Washington D.C.—U.S. Hemp Roundtable reported on two recent developments in efforts to get the U.S. Food and Drug Administration (FDA) to regulate hemp products such as cannabidiol (CBD).
Bill to Establish FDA Regulatory Framework for CBD Reintroduced
U.S. Senators Ron Wyden (D-OR), Rand Paul (R-KY) and Jeff Merkley (D-OR), announced the reintroduction of The Hemp Access and Consumer Safety Act. This bill would establish a framework for the FDA to regulate hemp-derived CBD as a dietary supplement or food and beverage additive.
The Hemp Access and Consumer Safety Act would :
- Give hemp-derived CBD products an opportunity to lawfully be used in dietary supplements, foods and beverages under the Federal Food, Drug and Cosmetic Act.
- Prioritize consumer safety, requiring manufacturers to comply with all existing federal regulations for the products that contain CBD.
- Ensure that these products are properly labeled.
“Despite being legally grown in the United States for nearly five years, hemp and hemp-derived CBD are still in a regulatory gray zone that puts consumers at risk and holds producers back,” Sen. Wyden said in his press release on the bill. “The FDA says it needs Congress to act. We’ve got the bill to ensure equal and safe access to hemp-derived CBD.”
Dr. Paul added, “Hemp-derived CBD products and businesses have earned their recognition in the marketplace, but the FDA, unfortunately, hasn't treated them like any other food additive or dietary supplement. The Hemp Access and Consumer Safety Act directs the FDA to regulate hemp products properly and provides a huge relief to hemp farmers, processors, and merchants.”
The U.S. Hemp Roundtable shared that it strongly endorses the legislation and applauds the Senators for championing efforts to regulate CBD products. "We commend Senator Ron Wyden for reintroducing The Hemp Access and Consumer Safety Act, a crucial piece of legislation that addresses the pressing need for FDA regulation of CBD,” said Jonathan Miller, General Counsel of the U.S. Hemp Roundtable. "This bill provides a much needed pathway for FDA to establish a clear and consistent framework for the production, marketing, and sale of hemp-derived CBD to ensure consumer safety while fostering a thriving, regulated market. We look forward to supporting his efforts and appreciate his longtime commitment to unlocking the full potential of the hemp industry.”
In addition to the U.S. Hemp Roundtable, the bill is endorsed by We Are For Better Alternatives (WAFBA), the American Herbal Products Association (AHPA), the Hemp Industries Association (HIA), National Hemp Growers Association, Realm of Caring, U.S. Hemp Authority (USHA) and Veterinary Cannabis Society, as well as the Midwest Hemp Council, Colorado Hemp Association, Kentucky Hemp Association, Georgia Hemp Association, iHemp Michigan, South Dakota Industrial Hemp Association, and the Virginia Hemp Coalition.
Congress is formally scrutinizing FDA’s inaction on hemp, CBD
(This article has been updated with the latest news from the hearing on July 28.)
On July 27, experts testified during a hearing on hemp and CBD before the House Oversight and Accountability Committee’s Subcommittee on Health Care and Financial Services. Titled Hemp in the Modern World: The Years long Wait for FDA Action, this hearing is the first time Congress has formally scrutinize the impact of FDA’s failure to develop a regulatory pathway for the sale of ingestible hemp products such as CBD, according to the U.S. Hemp Roundtable.
U.S. Hemp Roundtable General Counsel Jonathan Miller will testify, as will Rayetta G. Henderson, Ph.D., Senior Managing Scientist, ToxStrategies, LLC, and Rich Badaracco, former Drug Enforcement Administration agent and current Board Member of the US Hemp Authority, the hemp industry’s self-regulating organization. Oversight Committee Chairman James Comer (R-KY) first indicated his intention to hold such a hearing in an exclusive interview with Miller in January 2023.
- The threats to consumer health and safety.
- The "tremendous disruption" to hemp farmers and businesses.
“I am honored to serve as a witness for this historic hearing to testify to the extraordinary challenges faced by hemp farmers and CBD consumers over the past five years,” said Miller. "The U.S. Hemp Roundtable is grateful to Chairman James Comer, subcommittee chair Lisa McClain, and ranking member Katie Porter for this critical opportunity. I look forward to shedding light on the urgent need for clear regulations that ensure consumer safety and promote the growth of the hemp industry.”
