June 12, 2019Updated February 10, 2020
FDA Regulation of Cannabidiol (CBD) Consumer Products
Cannabidiol (CBD) is promoted as treatment for a range of
conditions, including epileptic seizures, post-traumatic
stress disorder, anxiety, and inflammation—despite limited
scientific anxiety, pain, inflammation, and posttraumatic stress disorder—despite limited scientific
evidence to substantiate or disprove many of these claims.
CBD is derived from the Cannabis sativa plant (commonly
referred to as cannabis), which includes both marijuana and
hemp. CBD and tetrahydrocannabinol (THC) are thought to
be the most abundant cannabinoids in cannabis. CBD is
considered to be nonpsychoactive and may be derived from
either hemp or marijuana. THC—a psychoactive
compound—is found at high levels in marijuana and low
levels in hemp. For additional information, see CRS
Reports R46189 and R44742.
Figure 1. Examples of Cannabis-Derived Products
Regulation of Cannabis: Overview
Botanically, marijuana and hemp are from the same species
of plant, Cannabis sativa, but from different varieties or
cultivars. Marijuana and hemp have separate definitions in
U.S. law and are subject to different statutory and
regulatory requirements. Marijuana (as defined in statute)
generally refers to the cultivated plant used as a
psychotropic drug, either for medicinal or recreational
purposes. It is a Schedule I controlled substance under the
Controlled Substances Act (CSA, 21 U.S.C. §§802 et seq.)
and is regulated by the Drug Enforcement Administration
(DEA). The unauthorized manufacture, distribution,
dispensation, and possession of marijuana is prohibited.
Despite the federal prohibition on growing, selling, or
possessing the drug, marijuana and marijuana-derived CBD
have been made available in states where medical and/or
recreational cannabis is allowed under state law. Hemp (as
defined in statute separately from marijuana) is generally
grown for broader (nonpsychotropic) purposes, including
for use in food, dietary supplements, fabrics and textiles,
and other industrial goods (see Figure 1).
Until December 2018, hemp was included in the CSA
definition of marijuana and was thus subject to the same
restrictions as marijuana. The Agriculture Improvement Act
of 2018 (2018 farm bill; P.L. 115-334) removed hemp and
its derivatives (including hemp-derived CBD) from the
CSA definition of marijuana. As a result, hemp is no longer
subject to regulation and oversight as a controlled substance
by DEA. Instead, hemp production is now subject to
regulation as an agricultural commodity bymany of these claims. In
the United States, CBD is marketed in food and beverages,
dietary supplements, and cosmetics—products that are
regulated by the Food and Drug Administration (FDA).
CBD is also the active ingredient in an FDA-approved
pharmaceutical drug, Epidiolex®. CBD is a plant-derived
substance from Cannabis sativa, the species of plant that
includes both hemp and marijuana, but from different plant
varieties or cultivars. CBD is the primary nonpsychoactive
compound in cannabis, whereas tetrahydrocannabinol
(THC) is cannabis’s primary psychoactive compound.
Regulation of CBD Products
Hemp and marijuana have separate definitions in U.S. law
and are subject to different statutory and regulatory
requirements. Marijuana is a Schedule I controlled
substance under the Controlled Substances Act (CSA, 21
U.S.C. §§802 et seq.) and is regulated by the Drug
Enforcement Administration (DEA). The unauthorized
manufacture, distribution, dispensation, and possession of
marijuana is prohibited. Marijuana-derived CBD is illegal
at the federal level, with the exception of use as an active
ingredient in the FDA-approved drug Epidiolex®. Despite
the federal prohibition on growing, selling, or possessing
the drug, marijuana-derived CBD that has not been
approved by FDA has been made available in states where
medical and/or recreational cannabis is legal under state
law. In some states, buying CBD may require obtaining a
medical cannabis prescription; elsewhere, CBD may be sold
only at a licensed dispensary. As a result of recent
legislative changes enacted in the 2018 farm bill
(Agriculture Improvement Act of 2018, P.L. 115-334),
hemp-derived CBD is not subject to regulation and
oversight as a controlled substance at the federal level.
