A warning letter has been issued to Curaleaf Inc. of Wakefield in Massachusetts for illegally selling and marketing CBD based products online with unsubstantiated medical claims that the products carry high medical potency in dealing with opioid withdrawal, Alzheimer’s disease, pain, cancer and even pet anxiety, among other ailments, announced the U.S. Food and Drug Administration.
Ned Sharpless, the acting FDA Commissioner said the top priority for the agency remains protecting and promoting public health. They are examining potential pathways for creating a lawful framework for marketing of products that contain cannabis or compounds like CBD which are derived from cannabis plants such as hemp.
But selling and using unapproved products with unsubstantiated medical benefit claims – that CBD is highly effective in mental health disorders and can treat serious diseases and conditions – can put consumers and patients at risk by making them inclined towards such products, leaving tested, prescription based medicines.
Moreover, there are plenty of unanswered questions about the safety, quality and effectiveness of these unapproved products infused with CBD.
The warning has clarified one thing – the agency stands firm at its stand and is committed to continue tracking and monitoring the CBD marketplace for ensuring the safety of the public. FDA will take requisite actions against companies that deceive consumers, making high claims and putting them at risk by selling products illegally, marketing them as a medical treatment for which they are not approved such as severe ailments like cancer and Alzheimer’s.
Given the buzz around cannabis and its derivative compound, CBD, the agency continues to make an integrated and collaborative approach to develop a regulatory framework that ensures public health safety while rendering positive effects, if any. The agency has created a high-level internal working group which will explore potential pathways for different types of CBD products to be marketed lawfully.
One of the major components of this job is obtaining and evaluating relevant information to address the long standing questions related to CBD products’ safety. These considerations will be taken in by the agency and will help in building the regulatory framework for CBD products while maintaining high public health standards as per the FDA’s rules.
In an attempt to understand CBD better and explore its potential arenas, the agency held a public meeting with stakeholders, retailers, business leaders, consumers and other officials on May 31. It has also opened a docket inviting written comments from people to gather scientific data and information about the safety, production, processing, marketing, labeling, sales and product quality of cannabis or cannabis derived compounds.
The agency has been committed to evaluate various aspects of CBD products, including several factors such as the existing drug approvals policies of the FDA, public health safety, scientific data backing up information claimed by companies and many other things.
They said they plan to report their progress by early this fall to address many questions surrounding CBD. They are using a stepwise, science-based approach which will ensure the safety of patients and public health, while fostering innovation for safe and effective products.
Curaleaf used its social media platforms, webpages and online store to unlawfully market its products to consumers, making high claims. Here is a list of unapproved and unsupported claims made by the company:
- CBD has proven to have characteristics that counteract cancer development.
- CBD had been efficacious in killing cancer cells of breasts.
- The use of CBD in Parkinson’s disease is also proved efficient.
- CBD is associated with efficient Alzheimer’s illness therapy.
- CBD is increasingly being embraced as a natural treatment for depression and anxiety in place of pharmaceutical therapy.
- CBD can also be used with opioid drugs, and several studies have shown that CBD actually reduces the severity of opioid withdrawal and reduces the growth of tolerance.
- CBD oil is gaining popularity as it serves as an all-natural source of relief for addressing the symptoms of many medical conditions such as chronic pain, anxiety, acute aches, etc.
- Many researches have found that CBD oil helps in combating mental health issues such as anxiety, depression, schizophrenia and even post traumatic stress disorder.
- CBD cures chronic pain caused from fibromyalgia, slipped spinal discs and can also help with eating disorders and addiction.
- Vets prescribe puppy Xanax to pet owners that helps in particular instances, however Xanax is not an ideal or a desirable medication to give to your dog regularly. Whereas cannabidiol is natural and offers similar soothing and healing results without the use of any chemicals.
- CBD can help reduce pain, spasms, nausea, inflammation and anxiety which are often related to cancer in dogs.
The FDA has requested for responses from Curaleaf within a span of 15 working days stating how these violations will be corrected. Failure to implement new regulatory method may lead to legal action against the firm that might include seizure of products and injunction.