FDA Regulation of Cannabidiol (CBD) Consumer Products

FDA Regulation of Cannabidiol (CBD) Consumer Products

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Updated February 10, 2020
FDA Regulation of Cannabidiol (CBD) Consumer Products
Cannabidiol (CBD) is promoted as treatment for a range of
Figure 1. Examples of Cannabis-Derived Products
conditions, including anxiety, pain, inflammation, and post-
traumatic 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.
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
Notes: This figure was created by CRS to provide a high-level
il ustration of the relationship between cannabis, marijuana, and
psychotropic drug, either for medicinal or recreational
hemp, per the statutory distinction. As the figure shows, it is difficult
purposes. It is a Schedule I controlled substance under the
to discern between marijuana and hemp based on appearance.
Controlled Substances Act (CSA, 21 U.S.C. §§802 et seq.)
and is regulated by the Drug Enforcement Administration
Legislative changes related to hemp enacted as part of the
(DEA). The unauthorized manufacture, distribution,
2018 farm bill were expected by many to generate market
dispensation, and possession of marijuana is prohibited.
opportunities for hemp-derived consumer products such as
Despite the federal prohibition on growing, selling, or
hemp-derived CBD. However, the 2018 farm bill explicitly
possessing the drug, marijuana and marijuana-derived CBD
preserved the Food and Drug Administration’s (FDA’s)
have been made available in states where medical and/or
authority under the Federal Food, Drug and Cosmetic Act
recreational cannabis is allowed under state law. Hemp (as
(FFDCA, 21 U.S.C. §§301 et seq.), including for hemp-
defined in statute separately from marijuana) is generally
derived products. Because the 2018 farm bill did not change
grown for broader (nonpsychotropic) purposes, including
FDA law, cannabis and cannabis-derived FDA-regulated
for use in food, dietary supplements, fabrics and textiles,
products are subject to the same authorities and
and other industrial goods (see Figure 1).
requirements as FDA-regulated products containing any
other substance (whether cannabis-derived or otherwise).
Until December 2018, hemp was included in the CSA
FDA Regulation of CBD Products
definition of marijuana and was thus subject to the same
restrictions as marijuana. The Agriculture Improvement Act
FDA, under the FFDCA, regulates many of the products
of 2018 (2018 farm bill; P.L. 115-334) removed hemp and
marketed as containing cannabis and cannabis-derived
its derivatives (including hemp-derived CBD) from the
compounds, including CBD. CBD is marketed and sold as
CSA definition of marijuana. As a result, hemp is no longer
an ingredient in food, cosmetics, and dietary supplements.
subject to regulation and oversight as a controlled substance
CBD is also the active ingredient in the drug Epidiolex—
by DEA. Instead, hemp production is now subject to
the first (and only) FDA-approved prescription drug
regulation as an agricultural commodity by the U.S.
formulation of highly purified, marijuana-derived CBD in
Department of Agriculture (USDA). The 2018 farm bill
the United States. As described below, FDA has determined
also expanded the statutory definition of what constitutes
that at this time CBD cannot be added to any food that is
hemp to include “all derivatives, extracts, cannabinoids,
sold in interstate commerce and that CBD cannot be
isomers, acids, salts, and salts of isomers,” as long as it
marketed as a dietary supplement. FDA has not made
contains no more than a 0.3% concentration of delta-9 THC
similar determinations for other FDA-regulated product
(7 U.S.C. §1639o). CBD products that do not meet the
categories (e.g., pharmaceutical drugs, cosmetics).
statutory definition of hemp continue to be prohibited (aside
from lawful use for research purposes) under the CSA and
remain regulated by DEA.
https://crsreports.congress.gov

