Medical Marijuana and Maintaining FDA Compliance

John Meyer
Associate Editor
Loyola University Chicago School of Law, J.D. 2019

Regardless of opinions on legalization, many people accept the idea that medical marijuana, and more specifically CBD, can be a powerful treatment for many medical conditions. However, there has been one major roadblock: the FDA. According to the FDA, more than 90 warning letters over the past 10 years have been released to companies claiming that their cannabis products cure various symptoms. The most common is the claim that marijuana prevents or treats cancer. In 2017, as the medical properties of marijuana continue to be trumpeted to the general public, the FDA is still working to protect the public by issuing warning letters to marijuana providers making unsubstantiated claims.

History of Marijuana in the United States

Marijuana has a long and complicated history in the United States. Until the 20th century, America considered hemp, the plant that actually produces marijuana, vital to the production of goods like clothing and rope. This resulted in a law that actually required farmers to grow it. Marijuana’s potential medical properties were also recognized, and in 1906 the Pure Food and Drug Act required over-the-counter labels to disclose if the product contained cannabis.

As time passed, however, marijuana became heavily associated with violence and crime due to racism and faulty early 20th century science. This incited the Marijuana Tax Act, passed in 1937—effectively the first criminalization of marijuana. Recreational use continued to grow, but the social acceptability of cannabis declined due to marijuana’s association with various racial minorities. In 1973, Nixon officially formed the U.S. Drug Enforcement Agency (DEA), and marijuana became a Schedule I drug under the Controlled Substances Act.

Drug scheduling is done in tiers, with Schedule I reserved for those substances with the highest potential for both abuse and dependence. Specifically, “[s]chedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse.” While many states in recent years have legalized marijuana for medical use, the federal government and thus the FDA have not.

The FDA’s Role in Regulating Medical Marijuana

The FDA has been involved in regulating medical marijuana since the 1906 Pure Food and Drug Act mentioned above. The Act was specifically an effort to protect consumers from “misbranded and adulterated food and drugs.” The FDA as it exists today operates under the Food, Drug, and Cosmetic Act originally enacted in 1938 in response to products causing serious injury and even death to consumers.

The FDA has no role in determining the legality of marijuana at the federal level, but does have the authority to regulate drugs transported or distributed across state lines. The FDA requires that before any company is allowed to claim that their drug is a treatment for any ailment, they must first submit studies on the “safety, efficacy and quality” to the FDA for review. After an FDA investigation of the product, the agency may or may not grant approval regarding its safety and efficacy. A company in the U.S. can only market and sell their drug after obtaining such approval.

This core idea that it is the FDA’s responsibility to protect consumers from adverse effects of improperly regulated goods is reflected in its recent press announcement regarding medical cannabis. Many cancer therapies have been FDA-approved, but the FDA is concerned that rising costs and uncertain pain relief may drive consumers and patients to the unproven effects of CBD. As mentioned in the announcement, if the companies who received the FDA’s warning letters do not take effective steps to comply, the FDA has the authority to serve an injunction against them or even seize the drugs.

Future of Medical Marijuana under FDA Regulation

This is not the first major contradiction of state and federal laws regarding medical marijuana. However, it presents a slightly different dilemma. Consumers rely on companies to make honest statements about their products and the FDA is required to validate those claims. As many states continue to stand in opposition to federal law, consumers are left without protections from unsubstantiated medical claims because there is no state level equivalent to the FDA.

The FDA has extensive information about their role in medical marijuana approval on their site, and FDA Commissioner Scott Gottlieb even suggests that if a company submits studies for proper drug approval of marijuana, the FDA will evaluate the scientific findings. In fact companies including GW Pharmaceuticals and Zynerba Pharmaceuticals are currently conducting preliminary studies in hopes of being the first to gain FDA approval of a marijuana-based product. However, as recently as 2016 the FDA has recommended that the DEA maintain marijuana as a Schedule I drug. It remains to be seen if the FDA will actually grant approval to a marijuana-based product but if it does, it would prop up medical marijuana to a level of legitimacy that potentially undermines current federal law.