Regulatory | C&T ®

KEY POINTS
• There is no outright prohibition against CBD-
containing cosmetics, but this does not mean
hemp products will no longer be regulated.

• This article reviews the ins and outs of CBD

cosmetic compliance as the current U.S.
legislation stands.

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 Into the
Weeds Walking the Regulatory Line of
CBD in Cosmetics

Allison Fulton and Sarah Blitz

FDA Legal Practice, Cannabis Team
Sheppard, Mullin, Richter & Hampton
Washington, D.C., and Los Angeles

C annabidiol (CBD), a substance derived from

the Cannabis L. sativa plant, has quickly gained
mainstream popularity. The Cannabis L. sativa
plant is known to contain over 100 cannabinoids,
including cannabinol (CBN), cannabigerol (CBG)
and others. Of the many cannabinoids, CBD
is found naturally in the plant in the highest concentrations. Hemp is one
strain of the Cannabis L. sativa plant that contains high concentrations of
CBD and low concentrations of tetrahydrocannabinol (THC), which is the
psychoactive component of the cannabis plant. CBD is not known to
have the same psychoactivity of THC—in other words, you do not
get high from CBD.
According to federal law, a Cannabis L. sativa plant that
contains less than 0.3% THC is considered hemp. Presently,
there are a variety of cosmetic products on the market that
prominently feature the inclusion of hemp-based CBD. These
products come in a variety of forms, from lip balms to bath bombs
and body oils.

