[House Hearing, 118 Congress]
[From the U.S. Government Publishing Office]
HEMP IN THE MODERN WORLD:
THE YEARSLONG WAIT FOR FDA ACTION
=======================================================================
HEARING
before the
SUBCOMMITTEE ON HEALTH CARE
AND FINANCIAL SERVICES
of the
COMMITTEE ON OVERSIGHT
AND ACCOUNTABILITY
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTEENTH CONGRESS
FIRST SESSION
__________
JULY 27, 2023
__________
Serial No. 118-57
__________
Printed for the use of the Committee on Oversight and Accountability
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Available on: govinfo.gov
oversight.house.gov or
docs.house.gov
______
U.S. GOVERNMENT PUBLISHING OFFICE
53-026 PDF WASHINGTON : 2023
COMMITTEE ON OVERSIGHT AND ACCOUNTABILITY
JAMES COMER, Kentucky, Chairman
Jim Jordan, Ohio Jamie Raskin, Maryland, Ranking
Mike Turner, Ohio Minority Member
Paul Gosar, Arizona Eleanor Holmes Norton, District of
Virginia Foxx, North Carolina Columbia
Glenn Grothman, Wisconsin Stephen F. Lynch, Massachusetts
Gary Palmer, Alabama Gerald E. Connolly, Virginia
Clay Higgins, Louisiana Raja Krishnamoorthi, Illinois
Pete Sessions, Texas Ro Khanna, California
Andy Biggs, Arizona Kweisi Mfume, Maryland
Nancy Mace, South Carolina Alexandria Ocasio-Cortez, New York
Jake LaTurner, Kansas Katie Porter, California
Pat Fallon, Texas Cori Bush, Missouri
Byron Donalds, Florida Shontel Brown, Ohio
Kelly Armstrong, North Dakota Jimmy Gomez, California
Scott Perry, Pennsylvania Melanie Stansbury, New Mexico
William Timmons, South Carolina Robert Garcia, California
Tim Burchett, Tennessee Maxwell Frost, Florida
Marjorie Taylor Greene, Georgia Summer Lee, Pennsylvania
Lisa McClain, Michigan Greg Casar, Texas
Lauren Boebert, Colorado Jasmine Crockett, Texas
Russell Fry, South Carolina Dan Goldman, New York
Anna Paulina Luna, Florida Jared Moskowitz, Florida
Chuck Edwards, North Carolina Vacancy
Nick Langworthy, New York
Eric Burlison, Missouri
Mark Marin, Staff Director
Jessica Donlon, Deputy Staff Director and General Counsel
Ryan Giachetti, Counsel
Sarah Feeney, Professional Staff Member
Ben Tardif, Professional Staff Member
Mallory Cogar, Deputy Director of Operations and Chief Clerk
Contact Number: 202-225-5074
Julie Tagen, Minority Staff Director
Contact Number: 202-225-5051
------
Subcommittee on Health Care and Financial Services
Lisa McClain, Michigan, Chairwoman
Paul Gosar, Arizona Katie Porter, California Ranking
Virginia Foxx, North Carolina Minority Member
Glenn Grothman, Wisconsin Alexandria Ocasio-Cortez, New York
Russell Fry, South Carolina Jimmy Gomez, California
Anna Paulina Luna, Florida Greg Casar, Texas
Nick Langworthy, New York Summer Lee, Pennsylvania
Eric Burlison, Missouri Jasmine Crockett, Texas
Vacancy Vacancy
C O N T E N T S
----------
Page
Hearing held on July 27, 2023.................................... 1
Witnesses
----------
Mr. Jonathan S. Miller, General Counsel, U.S. Hemp Roundtable
Oral Statement................................................... 7
Dr. Rayetta G. Henderson, Senior Managing Scientist,
ToxStrategies, LLC
Oral Statement................................................... 8
Mr. Richard A. Badaracco, President-Elect, Kentucky Narcotic
Officers
Association; (Retired) Assistant Special Agent in Charge, U.S.
Drug Enforcement Administration
Oral Statement................................................... 10
Dr. Gillian Schauer (Minority Witness), Executive Director,
Cannabis Regulators Association
Oral Statement................................................... 12
Written opening statements and statements for the witnesses are
available on the U.S. House of Representatives Document
Repository at: docs.house.gov.
Index of Documents
----------
* Statement for the Record, cbdMD; submitted by Chairman Comer.
* Statement for the Record, Council for Responsible Nutrition;
submitted by Chairman Comer.
* Statement for the Record, Dr. Kevin Sabet, PhD, Smart
Approaches to Marijuana (SAM); submitted by Rep. McClain.
* Letter to Reps. McClain and Porter, July 25, 2023, from the
American Trade Association for Cannabis and Hemp (ATACH);
submitted by Rep. Porter.
* Letter to Reps. Comer and Raskin, July 25, 2023, from the
Coalition for Access Now; submitted by Rep. Raskin.
* Report, American Trade Association for Cannabis and Hemp
(ATACH), ``Toward Normalized Cannabinoid Regulation'';
submitted by Rep. Porter.
Documents are available at: docs.house.gov.
HEMP IN THE MODERN WORLD:
THE YEARSLONG WAIT FOR FDA ACTION
----------
Thursday, July 27, 2023
House of Representatives
Committee on Oversight and Accountability
Subcommittee on Health Care And Financial Services
Washington, D.C.
The Subcommittee met, pursuant to notice, at 2:21 p.m., in
room 2247, Rayburn House Office Building, Hon. Lisa C. McClain
[Chairwoman of the Subcommittee] presiding.
Present: Representatives McClain, Foxx, Grothman, Comer (ex
officio), Porter, Lee, and Raskin (ex officio).
Mrs. McClain. All right. I want to welcome everyone to
today's hearing.
We are here, yet again, to discuss the failures of the--oh,
let me back up. Let me back up. Start over. Start over.
The Subcommittee on Healthcare and Financial Services will
come to order.
Welcome, everyone.
Without objection, the Chair may declare a recess at any
time.
I recognize myself for the purpose of making an opening
statement. Here we go.
I want to welcome everyone today. We are here, yet again,
to discuss the failures of the Food and Drug Administration.
Earlier this year, the Subcommittee learned how failures at the
FDA led to the infant formula crisis. Now, we are learning of
the FDA's failure to regulate hemp products.
In both cases, the FDA's action or, quite frankly, lack
thereof, have hurt families and children. The growth and sales
of hemp and hemp-derived products, including CBD, was legalized
in the 2018 Farm Bill.
CBD was also removed from Schedule I status, which are
drugs that have no currently accepted medical use and a high
potential for abuse. It makes sense to remove CBD from Schedule
I status. We know that CBD can have a medical use, because the
FDA approved a prescription CBD drug that is used to treat
children with severe forms of epilepsy. We also know that pure
CBD does not have a high potential for abuse and cannot cause a
high because it is not intoxicating. However, if you buy a CBD
consumer product off the shelf today, in many cases, there are
no way for the average consumer to verify its purity or even
the amount of CBD in it, or rely on the FDA's enforcement of
regulations.
In fact, one study tested almost 3,000 CBD products, showed
that only one-quarter of the brands tested their CBD products
for purity and that only 16 percent of those products tested
contained exclusively what was stated on their label. Sixteen
percent. And that is because the FDA has not regulated CBD as a
dietary supplement or food additive in the 5-years since hemp
was legalized.
It is also common for CBD products to contain contaminants,
like heavy metals, mold, and THC, which is the intoxicating
chemical in the cannabis plant. The widespread usage of CBD
products that contain other unknown contaminants has led to
children accidentally ingesting and overdosing on THC. This
could be fixed if the FDA regulated CBD as a dietary
supplement. That would mean that the FDA would have the
enforcement authority to enforce labeling requirements and keep
Americans safe and healthy.
