FDA Announces A Path Forward For CBD Consumer Products: A New Regulatory Framework Is Needed –


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Cannabis industry stakeholders waiting for the US Food and Drug
Administration (FDA) to forge a regulatory path forward for
cannabidiol (CBD) in consumer products such as conventional foods
and dietary supplements will now be waiting on Congress to act. FDA
announced, on January 26, 2023, that its existing food and dietary
supplements regulatory pathways are not appropriate for CBD
products and that the agency does not intend to initiate rulemaking
for CBD. Rather, FDA called for a new regulatory pathway for CBD
products that “balances individuals’ desire for access
to CBD products with the regulatory oversight needed to manage
risks.”1 Concurrent with this policy announcement,
FDA denied three citizen petitions from trade associations that
asked, among other things, for FDA to issue a regulation allowing
CBD products to be marketed as dietary supplements. Companies
waiting for certainty on the future of CBD product regulation will
have to wait until Congress acts, perhaps, to amend the Federal
Food, Drug, and Cosmetic Act to establish a unique regulatory
pathway for CBD.

This Advisory contextualizes FDA’s policy announcement in
the recent history of its actions with respect to CBD, summarizes
the key points of FDA’s announcement, and covers the
implications for stakeholders.

Background

Growth in the CBD industry followed significant changes in the
legal status of hemp and its derivatives, most notably, the
Agriculture Improvement Act of 2018, Public Law 115-334 (known as
the 2018 Farm Bill). The 2018 Farm Bill legalized the cultivation
and sale of hemp, defined as “[T]he plant Cannabis sativa L.
and any part of that plant . . . with a delta-9
tetrahydrocannabinol concentration of not more than 0.3 percent on
a dry weight basis.”2 The law also amended the
definition of marijuana in the Controlled Substances Act (CSA) to
exclude hemp and its derivatives from the CSA’s definition of
controlled substances.3 Congress expressly preserved,
however, FDA’s authority to regulate products containing CBD
(derived from hemp) and other products containing hemp or
hemp-derived compounds.4 Thus, while hemp is no longer a
controlled substance, FDA retained authority to regulate products
such as CBD.

Indeed, FDA issued a statement on the day the 2018 Farm Bill
passed, touting its awareness of the growing public interest in
cannabis and cannabis-derived products, including CBD, and
announcing the importance of clarifying FDA’s regulatory
authority over those products.5 FDA explained that it
was unlawful to market CBD in food or dietary supplements, but also
indicated that—

Pathways remain available for the FDA to consider whether there
are circumstances in which certain cannabis-derived compounds might
be permitted in a food or dietary supplement. Although such
products are generally prohibited to be introduced in interstate
commerce, the FDA has authority to issue a regulation allowing the
use of a pharmaceutical ingredient in a food or dietary supplement.
We are taking new steps to evaluate whether we should pursue such a
process. However, the FDA would only consider doing so if the
agency were able to determine that all other requirements in the
FD&C Act are met, including those required for food additives
or new dietary ingredients.6

Subsequently, FDA formed a “high-level internal agency
working group” to explore potential pathways for dietary
supplements and/or conventional foods containing CBD to be lawfully
marketed, including consideration of the necessary statutory or
regulatory changes and the public health impact of marketing such
products.7 FDA also convened a widely attended public
hearing to obtain scientific data and information about the safety,
manufacturing, product quality, marketing, labeling, and sale of
products containing cannabis or cannabis-derived compounds. While
FDA sorted out its approach to CBD, industry waited, and some
companies sought to lawfully market CBD as a dietary supplement
within the existing regulatory framework. For example, one company
submitted a new dietary ingredient notification (NDIN) to FDA on
March 3, 2021 for full-spectrum hemp extract (FSHE) which contains
CBD.8 FDA rejected the NDIN, however, having found that
the FSHE, which contains CBD, was a CBD product precluded from
marketing as a dietary supplement by the exclusion provision of the
FD&C Act.9 Following this rejection, it became clear
to many that FDA’s position was settled and that FDA believed
that lawful marketing of CBD as a dietary supplement was impossible
absent FDA proceeding through notice and comment rulemaking to
issue a regulation finding that CBD would be lawful in such
products. Three citizen petitions, submitted in 2019, 2020, and
2022, requested that FDA take such action, though each would be
denied alongside the January 2023 policy announcement, as we note
below.

FDA’s January 2023 CBD Policy Announcement

FDA’s work and progress on regulating CBD took a turn on
January 26, 2023, when FDA took coordinated action to issue the CBD
policy announcement and deny the three citizen petitions that
sought rulemaking on CBD. Principal Deputy Commissioner Janet
Woodcock’s announcement stated that after careful review by
an internal FDA working group, FDA concluded that a new regulatory
pathway for CBD was necessary; FDA’s current conventional
food and dietary supplement regulatory pathways would not be
appropriate for CBD. Such a pathway, would balance consumers’
desire for access to CBD products with the regulatory oversight
needed to manage risks. According to FDA, safety concerns and
limited ability to manage risks associated with CBD products under
the existing food and dietary supplement authorities drove
FDA’s policy determination. FDA noted that the agency
reviewed studies pertaining to Epidiolex, published scientific
literature, information submitted to the CBD public docket, and
studies conducted and commissioned by FDA. It concluded that the
use of CBD raises various safety concerns, especially for long-term
use, including potential risks to the liver and male reproductive
system and the risk for medication interactions. FDA also expressed
concern about CBD exposures by certain vulnerable populations, such
as children, and those who are pregnant. Ultimately, the agency
could not see how CBD products could meet safety standards
applicable to dietary supplements or food additives—for
example, FDA lacked adequate evidence to determine the level of CBD
that can be consumed, and the duration of consumption, before
causing harm.

