June 12, 2019
FDA Regulation of Cannabidiol (CBD) Products
Cannabidiol (CBD) is promoted as treatment for a range of
eliminate one obstacle to production and marketing of hemp
conditions, including epileptic seizures, post-traumatic
and hemp-derived compounds, including CBD. However,
stress disorder, anxiety, and inflammation—despite limited
the farm bill explicitly preserved FDA’s authority under the
scientific evidence to substantiate many of these claims. In
Federal Food, Drug and Cosmetic Act (FFDCA, 21 U.S.C.
the United States, CBD is marketed in food and beverages,
§§301 et seq.) and Section 351 of the Public Health Service
dietary supplements, and cosmetics—products that are
Act (PHSA, 42 U.S.C. §262), including for hemp-derived
regulated by the Food and Drug Administration (FDA).
products. According to FDA, “because the 2018 Farm Bill
CBD is also the active ingredient in an FDA-approved
pharmaceutical drug, Epidiolex®. CBD is a plant-derived
did not change FDA’s authorities, cannabis and cannabis-
substance from Cannabis sativa, the species of plant that
derived products are subject to the same authorities and
includes both hemp and marijuana, but from different plant
requirements as FDA-regulated products containing any
varieties or cultivars. CBD is the primary nonpsychoactive
other substance, regardless of whether the products fall
compound in cannabis, whereas tetrahydrocannabinol
within the definition of ‘hemp’ under the 2018 Farm Bill.”
(THC) is cannabis’s primary psychoactive compound.
FDA Regulation of CBD Products
Regulation of CBD Products
FDA, under the FFDCA, regulates many of the products
Hemp and marijuana have separate definitions in U.S. law
marketed as containing cannabis and cannabis-derived
and are subject to different statutory and regulatory
compounds, including CBD. Hemp-derived CBD is
requirements. Marijuana is a Schedule I controlled
generally marketed and sold as an ingredient in food or
substance under the Controlled Substances Act (CSA, 21
beverages, cosmetics, personal care products, and dietary
U.S.C. §§802 et seq.) and is regulated by the Drug
supplements. Epidiolex® is the first (and only) FDA-
Enforcement Administration (DEA). The unauthorized
approved prescription drug formulation of highly purified,
manufacture, distribution, dispensation, and possession of
marijuana-derived CBD in the United States.
marijuana is prohibited. Marijuana-derived CBD is illegal
at the federal level, with the exception of use as an active
There are several provisions of the FFDCA that FDA
ingredient in the FDA-approved drug Epidiolex®. Despite
believes restrict the use of CBD in food and dietary
the federal prohibition on growing, selling, or possessing
supplements. Under the FFDCA, it is a prohibited act to
the drug, marijuana-derived CBD that has not been
introduce into interstate commerce a food to which has
approved by FDA has been made available in states where
been added an approved drug or a drug for which
medical and/or recreational cannabis is legal under state
substantial clinical investigations have been instituted and
law. In some states, buying CBD may require obtaining a
made public. There are several exceptions to this: (1) if the
medical cannabis prescription; elsewhere, CBD may be sold
drug was marketed in food before approval as a drug or
only at a licensed dispensary. As a result of recent
before clinical investigations were instituted; (2) if the
legislative changes enacted in the 2018 farm bill
Secretary has issued a regulation approving the use of such
(Agriculture Improvement Act of 2018, P.L. 115-334),
drug in the food; (3) if the use of the drug in the food is to
hemp-derived CBD is not subject to regulation and
enhance the safety of the food and not to have independent
oversight as a controlled substance at the federal level.
biological or therapeutic effects on humans, and the use is
in conformity with specified requirements; or (4) if the drug
Legislative Changes in the 2018 Farm Bill
is a new animal drug whose use is not unsafe (21 U.S.C.
Legislative changes related to hemp enacted as part of the
§331(ll)). FDA has concluded, based on available evidence,
2018 farm bill were widely expected to generate additional
that these exceptions do not apply to CBD. However,
market opportunities for the U.S. hemp market. The 2018
according to FDA, cannabis-derived ingredients that do not
farm bill removed longstanding federal restrictions on the
contain CBD (or THC) may fall outside the scope of the
cultivation of hemp, making it no longer subject to
prohibition in §331(ll). More specifically, foods containing
regulation and oversight as a controlled substance by the
parts of the hemp plant that include only trace amounts of
DEA. Instead, hemp production is now subject to regulation
CBD (e.g., hemp seed and hemp-seed derived ingredients)
and oversight as an agricultural commodity under the U.S.
may be lawfully marketed under certain circumstances—
Department of Agriculture (USDA). The 2018 farm bill
pursuant to FDA approval as a food additive (by regulation)
also expanded the statutory definition of what constitutes
or a determination that the substance is generally
hemp to include “all derivatives, extracts, cannabinoids,
recognized as safe (GRAS). FDA has not approved hemp as
isomers, acids, salts, and salts of isomers,” as long as it
a food additive but has evaluated three GRAS notices
contains no more than a 0.3% concentration of delta-9 THC
related to hemp seed-derived ingredients (hulled hemp
(7 U.S.C. §1639o). All other cannabis is considered to be
seeds, hemp seed protein, and hemp seed oil), allowing
marijuana under the CSA and remains regulated by DEA.
them to be added to human food under specified conditions.
