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U.S. Food and Drug Administration

FDA News Release

Products Listing CBD as Inactive Ingredient Cited for Unapproved Drug and Misbranding Violations

The U.S. Food and Drug Administration has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD. The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved new drug application. The letters explain that, as CBD has known pharmacological effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA. Additionally, the letters cite substandard manufacturing practices, including failure to comply with current good manufacturing practices.

“The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other, unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products — prioritizing those that pose a risk to public health.”

The FDA issued warning letters to:

The products that are the subject of the warning letters issued today have not gone through the FDA drug approval process and are considered unapproved new drugs. There has been no FDA evaluation of whether these unapproved drug products are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products or whether they have dangerous side effects or other safety concerns.

The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to prevent, diagnose, mitigate, treat or cure various diseases, in violation of the FD&C Act.

Under the FD&C Act, any product intended to diagnose, cure, mitigate, treat or prevent a disease, and any product (other than a food) that is intended to affect the structure or function of the body of humans, is a drug. OTC drugs must be approved by the FDA or meet the requirements for marketing without an approved new drug application under federal law, including drug products containing CBD, regardless of whether CBD is represented on the labeling as an active ingredient or an inactive ingredient.

The FDA has not approved any CBD-containing drug products other than one prescription drug for the treatment of seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome in human patients.

The FDA has requested written responses from these companies within 15 working days stating how they will address these violations or providing their reasoning and supporting information as to why they believe these products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.

Today, the U.S. Food and Drug Administration issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act.

OTC CBD Products Currently Available in Pharmacies

Conferences | ASHP

Results of a study presented in a poster presentation during ASHP Midyear collected data of the available OTC CBD products being sold in Colorado pharmacies.

With recent surges in popularity, FDA guidance, and state legislation within the landscape of cannabis-derived compounds, pharmacies are increasingly supplying cannabidiol (CBD) products.

Of note, CBD is only 1 of the compounds found within the cannabis plant and has no psychoactive effects; delta-9-tetrahydrocannabidiol (THC) is a different compound that does produce psychoactive effects, and marijuana is a type of cannabis plant that possesses multiple naturally occurring compounds, including CBD and THC. 1

Study investigators Leticia Shea, PharmD, BCACP, Anna Carnazzo, PharmD candidate, and Janelle Matura, PharmD candidate, from the Rueckert-Hartman College for Health Professions at Regis University in Denver, Colorado, documented the OTC products currently being offered by pharmacies across Colorado. The findings were presented in a poster during the Association of Health-System Pharmacists (ASHP) 2020 Midyear Clinical Meeting and Exhibition.

Although there are myriad CBD products marketed and sold with medical claims, there is currently only 1 CBD product that has been evaluated and approved by the FDA for safety and efficacy. 1

As the CBD sphere of influence expands, pharmacists should “recognize the discrepancy between these CBD products and CBD approved by the FDA,” the researchers wrote. Importantly, pharmacists should also be prepared to effectively counsel patients on the use of untested CBD products that are available in their stores. 2

Of the 35 pharmacies included in the study, 18 (51%) sold at least 1 CBD product. Investigators took inventory of the CBD products at the 18 chain and independent pharmacies across the state of Colorado, located in both urban and rural regions. A total of 60 CBD products were recorded.

The majority of products took the form of oral drops/pumps, balms/salves, or creams/ointments. Other CBD product forms included topical oils, bath products, gummies, lotions, patches, and pet salves and balms.

Depending on the product form – oral, topicals, or transdermal – concentrations of compounds varied. In oral products, CBD concentrations varied from 10 to 60 mg/mL, with 13 (87%) labeled as “full spectrum” and therefore likely contained active cannabinoids other than CBD. In topical products, concentration ranged from 30 mg CBD/15 mL to 1000 mg CBD. Most topical products also contained other ingredients; among these products, 32% contained menthol, 17% contained camphor, 10% willow bark extract, and 10% contained peppermint, among other ingredients. The single transdermal product offered a 20mg CBD/24h dose, according to researchers.

Researchers reported that additional studies are needed to determine the safety and efficacy of these products in regard to the formulations themselves, as well as dosing.

“The impact of drug-interactions for topically applied CBD is currently unknown as no studies have evaluated [only CBD] topical formulations in humans,” investigators wrote. “The OTC CBD market is growing, and will be important for pharmacists to be cognizant of the variety of products being sold.”

Results of a study presented in a poster presentation during ASHP Midyear collected data of the available OTC CBD products being sold in Colorado pharmacies.