Mar 3, 20204 min read

Congress vs. The FDA

Illinois Hemp Growers Association

Join Us in Beecher March 4th!

On Wednesday March 4th, 2020, join President and CEO of the Illinois Hemp Growers Association Rachel Berry along with COO Chris Berry at Tulip Tree Gardens in Beecher IL. We will be there to show our support and help answer questions. Come see what Tulip Tree has to offer!

Saluting Agriculture

Agriculture is the art and science of cultivating the soil, growing crops and raising livestock. Hemp is a much needed addition to the awe-inspiring world of AG here in Illinois. The IHGA is here to serve you on your journey to developing a passion for agriculture through hemp.

The Illinois "Saluting Agriculture" specialty plate reading "HEMP" is now officially the registered license plate on our CEO's vehicle. Expect to be seeing this plate all around Illinois at a hemp event near you!

New Illinois Department of Agriculture Director

On Friday February 28th, Governor Pritzker appointed Jerry Costello II to serve as Director of the IDOA. So what do we know about our new Director?

Jerry Costello is an Army veteran and from July 2011 until May 2019 he was a State Representative for Illinois 116th District. He resigned from his position as rep to work as Director of Law Enforcement at the Illinois Department of Natural Resources.

Based on his voting record he was given a 0% rating by NORML. Although Director Costello's stance on hemp is not clear, this (along with his law enforcement background) may be an indicator of his attitude towards the cannabis plant.

The new Director's stance on industrial hemp may be in contrast to his predecessor John Sullivan, who was as cooperative as possible in implementing the Illinois industrial hemp program.

There isn't much to be done in terms of setting policy or enforcement at this point. Illinois has already scheduled to enter compliance with federal rules as of 10/31/2020. What the new Director can do though, is foster greater understanding and support of the hemp industry from the top down.

Where's the Illinois Hemp Harvest Report?

Wisconsin has already completed its industrial hemp harvest report. The report indicates an oversupply of CBD hemp. 3,390,464 pounds were reported as harvested and farmers had only been able to sell 6% of their production by the time final reports were due at the end of 2019.

Last we heard from the Illinois Department of Agriculture, the Illinois hemp harvest report was set to be released at the end of February. We contacted Jeff Cox's office today in regards to the status of the harvest report and there was no immediate response for comment.

We are looking forward to the harvest report being made available to everyone so we can digest the data and develop new resources for the industry. The window to inform potential growers before they make critical decisions for 2020 season is closing.

Congress vs. The FDA

HR5587 was introduced by congressman Colin Peterson (D-MN) on January 13th. The bill has two main objectives. First is to create an exception in the Federal Food Drug and Cosmetic act for hemp-derived CBD and the second is to mandate feasibility studies related to the federal hemp production program.

To amend the Federal Food, Drug, and Cosmetic Act with respect to the regulation of hemp-derived cannabidiol and hemp-derived cannabidiol containing substances.

The Secretary of Agriculture, in consultation with other relevant Federal and State agencies, shall complete a study on the market and regulatory barriers for producers operating under the domestic hemp production program

These study requirements seem to be in response to the mountain of public comments on the USDA hemp rules. Noticeably absent from these feasibility studies is an attempt to address the most pressing concern of hemp producers nationwide - compliance with 0.3% THC limit. They also fail to address the FDA's safety concerns, making it unlikely that the FDA would support the exception. The FDA doesn't view CBD as a safe substance. FDA regulators also currently oversee opiates.

Additionally, Mitch McConnell (R-KY) has made the Senate floor the place where bills like HR5587 that pass the House go to die. However, an improved version of this bill might not be dead on arrival. McConnell was a major supporter of the industrial hemp act because of the economic benefits to his home state of Kentucky. A bill like HR5587 would assuredly create better market conditions for McConnell's constituents.

What would an improved version of HR5587 look like? The immediate exception for hemp-derived CBD should be created but it should be contingent on unified, concrete guidance being developed and issued from the USDA and FDA so that the industry can continue to operate and grow in the short term. In the long term, study requirements are a good idea to push the FDA to complete the CBD safety studies but a 1 year timeline is unrealistic. In addition to the studies currently mandated by HR5587, studies should be done on the effect of a 0.3% limit vs 1.0% limit and safety studies to address FDA concerns should be included as well.

Former FDA Commissioner Scott Gottlieb, suggested that it could take up to five years to develop guidelines for CBD because of its complexity. This is also an unrealistic timetable for current producers to bear.

Meanwhile, the current Commissioner of the FDA has this to say about CBD:

“We’re not going to be able to say you can’t use these products. It’s a fool’s game to try to even approach that.” -Dr. Stephen Hahn, MD. Current Commissioner of the FDA.

So CBD is not going to be coming off the shelves. The stage is set for an improved version of a bill like HR5587 to pass as long as the House can get the votes they need in the Senate to present the FDA with a bill that eases their burden and addresses their concerns. Let's have the FDA and USDA issue unified guidance on how to navigate the CBD market in simple terms to encourage participation and growth in the short term and have them commit to a collaborative timetable that addresses production, marketing, and safety concerns in a reasonable amount of time in the long term.

An act of Congress is what got us into this situation, and it looks like an act of Congress may be what it takes to reliably move us forward. The FDA is empowered by Congress to enforce the Food Drug and Cosmetic Act which means that We the People - through our representatives in Congress - can ultimately dictate what role the FDA plays in regulation and enforcement related to hemp-derived CBD.