The Food and Drug Administration (FDA) may soon change its tune on hemp-derived CBD (Hemp CBD) thanks to a bill recently filed by chairman of the House Agriculture Committee, Rep. Collin Peterson (D-MN) and cosponsored by Reps. Thomas Massie (R-KY), James Comer (R-KY) and Chellie Pingree (D-ME).
HR 5587 is an Act “To amend the Federal Food, Drug, and Cosmetic Act [(FDAC)] with respect to the regulation of hemp-derived cannabidiol and hemp-derived cannabidiol containing substances.” As of the time of this writing, the bill’s text is not available on Congress.gov but is provided by Marijuana Moment’s Kyle Jaeger, who wrote a great article on the bill.
If passed in it’s current form, HR 5587 would amend the FDAC’s definition of dietary supplement (21 U.S.C. 321(ff)(3)(B)) as shown below in bold:
The term “dietary supplement” does not include—
(i) an article (other than hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance) that is approved as a new drug under section 355 of this title, certified as an antibiotic under section 357 of this title, or licensed as a biologic under section 262 of title 42, or
(ii) an article (other than hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance) authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,
which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.
The bill would also amend the FDAC to clarify that federal law does not prohibit a person from introducing Hemp CBD into interstate commerce, as shown by the proposed amendments to 21 U.S.C. 331(ll):
The introduction or delivery for introduction into interstate commerce of any food to which has been added a drug approved under section 355 of this title, a biological product licensed under section 262 of title 42, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public (other than hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance)[.]
This would be a significant change as the FDA has long held that Hemp CBD cannot be classified as dietary supplement because the FDAC’s definition of dietary supplement explicitly exempts any article that is approved or investigated as a drug unless the article was marketed as a dietary supplement or food prior to being publicly investigated as a drug. The FDA’s view is that Hemp CBD was not marketed as such prior to the investigation of CBD as a drug. The FDA could deal with this through regulation, as the FDAC does grant the FDA Secretary the authority to regulate around the definition of dietary supplement. That hasn’t happened, though, and it appears that the FDA is running out of time.
HR 5587, as currently drafted, only would apply to Hemp CBD, not other cannabinoids such as CBN or CBG. The 2018 Farm Bill encompasses all hemp-derived cannabinoids in its definition of “hemp” so HR 5587 could encompass more than just CBD without having to amend the Farm Bill. It’s likely that this bill was drafted in light of the CBD craze over the last few years so it isn’t all that surprising that CBD is the only cannabinoid listed. If HR 5587 picks up steam, it will be interesting to see whether the language is revised to encompass other, less popular cannabinoids, in order to prevent recurring problems.
In addition to removing obstacles related to making Hemp CBD a dietary supplement, the bill would also require the US Department of Agriculture (USDA), in consultation with other federal agencies, to submit to Congress a study on the following:
- the costs and requirements for establishing and operating a hemp testing program, including the costs and requirements for operating or contracting with a laboratory approved by the Drug Enforcement Agency;
- the costs and requirements for the destruction of hemp crops determined to be in excess of 0.3 percent delta-9 tetrahydrocannabinol or opportunities for remediation or alternative uses;
- the feasibility of producer compliance with sampling timetables;
- the feasibility of producer compliance with reporting requirements; and
- other known or potential challenges by the participation of States or producers in the domestic hemp production program.
It’s probably too early to tell whether this HR 5587 has a chance to become law. It was presented with bipartisan support but the legislative process can be unpredictable. Even if this bill does eventually become law, it will likely be subject to significant changes along the way. We simply don’t have enough information at this point to know what will happen.
We do know, however, that HR 5587 sends a clear message to the FDA, and to a lesser extent to the USDA, that lawmakers are not pleased with the treatment of hemp. For the FDA, this seems to be based on the agencies continued hostility towards Hemp CBD. For the USDA, it seems that lawmakers have heard the backlash against the USDA’s testing requirements including the need to test for total THC at DEA-certified labs.
Remember, federal agencies only exist because of federal lawmakers. They are creatures of statute, statutes that were crafted by lawmakers in Congress. If agencies fail to interpret a statute in the way the legislature wants, it has the unique power to amend the statute. That’s what is happening here.
This may seem like an outright rebuke, but in all fairness to the FDA, former commissioner Dr. Scott Gottlieb has told Congress that a legislative change may be needed in order for the FDA to regulate Hemp CBD in a timely manner. In addition, the USDA has publicly stated that testing hemp for THC content has proved challenging.
We’ll keep an eye on HR 5587 and all things Hemp CBD. 2020 is likely going to be another big year for cannabis, especially at the federal level. Stay tuned.
Powered by WPeMatico