But instead of regulating hemp-derived products under its
currently--currently existing authority, the FDA announced
earlier this year that it needs a new regulatory framework for
hemp and CBD. Translation: Give us more authority, give us more
money, give us more staff, and only then will we actually do
our duties under the law.
This announcement has led to confusion and uncertainty in
the market, which has suppressed the ability for good-faith
manufacturers to sell CBD products. It only benefits bad actors
who capitalize on the confusion and the flood of the market
with potentially unsafe products.
The FDA must do better and use their already existing
authority to regulate hemp-derived products. You know, actually
do the job they were signed up to do.
I now recognize the Ranking Member of the Subcommittee,
Ranking Member Porter, for her opening statement.
Ms. Porter. Thank you very much, Chairwoman.
I want to focus on doing the job that they are supposed to
do as well. But I want to focus on a different body, not the
FDA. I want to talk about Congress doing the job that it is
supposed to do.
Hemp-derived products may provide numerous health benefits,
such as easing anxiety, insomnia, chronic pain, and addiction.
That is why today, we have Members on both sides of the aisle
who are interested in determining how we should regulate these
products.
Right now, as the Chairwoman said, you can buy CBD and
other hemp-derived products in grocery stores, or you can order
them online to be shipped anywhere. While this framework
provides a great deal of accessibility, it also creates
challenges.
Because hemp-derived products are not federally regulated,
they may include, not just CBD, but THC, an intoxicant. These
products can be sold in packaging that makes them look like
traditional snack foods. That can be confusing to adults and
children alike, who may not want or intend to consume products
with intoxicating levels of THC.
This is a real problem. In fact, just a few weeks ago, the
FDA and the Federal Trade Commission issued warning letters to
six companies for illegally selling products containing THC. 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.
In fact, the FDA convened an internal working group to
explore how the agency might go about regulating hemp-derived
products. After its review, the FDA working group came back,
and they said, we need a new regulatory pathway for hemp-
derived products. They even added that they would like to work
with Congress--nobody wants to work with us--they would like to
work with Congress to get that pathway set up through
legislation.
Today, Republicans have convened this hearing because they
believe, apparently, that the FDA does not need any more
authority from Congress to properly regulate hemp-derived
products. The problem is that some of the same lawmakers who
want to do oversight of the FDA for being cautious about its
existing powers would turn around and blast the agency if they
ever felt like it went too far beyond its legal authority.
Look, we cannot have it both ways here. The FDA knows
Congress will appropriately hold it accountable if the agency
exceeds its authority. That is our job. So, the FDA is not
going to take the risk of going too far. Why ask them to take
that risk when we could just work together across the aisle on
some commonsense legislation?
Given the bipartisan interest, Members of Congress should
have no problem rolling up our sleeves--hell, I do not even
have any sleeves--and getting to work to establish the
regulatory pathway that the FDA says it needs. Let us not jump
to blaming the FDA until Congress has done everything it can to
set it up for success.
At this point, we should certainly evaluate how the FDA
does. In the meantime, the better institution to exhort to do
its job is us, Congress. We are the better oversight subject at
this point.
Thank you, and I yield back.
Mrs. McClain. Thank you, Ms. Porter.
The Chair now recognizes Chairman Comer for an opening
statement.
Mr. Comer. Well, I want to thank Chairwoman McClain for
having this very important hearing today on this very important
topic, and I want to thank our great witnesses who are here
today.
Five years ago, Congress passed the 2018 Farm Bill. That
bill removed hemp and hemp-derived products, including CBD,
from Schedule I status under the Controlled Substances Act.
Since that time, farmers, manufacturers, researchers, and
distributors have looked for various ways to grow the industry
and provide hemp and CBD products to the American people.
The U.S. Department of Agriculture's February 2022 National
Hemp Report shows that over 54,000 acres of U.S. land is
utilized for hemp farming. Clearly, hemp has so much potential
for our American economy, from growers and manufacturers to
businesses of all sizes and consumers of many backgrounds. And
since 2018, scientific research and careful study has continued
to shed light on both the efficiency and safety of these
products, especially CBD.
FDA continues to imply that adequate scientific data is not
available to inform their decision-making around CBD and hemp-
derived products. But there is ample available data studying
CBD and hemp-derived compounds. FDA is simply not being
transparent with the industry stakeholders or Congress in what
scientific studies it relies on, and often moves the goalpost
for researchers attempting to satisfy the FDA's requirements
through rigorous studies.
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.
It is well past time for FDA to do its job and act.
More than just a major obstacle to the economic prosperity
of our great farmers and producers of these products, the FDA's
inaction has also led to concerns for consumers. With no
regulations, shelves have been flooded with products that make
various claims about content and dosage that may or may not be
accurate, while others may be mislabeled and actually contain
intoxicating variants of the cannabis plant, like delta-8 or
delta-9 THC.
Consumers are often unaware that the CBD product that they
are ingesting is not only going to assist them with joint pain
and other relief, but could be adulterated with other
compounds. The American people need to know what is in their
products, and the FDA has the power to enforce reasonable
regulations by regulating CBD as a dietary supplement or food
additive--and I repeat that--regulate it as a dietary
supplement or food additive. But still they have not acted.
I am also concerned about the availability of potentially
dangerous products making their way into the hands of children.
Hemp-derived products like CBD and others intended for human
consumption should be clearly labeled with an accurate
accounting of their contents and available to responsible
adults who are aware of any side effects and risks associated
with those products.
I have said this before at Oversight hearings, but I take
hemp-derived CBD--hemp-derived CBD from labs in my
congressional district in Kentucky that I have seen and have
confidence in. I think we all agree that it is beneficial for
the industry and consumers alike when our shelves are stocked
with products that contain what they say contain, while
limiting the ability of irresponsible and bad-faith actors to
mislead consumers.
If CBD were regulated as a dietary supplement, the FDA
would have enforcement power to make this a reality. The hemp
industry would prosper. Consumers would have choice in the
market and ability to rely on accurate labeling. It would be a
win for our economy, a win for industry, and a win for the
American consumer. But instead of doing its job here, the FDA
has refused to act and use this as an opportunity for a power
grab, asking Congress for even more authorities and more money.
Let me be clear. Further bloating the Federal bureaucracy is
not the answer.
I look forward to hearing from the witnesses today to
obtain an accurate understanding of the issues here. I hope
there is bipartisan support on this issue, and I look forward
to ways we can work across the aisle to bring about positive
changes for the hemp industry, the Americans who rely on that
industry for their livelihood, as well as American consumers
demanding hemp products.
Thank you, Madam Chair, and I yield back.
Mrs. McClain. Thank you, Mr. Chairman.
The Chair now recognizes Ranking Member Raskin for an
opening statement.
Mr. Raskin. Well, thank you kindly, Chairwoman McClain, and
Chairman Comer also, for being here for this important hearing.
While the hearing itself is focused on hemp, I do think it
is part of a sweeping rethinking of cannabis policy that is
going on across the country. And earlier today, I am proud to
say that Congresswoman Mace and I introduced our bipartisan
Cannabis Users Restoration of Eligibility Act, or the so-called
CURE Act, or at least we hope people will call it the CURE Act.
Our bill would remove prior marijuana use as an obstacle to
people getting hired in the Federal Government or passing the
Federal security clearance process, and so it would allow for
people who have been denied security clearance on the sole
basis that they had once used marijuana, either legally as part
of a medical marijuana or recreational marijuana state, or
unlawfully in college or whatever, that these people would be
able to get their security clearance reviewed again, and that
no longer could be used to nullify their opportunity to be
hired in the Federal Government.
This change is imperative, and it is long overdue. I
learned of the problem because of a constituent who is a
distinguished scientist and doctor who was about to get hired
to a sub-Cabinet-level post in the Biden Administration, but
who failed the security clearance because he accurately and
faithfully reported on his security clearance form that he had
used medical marijuana because of a chronic back condition, and
then he was immediately disqualified. Even though they had
already told him they were going to offer him the job, he was
told he could no longer get the job because he had told the
truth about having used medical marijuana to treat a medical
condition.
