Today’s
Presenters
Alix Davis HarrisAlix Davis Harris is a marketing attorney, serving as Senior
Counsel for North American Hair Care brands at The Procter
& Gamble Company in Cincinnati, Ohio. Skilled at
formulating creative solutions on advertising issues, she
works with a wide range of multicultural, iconic, and
innovative brands like My Black is Beautiful®, Pantene Gold
Series®, Old Spice®, Head & Shoulders®, and Waterl<ss® to
help the business achieve successful campaigns and
promote superior products. Alix advises brands on a variety
of advertising matters, including hemp and CBD. She also
advises the company on data scraping and keyword
searching to ensure compliance in this evolving field.
Jennifer K. Mason
Jennifer is a Partner at Dinsmore who represents clients in commercial litigation and appellate matters in federal and state courts in Pennsylvania and West Virginia. Jennifer’s practice includes advising, writing and speaking on issues impacting the hemp and medical marijuana industries, including labeling and packaging, preparing and appealing licensure applications, banking and tax matters.
Today’s
Agenda
2
• Hemp Source & Why It Matters
• CBD Labeling
• CBD Product Adulteration
• The Importance of Intended Use
• CBD Product Sales
• FDA & FTC Enforcement of CBD Products
• 10 Key Takeaways Related to the Regulation of Cannabis Products
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What is the Difference Between Hemp and Marijuana?
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Hemp S ource & Wh y I t M a tter s
4
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Marijuana
• Federally, Marijuana remains illegal under the
Controlled Substance Act.
Hemp
• Any hemp plant, or part of a hemp plant, with a
Delta 9 THC of more than .03% on a dry weight
basis is marijuana.
• The DEA issued a guidance in which it determined
that even processed hemp, which originally had a
Delta 9 THC concentration of .03% or below on a
dry weight basis, but which is concentrated
thereafter to a higher percent during processing, is
marijuana.
• CBD derived from Marijuana plants does not
become legal by diluting the Delta 9 THC
concentration to .03% on a dry weight basis.
Marijuana Remains Illegal Under the Controlled Substance Act!
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• How do you know if a hemp derived product is legal?
• The determination of legality STARTS FROM DAY 1:
Was the product:
1. Cultivated,
2. Processed, and
3. Dispensed
in a manner that is consistent with a state
or tribal plan or the USDA regulations.
• If the product derives from hemp that was not grown
in conformance with state, tribal or USDA regulations,
it isn’t a legal product. It is the fruit of the poisonous
tree.
Hemp Products MAYbe Legal Under the US Farm Bills and State Regulations.
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• Why do you need to know whether a product is legal
from inception?
• If you are going to market a product, the product
should be legal for sale in the jurisdiction(s) you are
marketing it and labeled and packaged in
compliance with state and federal law.
Why is Legality from Inception Important to Marketing?
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La b e l ing/Packag ing
• FEDERAL LAWS/REGULATIONS:
FD&C Act
FOOD AND DRUG MODERNIZATION ACT
FAIR PACKAGING AND LABELING ACT
• STATE LAWS AND REGULATIONS
8
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In order for us to begin a discussion of the
labeling and packaging requirements for hemp
products, in our case CBD, we must begin with
an understanding of some of the the entities
that regulate the industry. These include (but
are not limited to) FDA, TTB, DEA, IRS and
various State Agencies
Today we will focus on the FDA statutes and
regulations and provide examples of State
Agency Regulations
FDA and State Labeling and Packaging Laws
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Article IV of the FD&C Act provides the FDA
Secretary with the authority to promulgate
regulations to establish standards of identity, quality
and filing of containers (labeling and packaging-ie
marketing)
1. Food Drug & Cosmetic Act (FD&C Act)
From Where Does the FDA Derive its Authority?
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Chapter III-Establishes prohibited acts:
• Can’t adulterate food, drugs devices or tobacco
products;
• Can’t misbrand food, drugs, devices or tobacco
products;
• Can’t introduce or deliver adulterated or misbranded
goods into interstate commerce.
FD&C Act (1938)
What Does the Act do?
What are Prohibited Acts?
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In 1958 Congress passed an amendment to the FD&C
Act giving the FDA authority to require premarket
approval for safety of components added to foods
(FDCA 201(s), (t), 402(a)(2), 409.)
