FDA issues stance warning in a press release to companies purporting to have cancer treatment with CBD that is not approved. The agency also claimed it is fast-tracking its procedures in matters relating to the regulation of cannabis and its extracts.
- Press release addressed to Curaleaf Inc., of Wakefield, Massachusetts accused of CBD unapproved products
- Agency claimed that these products are not tested to ascertain their value as advertised to users
- FDA expands its working network to ensure such companies operate lawfully
- Curaleaf Inc has fifteen working days to respond to the press release, failure to which legal action will be taken
Following claims by various marketing companies over the use of Cannabidiol products to treat not only multiple diseases but also numerous conditions, the Food and Drug Administration released a press release, warning these companies over such medically unapproved claims. Among the companies which received this warning letter included Curaleaf Inc., of Wakefield, Massachusetts.
Curaleaf Inc., of Wakefield, Massachusetts is accused of selling Cannabidiol unapproved products they claim they have they can treat cancer, Alzheimer’s disease, pain, Opioid withdrawal, and pet anxiety, among other conditions.
FDA Works on CBD Regulation
According to Food and Drug Administration which is currently scrutinizing the regulatory policies vis-à-vis law on the products that contain cannabis compounds and are not are unproved and have unsustainable therapeutic claims.
This poses a potential problem to patients and consumers of these products and can also result in them keeping off from proper medical care. The acting FDA Commissioner, Ned Sharpless, said that those products are not scientifically justified to ascertain their safety, effectiveness, and quality.
He added that the action is a clear view of the agency’s effort towards monitoring, protecting and supporting public health through action against companies that deceive its clients by putting at risk over unapproved products. He also called for consumer awareness on the existence of those unapproved products that do circulate on an online platform.
1/3 FDA is expediting its work to address the many questions about cannabidiol (CBD). This is an important national issue with public health impact, & an important topic for American hemp farmers and many other stakeholders. pic.twitter.com/XQbXb0KspU
— Dr. Amy Abernethy (@DrAbernethyFDA) July 12, 2019
The agency has established a vast network to work towards addressing regulations of cannabis-derived products to ensure a smooth operation of CBD invested companies as required by those laws. The agency the FDA and an internal working group are working on acquiring and evaluating information to address the questions that arise over the safety of using these products.
FDA Held Public Hearing on CBD in Consumer Products
So, a public hearing was held by the agency with the purpose of scientific data collection on safety, manufacturing, quality, marketing, labeling, and sale of these products.
— Scientific American (@sciam) June 1, 2019
FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. also emphasized on the agency affirmative action towards protecting the health and safety of the American citizens against the law violation and at the same time to the working that is done by the agency on potential opportunities on use of Cannabidiol and cannabis-related products on conditions and disease treatment.
Some of the unsupported and unapproved claims made by the company over Cannabidiol products as per the letter include the following:
- Cannabis has shown properties that counter the growth of cancer
- Cannabidiol has demonstrated ability in killing cancer cells and treating Parkinson’s disease
- CBD is used in the treatment of anxiety and depression effectively by the pharmaceuticals.
- Studies also show there is a positive effect on using CBD together with Opioid medication.
- CBD is becoming popular more so in its use as a pain and anxiety reliever.
Concerning the served warning letter from FDA, Curaleaf has been called upon to respond to the correction of violations and have fifteen working days to respond, failure to which legal action such as product seizure and injunction shall be actualized.
Another concern raised by the FDA over unapproved use of the product is lack of review of CBD products which is supposed to be done by them as an agency. FDA has not one any evaluation on the effectiveness and proper dosage of these products on the human body and also if they have side effects or other safety concerns.
Apart from warning against human consumption of such products, FDA has also warned against using the products on animals such as pets since they cannot justify on their safety and effectiveness because the use of Cannabis or cannabis-derived products on animals has also not been approved yet.
The agency aims at promoting health and professional drug use and in line with it;
it encourages the public against such products and calls for reporting over adverse reactions that could be as a result of using them.
In the past, FDA also sent warning letters to companies that have claimed to sell CBD related products and has always condemned them strongly. Some of those companies were companies in violation of the Federal Food, Drug and Cosmetic Act and Cosmetic Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.
According to FDA, it encourages and supports any justified use of a new product that is well supplied to the American citizen through a well-stipulated channel. And they just stay for providing them under proper procedures according to the laws and health act.
Proper health and use of such products can only be brought about if more research is done and correct health bodies such as Food and Drug Administration are involved in the process as required by law. On the other side, the public remains vulnerable against the use of unapproved CBD products and hence it is upon FDA to ensure that unauthorized sale and use of these products is completely stopped.