And then, when we began to look into this, there are, well,
hundreds of thousands, if not millions, of people who are
disqualified from even being even able to apply for positions
they are qualified to hold. And thousands of people that we
know of who have actually gone through the process and then
suddenly run into the professional guillotine of a marijuana
question on the security clearance form.
So--but I want to thank Ms. Mace for her collaboration and
cooperation on this bill. We look forward to moving it through
this Committee with the help, I hope, of Chairman Comer, who I
know has asked some good questions about it. But I am hoping
that we will be able to arrive at a good, commonsense bill that
all Americans would be able to get behind.
Now, turning back to the Federal rules related to hemp and
its derivatives, it is important here again that we take a
commonsense approach to these regulations. The FDA released a
statement earlier this year explaining that current regulatory
frameworks for foods and supplements are not appropriate for
cannabidiol, or CBD, one of the biggest hemp derivatives. The
FDA explained that the regulatory frameworks may not be
sufficient for managing risk in conducting appropriate
oversight for CBD products.
And I agree with my colleagues that we need reasonable
regulation of the hemp and hemp-derivative marketplace to
protect consumers and to ensure that good actors in the hemp
industry can grow their businesses and we can have a legitimate
and flourishing market in hemp, but we need to make sure that
the regulations make sense.
A vast world of hemp derivatives is flourishing beyond just
CBD. Among them are newly developed synthetic cannabinoids,
including delta-8 THC, which can have intoxicating effects when
consumed. Without regulation, companies can synthesize these
intoxicants from legal hemp and evade regulatory scrutiny and
Federal marijuana laws, sending products to market without
proper testing, labeling, or other safety precautions.
Hemp-derivative products can come in all sorts of different
forms. They cannot be easily or always categorized simply as
food or supplements. These products can be oils, tinctures,
vape pens and cigarettes, and even cosmetics and skin care. The
FDA realistically cannot regulate the entire world of hemp and
its derivatives without additional research authority and
resources.
So, I hope we can work with our colleagues to figure out
the proper path forward, and with the assistance of today's
expert witnesses, on regulating hemp and its derivatives so
that we can protect the American people and provide a more
effective framework for the regulation of a potentially strong
industry.
I thank you, Madam Chair, and I yield back to you.
Mrs. McClain. Thank you, Mr. Raskin.
I am pleased to introduce our witness panel today.
Jonathan Miller is a longtime advocate for the hemp
industry in the United States. He currently serves as the
general counsel for the U.S. Hemp Roundtable, which advocates
for the broader hemp industry, including agriculture, oil,
seed, fiber, and extracts like CBD. Welcome.
Dr. Rayetta Henderson is a toxicologist and senior managing
scientist at ToxStrategies. She is the lead author of several
peer-reviewed publications relating to the safety assessment
and toxicology testing of CBD as a dietary ingredient.
Richard Badaracco--did I say that right? Look at me--is the
incoming president of the Kentucky Narcotic Officers
Association, who brings four decades of experience as a
professional law enforcement officer. Among other law
enforcement roles, he brings special expertise as a retired
Assistant Special Agent In Charge at the U.S. Drug Enforcement
Administration. Thank you, sir, for your service.
And, finally, Dr. Gillian Schauer is an Executive Director
of the Cannabis Regulators Association, where she leads a
nonpartisan association agency involved in cannabis and hemp
regulation across 45 states and U.S. territories. Welcome.
Pursuant to Committee Rule 9, the witnesses will please
stand and raise their right hands.
Thank you.
Do you solemnly swear or affirm that the testimony that you
are about to give is the truth, the whole truth, and nothing
but the truth, so help you God?
Let the record show that the witnesses all answered in the
affirmative.
We appreciate all of you being here today and look forward
to your testimony.
Let me remind the witnesses that we have read your written
statements, and they will appear in full in the hearing record.
Please limit your oral statements to 5 minutes. As a reminder,
please press the button on the microphone in front of you so
that it is on, and the Members can hear you. When you begin to
speak, the light in front of you will turn green. After 4
minutes, the light will turn yellow. When the red light comes
on, your 5 minutes has expired, and we would ask you to please
wrap up.
I now recognize Mr. Miller to please begin his opening
statement.
STATEMENT OF JONATHAN S. MILLER
GENERAL COUNSEL
U.S. HEMP ROUNDTABLE
Mr. Miller. Madam Chairwoman, Ranking Member Porter, I am
grateful for the opportunity to testify before your Committee
today.
Chairman Comer, I am grateful for your presence today, but,
more importantly, for your decade-long leadership on behalf of
Kentucky and U.S. hemp farmers. You and I started on this
journey in 2012 and worked across the aisle to secure hemp's
legalization in the Bluegrass state.
Indeed, hemp's policy success has always been a bipartisan
hallmark. Unfortunately, the U.S. hemp industry has been
struggling considerably in the last few years, and this turmoil
is due, in large part, to decisions made by FDA.
When Congress passed the 2018 Farm Bill, it explicitly
legalized the sale of hemp and its derivatives, such as CBD.
Farmers across the Nation relied on this and invested
considerable resources to grow and market commercial hemp
crops, particularly for the product for which there was
immediate processing, infrastructure, and consumer demand: CBD
and cannabinoids.
But just a few hours after the Farm Bill was signed into
law, FDA asserted its opinion that it was illegal to market CBD
as a dietary supplement or to use as a food additive. Beyond
warning letters that mostly targeted illegal disease claims,
the agency has not engaged in meaningful enforcement. This
position, coupled with lack of action, has cast a cloud over
the industry.
FDA has swung back and forth with contradictory positions.
First, the agency affirmed its ability to regulate CBD under
current law. We agreed. But then, in the intervening 4 years,
FDA stalled, even ignoring congressional appropriations report
directives to take expedited action.
Finally, this January, the agency concluded that it could
not regulate CBD under existing regulatory pathways. It stated
a concern over the substance's safety. But in so doing, the FDA
relied on a narrow set of research focused on super-high-dosage
CBD isolate formulations, while refusing to acknowledge a range
of studies that demonstrate the safety of various CBD
formulations at much, much lower dosage levels, such as those
typically found in products sold at retail. A summary of these
studies appears in my written testimony.
Lack of a Federal framework has led to the proliferation of
unregulated products, some of which raise significant quality
and safety concerns. Surplus hemp CBD biomass is being
chemically converted into impairing products, such as delta-8
THC, which are being sold unregulated, sometimes to minors.
These products serve as a lifeline to U.S. farmers, and
when manufactured properly, can be of considerable value to
adult consumers. We oppose their ban or criminalization, but
they need to be strictly regulated for safety and kept out of
the hands of children.
Meanwhile, Federal regulatory uncertainty severely impacted
the hemp and CBD market, with reduced manufacturing demand
resulting in a more than 90 percent commodity price decline,
crushing farming opportunities.
Please see this chart behind me. In all but one category,
prices have collapsed due to FDA inaction. The one exception in
green, that line represents the price of hemp flour, which
recovered when it started being widely used for delta-8 THC.
It is clearly time for Congress to act. We support
legislation that has been introduced by a bipartisan coalition.
H.R. 1628 would provide a regulatory pathway for CBD as a food
and beverage additive. H.R. 1629 would ensure that hemp
ingredients could be lawfully marketed as dietary supplements.
In the Senate, S. 2451 and its companion House bill, H.R. 4849,
would provide both regulatory paths.
All of these would require compliance with the entire
existing comprehensive regulatory frameworks for dietary
supplements and food, which help ensure products are safe,
properly labeled, and produced under good manufacturing
practices.
While we disagree with FDA's opinion that a new regulatory
regime is needed, especially given the length of time this
would require, we are certainly open to stricter regulation of
CBD and other cannabinoid products on top of the existing
frameworks.
In the absence of FDA action, the hemp industry has
established the U.S. Hemp Authority, a self-regulatory
organization to promote high standards and best practices.
