For the first time, Congress officially addressed the impact of the U.S. Food and Drug Administration’s (FDA) inaction regarding the regulations of CBD products.
What Happened: In an opening statement at the hearing, “Hemp in the Modern World: The Years long Wait for FDA Action,” Republican representative Lisa McClain slammed the FDA, saying that they are asking for more money to fulfill their duties under the law.
“But instead of regulating hemp-derived products under its currently existing authorities, the FDA announced earlier this year that it needs a new regulatory framework for hemp and CBD,” she said. “Translation: Give us more authority, more money, more staff, and only then will we actually do our duties under the law.”
“But instead of regulating hemp-derived products under its currently existing authorities, the FDA announced earlier this year that it needs a new regulatory framework for hemp and CBD.
— Oversight Committee (@GOPoversight) July 27, 2023
Translation: Give us more authority, more money, more staff, and only then will we actually… pic.twitter.com/b4DF1ODSfK
For video on the historic hearing held by the House Oversight and Accountability Committee’s Subcommittee on Health Care and Financial Services, see below:
Per the report from U.S. Hemp Roundtable, many Congress members and hearing witnesses shared the following views:
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A regulatory framework for hemp-derived cannabinoids is urgently needed;
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FDA has the existing data, tools, expertise, and authority to regulate hemp-derived cannabinoids;
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The 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,” stated U.S. Hemp Roundtable general counsel, Jonathan Miller.
The hearing came on the heels of a bipartisan group of U.S. lawmakers reintroducing a measure that aims to secure the FDA's regulation of hemp-derived CBD products.
Democratic Senators Ron Wyden, Jeff Merkley, Rep. Earl Blumenauer, and Republican Senator Rand Paul reintroduced Hemp Access and Consumer Safety Act. The move comes seven months after the FDA announced it will not regulate CBD products as food and dietary supplements.
Even though in May the agency presented a potential framework for CBD, it recently reaffirmed that Congress is in charge.
FDA Vs Congress: Who Is In Charge?
Subcommittee leaders and members differed on which comes first: FDA or Congressional action. Democratic Rep. Katie Porter believes Congress should direct the agency to regulate CBD products through legislation, while McCain stated 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, “ said McCain.
The Federal Food, Drug, and Cosmetics Act prohibits any new dietary ingredient, food, or beverage from entering the market if it has been studied or approved as a drug.
The FDA approved Jazz Pharmaceuticals JAZZ Epidiolex, which is a CBD-based drug for treating children with severe forms of epilepsy. Epidiolex was initially approved for treating seizures connected to Lennox-Gastaut and Dravet syndromes and in 2020 for treating seizures related to tuberous sclerosis complex.
Last week, when reintroducing Hemp Access and Consumer Safety Act, bipartisan lawmakers reminded that the FDA has the authority to exempt items from this prohibition, but has yet to exempt hemp-derived CBD, despite Congressional action to legalize its production and sale.
“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,” Wyden stated “The FDA says it needs Congress to act. We’ve got the bill to ensure equal and safe access to hemp-derived CBD.”
45 Million Americans Rely On CBD
Miller added that “these products served as a lifeline to U.S. farmers, and when manufactured properly, can be of considerable value to adult consumers. 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.”
Paige Figi, founder of the Coalition for Access Now and the mother of Charlotte Figi, the young girl from Colorado who helped spread the word about the benefits of CBD for those suffering from rare forms of epilepsy, commented on the hearing.
“We have been united with families, athletes, seniors, veterans, and others who rely on the benefits of CBD for almost a decade,” Figi stated. “Today's hearing shows that common sense, bipartisan reform to push the FDA to do its job and regulate hemp-derived CBD as a dietary supplement is close. The 45 million Americans who rely on the benefits CBD for their chronic conditions are encouraged that members of Congress will stand up for their constituents to pass legislation that will support access for patients now.”
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