Legislative Changes in the 2018 Farm Bill
Legislative changes related to hemp enacted as part of the
2018 farm bill were widely expected to generate additional
market opportunities for the U.S. hemp market. The 2018
farm bill removed longstanding federal restrictions on the
cultivation of hemp, making it no longer subject to
regulation and oversight as a controlled substance by the
DEA. Instead, hemp production is now subject to regulation
and oversight as an agricultural commodity under the U.S.
Department of Agriculture (USDA). The 2018 farm bill
also expanded the statutory definition of what constitutes
hemp to include “all derivatives, extracts, cannabinoids,
isomers, acids, salts, and salts of isomers,” as long as it
contains no more than a 0.3% concentration of delta-9 THC
(7 U.S.C. §1639o). All other cannabis is considered to be
marijuana under the CSA and remains regulated by DEA.
Some stakeholders expected that these changes would
eliminate one obstacle to production and marketing of hemp
and hemp-derived compounds, including CBD. However,
the farm bill explicitly preserved FDA’s authority under the
Federal Food, Drug and Cosmetic Act (FFDCA, 21 U.S.C.
§§301 et seq.) and Section 351 of the Public Health Service
Act (PHSA, 42 U.S.C. §262), including for hemp-derived
products. According to FDA, “because the 2018 Farm Bill
did not change FDA’s authorities, cannabis and cannabisderived CBD products that do not meet the
statutory definition of hemp continue to be prohibited (aside
from lawful use for research purposes) under the CSA and
remain regulated by DEA.
Notes: This figure was created by CRS to provide a high-level
illustration of the relationship between cannabis, marijuana, and
hemp, per the statutory distinction. As the figure shows, it is difficult
to discern between marijuana and hemp based on appearance.
Legislative changes related to hemp enacted as part of the
2018 farm bill were expected by many to generate market
opportunities for hemp-derived consumer products such as
hemp-derived CBD. However, the 2018 farm bill explicitly
preserved the Food and Drug Administration’s (FDA’s)
authority under the Federal Food, Drug and Cosmetic Act
(FFDCA, 21 U.S.C. §§301 et seq.), including for hempderived products. Because the 2018 farm bill did not change
FDA law, cannabis and cannabis-derived FDA-regulated
products are subject to the same authorities and
requirements as FDA-regulated products containing any
other substance, regardless of whether the products fall
within the definition of ‘hemp’ under the 2018 Farm Bill.”
(whether cannabis-derived or otherwise).
FDA Regulation of CBD Products
FDA, under the FFDCA, regulates many of the products
marketed as containing cannabis and cannabis-derived
compounds, including CBD. Hemp-derived CBD is
generallyCBD is marketed and sold as
an ingredient in food or
beverages, cosmetics, personal care products, and dietary
supplements. Epidiolex® is
CBD is also the active ingredient in the drug Epidiolex—
the first (and only) FDAapprovedFDA-approved prescription drug
formulation of highly purified,
marijuana-derived CBD in the United States.
the United States. As described below, FDA has determined
that at this time CBD cannot be added to any food that is
sold in interstate commerce and that CBD cannot be
marketed as a dietary supplement. FDA has not made
similar determinations for other FDA-regulated product
categories (e.g., pharmaceutical drugs, cosmetics).
https://crsreports.congress.gov
FDA Regulation of Cannabidiol (CBD) Consumer Products
Food and Food Additives
There are several provisions of the FFDCA that FDA
believes restrict the use of CBD in food and dietary
supplements. Under the FFDCA, it is a prohibited act to
introduce into interstate commerce a food to which has
been addedunlawful to introduce
into interstate commerce a food (human or animal) to which
a drug has been added—either an approved drug or a drug
for which
substantial clinical investigations have been
instituted and
made public (21 U.S.C. §331(ll)). There are several
several statutory exceptions to this: (1) if the
drug was marketed in food before approval as a drug or
before clinical investigations were instituted; (2) if the
Secretary has issued a regulation approving the use of such
drug in the food; (3) if the use of the drug in the food is to
enhance the safety of the food and not to have independent
biological or therapeutic effects on humans, and the use is
in conformity with specified requirements; or (4) if the drug
is a new animal drug whose use is not unsafe (21 U.S.C.