States have stepped in, but a patchwork of inconsistent law has
emerged.
Without a Federal regulatory pathway for requiring such
standards, economic opportunities for U.S. hemp farmers will be
diminished, and consumers will not have access to safe, quality
products. Legislation is necessary to protect consumers, help
stabilize hemp markets, open up a promising economic
opportunity for U.S. agriculture, and honor the commitment made
to growers in the 2018 Farm Bill.
Madam Chairwoman, the hemp industry may be unique in that
we are coming to Congress to ask: Please regulate us.
We appreciate your consideration.
Mrs. McClain. Thank you, Mr. Miller.
The Chair now recognizes Dr. Henderson.
STATEMENT OF RAYETTA G. HENDERSON, PH.D.
SENIOR MANAGING SCIENTIST
TOXSTRATEGIES, LLC
Ms. Henderson. Chairwoman McClain, Ranking Member Porter,
Chairman Comer, Ranking Member Raskin, and Members of the
Subcommittee, thank you for inviting me to participate in
today's hearing. I appreciate the opportunity to talk about our
research and its utility in an overall evaluation of CBD to
support its safe use as a dietary ingredient.
I am a toxicologist and senior managing scientist at
ToxStrategies, a scientific consulting firm that provides
support for clients in the public and private sectors. I have
experience in the safety assessment of ingredients that are
often used in food, supplements, and/or feed. And since the
2018 Farm Bill, I have been actively involved in the safety
assessment of CBD and other hemp-derived products.
I am here today to present our recently published
preclinical safety studies that provide key information needed
to conduct robust science-based assessments to evaluate the
safety of CBD as a dietary ingredient. These studies, in
combination with other available data, provide a sufficient
basis from which to determine safe levels of CBD for oral
consumer use.
To ensure consumer protection, dietary ingredients must
meet the relevant prescribed safety standards for their
intended use, such as those established for new dietary
ingredients. We have conducted a safety testing program to
specifically address gaps identified for a CBD product that
would be expected to be filled as part of regulatory
compliance. The need for these studies was determined based on
standard practices typically employed in the safety evaluation
of dietary ingredients.
Before I present the outcome of these studies, it is
important to provide some background on how they are designed
and used to support safety. A fundamental concept in any safety
assessment is that the finding of a potential adverse effect
does not automatically mean there is a risk of that effect
occurring. Preclinical toxicology studies are intentionally
designed to be conducted at high enough exposure levels to
identify potential adverse effects. This is an important
distinction because exposure levels associated with human
consumption may be very different from exposure levels tested
in toxicology studies.
Substances considered to be beneficial and even necessary
for health can be toxic if consumed in large enough amounts.
Understanding the levels at which these effects might occur
provides the information necessary to determine levels of
consumption that are unlikely to be associated with such
effects.
When sufficient data are available for an ingredient, a
risk assessment can be performed based on information from
safety studies and exposure levels and consumers to evaluate
whether a sufficiently protective margin of safety exists and
determine a safe level of intake for consumers.
Our program included six preclinical toxicity studies on a
hemp-derived CBD isolate. All studies were performed according
to the highest standards available and involved a collaboration
and oversight of scientists from multiple disciplines and
research organizations. In addition, three manuscripts
summarizing these studies have undergone an independent peer-
review process and are now publicly available in scientific
journals. A copy of each is provided as an appendix to my
written statement.
First, CBD did not cause DNA or chromosomal damage in our
testing program. This is critical, as a genotoxic finding would
have precluded its use as a dietary ingredient. Next, our
studies demonstrated that CBD was well-tolerated following
repeated consumption in animal models up to the highest dose
tested of 140 milligrams per kilogram body weight for 90 days.
In our reproductive study, exposure up to 100 milligrams
per kilogram body weight a day did not cause adverse effects on
fertility or reproduction in female animals, nor did it cause
any developmental effects in offspring. For context, when
converted to milligrams a day based on body weight, this value
would be 100fold higher than a dietary supplement product
containing 70 milligrams of CBD.
Finally, no adverse effects on male reproductive parameters
were observed up to the highest dose tested of 300 milligrams
per kilogram body weight a day.
Together, this suite of studies provides the baseline data
that are typically required to evaluate use of a dietary
ingredient.
Providing the science to do safety and risk assessment for
dietary ingredients is expressly in line with the objective of
protecting the health and well-being of the American consumer.
We have conducted core safety studies that add to an already
extensive body of science for CBD, which includes human
clinical trials and studies in animal models.
Based on my experience performing similar evaluations, the
data available are sufficient for conducting a safety
assessment of hemp-derived CBD isolate. The process would
follow the same principles that we as risk assessors apply when
evaluating any ingredient for dietary use.
Recommendations for safe use, such as exposure levels, will
depend on a number of factors, including the data available for
review by the assessors and the population of interest for the
product. Recommendations for safe use could be refined as
necessary as new data continue to become available.
I thank the Subcommittee and its Members for your interest,
and look forward to answering any questions you may have.
Mrs. McClain. Thank you, Dr. Henderson.
The Chair now recognizes Mr. Badaracco.
STATEMENT OF RICHARD A. BADARACCO
PRESIDENT-ELECT
KENTUCKY NARCOTIC OFFICERS ASSOCIATION
(RETIRED) ASSISTANT SPECIAL AGENT IN CHARGE
U.S. DRUG ENFORCEMENT ADMINISTRATION
Mr. Badaracco. Chairman Comer, Chairwoman McClain, Ranking
Member Porter, and esteemed Members of the Subcommittee, I am
grateful for the opportunity to testify before your Committee
today.
My testimony today focuses on the absence of a Federal
regulatory structure to govern the marketing of CBD and other
hemp-derived products. Mr. Miller testified earlier that the
collapse of hemp and CBD led many farmers and businesses to
chemically convert CBD biomass into intoxicating compounds,
most prominently, delta-8 THC.
The passage of the Agricultural Improvement Act of 2018 and
the deregulation of hemp did not specifically address delta-8
THC, but effectively legalized the sale of hemp-derived delta-8
THC products with no oversight. Its popularity has grown
dramatically since 2020, gaining the attention of consumers and
market stakeholders alike throughout the country.
Hemp and marijuana are primarily the same plant and often
are not visually distinguishable. Each contain many
cannabinoids. The two well-known compounds naturally produced
in the cannabis plant are tetrahydrocannabinol, THC, both 8 and
9, and cannabidiol, CBD.
Mostly, the distinction between hemp and marijuana is the
concentration of delta-9 THC in the two plants. Hemp, by
definition, must contain no more than 0.3 delta-9 THC.
Marijuana plants usually contain anywhere from 5 to 30 percent
delta-9 THC. It is this substance that produces the
intoxicating effects of the marijuana plant.
CBD is a much more prevalent compound in the hemp plant, so
the standard method of creating delta-8 THC involves chemically
extracting CBD from hemp and converting it into delta-8 THC.
Delta-8 THC has psychoactive and intoxicating effects like
delta-9, having about half of the intoxicating effects of
delta-9.
In many states, including Kentucky, most delta-8 THC
products are sold throughout unregulated market sources, like
convenience stores, grocery stores, smoke/vape shops, gas
stations, and can even be ordered online. These products are
not reliably tested and have been found to contain many
impurities.
In addressing these issues, Congress and regulators may
choose to work with the U.S. Hemp Authority, the hemp
industry's self-regulating organization. In the absence of FDA
regulations, the Hemp Authority encourages manufacturers to
participate in the program to use best practices and high
standards in preparing their products. The standards are based
largely on FDA's regulatory regime concerning dietary
supplements in food and beverage additives and is enforced by
third-party auditors.
However, self-regulation is not sufficient. Federal
regulation is necessary to ensure that all products on the
marketplace maintain the highest safety standards. These
products and their abuse have become a concern for law
enforcement in many instances.