A food additive is defined as any substance intended or
reasonably expected to become a food component or
to affect a foods characteristic that is not generally
recognized as safe (GRAS).
If an additive is included in a food product that does
not have GRAS status, it will adulterate the food
product.
FD&C Amendments:
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Title IX prohibits the sale of any food that contains an
approved drug, an approved biological product, or a
“drug [or biological product] for which substantial
clinical investigations have been instituted and for
which the existence of such investigation has been
made public,” unless the food containing the drug or
biologic had been marketed prior to such approval or
testing.”
Note that food as defined by the FD&C Act includes
both food and beverages.
If a food product contains an approved drug, it is
adulterated.
Food and Drug Administration Amendments Act of 2007
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If there is a food that contains “CBD”, an approved drug, is that food prohibited?
14
Does the approval of Epidolex by FDA change
whether other CBD products (drugs/cosmetics) must
be approved by the FDA?
Remember. . . Pursuant to Chapter III of the FD&C Act
. . . You cannot adulterate a food, drug or cosmetic
product.
Cosmetics? Are adulterated if they contain poisonous
or deleterious substances. (Is the CBD poisonous or
deleterious?)
Drugs? Are adulterated if the additive makes the
product unsafe. (Does the CBD cause the product to
be unsafe?)
Does the approval of Epidolex for a specific use,
change the requirements for the addition of the
product to food?
Food? If the food contains “an approved drug”. (Is
the CBD being added to food the same as the
“approved drug”?)
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2. Food and Drug Modernization Act of 1997
15
Because of the myriad of regulations and the time and
complexity to get drugs to market, Congress passed the
Food and Drug Administration Modernization Act of 1997.
It broadened the FDA’s authority to Over the Counter drugs
by extending the agency’s inspection authority over OTC
drug records;
Ingredient labeling requirements were also expanded to
include inactive ingredients;
The FDAMA preempted labeling for OTC drugs and
cosmetics from state regulation where federal requirements
are in place.
The FDAMA provided streamlined procedures and
greater flexibility in FDA regulations regarding nutrient
content and health claims for foods. Such claims may be
permitted on food labels, without the need for FDA to
issue a regulation, if a scientific body of the US
government has published an authoritative statement
endorsing the claim.
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The purpose of the Act is to facilitate value
comparisons and to prevent unfair or
deceptive packaging and labeling. This
includes misbranding.
(c) The term “label” means any written, printed,
or graphic matter affixed to any consumer
commodity or affixed to or appearing upon a
package containing any consumer commodity.
https://www.govinfo.gov/content/pkg/USCO
DE-2011-title15/html/USCODE-2011-title15-
chap39.html
15 USC Chapter 39
3. Fair Packaging and Labeling Act
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(b) The term “package” means any container or wrapping
in which any consumer commodity is enclosed for use in
the delivery or display of that consumer commodity to
retail purchasers, but does not include—
(1) shipping containers or wrappings used solely for the
transportation of any consumer commodity in bulk or in
quantity to manufacturers, packers, or processors, or to
wholesale or retail distributors thereof;
(2) shipping containers or outer wrappings used by
retailers to ship or deliver any commodity to retail
customers if such containers and wrappings bear no
printed matter pertaining to any particular commodity;
or
(3) containers subject to the provisions of the Act of
August 3, 1912 (37 Stat. 250, as amended; 15 U.S.C. 231–
233), or the Act of March 4, 1915 (38 Stat. 1186, as
amended; 15 U.S.C. 234–236).
15 USC Chapter 39
Fair Packaging and Labeling Act
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Th e Imp or tance of In tended U se in M a rket ing
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Off label promotion rules . . . Why marketing matters!
1. It is Illegal to introduce a drug into interstate commerce unless it has undergone clinical trials demonstrating safety and efficacy FOR ITS INTENDED USE. 21 USC 355 (a), (b);
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Intended Use
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• A product’s intended use determines whether it is a medical product within the scope of FDA’s
jurisdiction.
• Intended use refers to “the objective intent of the persons legally responsible for the labeling of
drugs.”
⎯ FDA considers labeling, advertising, or oral or written statements, and other relevant circumstances surrounding the labeling and sale of the product.
• FDA will treat any product, including a cannabis product (hemp or otherwise), that is marketed with
a claim of therapeutic benefit or another disease claim to be a regulated product.
