Cannabidiol (CBD) and FDA—Regulating a New Market

The market for cannabis in the United States is on the rise. With several states permitting the use of medical marijuana, decriminalizing possession of marijuana or outright allowing possession by adults, marijuana is on the national radar. During 2016, the industry yielded US$6.7 billion in North American sales, primarily from regulated distribution in Colorado and Washington, according to a September 2017 report by Arcview Market Research. The pro-cannabis group further projected the industry to grow by a 22 percent compound annual growth rate (CAGR) for 2017, following efforts to open medical cannabis markets in states such as Pennsylvania, Maryland and Ohio.

With surging profits and research that alludes to the possible health benefits of cannabis products, it comes as no surprise that many businesses want a stake in this emerging market. Use of the Cannabis sativa plant for medical purposes is not new. Dating as far back as 1985, FDA approved three drugs derived from constituents of the Cannabis sativa plant: MARINOL® (dronabinol), Cesamet® (nabilone) and Syndros™ (dronabinol). However, the cultural normalization of marijuana has generated increased interest in, and awareness of, the constituents of Cannabis sativa. Cannabidiol (CBD) in particular has made its way to the forefront of the national consciousness and has been the subject of intensive research after the discovery of its potential positive effects on children with epilepsy.

According to the National Institute on Drug Abuse (NIDA), preclinical research indicated possible anti-seizure (Cochrane Database Syst Rev. 2014 Mar 5;(3):CD009270), anti-anxiety (Neuropsychopharmacology. 2011;36:1219-1226) and anti-tumor effects (J Neuroimmune Pharmacol. 2015 Apr28) from treatment with CBD. However, NIDA also stated evidence of CBD’s efficacy for these conditions is inconclusive at this point, and further clinical testing and evaluation are warranted. The current research has not been deemed sufficient to support drug approval. Nevertheless, the intense interest in CBD and the media attention surrounding its potential effects have resulted in an avalanche of food and dietary supplement products containing the extract. Many of these products are marketed as treatments for ailments such as cancer, autism, personality disorders and Alzheimer's disease.

Meanwhile, FDA has worked to curb the interstate distribution of these products. As recently as Nov. 1, 2017, FDA issued a news release highlighting the agency's efforts to curtail illegal sales of products containing CBD.

FDA's Crackdown on "Dietary Supplements" Containing CBD

The last few years have seen a spike in FDA attention on the CBD issue. On June 24, 2015, FDA's deputy director for regulatory programs testified before the U.S. Senate's Caucus on International Narcotics Control regarding matters surrounding the research, approval and distribution of products containing CBD. A flurry of warning letters followed in February 2016, sent to companies marketing CBD products as dietary supplements with claims to treat a multitude of diseases. On Oct. 31, 2017, FDA sent four similar warning letters to businesses marketing CBD products as dietary supplements.

In the recent warning letters, FDA stated the businesses established their products as drugs through health claims displayed on their labeling, including websites and social media accounts. Advertisements and testimonials attested to the health benefits of CBD. Examples of these claims include:

FDA determined the claims presented an intention for the products to diagnose, cure, mitigate, treat or prevent disease. Additionally, the products were not considered GRAS (generally recognized as safe) for these intended uses and fell under the definition of “new drugs” established by the Federal Food, Drug, and Cosmetic Act (FD&C). New drugs require prior approval by FDA to be introduced into interstate commerce.

FDA concluded the products were misbranded. Drug labeling requires “adequate directions for use” to be readily understood by a layperson. Since the products claimed to treat conditions that cannot be self-diagnosed (e.g., cancer and diabetes), and prescription drugs can only be used safely under the guidance of a licensed practitioner, the agency stated it was impossible to write adequate directions for these products.

Perhaps even more importantly, the letters further stated CBD is excluded from the definition of a "dietary supplement" under section 201(ff)(3)(B)(ii) of the FD&C, as it has been authorized for investigation as a "new drug" for which clinical trials have begun. There is an exception for substances that were previously marketed as supplements, but FDA determined this did not apply to CBD. Therefore, even if a CBD supplement product made no disease claims, FDA could still consider it in violation of the FD&C simply for containing the ingredient. Additionally, CBD is not approved as a food additive or affirmed GRAS, and its presence in a conventional food or beverage could likely yield the same result.

What Does This Mean for CBD Products?

Understanding how federal regulations impact the ability to sell CBD products across the United States is imperative for businesses seeking to enter this market. While certain states have developed their own laws regarding the sale of cannabis and cannabis-derived products, FDA established that the interstate distribution of CBD in food and dietary supplements is prohibited. Further complications stem from the classification of cannabis extracts as controlled substances by the U.S. Drug Enforcement Administration (DEA) and the fact that cannabis possession and use is still illegal under federal law.

As of this writing, FDA has not formally approved a drug product in which CBD is an active ingredient. Businesses making health claims like those referenced in the warning letters may be violating the FD&C by marketing misbranded and unapproved new drugs. CBD is also not approved as a food additive or affirmed as GRAS and is excluded from the definition of "dietary supplement." Therefore, any product intended for use as a conventional food, beverage or dietary supplement could violate the FD&C simply due to the presence of CBD as an ingredient.

Companies might try to circumvent federal regulation by distributing CBD products through online vendors. Though these businesses may not yet have seen intervention by government authorities, interstate distribution of CBD products can result in warning letters, which may lead to seizure, fines, injunction or other enforcement actions. FDA has suggested it will work with state and local authorities to determine when enforcement actions are warranted. Notwithstanding state and local laws that may permit distribution of cannabis-derived products, companies take a substantial risk if they choose to do so.

Anna Benevente is a senior regulatory specialist at Registrar Corp (registrarcorp.com), an FDA consulting firm that helps companies comply with FDA regulation. She has been assisting companies with U.S. FDA regulations since 2009 and has researched over 370 products to determine whether they meet FDA requirements for compliance.