However, Congress, law enforcement, and state legislators
can, right now address some of the complex issues surrounding
these substances, such as enact legislation regulating the
manufacturing, sale, and distribution of products containing a
hemp-derived cannabinoid, including licensing resale--
retailers.
Enact legislation enabling testing requirements of all
products containing hemp-derived cannabinoids and create rules
specifying pass-fail action levels for safety and toxicity.
Establish child safety packaging and labeling requirements
along with restrictions to advertising which may appeal to
minors.
Regulate the hemp industry so products contain only the
legal limit of 0.3 percent or less of a concentration of THC.
Mandatory reporting to a government entity when ingestion
of these substances led to an adverse reaction. Law enforcement
believes these events are underreported.
Seek state or Federal funding for forensic lab
infrastructure that could assist and help with the development
of improved hemp and marijuana differential methods.
And training for law enforcement officers concerning these
substances and navigating the possible implications of
arresting and prosecuting individuals under the influence.
In closing, I want to thank the Committee for examining
this important topic, and I look forward to your questions.
Mrs. McClain. Thank you, Mr. Badaracco.
The Chair now recognizes Dr. Schauer for her opening
statement.
STATEMENT OF GILLIAN SCHAUER, PH.D., MPH
EXECUTIVE DIRECTOR
CANNABIS REGULATORS ASSOCIATION
Ms. Schauer. Thank you, Chairman McClain, Ranking Member
Porter, Chairman Comer, and Members of the Subcommittee. Thank
you for inviting me to testify today.
My name is Gillian Schauer. I am the Executive Director of
the Cannabis Regulators Association, referred to as CANNRA.
CANNRA is a nonpartisan association of government agencies
implementing cannabis and hemp regulation across 45 states and
U.S. territories.
Prior to serving as the first Executive Director of CANNRA,
I spent more than a decade working with Federal, state, and
municipal agencies on cannabis-related policy, research, and
public health. I have a Ph.D. in behavioral science and a
master's in public health.
Thank you for holding this hearing. This is the No. 1 issue
facing my members, cannabis and hemp regulators. Because of a
broad definition of hemp in the 2018 Farm Bill, we have seen an
explosion of hemp-derived products that are intoxicating, that
are not regulated to be safe for consumers, and that can appeal
to and be accessed by youth. Red states, blue states, every
state is grappling with this issue.
Intoxicating hemp-derived cannabinoids, including delta-8,
HHC, THC-O-acetate, H4CBD, are being made chemically using CBD
as a source material. Many of these compounds have not been
studied for safety. People consuming them are literally the
test case for their safety. And yet they are widely available
across all states in gas stations, grocery stores, and online.
Farm bill-compliant cannabinoid hemp products can also
contain far more delta-9 THC than is legal in state-regulated
marijuana markets, and yet still be under the 0.3 percent
delta-9 THC threshold. They can contain high levels of THCA,
which readily converts to delta-9 THC when heated in products.
And products marketed as full-spectrum or whole-plant CBD that
contain all of the compounds found in the hemp plant can also
have enough delta-9 THC to be intoxicating.
Hemp and marijuana come from the same plant and have the
same compounds. Whether delta-9 THC comes from what we call
hemp or marijuana, it works the same in the body, yet the
Federal legality of it differs based on the source.
The Farm Bill did not create a Federal regulatory structure
to adequately protect consumers. Cannabinoid hemp products are
sold to anyone, anywhere, without any standards or Federal
regulations. These products, whether intoxicating or not, have
no required testing for contaminants, pesticides, heavy metals.
They are not regulated federally for ingredients or additives,
particularly those that could be harmful when smoked or vaped.
They have no required packaging and labeling to tell consumers
what is in the product and whether they are intoxicating. There
are no Federal restrictions on products that mimic commercial
food and candy, and kids can access intoxicating hemp products
because there are no Federal age restrictions.
This is in stark contrast to state-regulated marijuana
markets, which are highly regulated for consumer safety and
youth prevention. s have seen a range of public health and
safety issues directly linked to intoxicating cannabinoid
products, including accidental ingestion by young kids
resulting in hospitalization, overconsumption by teenagers
resulting in hospitalization, and unexpected impairment by
adults who thought they were purchasing something
nonintoxicating.
With no Federal regulation in place, state legislatures are
enacting policies state by state. Policy differs, but,
increasingly, states are bringing intoxicating hemp products
under the purview of the marijuana regulator, where the same
cannabinoids, but derived from marijuana, are being regulated.
Without Federal minimum standards, we are creating a patchwork
of regulation that creates consumer safety and market
challenges and leaves regulatory gaps that cannot be covered by
states alone, including in online markets and through
interstate commerce.
As an association of state regulators, CANNRA is not
encouraging the recriminalization of cannabinoid hemp products
but, rather, comprehensive regulation that protects consumers
and public health across a range of available products.
We have an opportunity to learn from the approaches that
states have taken to set thoughtful and comprehensive Federal
regulatory policy. A Federal regulatory agency with a focus on
public health and safety, like FDA, needs to be authorized and
funded with a specific timeframe in which to implement a
regulatory framework for these products.
And that framework cannot just focus on CBD. It must
contend with the breadth of hemp-derived cannabinoids we see on
the market today, both intoxicating and non, and it must
account for those products we do not yet know about. It must
consider the many ways cannabinoid hemp products are consumed:
as foods, as beverages, vaped products, smoked products. It
must also require contaminant testing and compliance and
enforcement. These essential components of a regulatory
framework for cannabinoid hemp extend beyond traditional food
and dietary supplement pathways.
These issues are far more nuanced and detailed than what I
have been able to cover with you in these opening remarks. My
written testimony provides additional information.
I would encourage all of you to reach out to CANNRA, to
connect with your state cannabis or hemp regulator, to hear
firsthand from them what this issue looks like on the ground in
your state, in your jurisdiction.
Thank you for your time and attention, and thank you for
including a regulatory perspective on this hearing about
regulation. I welcome your questions today and your continued
engagement moving forward.
Mrs. McClain. Thank you--thank you, Dr. Schauer.
The Chair now recognizes Chairman Comer for questions, 5
minutes.
Mr. Comer. Thank you, Madam Chair.
Mr. Miller, hemp products, including CBD, were removed from
Schedule I status in the 2018 Farm Bill. Is that correct?
Mr. Miller. Yes.
Mr. Comer. Since the 2018 Farm Bill, have private companies
attempted to enter the market with hemp and CBD products for
the American people?
Mr. Miller. Absolutely.
Mr. Comer. Do you have any data on the size of the CBD
market?
Mr. Miller. There is--there is considerable data in my
written testimony that--that----
Mr. Comer. OK.
Mr. Miller. [continuing]. We have shared with the
Committee.
Mr. Comer. The FDA has not regulated hemp-derived products,
including CBD, in the 5 years since the 2018 Farm Bill was
passed. Has the FDA's lack of action impacted the hemp
industry?
Mr. Miller. Yes. No. As I mentioned earlier, the lack of
action has cast a shadow over the industry. There have been--it
has kept a lot of big box stores from carrying products that
they otherwise would. It has kept a lot of big food and
beverage companies from adding CBD to their mixes. And as a
result, there was a decrease in demand when the supply went way
up. And as you have seen, economics 101, by the chart I shared
earlier----
Mr. Comer. Uh-huh.
Mr. Miller [continuing]. The prices collapsed----
Mr. Comer. Yes.
Mr. Miller [continuing]. And the farmers are bearing the
burden.
Mr. Comer. That is right. It has affected farmers too.
Mr. Miller. The farmers, worst of all.
Mr. Comer. In a bad way.
Mr. Miller. Yes.
Mr. Comer. So, Dr. Henderson, you are the lead toxicologist
at three published scientific papers analyzing data from
studies of CBD isolate. Is that correct?
Ms. Henderson. Yes, that is correct.
Mr. Comer. Your studies were designed to determine the
levels of CBD at which you would observe adverse effects?