Highlights from the testimony
Hearing witnesses and members of Congress shared the same sentiments, according to U.S. Hemp Roundtable. They discussed:
- a regulatory framework for hemp-derived cannabinoids is urgently needed
- FDA has the existing data, tools, expertise and authority to regulate hemp-derived cannabinoids
- a continued lack of FDA regulations for products containing hemp-derived cannabinoids poses a major consumer health and safety issue.
“Lack of a federal framework has led to the proliferation of unregulated products, some of which raise significant quality, safety, and other consumer protection concerns,” said U.S. Hemp Roundtable General Counsel, Jonathan Miller. Read Miller’s full written testimony here: 2023-Hearing-Packet.pdf (hempsupporter.com)
Dr. Gillian Schauer Ph.D., MPH., Executive Director of the Cannabis Regulators Association, said: “Whether through the Farm Bill or another priority piece of legislation, a broad regulatory framework is urgently needed to address hemp-derived cannabinoid products.”
U.S. Hemp Roundtable reported that subcommittee leaders and members differed on which comes first: FDA or Congressional action.
Chairwoman Rep. Lisa McCain (R-MI) stated that they already had the authority granted under the 2018 Farm Bill: “The pathway already exists, Congress spoke in 2018, the FDA just needs to do the job that the American taxpayer is paying them for and if they can’t do their job, maybe we should stop funding them or funding them at reduced levels. Again, the pathway already exists."
Addressing FDA's safety concerns on CBD
As WholeFoods has reported, the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (CFSAN) published its review the oral toxicity of cannabidiol (CBD). The authors of the review stated: "The toxicological profile of CBD raises safety concerns, especially for long term consumption by the general population." The Natural Products Association (NPA) weighed in on the review when it was released. Daniel Fabricant, Ph.D., NPA President and CEO, said: “Using drug standards to conduct a ‘supplement study’ is at the very least disingenuous and at the worst very harmful for the foundering and rudderless regulatory process on CBD. Instead of using actual dietary supplement data and research like the data we supplied to the agency in our citizen’s petition, the FDA instead chose to use drug data to draw conclusions that are three times the dose of the CBD drug Epidiolex. This is extremely troubling, confusing, and sets us back even further on one of our top priorities for the past several years, which is meaningful progress on a regulatory path for something that’s ubiquitous in the market.”
U.S. Hemp Roundtable noted that the FDA continues to rely on incomplete safety data as the basis for its continued refusal to regulate CBD as a dietary supplement or food additive, and while the agency claims a new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products, hearing witnesses and committee leaders disagreed.
“FDA simply has not been transparent with the industry stakeholders or Congress in what scientific studies relies on and often moves the goal post for researchers attempting to satisfy the FDA’s requirements through rigorous studies,” said U.S. House Oversight Chairman, Rep. James Comer (R-KY). “So even though we have more and more data available to regulators to make appropriate decisions about CBD in the marketplace, the FDA has taken no meaningful action to provide clear guidance and certainty in the market, refusing to regulate CBD products under existing lawful pathways. Without FDA regulations the good faith producers of these products are left with no path forward and consumers are left in the dark.”
Dr. Rayetta G. Henderson Ph.D., Senior Managing Scientist, ToxStrategies, LLC said, ”Based on my experience performing similar evaluations, the data available are sufficient for conducting a safety assessment of CBD following the same principles that we would apply for any ingredient proposed for use in foods or supplements.”
Miller also weighed in on this topic: “There are abundant consumer safeguards encompassed in the Federal Food, Drug and Cosmetic Act that would be applied to CBD products sold as dietary supplements. For example, the law precludes manufacturers and distributors from selling mislabeled or adulterated products and it requires manufacture and sale of products consistent with good manufacturing product standards. The law also requires reporting of serious adverse events, and it mandates strict labeling, including if FDA desires, warnings against the use of products by children. Finally, the FDA with the Consumer Product Safety Commission could require child-proof packaging,”
An alarming safety issue that witnesses at the hearing stressed: Llack of FDA regulatory framework for hemp-derived CBD has contributed to the proliferation of products containing intoxicating or impairing cannabinoids, most prominently delta-8 THC. These are being sold unregulated, sometimes to minors, U.S. Hemp Roundtable pointed out. And while none of the witnesses support the criminalization of these products, they said strict regulations are needed for safety and to keep them out of the hands of children.
“These products served as a lifeline to U.S. farmers, and when manufactured properly, can be of considerable value to adult consumers," Miller said. "Accordingly, we oppose their ban or criminalization. However, they need to be strictly regulated for safety and kept out of the hands of children. Kentucky’s General Assembly recently passed unanimously legislation to this effect – HB 544 – it should be a model for the nation."
