Today, the U.S. Food and Drug Administration 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 pet anxiety.
The company also made unsubstantiated claims that the products treat human diseases and conditions, such as cancer, Alzheimer’s disease, opioid withdrawal, and pain.
“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 Acting FDA Commissioner Ned Sharpless, M.D. “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.”
Given the interest in products containing cannabis or cannabis-derived compounds, and CBD in particular, the FDA has and 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. An important component of this work is obtaining and evaluating information to address questions related to the safety of CBD products. 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.
“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,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D.
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:
- “[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 widely available. 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.
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 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.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of the nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.