FDA Explores Regulation Guidelines For CBD & State Hemp Legislation Updates
Across the United States lawmakers are demonstrating a willingness to introduce legislation legalizing hemp and hemp-derived CBD. In light of these recent developments it is important to understand the current stance the Federal Drug Administration (FDA) takes regarding these products. There are still some gray areas concerning how the FDA will enact their authority, but recent statements indicate a positive trend. The following are brief explanations regarding recent hemp updates, as well as a current analysis of the FDA’s stance on CBD and hemp.
FDA To Work With Lawmakers on Hemp and CBD Regulations
The 2018 Farm Bill references the change in oversight regarding industrial hemp products. Rather than categorized under the authority of the Drug Enforcement Agency (DEA) hemp products such as CBD now fall under the jurisdiction of the Food and Drug Administration (FDA). There has been some confusion in the news as to what this means. Some outlets have claimed that CBD is illegal under FDA regulation.
Thanks to a December 20, 2018 FDA press release and the guidelines posted on the FDA’s website, companies and the public are able to piece together what this change in oversight means for the hemp industry. It is important to keep in mind that the FDA is a regulatory agency. This means that there will not be any breaking down of doors or raids on small businesses selling hemp by-products. News stories that report such facts ought to be double checked as they are most likely false.
Based off discussions with the PrimeMyBody legal team and after an extensive review of the FDA’s webpage and press releases, it is evident that the agency is still in a transitional phase. Their review of the 2018 Farm Bill precedent was undoubtedly delayed by the lengthy government shutdown.
The FDA has classified CBD as a drug after GW pharmaceutical marketed Epidiolex as a drug. Epidiolex contains CBD and is currently approved by the FDA for the purpose of treating epileptic seizures. However, the FDA realizes that this particular drug does not represent the entirety of the CBD market and as a result is taking steps to establish a regulatory process for products that might best be marketed as a dietary supplement.
The main concern as stated by the FDA pertains to the mislabeling of products. There have been claims of product labeled as CBD oil which were found to contain only olive oil or other contaminants. Such mislabeling is clearly a concern to public health and damages the perception and reputation of the hemp market as a whole. The agency’s statements on December 20th, 2018 indicate a willingness to reassess their classification of the substance (currently classified as a drug), as well as an openness to working with Congress to establish a workable means of insuring that the public is receiving what distributors claim they are selling.
On February 27th Scott Gottlieb, commissioner of the FDA reiterated the above analysis while meeting with the National Association of State Departments of Agriculture (NASDA). He assured heads of state departments and Hemp Round Table that,
“We’re [the FDA] also interested in hearing from stakeholders and talking to Congress on possible alternative approaches; to make sure that we have an appropriately efficient and predictable regulatory framework for regulating CBD”.
While it is still unknown what these talks will include, or on what time frame they will occur, it is a positive step forward that the FDA is working with lawmakers who passed the 2018 Farm Bill to create a regulatory scheme beneficial to the expansion of the CBD industry already realized on the federal level. [1, 2]
Idaho Hemp Oil and CBD Laws
Hemp Industry Daily recently reported on the seizure of a shipment of hemp in the state of Idaho. In light of the ongoing legal battle to right this wrong, the state and federal legislature have acted quickly to clarify the error on the part of law enforcement. U.S. representative, James Comer did so at the federal level by issuing a statement clarifying the legislative intent of the bill to allow for interstate travel. Additionally, H0221 is likely to pass into Idaho law—which will legalize industrial hemp and the derivatives of hemp in accordance with the 2018 Farm Bill. [3, 4]
Lawmakers heard several hours of testimony but postponed the vote on the bill in order to hear testimony from law enforcement concerning the legalization of hemp products. Police reiterated their concern that they will be unable to differentiate between hemp and marijuana. In light of the public and political outcry concerning the ongoing case pertaining to this very issue, in addition to the overwhelmingly favorable testimony given in support of the bill, we can soon expect exciting news from the state of Idaho. [5]
Wyoming and Ohio Hemp Oil and CBD Laws
Wyoming and Ohio are also beginning their process to align their state legislatures with federal law. Both states have recently passed or introduced bills legalizing hemp and the sale and distribution of hemp based products including CBD. HB 171 passed the Wyoming House legislature unanimously and awaits Senate confirmation. SB 57 in Ohio was recently introduced and General Counsel for U.S. Hemp Roundtable Jonathan Miller expressed high hopes for its passage as a model bill for hemp legalization. [6, 7]
References:
1. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628988.htm
2. https://hempsupporter.com/alternative-approaches-to-cbd-from-the-fda/
3. https://hempsupporter.com/hemp-battle-in-idaho/
4. https://legislature.idaho.gov/sessioninfo/2019/legislation/H0122/
6. https://hempsupporter.com/live-in-wyoming-urge-your-legislators-to-support-hemp/
7.https://hempsupporter.com/live-in-wyoming-urge-your-legislators-to-support-hemp/