The FDA and Cannabinoids: An Overview of Regulatory History in the U.S.

At Averix Bio, we believe increased FDA regulation is necessary to ensure the safety and long-term viability of this industry.

Cannabis-derived remedies have been used for centuries

The use of the Cannabis sativa plant for medicinal and other purposes has been around almost as long as civilization; for thousands of years, people around the world have used the plant to address a variety of health issues. In fact, many claim that the first recorded usage occurred around 2727 BC, when Emperor Sheng Neng of China used a cannabis-based tea to ease a variety of ailments, including malaria and gout.(1)

In the United States, the FDA plays an evolving role in cannabis regulation

Across the globe and across centuries, peasants and emperors alike have turned to cannabis-derived remedies as part of a holistic and natural approach to health and wellness. Here in the United States, consumers, medical professionals, scientists, and regulators have had a complex and frequently changing relationship with the plant. Today, the U.S. Food and Drug Administration (FDA) plays a large and evolving role in setting regulatory policy that covers Cannabis sativa—and products derived from it— at the federal level.

The federal government has been monitoring the safety of agricultural products using chemical analysis—a key responsibility of the modern FDA—since 1848. Initially dubbed The Bureau of Chemistry, the FDA received its current name in 1930, but its modern day functions began with the passage of the 1906 Pure Food and Drugs Act.(2) Since then, the FDA has evolved with changes in the economic, political, legal, and social landscape in the United States.

FDA Drug Committee meets circa 1940 (source: FDA)

1970: Cannabis sativa is classified as a Schedule I drug under the Controlled Substances Act

Since 1970, the federal government has controlled parts of the Cannabis sativa plant under the Controlled Substances Act (CSA). Listed in Schedule I of the CSA due to its high potential for abuse, the drug class “Marihuana” (commonly referred to as “marijuana”) gets most of its psychoactive effects from delta-9 tetrahydrocannabinol. Commonly known as THC, the presence—or absence—of this cannabinoid largely determines how hemp-derived products are treated under federal regulations today.

As cannabinoid science evolves, the FDA is working hard to catch up

The first cannabinoid to be extracted from the Cannabis sativa plant was Cannabinol (CBN). At the end of the 19th century, the compound was first isolated from a cannabis extract, and by 1940, researchers were able to synthesize it in a laboratory. CBD came next—later that same year—and THC followed just two years later. (4) These were important discoveries and advances; once the unique cannabinoids were isolated, it quickly became clear that the psychoactive qualities attributed to the Cannabis sativa plant were not found in CBD. In plain English—CBD won’t make you high.

Decades of research and advocacy followed, initially focused primarily outside of the United States. But by 2010, when Project CBD launched as a resource for researchers and consumers looking to understand the compound’s potential, people across the U.S. were paying attention. Stories spread, especially stories of children using CBD to treat intractable epilepsy. Perhaps the most famous story of all—that of Charlotte Figi—aired on CNN in 2013. Suddenly, demand for CBD was skyrocketing, but the federal government classified all compounds derived from the Cannabis sativa plant on their Schedule I list.

The 2014 Farm Bill begins to decriminalize hemp

The 2014 Farm Bill introduced legislation that began to decriminalize CBD. The legislation introduced a hemp pilot research program—defining industrial hemp as cannabis containing less than 0.3 percent THC. Despite this regulatory progress, the bill’s vague language led to much confusion. Many people interpreted the 2014 legislation as a legalization of CBD, but the Drug Enforcement Administration (DEA) didn’t agree. Nevertheless, people rushed into the CBD business at warp speed, flooding the market with cannabidiol-based products. From oil and tinctures to beverages and skin creams, CBD products were suddenly everywhere.

The 2018 Farm Bill throws open the door to legal cannabinoid research and commerce

As the CBD business boomed, many began asking for federal clarification and regulation. In 2018, Congress responded with a new Farm Bill that explicitly made hemp legal. The 2018 bill expands the pilot programs authorized in the 2014 bill to allow for widespread cultivation of hemp. It explicitly makes legal the transfer of hemp-derived products across state lines for commercial or other purposes. Hemp-derived products that are produced in a legal manner can be sold, transported, and possessed with no restrictions.(3)

Hemp is still a highly regulated crop

Despite this tremendous progress, numerous restrictions still exist when it comes to growing hemp. The biggest and most important restriction relates the previously mentioned restriction on THC content. Any cannabis plant that contains more than 0.3 percent THC would be classified as non-hemp cannabis (marijuana), and would not benefit from this new legal protection. It’s also important to note that currently, the federal government shares regulatory power over hemp farming with the states.

