CBD: Drug or a dietary supplement?

CBD: Drug or Dietary Supplement According to the FDA

With the swarm of popularity in cannabidiol (CBD) and the numerous beneficial proprieties it possesses, there is no wonder why it caught the attention of the Food and Drug Administration (FDA).

The 2018 Farm Bill was passed and contained a section that legalized hemp (CBD is a compound that is found in hemp), which typically is not a topic covered. The THC content in hemp plants must be 0.3 or lower to be considered legal.

What is the 2018 Farm Bill?

The Farm Bill focuses on legislation for “food and agriculture, rural economies, trade, on-farm energy production and so much more” (Farm Aid: A new Farm Bill is here!). It is renewed every five years by Congress, with the latest being in 2018. The Farm Bill will not only have dramatic effect on the production of hemp, but of CBD as well.

farm bill by New Frontier Data

So, How Does This Relate to CBD?

Prior to the 2018 Farm Bill CBD and hemp cultivation have been viewed as a good business. Cannabis sativa L. or hemp is a quick growing, easily harvested plant with many commercial uses. As a result of the legalization of hemp, CBD products became increasingly more available for consumers.

Currently it is “unlawful under the [Federal Food, Drug, and Cosmetic Act] to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived” according to Scott Gottlieb M.D., Commissioner of Food and Drugs at the FDA.

The Food and Drug Administration (FDA) is planning to meet on May 31st, 2019 to discuss hemp-derived products (Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for Comments). One topic that will be covered is whether CBD is a drug or dietary supplement.

But before we dive into that, how does the FDA define what is considered a drug? And what is regarded as dietary supplement?

How Does the FDA Define a Drug?

The FDA considers a “drug” any substance “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” or “articles (other than food) intended to affect the structure or any function of the body of man or other animals” (Human Drugs).

 


Similar to This: Cannabinoids 101


How Does the FDA Define a Dietary Supplement?

Dietary Supplements are considered any substance that is taken by mouth that includes “dietary ingredient. Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet”. Products that are labeled as “dietary supplements” are not regulated by the FDA and do not have to confirm safety prior to being available to the public (FDA 101: Dietary Supplements).

What is the Main Difference Between a Drug and a Dietary Supplement?

Essentially, any substance marked as a “drug” is required to go through rigorous testing to be considered safe, such as clinical trials with human subject. While products labeled as “dietary supplements” do not have to go through any testing and are thought to be safe, unless proven otherwise.

cbd oil
Medicinal cannabis with extract oil in a bottle

What Category Does CBD Fall Under?

As of now, the FDA has not labeled CBD products as a drug or dietary supplement. They hold “a firm stance on CBD and has repeatedly indicated that it is not permitted in dietary supplements, and any dietary supplements containing CBD that are currently on the market are therefore classified as illegal. The US FDA has stated that they are aware of the growing public interest in cannabis and cannabis-derived products, including CBD, but have not yet made an official statement to change their compliance status, and enforcement stance” (Baldwin).

The FDA understands that there is a considerable number of individuals enthusiastic about CBD and the benefits it appears to have. However, much about cannabidiol and cannabis-derived products are still unknown. The legalization of hemp from the 2018 Farm Bill “recognizes the importance, diversity, and opportunity of the plant and the products that can be derived from it, but also recognizes an important point: there is still a lot to learn about hemp and its products from commercial and market perspectives” (Farm Aid: A new Farm Bill is here!).

Resources

Baldwin, Nigel. “The Confusing World of CBD in Food and Supplements .” 09 April 2019. Interek. 11 May 2019.

Farm Aid: A new Farm Bill is here! n.d. 11 May 2019.

“FDA 101: Dietary Supplements.” 15 July 2015. U.S. Food & Drug Administration. 11 May 2019.

Hudak, John. The Farm Bill, hemp legalization and the status of CBD: An explainer. 14 December 2018. 11 May 2019.

“Human Drugs.” 14 September 2018. U.S. Food & Drug Administration. 11 May 2019.

“Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for Comments.” 03 April 2019. Federal Register. 2019 May 2019.