Ms. Henderson. That is correct. Yes.
Mr. Comer. In addition to your research, are you also aware
of other scientific studies on CBD that would be available to
FDA regulators?
Ms. Henderson. Yes, I am. Data on CBD specifically are
plentiful. CBD has been evaluated as a drug, as we know--
Epidiolex--and so FDA has access to the clinical and
nonclinical data packages submitted as part of that review.
It is also my understanding that FDA has commissioned and
has been conducting their own targeted safety studies on CBD.
There are other human clinical trials outside of Epidiolex,
with other CBD formulations, across a wide range of
populations. And in addition to our studies, there are other
studies that have been conducted by stakeholders that are not
published yet. And then there are other preclinical safety
related studies that are published.
So, there are a lot of data that we typically do not have
access to when reviewing an ingredient as a dietary supplement.
Mr. Comer. All right. So, Mr. Miller, given the
availability of scientific data related to CBD, would you agree
that the FDA is not doing its job here by saying there is not
enough data to proceed?
Mr. Miller. Correct. They--there is enough data to pursue a
regulatory pathway for dietary supplements and food and
beverage additives.
Mr. Comer. So, has the FDA at least been transparent with
stakeholders as to what it needs to move forward with
regulating CBD? And, if not, how so?
Mr. Miller. Well, as I mentioned in my testimony, we do not
think a new regulatory pathway is needed, but we would be happy
to entertain or--so even support additional regulatory
safeguards above what is currently under law. But the FDA has
not specified those in a way that has allowed Members of
Congress to draft legislation to accommodate that.
Mr. Comer. All right. Mr. Badaracco, I am very concerned
with--that without FDA regulations, products mislabeled as CBD
that are adulterated with other substances will continue to be
available and potentially present a danger to the public and
even children.
Can you describe some of what you are hearing in the law
enforcement community about the dangers consumers may face?
Mr. Badaracco. Well, I have--when I knew that I was
testifying at this hearing, I had caused a solicitation email
out to the members of KNOA, which is 400 members within the
state of Kentucky, to give firsthand or anecdotal reports of
these intoxicants being ingested by middle school children or
high school children and what the adverse--what the adverse--
what the adverse, if I will, results were.
Mr. Comer. Right, right.
Mr. Badaracco. And it--I am continuing to get reports from
across the state----
Mr. Comer. Right.
Mr. Badaracco [continuing]. From--I know in far eastern
Kentucky, there is a police department, there has been so many
of these instances----
Mr. Comer. Uh-huh.
Mr. Badaracco [continuing]. That that is their No. 1
priority----
Mr. Comer. Right.
Mr. Badaracco [continuing]. With these substances.
Mr. Comer. Right.
Mr. Badaracco. I have got two physicians from two hospital
ERs. I have not talked to them yet, but they want to talk to
me----
Mr. Comer. OK.
Mr. Miller [continuing]. As well as far as what they are
seeing.
Mr. Comer. Yes. So, it is a huge problem. We see that
everywhere. We have seen that in other products that claim to
contain CBD, and there is no regulatory body to regulate that.
And very seldom do I, as a typical Republican, advocate for
regulations, but what you have in the hemp industry, you have a
lot of credible actors that are doing the right thing, and then
there are a lot of bad actors.
And when I say it needs to be regulated like a
nutraceutical or the vitamins or things like that, you go in,
and the bottle of supplements--let us use as an example--it
says how many milligrams of this and what is in the supplement.
The FDA, to make sure that what the label advertises is what
actual--what the actual product is that the consumer gets.
And that is what we are asking for here. Right now, there
is no one to determine whether or not someone selling CBD is
being factual when they advertise what is on the bottle, and
that is a threat, not just to the industry, but to consumers as
well.
So, hopefully, the FDA will do that.
Madam Chair, thank you, and I yield back.
Ms. Porter. Madam Chair, I would like to enter into the
record a letter from the American Trade Association for
Cannabis and Hemp and a report titled, ``Toward Normalized
Cannabinoid Regulation.''
Mrs. McClain. Without objection.
Mrs. McClain. The Chair now recognizes Ms. Lee for 5
minutes.
Ms. Lee. Thank you, Madam Chairwoman. I literally was about
to get up and go to vote, so I appreciate being called on.
So, yes, we are here today because the Food and Drug
Administration has committed to using science and data as a
basis for making policy decisions to protect public health and
safety. FDA has publicly and repeatedly stated that it had a
roster of important questions about hemp-derived products that
needed answers before it could regulate these products.
They have questions about how much hemp-derived product an
individual could safely consume in a day, whether this amount
varies depending on the form taken, potential negative
interactions with other drugs or substances, effects on special
populations like children or the elderly, and the risk of long-
term exposure.
To be clear, I am glad we have extended hemp and CBD into
our marketplace. However, anecdotal evidence and marketing
claims are not the same as rigorous scientific research.
Dr. Schauer, what is the problem with using online
calculators or trusting product manufacturers regarding an
appropriate dose of CBD?
Ms. Schauer. Well, I think state hemp and cannabis
regulators would tell you that we need academic data, we need
nonpartisan data sources, and we need pathways that account for
what we are seeing in the field. So, we are not just seeing
dietary supplements in the field. We are seeing inhalables and
combustible products as well. We need data on those products.
Those products do not fit neatly into a regulatory pathway that
FDA currently has and need to be studied.
These novel cannabinoids that are coming out as well, being
converted from CBD, we need data to understand those. And,
increasingly, very few products are just CBD. The products
contain CBD and many other cannabinoids. We need to understand
how those cannabinoids interact, what their effects are on
humans. And we need not to be using humans as the test case for
that. We really do need science to create thoughtful
regulation.
Ms. Lee. So, would regulating industry through the existing
food and dietary supplemental regulatory pathway address these
concerns with the safety of CBD products? Yes or no?
Ms. Schauer. I do not believe that it will. If I can take a
second, there are three main reasons, I think, for that. One is
we have inhalable and combusted products that do not fit into a
food or dietary supplement pathway.
Two, dietary supplements usually follow GMP practices.
Every state is trying to use testing. We really need to know
what contaminants are in the products, and that is not a
traditional part of the dietary supplement pathway.
And then, finally, we need specific warnings and labeling
based on the route of administration, which, again, is not just
food or dietary supplement; it includes other pathways.
Ms. Lee. So, the FDA believes it needs additional
scientific studies and new authorities to balance consumer
access with appropriate safeguards and oversight. This
Subcommittee should understand the need for careful oversight,
and we should work with the FDA to achieve it.
In addition to protecting public health, we also need to
ensure we encourage diversity and inclusion in this growing
industry. I have worked hard in this Congress to promote
diversity, both in and out of committee hearings. In my role on
Science, Space, and Technology Committee, I will be sending a
letter to the Chair addressing the need for more diverse
witnesses.
Mr. Miller, can you tell us about the purpose of the U.S.
Hemp Roundtable's Minority Empowerment Committee?
Mr. Miller. Yes. As you are all too aware, cannabis has a
very sad history when it comes to disparate treatment of people
of color, and there has been structural racism that has
pervaded Federal farm programs. And so that is why our
organization, and I think the industry at large, has really
engaged in an effort to promote diversity and equity in our
ranks.
Ms. Lee. Thank you. Effective oversight and a dedication to
science and evidence are the best way to move forward with hemp
and CBD. However, I also want to be sure that we are deliberate
in our approach to regulation and do not follow the path of
overcriminalization. I am encouraged by the potential benefits
of these products and look forward to continuing to learn and
work on this issue.
With that, thank you so much, and I yield back.
Mrs. McClain. Thank you.
Pursuant to the previous order, the Chair declares the
Committee in recess, subject to the call of the Chair.
We will plan to reconvene rather quickly right after votes.
We just need to go vote, and we will come right back. Thank
you.
So, the Committee stands in recess.
[Recess.]
