On February 26, 2020 the Food and Drug Administration’s (“FDA”) new commissioner, Dr. Stephen Hahn, acknowledged the growing consumer demand for CBD products. “People are using these [CBD] products,” Hahn said in his first public speech regarding CBD since taking office in December. “We are not going to be able to say you can’t use these products. It’s a fool’s game to try to even approach that.” This comes as reassuring news for companies in the industry who have been marketing and labeling CBD products in the gray area between the 2018 Farm Bill’s de-scheduling of extracts derived from hemp plants and FDA’s de facto prohibition on CBD consumer products. The industry has not only been left without proper guidance, but industry participants have been penalized for the claims they have made about their products.
In November 2019, FDA issued warning letters to over fifteen CBD companies stating that the claims on their product labels violated FDA regulations. The warning letters cited violations including unsubstantiated health claims, marketing products for children, using CBD as an ingredient in foods and beverages, and marketing CBD as a dietary supplement. These warning letters included little new information and serve only to emphasize, that FDA holds all consumer CBD products to be illegal. This stance has amounted to that of an ostrich sticking its head in the sand. The astounding popularity of CBD and CBD products with American consumers serves to highlight the fact that FDA’s policy of total prohibition has caused it to fail its mandate to protect the health of US citizens given the widespread adoption by consumers.
FDA seems to somewhat acknowledge this consumer demand as it engaged in the Generally Recognized as Safe (“GRAS”) process, but after reviewing research provided by industry, sitting through a public hearing, and allowing for a comment period on the matter, FDA still claims it has not seen enough scientific data or research to provide GRAS status for CBD. Hahn himself recognized the need to be open to the fact that there may be value in CBD products, but he wants to be able to provide the American public with “information to make the right decisions” before issuing GRAS or regulations. All that the industry can do until FDA feels comfortable setting guidelines for CBD is wait, try not to draw attention to themselves, and attempt to utilize what little guidance has been given. On one hand some allowances must be made for FDA’s slow pace on CBD regulation as no substance has ever gone from Schedule I classification to mass adoption, on the other hand considering the products that FDA has no problem with that are far more dangerous than CBD, this tortoise-like pace and ostrich-like approach is infuriating.
In another promising move for industry, FDA has requested an additional $5 million dollars in the 2021 budget to be devoted to the regulation of cannabis-derived products such as CBD. The budget request states, “This new funding will enable FDA to continue regulating the usage of cannabis-derived substances, such as cannabidiol (CBD), in FDA-regulated products such as dietary supplements and when used as unapproved food and feed additives. The initiative will support regulatory activities, including developing policy, and continue to perform its existing regulatory responsibilities including review of product applications, inspections, enforcement, and targeted research.” The budget request, which is not finalized, brings a glimmer of hope that FDA will consider the urgency from industry and consumers alike, do its research, provide regulations and guidance, and designate CBD as GRAS.