Authored By: Dr. Emma F. Stone.
Dr. Emma F. Stone is passionate about plant medicine and the potential it holds in transforming the current medical paradigm. She has written extensively for the consumer watchdog website Leafreport, as well as Leafly, Weedmaps, Flowertown, Psychedelic Science Review, and contributed to industry reports and fact sheets detailing cannabis medicine, dosage, and delivery methods for diverse conditions. She’s currently working on a book exploring plant medicine and its uses.

11 million pounds of unsold hemp are sitting idle in Kentucky. For hemp farmers in Kentucky and the wider US, hemp is not the cash crop it was purported to be. Hemp farmers, the wider industry, and consumers alike, are living in a limbo borne of the indecisiveness and inaction of the FDA.

For Johnathon Miller, general counsel for the US Hemp Roundtable, the FDA stance regarding the illegality of CBD as a dietary supplement and food additive has discouraged large food manufacturers from entering the CBD space. The knock-on effects have hurt others, too–such as hemp farmers who can’t sell their crops, like those presently languishing on Kentucky farms. Miller also believes the spirit underpinning the 2018 Farm Bill, and the legalization of industrial hemp, is not being honored.

Fortunately, key actors in public policy are working to force the issue, and accelerate the regulation so sorely needed by this nascent industry. Hemp heroes Kurt Schrader, rep. for Oregon and Morgan Griffith, rep. for Virginia, are done waiting while the FDA dithers. The two representatives have made it their mission to get the conversation around hemp and CBD regulation moving. On July 27th, Schrader and Griffith made inroads with the passing of an appropriations amendment in the House that specifically targeted the FDA.

 

Unraveling the Issue: Where Did the 2018 Farm Bill Fall Short?

The passing of the 2018 Farm Bill explicitly legalized the sale of hemp and its derivatives such as CBD. Hemp holds so much promise–as a medicine, as a nutritional supplement, and as a crop. According to Regulate CBD Now, a non-profit arm of the U.S. Hemp Roundtable, hemp that is sown for CBD could potentially generate significantly more revenue per acre than corn–which could transform U.S. farming. Riding the wave following the passage of the Farm Bill, farmers across the nation invested considerable time and resources to cultivate industrial hemp crops, with an eye to the market where there is the greatest consumer demand–hemp-derived CBD and cannabinoids.

What the Farm Bill didn’t do, however, was amend the Food, Drug and Cosmetic Act to allow for the use of hemp or hemp-derived products in food or dietary supplements. Almost three years since the passage of the Farm Bill, hemp growers, CBD product innovators, and consumers find themselves in a legal no-man’s land. What is permitted? What isn’t? No-one really knows. Concerned consumers seeking guidance are largely left leaning on independent platforms such as Leafreport (https://www.leafreport.com/) to provide them with insights about whether certain CBD products even contain what they promise(https://www.leafreport.com/education/cbd-topicals-market-report-9816).

While different states have taken their own stances with respect to CBD legislation, what has become clear is that across the US, regulatory uncertainty has harmed hemp farmers, exposed consumers to potentially unsafe products of inconsistent quality, and stunted the development of this promising industry.

The rallying cry of “Hemp for victory!” that once sounded in the 1940s is yet to fulfill its potential in this presently unregulated landscape. Regulatory inaction has seen the gradual dismantling of an up-and-coming industry, limited demand from the manufacturing sector, a consequent decline in hemp prices and economic hardship for hemp farmers. Nowadays, the rallying cry sounding across the US is “Regulate CBD now!” Thanks to Reps. Kurt Schrader, D-Ore., and Morgan Griffith, R-Va, however, the push to regulate CBD is picking up momentum.

Forcing Regulatory Action: The Appropriations Amendment and H.R. 8179

Both Schrader and Griffith point to the FDA as the single source of authority capable of creating the necessary framework for CBD to be sold and consumed as a dietary supplement and food ingredient. While the FDA acknowledges the public interest in CBD, and scientific studies consistently provide evidence of its safety profile (https://realmofcaring.org/wp-content/uploads/2019/09/Safety-and-Side-Effects-of-Cannabidiol-a-Cannabis-sativa-Constituent.pdf), the agency has not yet established a legal pathway for its sale. Both Schrader and Griffith believe the FDA holds the livelihoods of hemp farmers and the safety of consumers in their hands–and their inaction is incurring critical costs for both.

Schrader took to the House floor on the 27th July to urge action. An appropriations amendment offered by Schrader and Griffith passed by a voice vote as part of an en bloc package, which is attached to the fiscal 2022 appropriations package, House Resolution 4502. The passed amendment targets FDA funding specifically, highlighting the need for the agency to create a regulatory framework for CBD as a dietary supplement and food ingredient no later than 180 days after enactment.

 

Schrader and Griffith also encouraged support for their bill, H.R. 8179, which would provide stability and a helping hand (economically speaking) to hemp farmers in this rapidly changing industry. H.R. 8179, also known as The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act, would additionally allow CBD and other hemp-derived products to legally be used in dietary supplements under the Federal Food, Drug and Cosmetic Act.

The bill prioritizes consumer safety, mandating that manufacturers comply with existing federal regulations for dietary supplements, by ensuring that all products containing CBD or hemp are properly labeled and prepared. For Schrader, both the appropriations amendment and H.R. 8179 speak to the needs of those who have been paralyzed by regulatory uncertainty–and suffered the consequences.

And Schrader and Griffith are not alone in their mission. In May, Sens. Ron Wyden, D-Ore., Rand Paul, R-Ky., and Jeff Merkley, D-Ore., filed S.B. 1698, the Hemp Access and Consumer Safety Act, that aims to correct CBD’s regulatory gray zone by requiring the FDA to act.


Why should consumers be concerned about the lack of regulation?

While it’s clear that hemp farmers and those involved in the manufacturing and retail of CBD are adversely affected by the FDA’s indecision, consumers are particularly vulnerable. As long as the FDA is not ensuring that CBD supplements and food comply with the federal regulations, eager consumers swept up in the CBD buzz may be ingesting sub-par products.

Many of the CBD products that have flooded the market are of dubious quality and safety, and may even intoxicate unwitting consumers due to the presence of THC. Black market CBD brands–especially vape products–are frequently made without observing protocols or undergoing potency or purity testing (https://www.leafreport.com/education/the-cbd-market-explained-a-guide-to-become-a-smart-consumer-3159). When it comes to hemp, assessing potency and purity is critical, as hemp is a phyto-remedial plant which siphons up the toxins, heavy metals and contaminants from the soil in which it grows.

Commentators such as Scott Melville, President of the Consumer Healthcare Products Association (CHPA), have labored the point that an ongoing lack of regulatory clarity keeps responsible consumer companies sidelined, and threatens public safety with unscrupulous hemp and CBD product manufacturers.


Where to from here?

Only the establishment of a regulatory pathway for hemp-derived CBD can guarantee consumers with access to safe, quality products. Likewise, only proper regulation can offer hemp farmers, whose lives and farms hang in the balance–some certainty.

The work and campaigning of representatives such as Schrader and Griffith, and nationwide initiatives such as Regulate CBD Now, are critical to placing pressure on the FDA to enforce a framework for CBD.

Regulation benefits all genuine actors involved with hemp, and is an initiative that should be vocalized and supported–so we can all contribute to the flourishing of this promising industry.