Mrs. McClain. The Subcommittee on Healthcare and Financial
Services will come to order, and we will reconvene.
The Chair now recognizes Mr. Grothman for 5 minutes.
Mr. Grothman. Mr. Miller, if CBD is regulated as a food
supplement or additive by the FDA, what would the economic
consequences be?
Mr. Miller. There would be enormous economic consequences.
I laid this out in my written testimony, but there are
independent studies. The Brightfield Group is one of those
economic groups that claim that that difference could be a $5
billion a year difference if these avenues are--these
regulatory pathways are made clear.
Mr. Grothman. OK. Other countries like U.K., Australia,
have regulated CBD. How is our--and they found it safe. How is
our market different than theirs?
Mr. Miller. It is not at all different. I think that we can
look at Australia and Great Britain and Canada for good
examples of how CBD could be regulated.
Mr. Grothman. OK. What do you think we should do with CBD
in this year's farm bill?
Mr. Miller. I would love to see the legislation like 1628,
1629 attached to this year's farm bill. I understand that there
are jurisdictional issues with the House Agriculture Committee,
but I am hopeful that those can be resolved. And perhaps, if it
has to be added in conference committee, we would be very
supportive.
Mr. Grothman. OK. What percentage of hemp farming is
dedicated to CBD and other extracts?
Mr. Miller. It used to be about 90 percent. That was the
last study I have seen. That was a couple years ago. I do think
it has declined a bit. There has been a growth in the fiber
side, but it certainly is still an overwhelming part of the
hemp industry.
Mr. Grothman. OK. So, we do not know. It has probably
dropped, though?
Mr. Miller. Yes.
Mr. Grothman. OK. What does action look like from Congress
so that we do not interfere with the FDA's authority?
Mr. Miller. Pass H.R. 1628, 1629. Congressman, you have
been a strong supporter of both of those bills in the last
Congress as well. We really appreciate that. But if we are able
to affirmatively direct FDA to regulate CBD as a dietary
supplement and food beverage additive, even if we are going to
add additional regulatory oversight on top of that, we are open
to that as well.
Mr. Grothman. OK. Mr. Badaracco, in your estimate, is it
legal to ship delta-8 THC products derived from CBD across
state lines?
Mr. Badaracco. It really depends on the state, I think, and
it is kind of a mixed bag, if you will, between----
Mr. Grothman. There is not a norm you can cite?
Mr. Badaracco. I am sorry?
Mr. Grothman. There is not a norm that you can cite?
Mr. Badaracco. No. No. I mean, you have states that
decriminalized marijuana. You have states that have
criminalized delta-8 products. You have states that have
medicinal only, states that have recreational and medicinal.
So, it is really a mixed bag across the country.
Mr. Grothman. OK. Can it be ordered on the internet?
Mr. Badaracco. Yes.
Mr. Grothman. OK. Why do you think some companies feel that
they can do this?
Mr. Badaracco. You know, it is without regulation--I mean,
there is two ways, and they are using the 2018 hemp bill to do
this. You know, I think it was an unintended consequence,
because they can extract--CBD and hemp is infinitesimal. I
mean, it is less--1 percent or even less. But there is
plentiful CBD in hemp, so they will extract the CBD, chemically
convert it into delta-8 THC, and then use that to make a
variety of retail products, whether that be hemp flowers and
they treat it with delta-8 for smoking, capsules, ingestibles
which is candy, brownies, other ingestibles.
Mr. Grothman. Does anybody have the idea of the size of
this so-called problem or problem?
Mr. Badaracco. I can only speak anecdotally from the
response I am getting from the memberships from the Kentucky
Narcotic Officers Association. I am getting more and more
firsthand, as well as anecdotal reports of these substances
being consumed by middle school and high school kids and having
adverse reaction. I am also----
Mr. Grothman. You think they are ordering it on the
internet?
Mr. Badaracco. I am sorry?
Mr. Grothman. You think they are ordering it on the
internet?
Mr. Badaracco. We do not know. We do not--we really do not
know. There are ongoing investigations concerning that, but at
this point, I do not know.
Mr. Grothman. Mr. Miller, are there any hard numbers on
this you know?
Mr. Miller. No. It has been gathered on a state-by-state
basis, but it is clear that kids have been getting it. Vape
stores, convenience stores, those are other places where you
will find that kind of commerce.
Mr. Grothman. OK. Thank you.
Mrs. McClain. Thank you, Mr. Grothman.
The Chair now recognizes the gentlelady from North
Carolina, Dr. Foxx.
Ms. Foxx. Thank you, Madam Chairwoman.
And I will follow up on Mr. Grothman's comments. Mr.
Badaracco, what are the dangers of problems associated with
consuming CBD products that may contain widely varying levels
of intoxicants?
Mr. Badaracco. I mean, with children having to go to the
emergency room--which there is reports that I referenced to
that we are starting to get now--it can add to agitation,
increased heart rate, nauseous, unconsciousness, things of that
nature. There was a report just yesterday from Covington,
Kentucky, of a 10-year-old, I think was the age of the
individual, who bought a gummy bear which turned out to be a
THC delta-8 gummy bear treated, and it had 10 dosages in it.
And the child consumed it and, of course, went to the ER and
was experiencing many of those symptoms that I had just
described. And I am finding this across the state.
Ms. Foxx. I was going to follow up about children, so thank
you for covering that in your answer.
Why doesn't the Drug Enforcement Agency go after
intoxicating CBD products that are synthesized from legally
grown hemp?
Mr. Badaracco. Well, I think it is--you are seeing kind of
a mixed bag from the court system. I know the Ninth Circuit
said that delta-8 is the derivative of hemp, so therefore it is
illegal. A Kentucky court has also expressed that opinion as
well, legalizing delta-8 in the state of Kentucky. But it is--
other than that, there is really no direction or regulatory
framework to use, because under 2018--the Farm Bill under 2018
where it is a derivative of hemp, it is being treated as legal.
Ms. Foxx. So, can the average person tell with any
confidence if a CBD product contains intoxicants?
Mr. Badaracco. Not really, no. Not right now. Not without
having a specific labeling of what exactly is in the
substances. Part of the--how should I say? You know, part of
the chemical process, you know, CBD is in large quantities from
the hemp plant, and it is extracted chemically to make delta-8
THC. And they use syrup--many, many manufacturers will use
solvents to make that conversion and acids to convert it as
well.
Ms. Foxx. Thank you.
Mr. Miller, we know the FDA has not been regulating hemp-
derived products, but has the FDA engaged in any meaningful
enforcement?
Mr. Miller. No. The only enforcement actions they have
taken so far are sending warning letters. Most of those warning
letters have been to companies that have been making outrageous
medical claims, like this CBD is going to cure cancer or it is
going to cure COVID. But to date, they have not been seizing
anything off the shelves or taken any other more direct
enforcement action.
Ms. Foxx. Mr. Miller, do you believe that delta-8 THC and
other compounds derived from CBD that can be intoxicants are
legal to produce and sell under Federal law?
Mr. Miller. You know, it is still an open question, but as
Rich mentioned earlier, the Ninth Circuit has weighed in and
says that they are legal. A number of state courts have said
the same thing. However, in certain states, we have seen them
be declared illegal. New York is one of those, for example. So,
it is really a mixed bag and really a reason why FDA--we need
to have a Federal approach. And as we argue, let us not ban
them, let us not criminalize them, but let us strictly regulate
them and keep these intoxicating compounds out of the hands of
children.
Ms. Foxx. So, mention was made already of the 2018 Farm
Bill. With the passage of that bill, did Congress intend to
allow for the sale of intoxicants?
Mr. Miller. You know, when we were lobbying up on the Hill
for the 2018 Farm Bill, in 2014, for that matter, we said hemp
is not marijuana. Hemp is not intoxicating. And so, I do not
believe that that was the intent of Congress. But the language
got written as it was, and this loophole was found. And
frankly, as I mentioned earlier, it has really been a lifesaver
for many farmers who have struggled because of CBD lack of
regulation. We just need to get a hold of it. We need to
regulate it. We need to get it out of the hands of kids.