FDA Regulation of Cannabidiol (CBD) Consumer Products
Food and Food Additives
pathway. To date, FDA has approved one CBD-containing
There are several provisions of the FFDCA that FDA
drug—GW Pharmaceuticals’ Epidiolex—which is available
believes restrict the use of CBD in food and dietary
by prescription for the treatment of seizures associated with
supplements. Under the FFDCA, it is unlawful to introduce
Lennox-Gastaut syndrome or Dravet syndrome in patients
into interstate commerce a food (human or animal) to which
two years old and older. In general, if a product claims that
a drug has been added—either an approved drug or a drug
its intended use is to cure, mitigate, treat, or prevent a
for which substantial clinical investigations have been
disease, FDA considers that product to be a drug and
instituted and made public (21 U.S.C. §331(ll)). There are
subject to premarket approval. Thus, for a CBD product to
several statutory exceptions to this (e.g., if the Secretary has
make therapeutic claims, whether hemp-derived or
issued a regulation approving the use of such drug in food).
otherwise, it must be approved by FDA for that use.
However, FDA has concluded, based on available evidence,
that none of the statutory exceptions are the case for CBD,
CBD Market in the United States
and because CBD is an active ingredient in an approved
From an industry perspective, there are three markets for
drug, FDA has taken the position that it is unlawful to
CBD: hemp-derived CBD, marijuana-derived CBD (a
introduce into interstate commerce food containing added
Schedule I controlled substance), and pharmaceutical CBD
CBD. In addition, independent of its status as a drug
(only Epidiolex). In 2014, total U.S. CBD sales were a
ingredient, CBD has not been approved as a food additive.
reported $108 million. In 2018, more than 1,000 companies
Furthermore, according to FDA, based on a lack of
produced and marketed CBD for the U.S. market, and U.S.
scientific information supporting its safety in food, the
CBD sales were estimated at $534 million, according to the
agency cannot conclude that CBD is generally recognized
Hemp Business Journal. That dollar amount is projected to
as safe (GRAS) for use in food.
exceed $1 billion in 2020 and to reach nearly $2 billion in
2022. Although some industry analysts foresee a strong
According to FDA, cannabis-derived ingredients that do not
market for marijuana-derived CBD, it remains prohibited
contain CBD (or THC) may fall outside the scope of this
(aside for lawful research purposes) under the CSA if the
prohibition. More specifically, foods containing parts of the
product does not meet the statutory definition of hemp in 7
hemp plant that include only trace amounts of CBD (e.g.,
U.S.C. §1639o. At the retail level, consumer products
hemp seed and hemp-seed derived ingredients) may be
labeled as containing CBD are being sold in food and
lawfully marketed under certain circumstances—pursuant
beverages, dietary supplements, and other product
to FDA approval as a food additive (by regulation) or a
categories—despite FDA’s position that CBD may not be
determination that the substance is GRAS. FDA has not
sold in food and beverages or dietary supplements.
approved hemp as a food additive but has evaluated three
GRAS notices related to hemp seed-derived ingredients
Considerations for Congress
(hulled hemp seeds, hemp seed protein, and hemp seed oil),
Some Members of Congress have expressed support for a
allowing them to be added to human food under specified
regulatory framework for hemp-derived CBD in certain
conditions.
FDA-regulated products. Although FDA could issue a
regulation allowing CBD to be added to food or allowing its
Dietary Supplements
use in dietary supplements, the agency has never issued
The FFDCA excludes from the definition of a dietary
such a regulation for any drug (whether cannabis-derived or
supplement an article that is an active ingredient in an
not). In absence of such a framework, Congress has
approved drug, or that has been authorized for investigation
directed FDA to undertake various activities related to
as a new drug and for which the existence of such clinical
hemp-derived CBD, including to issue a policy of
investigations has been made public. An exception to this is
enforcement discretion with respect to CBD products that
if FDA issues a regulation finding that the use of such
meet the statutory definition of hemp that also come under
article in a dietary supplement is lawful. An article that is
FDA jurisdiction. In addition, legislation has been
approved as a drug or being investigated as a drug may be
introduced in the 116th Congress that would amend those
marketed in or as a dietary supplement if it was marketed as
FFDCA provisions that FDA has identified as restricting
a dietary supplement or as a food prior to its approval or
marketing of CBD in food and dietary supplements.
clinical investigation (21 U.S.C. §321(ff)(3)). Because CBD
Questions remain regarding the therapeutic benefits of
is an active ingredient in an approved drug (i.e., Epidiolex)
CBD. To date, FDA has approved one CBD drug product—
and was the subject of clinical investigations before it was
Epidiolex—but the mechanism by which the drug exerts its
marketed in food, FDA has determined that CBD may not
anticonvulsant effects is not known. Clinical trials to
be marketed in or as a dietary supplement.
support the approval of Epidiolex demonstrated the
Other FDA-Regulated Products
potential for liver injury at certain doses, and CBD may
interact with other drugs or dietary supplements. Other
FDA has not determined that CBD may not be added to
concerns include the potential dosing and cumulative
cosmetics, provided therapeutic claims are not made and
effects of exposure to CBD from multiple sources (e.g.,
that the product is not otherwise adulterated or misbranded.
supplements and cosmetics); whether there are populations
In addition, CBD may be lawfully marketed as a drug,
for whom CBD is not appropriate (e.g., pregnant women);
pursuant to FDA approval and in compliance with
and whether allowing CBD to be marketed as a supplement
applicable statutory and regulatory requirements. If a firm
or food could undermine incentives for conducting clinical
seeks to market CBD as a treatment or an otherwise
trials and obtaining evidence to support drug approval.
therapeutic product, the firm generally would need to obtain
premarket approval from FDA via the new 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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