FDA Regulations and CBD: Is A Big Change Coming?
The FDA has called for a meeting to review rulings on CBD Oil and products made with it.
Editor’s Note, 9/10/2019: Since this article was originally published, the FDA has published a document noting their commitment to fact finding on CBD Oil and its uses. Further, they made public comments on CBD Regulations available to read, here.
Following an April 2nd (2019) statement from former Commissioner Scott Gottlieb, the FDA will today begin consultation on regulating CBD products. The agency is expected to hear insights from 140 members of the public regarding future FDA rulings on CBD. Representatives include cannabis industry figures, researchers, and food & drink manufacturers. According to a notice in the Federal Register, its goal will be to “obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.”
In a 23 May Tweet, FDA Deputy Commissioner Dr Amy Abernethy stated that, “thus far, the data appear insufficient. A key goal of our upcoming public hearing on 5/31 is to obtain better information. We hope some of the knowledge gaps can be filled, but there is uncertainty.” The results of the hearing will later be used by a high-level working group that will “explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed” (OH&S).
This is a significant step for businesses that are looking for clear regulations before entering the American CBD market.
Why Is This FDA and CBD Oil Hearing Necessary?
The FDA is America’s food and drugs regulator. As such, it is primarily concerned with the safety of all drugs, supplements, and foods in the US. The agency intends to fully explore CBD’s risks and benefits before authorizing its use in supplements and food. In particular, the hearing will review safe levels of cannabinoid exposure and cannabinoid consumption in vulnerable populations. Some of these include pregnant women and children. It will also examine how the consumption method changes the effects of cannabinoids. This will include interactions between cannabinoids and other supplements or drugs.
The 2018 “Farm Bill”, or the Agriculture Improvement Act of 2018, legalized hemp and hemp-derived CBD nationwide. However, the bill maintained the FDA’s authority to regulate these products. The FDA ruling on CBD, for now, maintains that companies may not market products containing CBD. The agency’s posting in the Federal Register notes that: “Because the 2018 Farm Bill did not change FDA’s authorities, cannabis and cannabis-derived products are subject to the same authorities and requirements as FDA-regulated products containing any other substance, regardless of whether the products fall within the definition of “hemp” under the 2018 Farm Bill.”
The hearing will review proper manufacturing practices, testing methods, and labeling, as well as cannabinoids in food and supplements.
The FDA has suggested that highly-concentrated CBD products would require the same oversight as pharmaceuticals.
What Could Regulated CBD Mean for the Industry?
National companies that have refrained from marketing CBD products will be closely watching the results of today’s hearing. Due to lax enforcement, the agency’s position hasn’t prevented companies, dispensaries, and cafes across America from selling food and drinks with CBD, though sometimes local authorities stepped in. But larger, nationwide businesses have remained cautious until now. However, several major companies have announced plans to release CBD-infused products as soon as regulations are clarified. For example, Ben & Jerry’s have announced their intention to produce ice cream with added CBD as soon as the FDA gives the thumbs up.
The company has even gone so far as to invite customers who want CBD-infused ice cream to join FDA discussions. Although the public hearings will take place starting today, it’s not too late if you want to have your say. CBD enthusiasts who would like to influence future FDA ruling have until 2 July to put in their two cents.
The public consultation represents a big opportunity for the American CBD market. Yet, the industry will have to wait until consultations finish (and potentially much longer) before setting up shop. The FDA is moving slowly on this issue. Earlier this year, former FDA Commissioner Scott Gottlieb indicated that the regulator might wait for congressional approval before making a ruling. He explained: “There is not a good proxy for us doing this through regulation, and if we […] find this is sufficiently complicated for the agency, we will come back and have a conversation with Congress on with how we might be able to work together on this.”
In short, if you’re looking forward to grabbing a Starbucks-brand CBD coffee next time you hit up the mall, you shouldn’t hold your breath. This could take a while.