FDA “stands firm” in monitoring CBD marketplace with recent warning letter

25 Jul 2019 --- The US Food and Drug Administration (FDA) has issued a warning letter to US-based Curaleaf Inc., for illegally selling unapproved products containing cannabidiol (CBD) online. The company has made unsubstantiated claims that its products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases, according to the FDA. “As we examine potential regulatory pathways for the lawful marketing of products with CBD, protecting and promoting public health remains our top priority,” says Acting FDA Commissioner Ned Sharpless, MD.

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, Sharpless notes.

The hazy regulatory environment surrounding cannabis-derived products – most of which contain CBD and are found in a plethora of supplements, foods and other products – has allowed for confusion in the space and NPD is left in the “pending” stage. Players from a range of backgrounds have been attracted to the platform, spanning food and beverage, pharmaceutical, personal care and even biotech. 

Earlier this month, the Center for Science in the Public Interest (CSPI) filed comments to the FDA in support of the agency asserting a more active role in regulating consumer health and safety with regard to cannabis use. https://www.nutritioninsight.com/news/fda-is-late-to-the-table-on-cannabis-cspi-urges-agency-to-act-on-regulating-cbd.html

According to Sharpless, the FDA’s warning towards Curaleaf demonstrates that the agency stands firm in its commitment to continue monitoring the marketplace and protecting the public health. This is done by taking action as needed against companies that deceive consumers and put them at risk by illegally selling products marketed for unapproved therapeutic uses, such as those claiming to treat cancer or Alzheimer’s disease. 

 The FDA’s warning towards Curaleaf demonstrates that the agency stands firm in its commitment to continue monitoring the marketplace and protecting the public health. “Consumers should beware of purchasing or using any such products,” he highlights. “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 address the regulation of products made from CBD that fall under its jurisdiction,” an FDA statement reads. 

Moving forward with CBD
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 recognize the potential opportunities and significant interest in drugs 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.”

In the same arena, the International Cannabinoid Analysis Program (ICAP), a new third-party certification program for manufacturers and brands in the hemp and CBD product market will be launched this September.

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 claiming to contain CBD that are marketed for therapeutic or unapproved medical uses. 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. 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.

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.

Edited by Kristiana Lalou