Some stakeholders expected that these changes would
https://crsreports.congress.gov
link to page 2 
FDA Regulation of Cannabidiol (CBD) Products
The FFDCA expressly excludes from the definition of a
nearly $2 billion in 2022, divided about evenly among the
dietary supplement a substance that is an active ingredient
three markets. At the retail level, CBD is marketed in a
in an approved drug, or a drug for which substantial clinical
range of foods and beverages, dietary supplements, and
investigations have been instituted and made public, unless
cosmetic and personal care products, some of which are
the substance was marketed as a dietary supplement or food
now being sold by large retailers such as CVS Pharmacy
before approval or before clinical investigations were
and Walgreens.
instituted. An exception to this is if FDA promulgates
regulations that use of such substance in a dietary
Figure 1. Total U.S. CBD Sales, by Channel
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
Source: Hemp Business Journal, The CBD Report: 2018 Industry
Outlook, 2019 (New Frontier Data). Al pharmaceutical channel sales
claims. Pursuant to the FFDCA, if a product is
are represented by the drug Epidiolex®.
accompanied by claims implying that its intended use is the
cure, mitigation, treatment, or prevention of a disease, FDA
Considerations for Congress
generally considers that product to be a drug and subject to
While the 2018 farm bill removed hemp and its derivatives
premarket approval. If a company has not obtained
from the definition of marijuana in the CSA, several
approval of a drug prior to marketing, it is in violation of
obstacles may limit the marketing of hemp and its
the FFDCA. Thus, for a CBD product to make therapeutic
derivatives, including CBD, particularly in FDA-regulated
or disease-treating claims, whether hemp-derived or
products. One obstacle is that these products remain subject
otherwise, it must be approved by FDA for that use. While
to the FFDCA, and FDA has determined that it is unlawful
FDA has issued warning letters to manufacturers of CBD
to introduce food containing added CBD into interstate
products marketed as dietary supplements for various
commerce, or to market CBD products as, or in, dietary
FFDCA violations, including for making unsubstantiated
supplements. While FDA can initiate rulemaking to
claims, the agency has not yet taken enforcement action
approve the use of CBD in food or to allow its use in
against companies marketing CBD cosmetic products.
dietary supplements, former FDA Commissioner Gottlieb
has stated that because rulemaking is often a “long process”
Some in Congress have asked FDA to clarify its position
and given the complexity of this issue, a legislative fix may
regarding hemp-derived products, and FDA has established
be a more efficient option. Congress could, for example,
a working group “to consider whether there are legislative
allow for CBD in dietary supplements in specific
options that might lead to more efficient and appropriate
concentrations. However, one consideration in determining
pathways than might be available under current law.” Some
whether a legislative fix is appropriate is the potential for
states and local jurisdictions (e.g., Maine, New York, and
adverse health effects. Dietary supplements are not
California) have decided to disallow the sale of hemp-
evaluated by FDA for safety and effectiveness prior to
derived CBD edible products, given concerns that hemp-
marketing, and clinical trials to support approval of
derived CBD is not an FDA-approved food additive. Law
Epidiolex® have demonstrated the potential for liver injury.
enforcement officials are also highlighting the need for
Questions also remain regarding the therapeutic benefits of
testing and sampling technologies and protocols to more
CBD; to date, FDA has approved one CBD drug product.
readily distinguish between hemp and marijuana.
Per FDA, “any product intended to have a therapeutic or
CBD Market in the United States
medical use, and any product (other than a food) that is
intended to affect the structure or function of the body of
From an industry perspective, there are three markets for
humans or animals, is a drug.” CBD is marketed in a range
CBD: hemp-derived CBD, marijuana-derived CBD
of FDA-regulated products, and because there are so many
(currently a Schedule I controlled substance), and
of these products on the market, FDA has focused its
pharmaceutical CBD (currently only Epidiolex®). In 2018,
enforcement priorities on those companies and products
CBD sales in the United States from all three markets were
that pose the greatest risk to consumers. Despite continued
estimated at $534 million, according to the Hemp Business
promotion and sales of CBD—whether hemp- or
Journal (Figure 1). More than 1,000 companies produced
marijuana-derived—as treatment for a range of conditions,
and marketed CBD for the U.S. market. Compared to 2014,
there remains considerable regulatory and legal uncertainty
when total CBD sales were a reported $108 million, U.S.
in the U.S. CBD market.
sales of CBD have risen fivefold. This same source projects
U.S. sales of CBD will exceed $1 billion in 2020 and reach
Agata Dabrowska, Analyst in Health Policy
https://crsreports.congress.gov
FDA Regulation of Cannabidiol (CBD) Products
IF11250
Renée Johnson, Specialist in Agricultural Policy
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