The letter was addressed to Joseph Lusardi, the President of Curaleaf. The letter stated that the U.S. Food and Drug Administration reviewed the Curaleafwebsite and found the information on the website to be against the FD&C Act. The company also sells animal drugs that are not approved by the FDA and are unsafe. This violates the FD & C Act. Also, claims that CBD can help to treat diseases such as Parkinson’s Disease and Alzheimer. The FDA said that the products that were classified on Curaleaf’s website as dietary supplements could not be dietary supplements because they do not meet the requirements under the FD & C Act.
Furthermore, the FDA has made a promise to continue to restrict companies that tout CBD claims to influence the sale of their products. The public announcement of the warning to Curaleaf has caused a reduction in shares. Despite the legalization of CBD from hemp, the FDA has only approved one drug so far, Epidiolex. This drug is used to treat children with seizures. No other drug has been approved thus far.
Therefore, CBD products that are being sold on the market may not be real CBD products because many of them may contain higher THC levels than that which is stipulated in the Farm Bill. Some products are also made from other compounds under the disguise of CBD products.
Touted effects of CBD
CBD products are becoming popular to consumers on the market, and so the FDA is considering creating pathways to allow the availability of CBD products on the market. A group at the FDA is assessing the FDA policies. The FDA also said that the ensuring of public health is its main priority. The sale of unapproved products with unsubstantiated claims of the effects of CBD such as treatment of Alzheimer is unacceptable. Some of the products have labels that tout the effects of CBD.
Response from Curaleaf
The FDA has given CuraLeaf fifteen days to respond to the warning letter. FDA said that a failure to respond could cause legal actions to be taken against Curaleaf. Legal action could take the form of a product seizure or an injunction preventing the company from continuing with its operations. A spokesperson for Curaleaf stated that the matter is in the hands of their lawyer, and a response will be made within the specified time stipulated by the FDA.