FDA Warns Company Marketing Unapproved Cannabidiol Products With Unsubstantiated Claims to Treat Cancer, Alzheimer's Disease, Opioid Withdrawal, Pain, and More

Agency is expediting work to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD

The FDA recently announced that it has issued a warning letter to Curaleaf Inc, of Wakefield, Massachusetts, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer's disease, opioid withdrawal, pain, and pet anxiety, among other conditions or diseases.

"As we examine potential regulatory pathways for the lawful marketing of products containing cannabis and cannabis-derived compounds like CBD, protecting and promoting public health remains our top priority. Selling unapproved products with unsubstantiated therapeutic claims—such as claims that CBD products can treat serious diseases and conditions—can put patients and consumers at risk by leading them to put off important medical care. Additionally, there are many unanswered questions about the science, safety, effectiveness, and quality of unapproved products containing CBD," says Acting FDA Commissioner Ned Sharpless, MD. "Today's 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 by illegally selling products marketed for therapeutic uses for which they are not approved, such as those claiming to treat cancer or Alzheimer's disease. Consumers should beware of purchasing or using any such products."

Given the interest in products containing cannabis or cannabis-derived compounds, and CBD in particular, the FDA has and continues to take an agencywide, integrated, and collaborative approach to addressing the regulation of products made from CBD that fall under its jurisdiction. The agency has established a high-level internal working group to explore potential pathways for various types of CBD products to be lawfully marketed. An important component of this work is obtaining and evaluating information to address outstanding questions related to the safety of CBD products that will inform the agency's consideration of potential regulatory frameworks for CBD while maintaining the FDA's rigorous public health standards. As part of that work, the FDA held a public hearing in May, and opened a docket for written comments, to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.

"We will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law through actions like those the FDA is taking today. At the same time, we also recognize the potential opportunities and significant interest in drug and other consumer products containing CBD," says FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD. "We understand this is an important national issue with public health impact and of interest to American hemp farmers and many other stakeholders. The agency has a well-established pathway for drug development and drug approvals, and we remain committed to evaluating the agency's regulatory policies related to other types of CBD products. We plan to report our progress by early this fall as we expedite our work to address the many questions about CBD. The step-wise, science-based approach we're taking protects patients and the public health, fosters innovation for safe and appropriate products, and promotes consumer confidence."

As described in the warning letter issued to Curaleaf, the company used product webpages, its online store and social media websites to make unfounded claims about more than a dozen different CBD products. Examples of the unsupported and unapproved claims made by the company include the following:

• "CBD has been demonstrated to have properties that counteract the growth of [and/or] spread of cancer."

• "CBD was effective in killing human breast cancer cells."

• "CBD has also been shown to be effective in treating Parkinson's disease."

• "CBD has been linked to the effective treatment of Alzheimer's disease."

• "CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety."

• "CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance."

• "CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety … ADHD."

• "What are the benefits of CBD oil? … Some of the most researched and well-supported hemp oil uses include … anxiety, depression, posttraumatic stress disorders, and even schizophrenia … chronic pain from fibromyalgia, slipped spinal discs … eating disorders and addiction."

• "[V]ets will prescribe puppy Xanax to pet owners which can help in certain instances but is not necessarily a desirable medication to give your dog continually. Whereas CBD oil is natural and offers similar results without the use of chemicals."

• "For dogs experiencing pain, spasms, anxiety, nausea, or inflammation often associated with cancer treatments, CBD (aka cannabidiol) may be a source of much-needed relief."

The FDA has requested responses from Curaleaf within 15 working days stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure and injunction.

The agency continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses that have not been approved by the FDA. The FDA approval process ensures that drugs on the market are safe and effective for their intended therapeutic uses. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas, and topical lotions and creams. Often such products are sold online and are therefore available throughout the country. Other than one prescription human drug product to treat rare, severe forms of epilepsy, the FDA has not approved any other CBD products, and there is very limited information for other marketed CBD products, which likely differ in composition from the FDA-approved product and have not been evaluated for potential adverse effects on the body.

Unlike drugs approved by the FDA, the manufacturing process of these products has not been subject to FDA review as part of the drug approval process, and there has been no FDA evaluation of whether these products are effective for their intended use, what the proper dosage is, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. Unsubstantiated claims associated with CBD products may lead consumers to put off getting important medical care, such as proper diagnosis, treatment and supportive care. For that reason, it's important that consumers talk to a health care professional about the best way to treat diseases or conditions with existing, approved treatment options. The FDA also cautions pet owners against the use of such products and recommends talking with a veterinarian about appropriate treatment options for pets. The agency also has not approved cannabis or cannabis-derived compounds like CBD for any use in animals and cannot ensure the safety or effectiveness of these products.

The FDA has previously sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the Federal Food, Drug, and Cosmetic Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.

The agency encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency's MedWatch program.

For more information, read the following:

• What You Need to Know (And What We're Working to Find Out) About Products Containing Cannabis or Cannabis-Derived Compounds, Including CBD

• FDA Is Committed to Sound, Science-Based Policy on CBD

• FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers

Source: FDA