Since the 2014 Farm Bill passed, products containing cannabidiol (“CBD”) derived from hemp (“Hemp-CBD”) have become widely popular and available in a wide range of stores and online. The Food and Drug Administration (“FDA”) has, for the most part, sat on the sidelines. The FDA has occasionally sent out warning letters to Hemp-CBD distributors who made medical claims about their products, but that was it. The days of relative non-enforcement may be over, as the FDA has recently seized Hemp-CBD products.
This two-part series will take a look at how the FDA will regulate Hemp-CBD. Today’s post will focus on why the FDA does not currently view Hemp-CBD is a dietary supplement. Tomorrow, we’ll examine some issues with the FDA’s position and look at how the agency may regulate Hemp-CBD in the near future.
The 2018 Farm Bill makes it explicit that it does not limit the FDA’s authority to regulate consumer products, and the FDA has made clear that it is focused on Hemp-CBD, making an announcement on Hemp-CBD just moments after the 2018 Farm Bill was signed by Trump. FDA’s jurisdiction over products is triggered by the Food, Drug & Cosmetics Act (“FDCA”).
For the purposes of this post we’ll look at the following categories of products under the FDCA and FDA regulation:
“Drug” is any article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” or “intended to affect the structure or any function of the body of man or other animals. In addition, anything intended as a component of a drug is also drug. 21 USC § 321(g). The FDA’s jurisdiction is triggered by the intended use oof an item. The FDA determines intended use generally based on claims made by the distributers of a product, which are often uncovered on labeling, advertising, and other promotional activities related to a product. Drugs are tightly regulated by the FDA and subject to pre-approval before being introduced into interstate commerce.
“Food” is any “article for use as food or drink for man.” Unlike drugs, which are determined by intended use, the FDA exerts its jurisdiction over food based on actual use.
“Dietary supplement” is a product intended to supplement the diet that contains one or more of the following: (a) a vitamin; (b) a mineral; (c) an herb or other botanical; (d) an amino acid; (e) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (f) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (a) through (e). 21 U.S.C. § 321(ff).
Hemp-CBD appears to makes the most sense as “dietary supplement.” After all, it is is a concentrate of a botanical: hemp. Hemp-CBD could also be a food (based on actual use) or drug (based on intended use). The FDA’s warning letters mostly have focused on Hemp-CBD as a drug, but those letters and other statements by the FDA make it clear that the FDA does not believe that Hemp-CBD qualifies as a dietary supplement or food. For today’s post, we’ll focus on the dietary supplement side of things.
Drug Exclusion Rule
There is an exclusion clause in the definition of “dietary supplement” that generally disallows the use of an FDA approved “drug” as a dietary supplement. We will call this the “Drug Exclusion Rule.” The FDCA’s definition of “dietary supplement” excludes any article that is approved as a new drug or has been subject to a publicized Investigational New Drug (“IND”) clinical investigation, unless the substance was marketed in food or as a dietary supplement before the FDA approved it as a new drug or began the IND investigation. The FDA addresses numerous cannabis related issues on its “FDA and Marijuana: Questions and Answers” page (“FDA FAQs”). According to the FDA FAQs, products containing CBD cannot be sold as dietary supplements because CBD has been investigated and approved as a new drug, namely Epidiolex.
Though the FDA FAQs is a nonbinding guidance document, it seems to indicate that the Drug Exclusion Rule applies to CBD, because of the approval of Epidiolex and IND investigations of CBD:
The existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain and GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome ).”
However, to determine whether the Drug Exclusion Rule applies, the FDA also needs to prove that CBD was not marketed as a food or dietary supplement prior to those investigations, which started in 2014. Check back early next week, when I’ll take a close look at the FDA’s position on that issue, and take a look at how the agency may regulate Hemp-CBD in the near future.