By Medical marijuana attorney Richard M. Blau, Chair, GrayRobinson’s Regulated Products Department
The U.S. Food and Drug Administration (FDA) announced on November 1, 2017, that it sent warning letters to four companies accused of making false claims in marketing promotions for online sales of products containing cannabidiol (CBD). The promotions claimed that the CBD products help treat or cure cancer and other diseases.
CBD is a different compound from tetrahydrocannabinol (THC), the psychotropic cannabinoid that is the principal psychoactive constituent of cannabis. THC is most associated with the burgeoning medical (and recreational) marijuana industry.
In contrast, CBD products typically are derived from hemp or hemp seeds and occupy more of a niche industry associated with nutritional supplements and personal care products promoted as alternatives to more mainstream health products. At least 16 states have laws allowing cultivation of hemp for research and/or commercial purposes. In 2016, the hemp industry earned an estimated $688 million in U.S. sales, setting a new record according to an analysis by the Hemp Business Journal. Hemp-derived CBD accounted for an estimated $130 million share of that total, the trade publication reported.
Despite the expanding nature of the industry, the recent warning letters demonstrate that the federal government continues to take a proactive position on enforcement of drug laws relating to CBD as well as THC.
The FDA’s warning letters to emphasize the illegality of selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes. Selling such unapproved products with unsubstantiated therapeutic claims constitutes a violation of the Federal Food, Drug and Cosmetic Act.
CBD is not FDA approved in any drug product for any indication. The FDA issued warning letters to four companies – Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC – citing unsubstantiated claims related to more than 25 different products spanning multiple product webpages, online stores and social media websites. The companies used these online platforms to make unfounded claims about their products' ability to limit, treat or cure cancer and other serious diseases. Examples of claims made by these companies include:
- "Combats tumor and cancer cells;"
- "CBD makes cancer cells commit ‘suicide’ without killing other cells;"
- "CBD … [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow;" and
- "Non-psychoactive cannabinoids like CBD (cannabidiol) may be effective in treating tumors from cancer – including breast cancer.
In a press release dated November 1, 2017, the FDA noted that the manufacture of the products in question "has not been subject to FDA review as part of the drug approval process and there has been no FDA evaluation of whether they work, what the proper dosage is, how they could interact with other drugs, or whether they have dangerous side effects or other safety concerns." The FDA requested responses from each of the four companies explaining how the violations will be corrected. The agency also warned that failure to correct the violations promptly may result in legal action, including product seizure and injunction.
In December of 2016, the U.S. Drug Enforcement Administration (DEA) finalized its formal rulemaking to confirm that CBD is considered an illegal substance—just like other marijuana products. The agency’s action finalized a draft rule proposed in 2011 to establish a distinct entry for marijuana extracts (like CBD) in the federal schedules of controlled substances, separate from marijuana. In explaining its December 2016 finalization of the regulation expressly adding derivatives like CBD to the list of controlled substances, the DEA characterized the rule as bringing U.S. marijuana enforcement into better compliance with international drug control regulations.
Courts largely have afforded DEA broad latitude in controlling substances derived from the cannabis plant. The DEA has consistently taken the position that cannabinoids are the same as marijuana, and therefore constitute a Schedule I substance under the federal Controlled Substances Act, and illegal in all circumstances. Marijuana reformers often point to Hemp Industries Association v. DEA, 357 F.3d 1012 (9th Cir. 2004) to say that non-psychoactive hemp is not a controlled substance. While the appellate court in that case ruled that not all cannabis plants fall under the Controlled Substances Act, most courts, including the cases U.S. v. Plume 447 F.3d 1067 (8th Cir. 2006), U.S. v. Proyect, 989 F.2d 84 (2d Cir. 1993), and U.S. v. Spann 515 F.2d 579 (10th Cir. 1975), have held the opposite.
The federal government’s prohibitionist position regarding marijuana, CBD and other cannabis derivatives is in direct conflict with states across America (29 plus the District of Columbia) that have legalized medical and/or recreational marijuana, along with a variety of derivative products such as CBD oils. Products rich in CBD typically are used by medical marijuana patients for everything from reducing seizures, to serving as an anti-inflammatory, to alleviating anxiety.
Because of the existing legal conflict, shipping CBD products across state lines violates both federal law. That behavior, and the dictates of existing federal law, have led to a series of cease and desist letters from the FDA to producers shipping products across state lines. The latest warning letters, focused on marketing claims associated with CBD products, are identified by marijuana industry advocates as part of a continuing determination by the federal authorities to curb, if not eliminate, the expanding commercialization of legalized cannabis.
How this all plays out may be influenced by ongoing litigation pending before the U.S. Court of Appeals for the Ninth Circuit. Lawyers representing the Hemp Industries Association and hemp businesses have filed a petition with the Ninth Circuit arguing that the DEA’s finalized drug code classification rule for CBD and other marijuana extract violates multiple laws and stands to chill a multibillion-dollar business. Whether a decision will be rendered before the year’s end is unclear.