Developments in 2018

This year, FDA took two significant actions related to the cannabis plant: (1) the agency approved the first drug with an active ingredient (cannabidiol or CBD) derived from the cannabis plant; and (2) the Commissioner issued a lengthy public statement on FDA’s stance with respect to hemp-derived products, including CBD, after President Trump signed the Agricultural Improvement Act of 2018, Pub. Law 115-334 (2018 Farm Bill) into law. The law signifies continuing momentum for the cannabis industry in terms of what it is lawful to grow and market in the US, and the law will impact the marketability of hemp-derived products. As the 2018 Farm Bill did not amend the FDCA, the cannabis industry still faces significant hurdles with respect to future plans to add hemp-derived substances to food, beverages, and dietary supplements. The Commissioner’s announcement makes clear that FDA will exercise its existing authorities to take enforcement actions against hemp-derived CBD or THC products. Though the Commissioner’s statement has tempered the cannabis industry’s enthusiasm for such products, his contemporaneous announcement that three hemp ingredients may be lawfully marketed under the agency’s Generally Recognized as Safe (GRAS) notice process will spark innovation in the form of new food and beverage products that use such ingredients.

First Drug Approved

In June, FDA approved the CBD oral solution for patients two years of age and older who have seizures associated with two forms of severe epilepsy. According to the US Drug Enforcement Administration (DEA) and FDA, the CBD in the 

approved drug is extracted from the cannabis plant and is a purified drug substance. The FDA-approved drug has no more than 0.1 percent residual tetrahydrocannabinol (THC), marijuana’s psychoactive component. In September, DEA announced an order scheduling the drug under the least restrictive schedule of the Controlled Substances Act (CSA), schedule V, and noted that all other CBD products remain under the most restrictive schedule, schedule I. Although FDA did not post any warning letters for illegally marketed CBD-related products in 2018, the Commissioner noted in June that FDA has taken actions against the illegal marketing of such products. In his statement issued after the Farm Bill became law, the Commissioner cited past warning letters and reiterated that FDA will take enforcement actions to protect the public from illegally marketed cannabis-derived products.
 

The cannabis industry still faces significant hurdles with respect to future plans to add hemp-derived substances to food, beverages, and dietary supplements.

Ramifications of the 2018 Farm Bill

On December 20, President Trump signed the 2018 Farm Bill into law. The law permits a state or Indian tribe that wants primary regulatory authority over hemp production within the state or territory to submit plans to the Secretary of the US Department of Agriculture (USDA) for monitoring and regulating that production. Importantly, the law creates a new definition of “hemp” that differentiates hemp from the schedule I drug marijuana, but does not amend the FDCA.  As a result, FDA will continue to regulate hemp-derived products under FDA’s existing authority to regulate food, drugs, and dietary supplements, and the cannabis industry will encounter federal restrictions on such products, even if derived from hemp. The law makes two changes to the CSA:

• Creates a carve out for hemp from the CSA’s definition of marijuana, such that marijuana would be limited to the cannabis plant and its derivatives with a THC of 0.3 percent or more on a dry weight basis

• Excludes THC in hemp from schedule I of the CSA
   

The law would create a new definition of "hemp" that differentiates hemp from the schedule I drug, marijuana.

As a result, the law appears to exclude all cannabinoids (which include CBD) with less than 0.3 percent THC on a dry weight basis from the CSA’s definition of marijuana. Though hemp is now a legal substance under federal law, FDA will still regulate the addition of cannabis and derivatives of cannabis (e.g., CBD, THC) to food and drinks, deem foods with such derivatives to be adulterated and require agency approval of new drug applications. Finally, the 2018 Farm Bill includes a rule of construction that states that nothing in the applicable title of the law or an amendment made by the applicable title prohibits the interstate commerce of hemp or hemp products. However, the law did not change the FDCA’s statutory provision on interstate commerce. That provision presumes the existence of the connection with interstate commerce that is required for FDA to exercise its jurisdiction to enforce the FDCA with respect to products including food, drugs, and cosmetics.

The Commissioner issued an announcement concurrent with President Trump’s signing of the 2018 Farm Bill. The statement:

• Explained that FDA will continue to treat cannabis-derived compounds like any other drug, food or dietary supplement that the agency regulates, regardless of the source of the cannabis-derived substance, e.g., plants classified as hemp

• Reminded industry that even if the cannabis-derived substance is hemp-derived, it is unlawful to introduce foods that contain added CBD or THC into interstate commerce

• Noted that it is a violation of the FDCA to market CBD and THC products as dietary supplements  

• Asserted that FDA will take enforcement action against companies illegally selling any cannabis and cannabis-derived products that put consumers at risk and that are marketed in violation of the FDCA

• Indicated that FDA will update its guidance on cannabis products to address questions under the 2018 Farm Bill

The Commissioner also announced that FDA evaluated three hemp ingredients and determined they could be lawfully marketed:  hulled hemp seeds, hemp seed protein, and hemp seed oil. We expect to see a substantial increase in the number of marketed foods and beverages that contain such ingredients.

Looking Ahead to 2019

Though FDA reaffirmed its jurisdiction with respect to cannabis derivatives in food, the agency did not address the addition of CBD or other cannabis derivatives to cosmetics in the Commissioner’s announcement and has not addressed cosmetics in its current cannabis guidance. We expect FDA to weigh in on the addition of hemp-derived substances to cosmetics products next year. FDA also announced it will hold a public meeting on appropriate hemp products in the near future. Additionally, FDA, USDA and the US Department of Justice (DOJ) likely will issue guidance interpreting the 2018 Farm Bill’s provisions on hemp and interstate commerce in hemp and hemp products. After the passage of the 2014 Farm Bill, the three government entities issued a Statement of Principles on Industrial Hemp, which reaffirmed that the 2014 law did not change any FDA authorities in the FDCA. The 2014 Farm Bill legalized the growing and cultivating of industrial hemp for research purposes in states where such conduct was legal despite federal restrictions on hemp production, but like the 2018 Farm Bill, it did not amend the FDCA. We anticipate that FDA will be asked to review an increased number of new drug applications and other regulatory submissions for products that contain cannabinoids (including CBD).

Read more on FDA 2018 Year in Review.