§331(ll)). FDA has concluded, based on available evidence,
that these exceptions do not apply to CBD. However,
according (e.g., if the Secretary has
issued a regulation approving the use of such drug in food).
However, FDA has concluded, based on available evidence,
that none of the statutory exceptions are the case for CBD,
and because CBD is an active ingredient in an approved
drug, FDA has taken the position that it is unlawful to
introduce into interstate commerce food containing added
CBD. In addition, independent of its status as a drug
ingredient, CBD has not been approved as a food additive.
Furthermore, according to FDA, based on a lack of
scientific information supporting its safety in food, the
agency cannot conclude that CBD is generally recognized
as safe (GRAS) for use in food.
According to FDA, cannabis-derived ingredients that do not
contain CBD (or THC) may fall outside the scope of thethis
prohibition in §331(ll). More specifically, foods containing
parts of the
hemp plant that include only trace amounts of
CBD (e.g.,
hemp seed and hemp-seed derived ingredients)
may be
lawfully marketed under certain circumstances—pursuant
pursuant to FDA approval as a food additive (by regulation)
or a
determination that the substance is generally
recognized as safe (GRAS)GRAS. FDA has not
approved hemp as
a food additive but has evaluated three
GRAS notices
related to hemp seed-derived ingredients
(hulled hemp
seeds, hemp seed protein, and hemp seed oil), allowing
allowing them to be added to human food under specified conditions.
https://crsreports.congress.gov
FDA Regulation of Cannabidiol (CBD) Products
The FFDCA expressly
conditions.
Dietary Supplements
The FFDCA excludes from the definition of a
dietary supplement a substance dietary
supplement an article that is an active ingredient
in an
approved drug, or a drug for which substantialthat has been authorized for investigation
as a new drug and for which the existence of such clinical
investigations have been instituted and made public, unless
the substance was marketed as a dietary supplement or food
before approval or before clinical investigations were
instituted. An exception to this is if FDA promulgates
regulations that use of such substance in a dietary
supplement is lawful (21 U.S.C. § 321(ff)(3)). Because
CBD is an active ingredient in an approved drug (i.e.,
Epidiolex®) and was the subject of clinical investigations
before it was marketed in food, FDA has determined that it
may not be marketed in or as a dietary supplement.
In a December 2018 statement, FDA stated that it is
“unlawful under the [FFDCA] to introduce food containing
added CBD or THC into interstate commerce, or to market
CBD or THC products as, or in, dietary supplements,
regardless of whether the substances are hemp-derived.”
The agency reiterated this view in an April 2019 statement.
In addition, since 2015, FDA has issued numerous warning
letters to firms marketing CBD products as dietary
supplements and making unsubstantiated therapeutic
claims. Pursuant to the FFDCA, if a product is
accompanied by claims implying that its intended use is the
cure, mitigation, treatment, or prevention of a disease, FDA
generally considers that product to be a drug and subject to
premarket approval. If a company has not obtained
approval of a drug prior to marketing, it is in violation of
the FFDCA. Thus, for a CBD product to make therapeutic
or disease-treating claims, whether hemp-derived or
otherwise, it must be approved by FDA for that use. While
FDA has issued warning letters to manufacturers of CBD
products marketed as dietary supplements for various
FFDCA violations, including for making unsubstantiated
claims, the agency has not yet taken enforcement action
against companies marketing CBD cosmetic products.
