Hemp-Derived Cannabidiol (CBD) and Related Hemp Extracts

Hemp-Derived Cannabidiol (CBD) and Related Hemp Extracts

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Updated June 21, 2019
Hemp-Derived Cannabidiol (CBD) and Related Hemp Extracts
Cannabidiol (CBD) is a plant-derived compound from
through a variety of channels, including specialty retailers
Cannabis sativa, the species of plant that includes both
(e.g., natural grocery stores, tobacco shops, yoga studios),
hemp and marijuana, but from different plant varieties or
direct-to-consumer online sales, farmers’ markets, herbal
cultivars. CBD is the primary nonpsychoactive compound
practitioners, and large retailers.
in cannabis, whereas tetrahydrocannabinol (THC) is
cannabis’s primary psychoactive compound.
Figure 1. U.S. Hemp-Based Product Sales, 2017
CBD is
promoted as treatment for a range of conditions—including
epileptic seizures, post-traumatic stress disorder, anxiety,
and inflammation—despite limited scientific evidence to
substantiate many of these claims. In the United States,
CBD is marketed in a range of consumer products—food
and beverages, dietary supplements, personal care products,
and cosmetics—subject to regulation by the Food and Drug
Administration (FDA). Consumer products containing
plant-based CBD are either hemp- or marijuana-derived.
Market for Hemp-Derived CBD
The 2018 farm bill (Agriculture Improvement Act of 2018,
P.L. 115-334) included a number of provisions intended to
facilitate the commercial cultivation, processing, marketing,
and sale of hemp in the United States, expanding on
policies enacted in the previous farm bill. It expanded the

statutory definition of what constitutes hemp to include:
Source: Hemp Business Journal estimates. Percent of gross revenues.
Figure 2. Hemp-Derived Supplement Market, 2018
the plant Cannabis sativa L. and any part of that
plant, including the seeds thereof and all
derivatives, extracts, cannabinoids, isomers, acids,
salts, and salts of isomers, whether growing or not,
with a delta-9 tetrahydrocannabinol [delta-9 THC]
concentration of not more than 0.3 percent on a dry
weight basis. (7 U.S.C. §1639o)
The 2018 farm bill also amended U.S. drug laws to remove
longstanding federal restrictions on cultivation of hemp,
excluding it from regulation and oversight as a controlled
substance by the U.S. Drug Enforcement Administration
(DEA). Hemp production is now subject to regulation and
oversight as an agricultural commodity by the U.S.
Department of Agriculture (USDA).
Cannabis not defined as hemp is considered to be
marijuana under the Controlled Substances Act (CSA, 21

