Congressional Leaders and Industry Experts Testify On
FDA’s Failure To Regulate Hemp-Derived Cannabinoids
WASHINGTON
D.C. — On Thursday, July 27th at 2:00 PM ET, U.S. Hemp Roundtable General
Counsel, Jonathan Miller, testified during a historic hearing on hemp and
CBD before the House Oversight and Accountability Committee’s
Subcommittee on Health Care and Financial Services. The hearing, “Hemp in
the Modern World: The Years long Wait for FDA Action,” was the first time Congress has formally scrutinized
the impact of the U.S. Food and Drug Administration’s (FDA) failure to
develop a regulatory pathway for the sale of ingestible hemp products
such as CBD.
Hearing
witnesses and members of Congress shared the same sentiments: 1) a
regulatory framework for hemp-derived cannabinoids is urgently needed, 2)
FDA has the existing data, tools, expertise and authority to regulate
hemp-derived cannabinoids, and 3) 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.
“Whether
through the Farm Bill or another priority piece of legislation, a broad
regulatory framework is urgently needed to address hemp-derived
cannabinoid products,” said Dr. Gillian Schauer Ph.D., MPH.,
Executive Director of the Cannabis Regulators Association.
“Self-regulation
is not sufficient; federal regulation is necessary to ensure that all
products on the marketplace maintain the highest safety standards,”
said Mr. Richard A. Badaracco, President-Elect, Kentucky Narcotic
Officers Association, (Retired) Assistant Special Agent in Charge, U.S.
Drug Enforcement Administration.
Subcommittee
leaders and members differed on which comes first: FDA or Congressional
action. Rep. Katie Porter (D-CA) implied that Congress should direct the
agency to regulate CBD products through legislation, while Chairwoman
Rep. Lisa McCain (R-MI) stated they already had the authority granted
under the 2018 Farm Bill.
“We should
all be able to agree that the federal government needs to regulate
hemp-derived products in a way that protects our constituents while also
making safe products available to them,” said Sub-Committee Member,
Rep. Katie Porter (D-CA). Given the bipartisan interest, members of
Congress should have no problem rolling up our sleeves, hell I don’t even
have any sleeves, and getting to work to establish the regulatory pathway
that the FDA says it needs.”
“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 Subcommittee Chair Rep. Lisa McCain (R-MI).
As previously reported by the U.S. Hemp Roundtable, 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. The agency
also 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.”
“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,”
said Miller. 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.
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