Some in Congress have asked FDA to clarify its position
regarding hemp-derived products, and FDA has established
a working group “to consider whether there are legislative
options that might lead to more efficient and appropriate
pathways than might be available under current law.” Some
states and local jurisdictions (e.g., Maine, New York, and
California) have decided to disallow the sale of hempderived CBD edible products, given concerns that hempderived CBD is not an FDA-approved food additive. Law
enforcement officials are also highlighting the need for
testing and sampling technologies and protocols to more
readily distinguish between hemp and marijuana.
CBD Market in the United States
From an industry perspective, there are three markets for
CBD: hemp-derived CBD, marijuana-derived CBD
(currently a Schedule I controlled substance), and
pharmaceutical CBD (currently only Epidiolex®). In 2018,
CBD sales in the United States from all three markets were
estimated at $534 million, according to the Hemp Business
Journal (Figure 1). More than 1,000 companies produced
and marketed CBD for the U.S. market. Compared to 2014,
when total CBD sales were a reported $108 million, U.S.
sales of CBD have risen fivefold. This same source projects
U.S. sales of CBD will exceed $1 billion in 2020 and reach
nearly $2 billion in 2022, divided about evenly among the
three markets. At the retail level, CBD is marketed in a
range of foods and beverages, dietary supplements, and
cosmetic and personal care products, some of which are
now being sold by large retailers such as CVS Pharmacy
and Walgreens.
Figure 1. Total U.S. CBD Sales, by Channel
Source: Hemp Business Journal, The CBD Report: 2018 Industry
Outlook, 2019 (New Frontier Data). All pharmaceutical channel sales
are represented by the drug Epidiolex®.
Considerations for Congress
While the 2018 farm bill removed hemp and its derivatives
from the definition of marijuana in the CSA, several
obstacles may limit the marketing of hemp and its
derivatives, including CBD, particularly in FDA-regulated
products. One obstacle is that these products remain subject
to the FFDCA, and FDA has determined that it is unlawful
to introduce food containing added CBD into interstate
commerce, or to market CBD products as, or in, dietary
supplements. While FDA can initiate rulemaking to
approve the use of CBD in food or to allow its use in
dietary supplements, former FDA Commissioner Gottlieb
has stated that because rulemaking is often a “long process”
and given the complexity of this issue, a legislative fix may
be a more efficient option. Congress could, for example,
allow for CBD in dietary supplements in specific
concentrations. However, one consideration in determining
whether a legislative fix is appropriate is the potential for
adverse health effects. Dietary supplements are not
evaluated by FDA for safety and effectiveness prior to
marketing, and clinical trials to support approval of
Epidiolex® have demonstrated the potential for liver injury.
Questions also remain regarding the therapeutic benefits of
CBD; to date, FDA has approved one CBD drug product.
Per FDA, “any product intended to have a therapeutic or
medical use, and any product (other than a food) that is
intended to affect the structure or function of the body of
humans or animals, is a drug.” CBD is marketed in a range
of FDA-regulated products, and because there are so many
of these products on the market, FDA has focused its
enforcement priorities on those companies and products
that pose the greatest risk to consumers. Despite continued
promotion and sales of CBD—whether hemp- or
marijuana-derived—as treatment for a range of conditions,
there remains considerable regulatory and legal uncertainty
in the U.S. CBD market.
Agata Dabrowska, Analyst in Health Policy
https://crsreports.congress.gov
FDA Regulation of Cannabidiol (CBD) has been made public. An exception to this is
if FDA issues a regulation finding that the use of such
article in a dietary supplement is lawful. An article that is
approved as a drug or being investigated as a drug may be
marketed in or as a dietary supplement if it was marketed as
a dietary supplement or as a food prior to its approval or
clinical investigation (21 U.S.C. §321(ff)(3)). Because CBD
is an active ingredient in an approved drug (i.e., Epidiolex)
and was the subject of clinical investigations before it was
marketed in food, FDA has determined that CBD may not
be marketed in or as a dietary supplement.
