The Ken­tucky Sen­a­tor draft­ed a pro­pos­al that would clear a path for the law­ful mar­ket­ing of hemp-derived CBD prod­ucts.


5 min read

Opin­ions expressed by Entre­pre­neur con­trib­u­tors are their own.


Ken­tucky Sen­a­tor Mitch McConnell ®, a chief pro­po­nent of a hemp legal­iza­tion pro­vi­sion in the 2018 Farm Bill, has put the pres­sure on the Food and Drug Admin­is­tra­tion (FDA) to expe­dite the path for law­ful mar­ket­ing of hemp-derived CBD prod­ucts. It’s the lat­est push by the Sen­a­tor to get CBD prod­ucts more fund­ing to edu­cate con­sumers and to uti­lize the ben­e­fits in food items or dietary sup­ple­ments.

Pri­or to today’s move­ment from McConnell, the FDA has said that allow­ing CBD to be sold as food items or dietary sup­ple­ments would require it to devel­op alter­na­tive reg­u­la­tions that could take years to com­plete if no con­gres­sion­al action was used. 

McConnel­l’s plan is to insert lan­guage into a con­gres­sion­al spend­ing report that is ask­ing the FDA to “issue a pol­i­cy of enforce­ment dis­cre­tion with regard to cer­tain prod­ucts con­tain­ing CBD” with­in 120 days — some­thing that will help stake­hold­ers clar­i­fy rules, which, in effect, could make banks become more will­ing to ser­vice CBD com­pa­nies.

RELATED: Farm­ers to FDA: Only CBD From Amer­i­can-Grown Hemp Is Legal

Here’s a look at the full report lan­guage from Mitch McConnell to the FDA:

“As pre­vi­ous­ly men­tioned, the Com­mit­tee pro­vides $2,000,000 for research, pol­i­cy eval­u­a­tion, mar­ket sur­veil­lance, issuance of an enforce­ment dis­cre­tion pol­i­cy, and appro­pri­ate reg­u­la­to­ry activ­i­ties with respect to prod­ucts under the juris­dic­tion of the Food and Drug Admin­is­tra­tion which con­tain cannabid­i­ol (CBD) and meet the def­i­n­i­tion of hemp, as set forth in sec­tion 297A of the Agri­cul­tur­al Mar­ket­ing Act of 1946 (7 U.S.C. 1639o). With­in 90 days, FDA shall pro­vide the Com­mit­tee with a report regard­ing the Agency’s progress toward obtain­ing and ana­lyz­ing data to help deter­mine a pol­i­cy of enforce­ment dis­cre­tion, and the process in which CBD meet­ing the def­i­n­i­tion of hemp will be eval­u­at­ed for use in prod­ucts. With­in 120 days, FDA shall issue a pol­i­cy of enforce­ment dis­cre­tion with regard to cer­tain prod­ucts con­tain­ing CBD meet­ing the def­i­n­i­tion of hemp as defined by sec­tion 297A of the Agri­cul­tur­al Mar­ket­ing Act of 1964 (7 U.S.C. 1639). Such enforce­ment dis­cre­tion shall be in effect until FDA estab­lish­es a process for stake­hold­ers to noti­fy FDA for use of CBD in prod­ucts that include safe­ty stud­ies for intend­ed use per prod­uct, and makes a deter­mi­na­tion about such prod­uct. FDA is encour­aged to con­sid­er exist­ing and ongo­ing med­ical research relat­ed to CBD that is being under­tak­en pur­suant to an Inves­ti­ga­tion New Drug (IND) appli­ca­tion in the devel­op­ment of a reg­u­la­to­ry path­way for CBD in prod­ucts under the juris­dic­tion of FDA and to ensure that any future reg­u­la­to­ry activ­i­ty does not dis­cour­age the devel­op­ment of new drugs.”

CBD industry response

In gen­er­al, the CBD indus­try has been recep­tive to McConnel­l’s pro­pos­al to the FDA. Here’s what both John Hue­moeller, CEO of AXIM Biotech­nolo­gies, Inc., and Jenelle Kim, Founder and Chief For­mu­la­tor of JBK Well­ness Labs, had to say.

Hue­moeller: “Last year, hemp and CBD were legal­ized through the 2018 Farm Bill. A few months ago, the DEA request­ed an increase in the amount of cannabis grown in the U.S. for research. Now it’s time for the FDA to rec­og­nize that cannabis and CBD prod­ucts aren’t just a fad, but, because of their many well­ness ben­e­fits, they are here to stay. We look for­ward to under­stand­ing how these new reg­u­la­tions may help the indus­try grow by set­ting need­ed safe­ty stan­dards and pro­vide con­sumers with an over­all improved lev­el of trust in CBD and oth­er cannabis prod­ucts.”

Kim: “Mitch McConnell’s move to call on the FDA is cer­tain­ly a pro­gres­sive and impor­tant move, which will help to open the doors for more peo­ple to reap the incred­i­ble ben­e­fits of CBD. It is vital to remem­ber that hemp is one of the 50 Fun­da­men­tal Herbs in Chi­nese Med­i­cine and its heal­ing prop­er­ties date back 4000 years. For a med­i­c­i­nal herb that has been used respon­si­bly for thou­sands of years as a treat­ment for pain and fatigue, among oth­er con­di­tions, to be giv­en a larg­er oppor­tu­ni­ty is cer­tain­ly a win­ning sit­u­a­tion for all involved.”

RELATED: FDA Begins Eval­u­at­ing Cannabis Sci­en­tif­i­cal­ly

In order to hit McConnel­l’s tar­get of 120 days, there’s some work still left to be com­plet­ed.

On Tues­day, the Sen­ate Appro­pri­a­tions Sub­com­mit­tee on Agri­cul­ture will mark up the pro­vi­sion of the spend­ing report. Next, the Appro­pri­a­tions Com­mit­tee will receive it two days lat­er. Final­ly, The FDA would need to sub­mit a report to the com­mit­tee with­in 90 days, which opens up the pos­si­bil­i­ty of a new pol­i­cy. Last­ly, if the new enforce­ment guide­lines are estab­lished, they would con­tin­ue to be imple­ment­ed until the reg­u­la­to­ry process is final­ized by the FDA.

In sup­port of Mitch McConnell’s pro­pos­al, Ore­gon Sen­a­tor Jeff Merkley praised the bill dur­ing the sub­com­mit­tee meet­ing last Thurs­day, with Merkley specif­i­cal­ly men­tion­ing the rev­enue that hemp will bring to his state alone. “You might note that this year in Ore­gon, the hemp indus­try may well be a bil­lion-dol­lar crop, and that is an incred­i­ble addi­tion to income for our agri­cul­tur­al com­mu­ni­ty,” he said.

Only time will tell where McConnel­l’s pro­pos­al and time­line goes, but it is a big day for the CBD indus­try as a whole to have such sup­port.

Source link