FDA Commissioner’s Resignation Raises Questions About CBD Regulation
In a surprise move, the Commissioner of the Food and Drug Administration (FDA) Scott Gottlieb announced Tuesday that he will be resigning from his post at the end of the month. During his tenure, Gottlieb focused much of the Agency’s resources toward addressing tobacco use in teens, and curbing the proliferation of e-liquids, and vaporized nicotine delivery systems, again primarily among youth populations.
Gottlieb also demonstrated a willingness to reconsider certain FDA policies toward CBD in a statement on CBD and hemp derivatives, issued on the same day the 2018 Farm Bill was passed. We discussed the implications of this FDA statement, and the repercussions it is having at the state level a recent blog post.
Gottlieb’s resignation will certainly have implications for the future of CBD regulation in the US. One of the most common questions we get asked is regarding marketing, labeling claims, and ingredient claims for CBD products, all which fall under the purview of the Food Drug and Cosmetics Act. The 2018 Statement made clear that the FDA was continuing to enforce its policy of prohibiting the addition of CBD isolate to ingestible products. However, it also indicated a willingness to revise FDA policy toward CBD and to proliferate legal paths to market for hemp. It also acknowledged the potential to revise the current FDA prohibition against labeling products containing CBD as dietary supplements. While it did not bring about any substantive change, the tone of the Statement was anything but hostile towards hemp.
While Gottlieb’s resignation alone may not indicate an immediate change in FDA policy toward CBD, it definitely creates a degree of uncertainty as to what will be atop the agenda of Commissioner Gottlieb’s replacement. Will the new Commissioner focus on addressing the opioid epidemic? On continuing the legacy of Gottlieb’s crusade against teen tobacco and vaporizer use? This is certainly an interesting juncture to see such a monumental change at a federal agency that, perhaps more than any other has the biggest say in the future of the hemp industry. The USDA will shortly establish federal regulations for hemp cultivation under the 2018 Farm Bill, but the FDA is the agency creating the biggest bottleneck for finished consumer CBD products reaching market.
Of course, the dream scenario is a pro-hemp advocate, who will immediately place a Generally Recognized as Safe (GRAS) certification on CBD, and approve it as a food ingredient. While aspirational, there is always the potential that this unpredictable administration will recognize the economic potential of this emerging industry, and appoint a visionary Commissioner who will establish the FDA version of a “Green New Deal” for hemp, and hemp by-products.
March 6, 2019
This post was written by Kight on Cannabis attorney Kamran Aryah. Kamran works closely with clients to develop compliance strategies in the hemp and CBD industry. Kight on Cannabis is a law firm founded by attorney Rod Kight that represents legal cannabis businesses. You can contact us by clicking here.