Other FDA-Regulated Products
FDA has not determined that CBD may not be added to
cosmetics, provided therapeutic claims are not made and
that the product is not otherwise adulterated or misbranded.
In addition, CBD may be lawfully marketed as a drug,
pursuant to FDA approval and in compliance with
applicable statutory and regulatory requirements. If a firm
seeks to market CBD as a treatment or an otherwise
therapeutic product, the firm generally would need to obtain
premarket approval from FDA via the new drug approval
pathway. To date, FDA has approved one CBD-containing
drug—GW Pharmaceuticals’ Epidiolex—which is available
by prescription for the treatment of seizures associated with
Lennox-Gastaut syndrome or Dravet syndrome in patients
two years old and older. In general, if a product claims that
its intended use is to cure, mitigate, treat, or prevent a
disease, FDA considers that product to be a drug and
subject to premarket approval. Thus, for a CBD product to
make therapeutic claims, whether hemp-derived or
otherwise, it must be approved by FDA for that use.
CBD Market in the United States
From an industry perspective, there are three markets for
CBD: hemp-derived CBD, marijuana-derived CBD (a
Schedule I controlled substance), and pharmaceutical CBD
(only Epidiolex). In 2014, total U.S. CBD sales were a
reported $108 million. In 2018, more than 1,000 companies
produced and marketed CBD for the U.S. market, and U.S.
CBD sales were estimated at $534 million, according to the
Hemp Business Journal. That dollar amount is projected to
exceed $1 billion in 2020 and to reach nearly $2 billion in
2022. Although some industry analysts foresee a strong
market for marijuana-derived CBD, it remains prohibited
(aside for lawful research purposes) under the CSA if the
product does not meet the statutory definition of hemp in 7
U.S.C. §1639o. At the retail level, consumer products
labeled as containing CBD are being sold in food and
beverages, dietary supplements, and other product
categories—despite FDA’s position that CBD may not be
sold in food and beverages or dietary supplements.
Considerations for Congress
Some Members of Congress have expressed support for a
regulatory framework for hemp-derived CBD in certain
FDA-regulated products. Although FDA could issue a
regulation allowing CBD to be added to food or allowing its
use in dietary supplements, the agency has never issued
such a regulation for any drug (whether cannabis-derived or
not). In absence of such a framework, Congress has
directed FDA to undertake various activities related to
hemp-derived CBD, including to issue a policy of
enforcement discretion with respect to CBD products that
meet the statutory definition of hemp that also come under
FDA jurisdiction. In addition, legislation has been
introduced in the 116th Congress that would amend those
FFDCA provisions that FDA has identified as restricting
marketing of CBD in food and dietary supplements.
Questions remain regarding the therapeutic benefits of
CBD. To date, FDA has approved one CBD drug product—
Epidiolex—but the mechanism by which the drug exerts its
anticonvulsant effects is not known. Clinical trials to
support the approval of Epidiolex demonstrated the
potential for liver injury at certain doses, and CBD may
interact with other drugs or dietary supplements. Other
concerns include the potential dosing and cumulative
effects of exposure to CBD from multiple sources (e.g.,
supplements and cosmetics); whether there are populations
for whom CBD is not appropriate (e.g., pregnant women);
and whether allowing CBD to be marketed as a supplement
or food could undermine incentives for conducting clinical
trials and obtaining evidence to support drug approval.
Agata Dabrowska, Analyst in Health Policy
https://crsreports.congress.gov
FDA Regulation of Cannabidiol (CBD) Consumer Products
IF11250
Renée Johnson, Specialist in Agricultural Policy
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https://crsreports.congress.gov | IF11250 · VERSION 1 · NEW3 · UPDATED