FDA’s Oversight of Hemp-Derived Compounds

FDA’s Oversight of Hemp-Derived Compounds

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August 18, 2023
FDA’s Oversight of Hemp-Derived Compounds
In January 2023, the Food and Drug Administration (FDA)
cannabinoids. USDA reports that the farm-level value of all
issued a statement that the agency would “work with
hemp flower production totaled $204 million in 2022, down
Congress” to develop “a new regulatory pathway” for
from $687 million in 2021 (Table 1). Estimates of the retail
cannabidiol (CBD), a hemp-based cannabinoid. This action
value of hemp-derived cannabinoids vary but likely exceed
followed years of FDA review by a high-level internal
$2 billion annually in the United States.
working group related to the regulation of CBD products. In
July 2023, several Members of Congress issued a Request
Table 1. U.S. Hemp Production by Market, 2021-2022
for Information (RFI) soliciting stakeholders on how to
2021
2022
Change
“
Production Type and
provide a legal pathway” for marketing CBD products.
Market Segment
Some in Congress have continued to introduce legislation
($mil ion)
(percentage)
that would allow for the use of hemp-derived CBD and
Hemp Production in Outdoor Open Field
related substances in dietary supplements and as a food
Floral hemp
623.0
179.0
(71%)
additive. This issue, or aspects of it, could be debated as
Congress considers reauthorization of the next farm bill.
Hemp grains
6.0
3.6
(40%)
Hemp fiber
41.4
28.3
(32%)
Background
Hemp seed
41.5
1.5
(96%)
The Agriculture Improvement Act of 2018 (P.L. 115-334;
2018 farm bill) removed long-standing federal restrictions
Subtotal
711.9
212.4
(70%)
on the cultivation of hemp. Following the 2018 farm bill,
Hemp Production Under Protection
hemp is now an agricultural crop regulated by the U.S.
Floral hemp
64.4
24.7
(62%)
Department of Agriculture (USDA) under the Domestic
Hemp Production Program (7 U.S.C. §1639(o)-(r); 7 C.F.R.
Hemp seed
23.7
0.6
(98%)
§990). The 2018 farm bill, however, explicitly preserved
Clones/Transplants
23.8
0.7
(97%)
the authority of the Food and Drug Administration (FDA)
Subtotal
111.9
26.1
(77%)
under the Federal Food, Drug, and Cosmetic Act (FFDCA;
21 U.S.C. §§301 et seq.) related to hemp-based products
Total Farm-Level Value
823.8
238.4
(71%)
such as CBD and other hemp-derived cannabinoids that
Planted Acres (all uses)
54,152
28,314
(48%)
may be used as an ingredient in food and some consumer
Source: CRS from USDA’s 2021 and 2022 National Hemp Report,
products. Immediately after enactment of the 2018 farm
https://www.nass.usda.gov/Surveys/Guide_to_NASS_Surveys/Hemp/.
bill, FDA stated that it is “unlawful” under FFDCA to
introduce food containing added cannabinoids into
Hemp-Derived Cannabinoids
interstate commerce, or to market such products as (or in)
Botanically, hemp is from the plant species Cannabis
dietary supplements, “regardless of whether the substances
sativa—the same plant as marijuana—but from different
are hemp-derived.” Although FDA has continued to
varieties or cultivars and grown for non-psychoactive
maintain that it is unlawful to add hemp-derived
purposes. Cannabinoids refer to the unique chemical
cannabinoids to food or to market cannabinoids including
compounds produced in the cannabis plant (both hemp and
CBD as an ingredient in food and beverages or as a dietary
marijuana). There are more than 100 cannabinoids in the
supplement, consumer products containing these
cannabis plant. These compounds exist in varying amounts
compounds continue to be marketed in violation of FDA’s
in the cannabis plant and are known to exhibit a range of
determination. Hemp Business Daily reports there were
psychological and physiological effects. The two most well-
more than 3,000 known hemp-derived CBD brands in 2020.
researched and abundant cannabinoids in the cannabis plant
are tetrahydrocannabinol (THC) and CBD. THC is the
Some claim that the lack of a federal regulatory framework
primary psychoactive compound; some THC variants and
for hemp-derived compounds has contributed, in part, to
isomers (such as delta-8 THC) are known intoxicants.
disruption of the U.S. hemp market, leading to both lower
Certain other cannabinoids, notably CBD, are not
prices received by growers and subsequent production
considered to be psychoactive. Still other cannabinoids, as
declines. USDA reports that the farm-level value of hemp
well as their interactions with THC, have not been
sales and planted acres declined sharply between 2021 and
extensively researched. More background is available in
2022. This decline spans all production types (i.e., grown in
CRS Report R44742, Defining Hemp: A Fact Sheet.
the open field or under protection, such as in a greenhouse)
and all market segments (i.e., hemp flower, grain, seed, and
FDA’s Review of Cannabis Compounds
fiber). Losses were pronounced in the hemp flower market,
In May 2019, FDA conducted a public hearing and initiated
which is the source of most hemp-based derivatives and
its formal review “to obtain scientific data and information
compounds such as hemp-derived CBD and other
about the safety, manufacturing, product quality, marketing,
https://crsreports.congress.gov