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 Into the Weeds
Regulations for CBD cosmetics in the U.S.
are complex and evolving. The 'Farm Bill'
legalized hemp but this does not mean hemp-
containing products will not be regulated.
However, the regulatory landscape for cos-
metics containing CBD in the U.S. is complex
and evolving. The Agriculture Improvement Act
of 2018, also known as the “Farm Bill,” removed
hemp from the Controlled Substances Act. This
means hemp is no longer considered an illegal
substance under U.S. federal law. This does
not mean, however, that hemp products will no
longer be regulated.
In the wake of the Farm Bill, the U.S. Food
and Drug Administration (FDA) released a
series of statements clarifying its position on
CBD in FDA-regulated products. The FDA has
also issued a steady stream of warning letters to
companies marketing CBD products, including
topicals and creams, that cross the line into
unfounded drug claims.
For example, in March 2019, the FDA issued
a warning letter related to the sale of a CBD
salve that purported to “treat chronic inflamma-
tion and other conditions.” The FDA also issued
a warning letter to a company selling a CBD
“muscle gel” advertised for reducing inflamma-
tion and relieving arthritis pain. CBD-containing
cosmetics also have been cited for more egre-
gious claims—such as treating cancer tumors
and heart disease.
The FDA currently prohibits the introduction
of food or dietary supplements containing added
CBD, regardless of whether the CBD is hemp-
derived. This is because under the Federal Food,
Drug, and Cosmetic Act (FDCA), a manufacturer
may not introduce into commerce a food or
The national market for hemp-derived CBD
in skin care is expected to reach $7 billion by
2023, according to Hemp Industry Daily.
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CT190708_Regulatory_Fulton_fcx.indd 22
dietary supplement containing an active ingre-
dient that is in an FDA-approved drug, or for
which substantial clinical investigations have
been conducted and been made public. CBD
is the active ingredient in the FDA-approved
drug Epidiolex, and has been the subject of
substantial clinical investigations that have
been made public. Therefore, CBD is not
permitted in food or supplements.
However, there is not a similar provision in
the FDCA that prohibits the inclusion of CBD,
or other drug active ingredients, in cosmetic
products. In other words, there is no outright
prohibition against CBD-containing cosmetics.
The ‘Why’ of CBD
Cosmetic Compliance
Before getting into what cosmetic manufac-
turers should do in order to remain compliant,
it is important to understand why. The FDA
regulates cosmetics under the FDCA, the Fair
Packaging and Labeling Act, and Title 21 of
the Code of Federal Regulations (CFR). Under
the FDCA, cosmetics are defined as “articles
intended to be rubbed, poured, sprinkled or
sprayed on, introduced into, or otherwise
applied to the human body...for cleansing,
beautifying, promoting attractiveness or alter-
ing the appearance.”
Unlike drugs, cosmetic products and
ingredients do not require FDA approval
before they can be marketed; the exceptions
are color additives, and sunscreens and
antiperspirants—which the FDA considers as
“drugs” under the FDCA. Cosmetic manufac-
turers are also not required to register their
establishments—although the FDA does have
a voluntary registration program; nor list their
products with the FDA.
The FDA classifies products as cosmetics
or drugs according to their intended use. The
6/18/19 12:55 PM
 Into the Weeds
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24 | www.CosmeticsandToiletries.com Vol. 134, No. 7 | July/August 2019
CT190708_Regulatory_Fulton_fcx.indd 24
intended use is determined primarily by the
claims a manufacturer makes in its pro-
motional materials, including on websites
and in TV ads. For example, a topical
cream intended for “moisturizing” would
be considered a cosmetic; a topical cream
intended for “reducing inflammation” or
“pain relief” would be considered a drug.
And certainly more aggressive claims—such
as “helping to cure or prevent diseases”
including cancer or rheumatoid arthritis—
would not be considered appropriate claims
for cosmetics.
Products also can be both cosmetics and
drugs as the categories are not mutually
exclusive. For example, an eye cream that
purports to “reduce inflammation” and also
“provides key nutrients for moisturizing”
is making both drug and cosmetic claims,
respectively.
A product’s claims can also be implied.
For example, the FDA may consider a claim
that a product “improves joint mobility
and reduces joint inflammation and pain”
to be an implied claim for treating rheu-
matoid arthritis. In the same way, a claim
that a product “prevents bone fragility in
older women” may imply that it prevents
osteoporosis.
The FDA has stated that a product’s
intended use also can be established based
on consumer perception; i.e., established
through the product’s reputation, or by
ingredients that have a well-known, to the
public and industry, therapeutic use. Assert-
ing a non-claims based theory of intended
use, however, would likely not withstand
judicial scrutiny. Nevertheless, companies
should understand the consumer takeaways
and perceptions so that adequate context
can be provided in a product’s promotional
materials.
Although cosmetic manufacturers
are not required to register with the FDA
or submit their products for pre-market
approval, they do have a legal responsibility
to ensure the safety and labeling of their
products. The FDCA prohibits the introduc-
tion of cosmetics that are “adulterated” or
“misbranded,” and a cosmetic is considered
adulterated if it contains a substance that
may make the product harmful to consum-
ers under customary conditions of use.
6/18/19 12:55 PM
 Examples include if a product contains a
filthy, putrid or decomposed substance; if it is
manufactured or held under insanitary condi-
tions where it may have become contaminated
with filth; or may have become harmful to
consumers. Events that may render a cosmetic
adulterated often relate to the product’s manu-
facturing or the failure of ingredients to meet
specifications—for example, a preservative that
does not prevent bacterial contamination. A
cosmetic would be deemed misbranded if its
labeling is false or misleading; if it does not bear
the required labeling information; or if the con-
tainer is made or filled in a deceptive manner.
The ‘How’ of CBD
