Despite the dearth of approved marijuana products, the term “medical marijuana” has become commonplace, and the term’s prevalence continues to increase as more states legalize the use of the marijuana plant and its active derivatives for medical purposes, and marijuana dispensaries continue to expand throughout the United States. As of 2017, 29 states and the District of Columbia have approved the use of marijuana for medical purposes. (Despite state laws legalizing marijuana for medical and/or recreational use, marijuana remains a Schedule I controlled substance its distribution and use remain illegal under Federal law.)
Studies on the potential of the marijuana plant or its extracts continue to expand and include, among others, treating pain, preventing seizures, and treating autoimmune disorders such as Crohn’s disease. However, despite assertions of efficacy, the U.S. Food and Drug Administration (FDA) has not recognized or approved the marijuana plant as a medicine, and to date, the FDA has only approved three products – Marinol® and Syndrox®, which include the active ingredient, dronabinol, a synthetic delta-9-tetrahydrocannabinol (“THC”), to treat nausea associated with chemotherapy and loss of appetite in AIDS patients; and Cesamet®, which includes the active ingredient, nabilone, a synthetically derived compound with a structure similar to THC, to treat nausea and vomiting associated with chemotherapy. These drugs are available by prescription only.
The FDA, an agency within the U.S. Department of Health and Human Services, is responsible for assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use and medical devices. Before a drug can be tested in people, a drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it’s likely to be safe and work well in humans. Drug companies seeking to commercialize a drug in the United States must provide the FDA with appropriate scientific evidence from clinical tests to prove a drug is safe and effective for its intended use. A team of physicians, statisticians, chemists, pharmacologists, and other scientists at FDA reviews the company’s data and proposed labeling. If the independent and unbiased review establishes that a drug’s health benefits outweigh its known risks, the drug may be approved for sale. (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/)
According to Section 321(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act:
The term “drug” means . . . (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement . . . is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made . . . is not a drug under clause (C) solely because the label or the labeling contains such a statement.
A drug is misbranded if the drug fails to bear adequate directions for its intended use(s). (See 21 U.S.C. § 352(f)(1)) “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. (See 21 C.F.R. § 201.5) Prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner. (See 21 U.S.C. § 353(b)(1)(A))
As part of the FDA’s efforts to protect consumers from health fraud, the FDA from time to time issues warning letters to companies, for example, companies that are illegally selling products that claim to prevent, diagnose, treat, or cure a disease or disorder without scientific evidence to support these claims. Selling these unapproved products with unsubstantiated therapeutic claims is a violation of the Federal Food, Drug and Cosmetic Act.
The FDA has grown increasingly concerned at the proliferation of “medical marijuana” companies claiming their products treat or cure serious diseases like cancer. On November 1, 2017, 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. According to the FDA’s warning letters, the companies made 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.”
Unlike drugs approved by the FDA, the manufacture of the products identified in the recent warning letters 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 has requested responses from the companies stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure and injunction.
While marketing in the marijuana industry is a necessary business objective similar to mainstream businesses, medical marijuana companies must be sure to adhere to appropriate FDA guidelines in describing applications of their products and not overreach in asserting efficacy to treat or prevent illness. Seyfarth Shaw is a recognized leader in counseling marijuana companies and providing guidance on the nuances of the FDA’s guidelines as they pertain to marijuana and its application in sick patients.