FDA’s Oversight of Hemp-Derived Compounds
labeling, and sale of products containing cannabis or
minimize risks related to CBD products” such as through
cannabis-derived compounds” (84 Federal Register 12969;
clear product labeling, prevention of contaminants, content
Docket No: FDA-2019-N-1482). FDA’s docket contains
limits, and control measures (e.g., minimum purchase age
roughly 4,300 public comments and submitted materials.
to “mitigate the risk of ingestion by children”). A new
Currently, the only FDA-approved use of CBD as a
regulatory pathway could also provide access and oversight
pharmaceutical drug that contains an active ingredient
of certain CBD-containing products for animals such as
derived from cannabis is Epidiolex, which is medically
domesticated pets and food-producing animals. Current
prescribed to treat seizures associated with rare and severe
FDA safety standards for dietary supplements require that
forms of epilepsy. More background on FDA requirements
products are “reasonably expected to be safe” while the
related to the use of hemp-derived compounds as an
safety standards for food ingredients require products to
ingredient in food, dietary supplements, and other consumer
have “reasonable certainty of no harm.”
products is available in CRS Report R46189, FDA
Regulation of Cannabidiol (CBD) Consumer Products:
Selected FDA Statements on the Safety of Hemp-Derived CBD
Overview and Considerations for Congress.
and Other Cannabinoids
FDA has conducted a series of cannabinoid-related
Fol owing are selected excerpts from FDA’s statements, various
activities since initiating its review in 2019, as documented
agency warning letters, and consumer safety announcements.
on the agency’s websites related to cannabis. FDA has
• “The use of CBD raises various safety concerns, especial y with long-
continued to issue warning letters to companies for illegally
term use. Studies have shown the potential for harm to the liver,
selling CBD products or food and beverage products that
interactions with certain medications and possible harm to the male
contain CBD; for selling such products for advertised uses
reproductive system. CBD exposure is also concerning when it comes
such as pain relief, to treat medical conditions, or opioid
to certain vulnerable populations such as children and those who are
addiction; or for use in food-producing animals. FDA has
pregnant” and “poses risks to animals, and people could be
also issued warning letters to companies illegally selling
unknowingly exposed to CBD through meat, milk and eggs from
delta-8 THC products. Both FDA and the Federal Trade
animals fed CBD.”
Commission (FTC) have issued warnings to companies for
• “… CBD products that are especial y concerning from a public health
illegally selling certain copycat food products containing
perspective due to the route of administration, including nasal,
delta-8 THC that are misleading to consumers, since they
ophthalmic and inhalation.”
are packaged to mimic popular brands like Doritos and
• “… there have been numerous poison control center alerts involving
Jolly Rancher. FDA also has issued warnings to consumers
pediatric patients who were exposed to delta-8 THC-containing
about the accidental ingestion by children of food products
products” and “animal poison control centers have indicated a sharp
containing THC and other cannabinoid-containing products.
overal increase in accidental exposure of pets to these products.”
FDA has continued to conduct its scientific data and
Source: CRS from various FDA press releases. For more on the
information review of products containing cannabis or
potential safety risks, see CRS Report R46189, FDA Regulation of
cannabis-derived compounds, including hemp-based
Cannabidiol (CBD) Consumer Products: Overview and Considerations for
compounds. FDA and its science advisory committee have
Congress.
compiled documentation and conducted literature reviews
on the safety of ingesting cannabinoid-containing products,
Recent Congressional Actions
including gender differences in use and response. FDA also
The 118th Congress has continued to consider legislation
has issued industry guidance for clinical research. FDA has
that would allow hemp-derived CBD and hemp-derived
responded to Generally Recognized as Safe (GRAS) notices
CBD-containing substances to be marketed as dietary
for hemp seed-derived ingredients for use in human food
supplements or food additives (e.g., H.R. 4849/S. 2451,
and beverages, covering hulled hemp seed (GRN765),
H.R. 1628, H.R. 1629). In addition, the Subcommittee on
hemp seed protein powder (GRN771), and hemp seed oil
Health Care and Financial Services of the House
(GRN778). FDA has rejected citizen petitions that would
Committee on Oversight and Accountability held a hearing
allow CBD products to be marketed as dietary supplements.
in July 2023 titled “Hemp in the Modern World: The
FDA continues to review petitions for hemp seedcake and
Yearslong Wait for FDA Action,” which examined FDA’s
meal for use as an animal feed ingredient. FDA claims data
oversight of hemp and hemp CBD products.
is needed to help ensure ingredients derived from hemp are
safe for use in feed for food-producing animals.
In July 2023, several Members of Congress and leadership
of the House Energy and Commerce and Senate Health,
In January 2023, FDA concluded that “existing regulatory
Education, Labor, and Pensions (HELP) Committees issued
frameworks for foods and supplements are not appropriate”
a bicameral RFI on FDA’s regulation of CBD. The RFI
for CBD, referring the issue to the U.S. Congress. FDA
solicits stakeholders on how to provide a “legal pathway to
stated that the agency’s “existing foods and dietary
market for CBD products,” including other cannabinoid-
supplement authorities provide only limited tools for
containing hemp products. The RFI’s questions for
managing many of the risks associated with CBD products”
stakeholders span market dynamics; regulatory pathways
and that “under the law, any substance, including CBD,
and scope; federal-state regulatory and enforcement
must meet specific safety standards to be lawfully marketed
interactions; public safety and risk; consumer protections
as a dietary supplement or food additive.” FDA stated “a
and quality controls; and questions related to product form,
new regulatory pathway would benefit consumers by
packaging, accessibility, and labeling.
providing safeguards and oversight to manage and
Renée Johnson, Specialist in Agricultural Policy
https://crsreports.congress.gov

FDA’s Oversight of Hemp-Derived Compounds

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