Ms. Foxx. So, do you believe intoxicants should be sold
under the farm bill?
Mr. Miller. I would like to see new legislation that would
put intoxicating cannabinoids under a stricter regulatory
regime, whether that be at FDA or, potentially, the TTB is
another possibility. But we look to Congress to try to make
sure that they are regulated in a way that will help keep them
away from kids.
Ms. Foxx. Thank you. And thank you, Madam Chair.
Mrs. McClain. Thank you.
I recognize myself for 5 minutes.
Thank you all again for being here. I really appreciate it.
I want to understand a little bit about regulation. Am I
assuming, Mr. Miller, without regulation from the FDA right
now, is there any way for the average consumer to verify the
ingredients?
Mr. Miller. As both Rich and I mentioned in our testimony,
there is a self-regulating organization called the U.S. Hemp
Authority that provides a certificate for manufacturers who go
through an intensive process of good manufacturing practices,
truth in labeling, and they put on the label----
Mrs. McClain. So, as consumers, we should look for that, so
that would be----
Mr. Miller. Yes, I would look for the U.S. Hemp Authority
label. Some states have also stepped into the breach and have
come up with good regulatory structure.
Mrs. McClain. If there is a consequence, meaning I have a
CBD product and I say it is X and it is less than X or,
unfortunately, more than X, whatever it may be, is there any
consequence to my action if I falsify what is in the
ingredients?
Mr. Miller. In some states, there is some regulatory
ability to do that, but the vast majority of products, there is
no enforcement.
Mrs. McClain. Not real enforcement, so to speak?
Mr. Miller. No.
Mrs. McClain. OK. I am curious how this has affected the
private sector's ability to participate in marketing a product
that was legalized in the 2018 Farm Bill.
Mr. Miller. I mean, it has devastated our industry, and it
has imposed tremendous burdens because of this lack of
regulatory authority.
Mrs. McClain. Hence, you showed us that slide at the very
beginning of the opening.
Mr. Miller. Right.
Mrs. McClain. The only one I think you said that was
profitable was the flower?
Mr. Miller. Yes. The flower that is converted into delta-8
THC, which we mentioned----
Mrs. McClain. And that is very dangerous, right?
Mr. Miller. It can be dangerous. Certainly, if it is
manufactured improperly and if it is sold to children.
Mrs. McClain. And there is no regulation on that as of
current?
Mr. Miller. No. No, regulation at all.
Mrs. McClain. OK. Has the FDA been receptive to efforts
from private sectors to have their products regulated?
Mr. Miller. No. The FDA meets with us--the industry about
once a year. They are always listening sessions, so we do the
talking and they do the listening.
Mrs. McClain. So, just to be clear, this is private
industry petitioning for more regulation?
Mr. Miller. Yes.
Mrs. McClain. I mean, that is like cats and dogs living
together.
Mr. Miller. I know. We are begging. We are begging.
Mrs. McClain. OK. Can you explain why regulations in this
instance would not help industry? If we did not regulate it,
would it help industry?
Mr. Miller. No, no. Regulation will help industry because
it would help stabilize the markets. These big box stores and
big food companies would start carrying their products, the
prices would go up, and it would give consumers a lot more
confidence that these products are safe. Right now, they are
taking a risk in buying them. So, regulation would be really
good for business, which----
Mrs. McClain. OK. So, it is good for business. It helps
protect children. It was instituted in the 2018 Farm Bill, yet
the FDA has slow-walked, maybe, not even at all, done any sort
of regulation on this?
Mr. Miller. Yes. They--oh, go ahead.
Mrs. McClain. Correct?
Mr. Miller. Correct.
Mrs. McClain. I just find that ironic that we give this
agency money, authority, and they cannot do their job. I would
love to come into work and say, you know what, if you just paid
me a little bit more, I will go to a few more hearings, I will
take a few more votes. It just does not work like that, right?
I am sure the average American would love to do that.
Do the job you were signed up to do. I mean, I am almost on
the opposite. I think we should start rescinding dollars until
people actually start doing the job they signed up to do, and
stop with the excuses. It drives me crazy.
I often wonder, Mr. Miller, I am just curious, it is my
understanding, and I could be wrong, that the FDA has not
returned to its pre-pandemic telework policy. Is that correct?
Mr. Miller. I am unaware of their policies.
Mrs. McClain. Anybody have any data on that?
The data I show is they have not returned back to work a
hundred percent.
Do you believe that the failure to work in person may be
contributing to this?
Mr. Miller. Yes, I would not comment because this has been
a running problem since before the pandemic hit.
Mrs. McClain. Yes. Perhaps if we just went back to work, we
would have more hours in the day to do the job that we signed
up to do.
What are the concrete steps that the FDA can immediately do
to engage--to take this more seriously? If you could have a
wish list, what could the FDA do right now?
Mr. Miller. Well, the first thing is they could immediately
start regulating these products as dietary supplements and food
and beverage additives.
Mrs. McClain. And they have the authority to do that?
Mr. Miller. We believe they have the authority to do that.
Mrs. McClain. I do too.
Mr. Miller. Now, they would like to have an additional set
of regulations on top of those, and we are not opposed to that.
And so, the next best thing they can do is to define, very
specifically, what that regulatory structure would look like,
so to aid Congress in developing a regulatory regime.
Mrs. McClain. Very good. Thank you, again. And I thank each
of you for being here today. I appreciate your insightful
testimony and expertise. Unfortunately, the government
bureaucracy appears to have gotten in the way of the American
hemp industry and consumer safety, the actual opposite of what
they were supposed to do.
To be clear, the industry wants regulation to inject
certainty into the market so good-faith businesses can prosper
and deliver high demand products to consumers. And we want this
opportunity to happen right here in the United s to benefit
growers and everyone else up and down the supply chain, all the
way to the end of consumers who consume the hemp product. It is
interesting to note that, even though the FDA has not approved
CBD products as dietary supplements or food additives 5 years
after the passage of the 2018 Farm Bill.
Mr. Miller, as he indicated in his testimony, the FDA also
has not engaged really in any meaningful enforcement actions
either. Again, wouldn't it be nice to just pick and choose what
you get to do every day? I would love that, just love it.
The FDA has not always been transparent or consistent in
their decision-making with the hemp industry either, and that
is unfortunate. And although FDA claims to have the available
safety data, it is limited. The fact is, is that there is data
available to regulators to actually make informed decisions
about labeling requirements, dosages, and other measures
necessary to actually ensure public safety.
There is rigorous scientific process that goes into the
toxicology testing and research that scientists like Dr.
Henderson and others have conducted. On top of that, the
research is peer-reviewed before it is published. FDA has
research data available to them to make appropriate decisions
under their existing authorities.
We have also heard from law enforcement professionals with
years of experience, like Mr. Badaracco, about the difficulties
consumers face in an unregulated market. Lack of FDA action has
left a market where dangers lurk for consumers who may receive
products altered with unlabeled substances or with wildly
inconsistent dosages.
And finally, Dr. Schauer enlightened us as to how it is
likely just the first step for the FDA. CBD is just one of many
derivatives of the cannabis plant, and the public needs the FDA
not to just start doing its job with respect to CBD, but
continue to be engaged in this emerging market for the benefit
of industry and consumers alike.
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 cannot do their job, maybe we should stop
funding them or funding them at reduced levels. Again, the
pathway already exists.
Once again, I truly want to thank you all for being here
today.
And with that, without objection, all Members will have 5
legislative days within which to submit materials, to submit
additional written questions for the witnesses which will be
forwarded to the witnesses for their responses.
If there is no further business, without objection, the
Subcommittee stands adjourned. And again, thank you, and have a
nice recess.
[Whereupon, at 3:50 p.m., the Subcommittee was adjourned.]