Cosmetic Compliance
How can companies ensure their CBD
cosmetics comply? First, cosmetic products
containing CBD may currently be marketed
in the U.S., so long as the products meet the
adulteration and misbranding provisions of the
FDCA, including all labeling requirements under
21 CFR Parts 700 and 701. These adulteration
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CT190708_Regulatory_Fulton_fcx.indd 25
and misbranding provisions ensure that products
on the market are safe for consumers to use; and
of course, safety goes to the heart of the FDA’s
mission to protect the public health.
Cosmetics are not subject to specific FDA
regulations on good manufacturing practices
(GMP) but the FDA has published a guidance
document that incorporates international
consensus standards for manufacturing cosmet-
ics: “Cosmetics—Good Manufacturing Practices
(GMP)—Guidelines on Good Manufacturing
Practices,” ISO 22716:2007. The guidelines make
recommendations for processing and laboratory
controls, such as testing raw materials, in-
process products and finished products to ensure
product uniformity and consistency, storage of
materials under controlled conditions, calibra-
tion of manufacturing and laboratory equipment,
and testing of retained samples for preservation
against microbial contamination. Companies
that follow these guidelines can minimize the
risk of product contamination and adulteration.
Product testing at the time of launch is espe-
cially important to ensure the product contains
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6/18/19 12:55 PM
 Into the Weeds
the labeled amount of CBD and THC, if any.
Higher levels of CBD, and especially THC, could
lead to consumer adverse events and render
a product illegal in some states. Companies
should also test their products through their
shelf life, e.g., every six months until expiration,
for CBD/THC levels and contamination such
as bacteria and natural degradants. Companies
that set and follow quality standards for CBD
in their products may be well-positioned in a
competitive marketplace.
Product testing at
the time of launch is
especially important
to ensure any CBD or
THC content is properly
labeled and legal.
Second, marketers of CBD-containing
cosmetics should have scientific support show-
ing that CBD in the cosmetic is safe for topical
use for all intended consumers. Cosmetics that
are unsafe for their intended use could garner
attention from regulators worldwide, not to
mention ire from customers. The FDA has not
commented on the level of CBD that is safe
for over-the-counter use in cosmetics (or other
products). It has done so, however, for the CBD
drug Epidiolex; pediatric patients are dosed
starting at 5 mg/kg per day, with a maximum
daily dose of 20 mg/kg. Of course, Epidiolex is
taken orally as a solution, unlike topical cosmet-
ics. Therefore, companies should develop solid
safety data, including clinical data, to support
the level of CBD present in a product.
Third, cosmetic products containing CBD
should be promoted using claims that are only
cosmetic in nature. Specifically, this pertains
to those for beautifying, promoting attractive-
ness and moisturizing. Companies should take
note that some seemingly cosmetic claims have
been viewed by the FDA as drug claims. These
include: acne treatment; promoting eyelash
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CT190708_Regulatory_Fulton_fcx.indd 26
growth; sunscreen protection and SPF claims
in makeup; hair restoration; wrinkle removal;
and stretch mark reduction.
Finally, cosmetic products containing CBD
should avoid all explicit and implicit drug-like
claims, including those that are common for
CBD products: healing, relief from pain and
joint aches, anti-inflammation, analgesic,
etc. The FDA has placed a high priority on
CBD products that make drug-like claims, as
evidenced in the warning letters and state-
ments by the outgoing FDA Commissioner,
who raised concerns in April 2019 over large
retailers selling CBD topicals.
Following all of these guidelines will help
companies to reduce the risk of running afoul
of the FDA’s laws and restrictions.
State and International
Considerations
Within the U.S., state-level efforts also
are under way to regulate the use of CBD
in cosmetics. For instance, California has
legislation pending (AB-228) to modify the
California Health and Safety Code that
contains provisions of the Sherman Food,
Drug and Cosmetic Laws to affirmatively
state: “A cosmetic is not adulterated because
of the fact that it includes industrial hemp
products, including cannabidiol derived from
industrial hemp. The sale of cosmetics that
include industrial hemp products or can-
nabidiol derived from industrial hemp shall
not be restricted or prohibited based solely on
the inclusion of industrial hemp products or
cannabidiol derived from industrial hemp.”
While it remains to be seen whether AB-228
becomes law, it is important to acknowledge
that state-level legislative efforts may also
impact the ability of companies to distribute
CBD-containing cosmetics.
Furthermore, companies must be aware
that compliance in international markets may
impose further restrictions or requirements.
For instance, European Union Regulation
No. 1223/2009 (the Cosmetics Regulation)
defines a cosmetic product as “any substance
or mixture intended to be placed in contact
with external parts of the human body for the
purposes of cleaning, perfuming, changing its
appearance, protecting, keeping in good condi-
tion or correcting body odors.”
6/18/19 12:55 PM
 Under the governing articles and associ-
ated annex, however, cannabis is included in Want More?
the list of prohibited substances; specifically,
For more on the EU’s view
“the flowering or fruiting tops of the cannabis
of CBD, see page 14 in the
plant” are prohibited. The seeds and leaves of February digital edition.
the plant are not prohibited; therefore, CBD
may be used in cosmetics placed on the EU
market when the CBD is obtained from canna-
bis seeds and leaves and not accompanied by
the fruiting tops of the cannabis plant. General
legal requirements for cosmetic products,
including those relating to safety and safety
reports, also apply.

Conclusions
Joining the CBD product bandwagon may
be lucrative but companies should use caution
and consult with qualified counsel in order to
avoid not only potential pitfalls, but also FDA
and international enforcement actions.

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