States retain some control over hemp production and regulation

Section 10113 of the Farm Bill mandates that state departments of agriculture must consult with the state’s governor and chief law enforcement officer when developing their hemp licensing and regulatory plans. These plans must then be approved by the Secretary of USDA. If a state does not develop its own plan, the USDA will step in to offer a federally-run program. Violations of these approved programs can be considered violations of federal hemp law, with some activities (including repeat offenses) classifying as felonies. The bottom line is that cultivating hemp is legal, but it’s a highly regulated crop, whether you grow it for personal or industrial production.

The 2018 Farm Bill asserts the importance of hemp research

If the 2014 Farm Bill cracked the door for legal hemp research, the 2018 bill pushed it wide open. Section 7605 of the bill reaffirms the protections for hemp research and the conditions under which such research can and should be conducted. And section 7501 brings hemp under the aegis of the Critical Agricultural Materials Act. The bill essentially establishes the importance of learning more about what hemp and its products.

Hemp growers now benefit from Federal Crop Insurance

Despite the increased regulation, in many important ways the 2018 Farm Bill treats hemp just like other agricultural commodities. By making hemp a mainstream crop, the legislation allows hemp farmers to benefit from protections under the Federal Crop Insurance Act. This is a critical aid that helps farmers who face crop losses in the normal course of agricultural production.

CBD loses its Schedule I status, but questions remain

Section 12619 of the Farm Bill removes hemp-derived products from its Schedule I status under the Controlled Substances Act, but the area is still very gray. The Farm Bill ensures that any cannabinoid that is derived from hemp will be legal, if and only if the production of that hemp is done by a licensed grower and abides by all federal and state regulations. Any cannabinoids produced outside of these regulations remain Schedule I controlled substances under federal law and are thus illegal. These nuances make it especially important for businesses who want to ensure their products stay on the right side of the regulations to obtain their hemp-derived ingredients from a supplier that is committed to full transparency, trackability, and compliance. As the Brookings Institute concludes in their concise review of the legislation, “under the 2018 Farm Bill, there will be more broadly available, legal, CBD products; however, this does not mean that all CBD products are legal moving forward. Knowing your producer and whether they are legal and legitimate will be an important part of consumer research in a post-2018 Farm Bill world.”(4)

Current developments bring cannabinoid regulations closer

As the FDA continues to refine their policies with respect to cannabinoids and hemp, Averix Bio is prepared for all the changes to come. In December of 2019, Congress directed the FDA to conduct a sampling study of the current CBD marketplace via the Further Consolidated Appropriations Act, 2020 (P.L. 116-94). As expected, the recently completed first round of testing showed that many of the products did not contain the listed cannabinoid amounts, were mislabeled, and/or were adulterated or contaminated with other substances.(5) These findings are not surprising given the current unregulated state of the market.

In July, the agency released draft guidance entitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry.” Industry participants are invited to comment through September 21, 2020 in advance of the FDA’s finalized guidelines.(6) We expect guidance to come soon addressing the consumer market as well.

We’re ready

Averix Bio is leading the charge in this evolving industry as a cannabinoid extractor committed to being trackable, transparent, and trustworthy. We know that a clear and structured regulatory framework is the future of the industry, and we’ve built our business from the ground up to support quality and compliance. FDA regulation is coming, and we’re ready.

Resources:

Understanding Marijuana. (2002). Google Books. https://books.google.nl/books?id=r9wPbxMAG8cC&pg=PA10&lpg=PA10&dq=shen+neng+china+marijuana&source=bl&ots=TrhItZGhxt&sig=f7scKdT5yY5lJNIZVZH6CGF53iQ&hl=en&sa=X&redir_esc=y#v=onepage&q=shen%20neng%20china%20marijuana&f=false
The History of FDA’s Fight for Consumer Protection. (2018, June 29). U.S. Food and Drug Administration. https://www.fda.gov/about-fda/history-fdas-fight-consumer-protection-and-public-health
Hemp Production and the 2018 Farm Bill. (2019, July 25). U.S. Food and Drug Administration. https://www.fda.gov/news-events/congressional-testimony/hemp-production-and-2018-farm-bill-07252019
Hudak, J. (2018, December 13). The Farm Bill, hemp legalization and the status of CBD: An explainer. Brookings. https://www.brookings.edu/blog/fixgov/2018/12/14/the-farm-bill-hemp-and-cbd-explainer/
I. (2020, July 9). FDA: Many CBD products contain far less, sometimes more, than advertised. Hemp Industry Daily. https://hempindustrydaily.com/fda-many-cbd-products-contain-far-less-sometimes-more-than-advertised/?fbclid=IwAR2gs4x6GQYW_w6CRNeTsMSk6LS9BjDnKvr7BL-ZPB6Zf9ntIltg8jAMne0
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Cl. (2020, September 21). U.S. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cannabis-and-cannabis-derived-compounds-quality-considerations-clinical-research-guidance-industry