U.S.C. §§801 et seq.) and remains regulated by DEA.
Source: Brightfield Group, Hemp-Derived CBD, September 2018.
Percent of gross revenues.
Changes enacted in the 2018 farm bill related to hemp were
widely expected to generate additional market opportunities
Hemp-derived CBD sales account for about one-fourth of
for the U.S. hemp market. As an agricultural commodity,
the total U.S. annual hemp market sales (Figure 1.). The
hemp is cultivated for use in the production of a wide range
Hemp Business Journal reports that hemp-derived CBD
of consumer and industrial products, including food,
sales in the United States totaled $240 million in 2018, up
personal care products, textiles, paper, and construction
from $59 million in 2014. This same source projects the
materials (Figure 1). Perhaps the fastest-growing market
U.S. market for hemp-derived CBD products will reach
for hemp is for hemp-derived CBD and related hemp
$647 million by 2022. Others project even higher sales. For
extracts. Following changes in the 2018 farm bill, hemp
example, the Nielsen Company predicts the U.S. hemp-
was widely expected to become the dominant means to
derived CBD market (including sales of food and beverage
source CBD for use in a range of consumer products,
products containing CBD) could reach $6 billion annually
including foods, beverages, cosmetics, topical creams, and
by 2025, and the Brightfield Group predicts the hemp-
dietary supplements. Hemp-derived CBD supplements are
derived CBD market could reach $22 billion by 2022.
marketed in a variety of products (Figure 2) and sold
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Hemp-Derived Cannabidiol (CBD) and Related Hemp Extracts
Continued Regulatory Uncertainty
Other industry concerns involve products marketed as
Despite continued promotion and sales of CBD—whether
hemp-derived CBD that are produced from pressed hemp
hemp- or marijuana-derived—as treatment for a range of
seeds, and not the hemp flower, resulting in a product with
conditions, there remains regulatory uncertainty in the U.S.
low CBD levels. The cannabis plant’s cannabinoids are
CBD market. The 2018 farm bill explicitly preserved
mostly concentrated in the flowering head of the plant,
FDA’s authority to regulate cannabis and cannabis-derived
where the plant’s trichomes tend to be located. Trichomes
compounds under the Federal Food, Drug, and Cosmetic
are the small resin-like hairs/glands of the flowering buds,
Act (FFDCA, 21 U.S.C. §§301 et seq.) and other FDA
but may also cover the leaves, bracts, and stems of plants.
laws. FDA is responsible for oversight and regulation of
Cannabinoids may be present in other parts of the plant,
certain consumer products containing CBD (e.g., food,
including the seeds, but in lower quantities.
dietary supplements, cosmetics). FDA has stated it is
“unlawful” under the FFDCA to introduce food containing
Some claim there may be public health and safety risks
added CBD into interstate commerce, or to market CBD
associated with any cannabis extraction, given that cannabis
products as or in dietary supplements, regardless of whether
tends to bioaccumulate toxins in the soil. Contamination
derived from hemp, in part because CBD is an active
also depends on how the plant is produced and the types of
ingredient in an approved drug (i.e., Epidiolex®). FDA is
production inputs used. Contamination risks include the
reviewing its CBD policy and related product safety issues.
possible presence of metals, chemicals, pesticides, and
(See CRS In Focus IF11250, FDA Regulation of
other adulterants, as well as residual solvents depending on
Cannabidiol (CBD) Products.)
how compounds in the plant are extracted. CBD is extracted
from the cannabis plant using a variety of methods,
Over the past few years, FDA has issued warning letters to
including lipid or alcohol/ethanol infusions, CO2 extraction,
numerous manufacturers of cannabis-derived CBD products
and extractions using chemical solvents (such as hexane,
marketed as dietary supplements. In the letters, the agency
butane), as well as solvent-free extractions. The lack of
has cited several FFDCA violations, including that upon
production and processing standards in the CBD industry
testing the chemical content of the products, several did not
heightens concerns about product safety and quality.
contain CBD levels claimed on the label. Studies by
independent researchers have corroborated these concerns,
Considerations for Congress
with laboratory tests showing that CBD products in the U.S.
To address safety and quality concerns, many commenters
market may contain CBD levels that differ from what is
at FDA’s May 2019 public hearing on CBD expressed the
indicated on the label. For example, a study by researchers
need for the agency to actively regulate CBD and enforce
at the University of Pennsylvania found that nearly 70% of
relevant FFDCA violations. Some in the hemp industry are
online CBD products tested contained CBD levels that were
advocating for developing and implementing labeling and
either lower or higher than indicated on the label. Tests also
manufacturing standards specific to hemp-derived CBD,
indicate that some CBD products contain harmful
including product certification, operating procedures, and
contaminants. A study by researchers at Virginia
recordkeeping consistent with Current Good Manufacturing
Commonwealth University found that some products
Practice regulations for dietary supplements that are
contained such contaminants, including compounds found
enforced by FDA. Congress could also direct FDA to
in illegal synthetic cannabis products.
develop industry guidance for hemp-derived CBD,
representing the agency’s current thinking on how the
Hemp’s Potential for Sourcing CBD
industry can best comply with applicable laws and
Within the CBD industry, some have raised quality and
regulations. In addition, most agriculture-based groups
safety concerns about sourcing CBD from hemp. Some
advocate for federally supported hemp research. Such
claim hemp-derived CBD is less preferable to deriving
actions could support the safe and orderly marketing of
CBD from marijuana. Hemp flowers are often smaller in
hemp-derived CBD and related hemp-derived products.
size and contain less resin than marijuana flowers, and may
contain lower amounts of cannabinoids. Cannabinoids are
Many in the hemp industry advocate for relaxing the
the many chemical compounds produced in cannabis—
statutory threshold for hemp. Some consider the 0.3% THC
including CBD and THC—that are associated with bringing
threshold definition to be arbitrary and without a clear
about certain psychological and physiological effects. Some
scientific basis, despite its established use. Amending the
claim hemp’s statutory threshold requiring THC
statutory definition for hemp could increase the types of
concentrations of no more than 0.3% may limit the presence
CBD product formulations available to hemp producers,
of, and possible positive interactive effects between, CBD
and allow them to compete with other CBD products
and other cannabinoids (including THC) that may be
formulated from cannabis strains with THC concentrations
present in the cannabis plant. The hemp plant’s genetics and
above 0.3%. Prior legislation has proposed alternative
the presence of other plant compounds may influence
thresholds. For example, H.R. 3530 (115th Congress)
cannabinoid volumes in the hemp flower. While illegal at
proposed to define research hemp as having a delta-9 THC
the federal level, CBD products marketed and sold in states
concentration of less than 0.6%. Raising hemp’s statutory
with legalized medical and/or recreational marijuana tend to
threshold might also simplify enforcement, as it is difficult
be formulated from cannabis with THC concentrations
to measure THC concentrations at current regulated levels.
generally ranging from 0.45% to 1.5%. Some CBD
products in the market contain even greater THC levels.
Renée Johnson, Specialist in Agricultural Policy
IF10391
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Hemp-Derived Cannabidiol (CBD) and Related Hemp Extracts

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