The agency all but explicitly asked Congress to act, stating
that “FDA is prepared to work with Congress on this
matter” and “FDA looks forward to working with Congress
to develop a cross-agency strategy for the regulation of these
products to protect the public’s health and safety.” It
provided a light roadmap, including recommendations for including
safeguards and oversight to manage and minimize risks associated
with use of CBD products, such as clear labels, prevention of
contaminants, CBD content limits, and minimum purchase age.

Finally, FDA turned to the topic of compliance actions and
essentially preserved the status quo. Per Dr. Woodcock, “FDA
will continue to take action against CBD and cannabis-derived
products to protect the public, in coordination with state
regulatory partners, when appropriate. FDA will remain diligent in
monitoring the marketplace, identifying products that pose risks
and acting within our authorities.” As FDA-watchers are
aware, the agency has not initiated any industry-wide compliance
action, but has more selectively targeted companies marketing
products that in FDA’s view, threaten the public health
and/or are marketed to children. The agency has particularly
focused its compliance actions on products that make claims to
treat diseases or other specific health
conditions.10

Implications

FDA’s action (or inaction), depending on your viewpoint,
likely disappointed some in industry who expected that FDA would
issue a regulation. Ultimately, FDA’s stance leaves Congress
in the driver’s seat when it comes to establishing a
regulatory path forward for CBD. In fact, shortly after FDA’s
announcement, Rep. Morgan Griffith (R-VA) (House Energy &
Commerce Oversight Subcommittee Chair) announced that he was in
contact with FDA regarding the CBD announcement and “look[s]
forward to working with the FDA so we may create a safe pathway for
these products to come to market.”11 Rep.
Griffith, and others in Congress, would not be starting from
scratch. Dozens of bills, including those on which he worked, have
been introduced in both the House and Senate that propose to
regulate cannabis and/or CBD. Arnold & Porter’s
comprehensive Cannabis
State-of-Play Advisory
 highlights the legislation related
to cannabis and CBD introduced by the 117th Congress.

As noted above, FDA did not announce a new compliance policy or
stance with respect to CBD, and we expect that FDA will continue to
regulate CBD largely the same as it has in the preceding
years—by taking selective compliance action, particularly
with respect to disease claims or products marketed to children, as
it deems necessary. We will continue to monitor developments with
respect to both CBD and cannabis.

© Arnold & Porter Kaye Scholer LLP 2023 All Rights
Reserved. This Advisory is intended to be a general summary of the
law and does not constitute legal advice. You should consult with
counsel to determine applicable legal requirements in a specific
fact situation.

Footnotes

1 Statement from Janet Woodcock, M.D., Principal Deputy
FDA Commissioner, FDA Concludes that Existing Regulatory Frameworks
for Foods and Supplements are Not Appropriate for Cannabidiol, Will
Work with Congress on a New Way Forward (Jan. 26, 2023),
availablehere.

2 7 U.S.C. 1639o(1).

3 Section 12619(b) of the 2018 Farm Bill also amended
Schedule I of the CSA to exclude the THC found in hemp from the
definition of “tetrahydrocannabinols.”

4 See 2018 Farm Bill, section 10113, §
297D(c)(1).

5 By the time the 2018 Farm Bill passed, FDA had already
approved a highly purified form of CBD in a prescription drug,
Epidiolex.

6 Statement from FDA Commissioner Scott Gottlieb, M.D.,
on signing of the Agriculture Improvement Act and the
Agency’s Regulation of Products Containing Cannabis and
Cannabis-Derived Compounds (Dec. 20, 2018),
availablehere.

7 Statement for FDA Commissioner Scott Gottlieb, M.D., On
New Steps to Advance Agency’s Continued Evaluation of
Potential Regulatory Pathways for Cannabis-Containing and
Cannabis-Derived Products (Apr. 2, 2019),
availablehere.

8 FDA Response to NDI 1199 – Full Spectrum Hemp
Extract (FSHE), FDA-2021-S-0023-0050,
availablehere.

9 See 21 U.S.C. 321(ff) (excluding from the
dietary supplement definition, an article that is approved as a new
drug or authorized for investigation as a new drug for which
substantial clinical investigations have been instituted and made
public, which was not before such approval or authorization
marketed as a dietary supplement or food unless FDA issued
a regulation finding that the article would be lawful under the
FD&C Act). FDA reached this conclusion because CBD is the
active ingredient in an approved drug product, and the existence of
substantial clinical investigations involving CBD had been made
public. Additionally, FDA determined that CBD was not marketed as a
dietary supplement or conventional food before it was authorized
for investigation as a new drug.

10 See, e.g., FDA Warning Letter to Naturally
Infused LLC (Nov. 16, 2022), availablehere,
(“[T]he Agency is particularly concerned that
some of your products are in forms that are appealing to children.
For example, your CBD Lollipops, CBD Gummies, and Delta-8 THC
Gummies are in forms that would be attractive to children and could
easily be mistaken for traditional foods that are commonly consumed
by children. Furthermore, you market other products that consumers
may confuse with traditional foods for humans, including CBD
Infused Sugar and CBD and Delta-8 THC Infused coffees. Therefore,
there is a risk that consumers of these products, including
children, will unintentionally consume CBD or Delta-8 THC
ingredients. Additionally, we note that the CBD coffee products
appear to contain caffeine. Evidence suggests that CBD may affect
caffeine metabolism and may increase and/or prolong
caffeine’s effects.”).

11 Griffith Offers to Work with FDA to Develop CBD
Pathway, InsideHealthPolicy (Feb. 2, 2023),
availablehere.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.

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