Reed Smith Client Alerts

Recently, the Food and Drug Administration (FDA) announced a public hearing, to be held on May 31, 2019, “to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.”1  The announcement provides a unique forum for industry stakeholders to voice their interests and concerns over the regulation of cannabis plants and derivatives (including cannabidiol (CBD)), and their uses in both products and foods, since the passage of the 2018 Farm Bill. All industry stakeholders should closely monitor the hearing, and consider submitting comments following the hearing, as the outcome will likely affect how FDA intends to regulate cannabis and cannabis-derived products.

Authors: Rachael G. Pontikes Emily L. Hussey

Cannabis buds

Background

The Agricultural Improvement Act of 2018, Pub. L. 115-334 (the 2018 Farm Bill) changed certain rules and restrictions with respect to the production and marketing of hemp. Among other things, the 2018 Farm Bill removed hemp’s previous designation as a controlled substance, meaning that cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under federal law. In the wake of this change, companies rapidly introduced products containing cannabis and cannabis-derived ingredients, including hemp and hemp-derived products, to the market. Such products include cannabis oil, cannabis-based cosmetics and skin care products, cannabis supplements, cannabis beverages, and even cannabis-based dog treats.2

Some of these products, however, make what FDA perceives to be unsubstantiated claims about their therapeutic benefits and FDA is concerned about the public health risk posed by these products. FDA’s stated goal in announcing the public hearing is to consider various approaches to regulating the development and marketing of cannabis and cannabis-derived products, including their potential use in dietary supplements, other foods and cosmetics. Although FDA stated that it “does not intend for this hearing to produce any decisions or new positions on specific regulatory questions…this hearing is expected to be an important step in our continued evaluation of cannabis and cannabis-derived compounds in FDA-regulated products.”