The US Food and Drug Administration issued on July 23 a warning letter to Curaleaf Inc. for selling products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease and opioid withdrawal, 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,” said FDA Acting Commissioner Ned Sharpless in a news release. “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.”

Sharpless noted there are “unanswered questions” surrounding the safety, effectiveness and quality of unapproved CBD products. He added the FDA will remain committed to monitoring the marketplace for products that make unsanctioned claims that include treating cancer or Alzheimer’s disease.

The FDA said it continues to take an agency-wide, 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. 

One component of the FDA’s effort 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. 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,” said FDA Principal Deputy Commissioner Amy Abernethy. “At the same time, we also recognize the potential opportunities and significant interest in drug and other consumer products containing CBD. We understand this is an important national issue with public health impact and of interest to American hemp farmers and many other stakeholders. 

Abernethy noted the FDA has a pathway for drug development and drug approvals, and the agency will remain committed to evaluating its 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” she said. “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 claims about more than a dozen different CBD products. Examples of the unsupported and unapproved claims made by the company include:

• “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, post-traumatic 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 requested responses from Curaleaf within 15 working days outlining how the violations will be corrected. Failure to correct the violations promptly could result in legal action, including product seizure and injunction.

Curaleaf, which operates in a dozen states and offers edibles, vape oils and concentrates, topical lotions, capsules and tinctures, said in a July 26 news release it scrubbed its social media accounts and website of statements with which the FDA took issue. 

The company also noted some of the products mentioned in the FDA’s letter had been discontinued. As of July 29, the only Curaleaf CBD products available for purchase online were lotions, topical patches, massage oil and lip balm.

"Our industry needs, wants and appreciates the work the FDA is doing to ensure there is regulation and compliance in the CBD marketplace," said Curaleaf CEO Joseph Lusard. "We care deeply about our customers and making a difference in our industry. Curaleaf is committed to being an ethical and responsible company and working with the FDA to be a leader in our industry, setting the standards and guidelines to best service our customers and the communities we serve."

The FDA said it is concerned by the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses that have not received the agency’s approval. 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. 

The FDA is concerned unsubstantiated claims associated with CBD products may lead consumers to put off medical care, such as proper diagnosis, treatment and supportive care. The FDA also warns 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.

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