⎯ Any new drug must be approved by the FDA for its intended use before it may be introduced.
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Off label promotion rules . . . Why marketing matters!
2. If a manufacturer markets an approved drug beyond its intended use, it becomes an unapproved new drug with respect to that additional use. 65 Fed. Reg. 14, 286;
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Off label promotion rules . . . Why marketing matters!
3. According to FDA-Marketing off-label is considered misbranding, regardless of truthfulness.
(But see Sorrell v IMS Health, 131 S.Ct. at 2671 and Amarin Pharma, Inc. V FDA, 2015 Us. Dist Lexis 103944 (S.D.N.Y. Aug. 7, 2015)–suggests ban on truthful marketing of off-label uses is an unconstitutional restriction on speech.)
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Intended Use
23
Current drug – Epidiolex ( Ultra Concentrated CBD)
• June 2018: Initial approval by the FDA to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in
patients 2 years of age and older
• July 2020: Additional approval by the FDA to treat seizures associated with tuberous sclerosis complex (TSC) in patients 1
year of age and older
“The FDA continues to believe the drug approval process represents the best way to make new medicines,
including any drugs derived from cannabis, available to patients in need of appropriate medical therapy such
as the treatment of seizures associated with these rare conditions. This paradigm ensures new therapies are
safe, effective, and manufactured to a high quality that provides uniform and reliable dosing for patients.”
- Douglas Throckmorton, M.D., CDER
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Intended Use Claims
24
• Ensure that any claims made are general wellness/health maintenance or structure/function claims rather
than disease/medical claims
• Most significant FDA enforcement risk associated with claims related to serious health-related claims and
claims targeting vulnerable populations
GENERAL WELLNESS CLAIMS DISEASE CLAIMS
Supports the immune system Prevents COVID-19 and the flu
Promotes a healthy circulatory system Prevents cardiovascular disease
Helps improve mood Reduces anxiety and depression
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Most States have adopted Acts related to Food, Drugs
and Cosmetics that are similar to the Federal FD&C Act.
These State Acts often contain labeling requirements:
• CDPH (California Department of Public Health)-
Sherman Food, Drug and Cosmetic Law (Effective
1/1/18) Chapter 4 Packaging, Labeling and
Advertising) https://www.cdph.ca.gov/Programs/CEH/DFDCS/MCSB/CDPH%20Document%20Library/Packa
gingChecklist.pdf
• ODOA (Oregon Department of Agriculture) and
Oregon Health Authority/OAR 333-150-0000,
Chapter 2 -401.11 https://www.oregon.gov/ODA/shared/Documents/Publications/InternalServices/LabelingCons
umerPackaging.pdf
https://www.oregon.gov/oha/PH/HEALTHYENVIRONMENTS/FOODSAFETY/Documents/FactSh
eet29Additives.pdf
4. State Compliance: State Laws and Regulations
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In addition, other State Regulators control labeling and
packaging of cannabis products:
• These include Agencies such as the DCC
(Department of Cannabis Control) in California: https://www.cdph.ca.gov/Programs/CEH/DFDCS/MCSB/CDPH%20Document%20Library/Packa
gingChecklist.pdf
• OLCC (Oregon Liquor & Cannabis Commission) in
Oregon; https://www.oregon.gov/olcc/marijuana/Documents/Packaging_Labeling/PackagingandLabeli
ngGuide.pdf
• And the WVDOA (West Virginia Department of
Agriculture) in West Virginia https://agriculture.wv.gov/wp-content/uploads/2020/10/WV-Hemp-Products-Guide.pdf
https://agriculture.wv.gov/wp-content/uploads/2020/07/61-30-Hemp-Product-Rule-
Legislative-Final3656.pdf
State Compliance Cont.
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1. Warning Letters: FDA has issued some
warning letters to entities.
Those warning letters are focusing on entities
making unapproved health claims.
2. Lack of Enforcement Capability: At
this time, FDA simply doesn’t have the
enforcement capacity to pursue enforcement.
Therefore, it is prioritizing the types of claims
against which it will engage in enforcement.
3. Anti-Commandeering: Further, the
Federal Government can’t require states to
enforce a federal regulatory program- (Anti-
Commandeering Cases)
If CBD is an approved drug, and has not been approved for the intended uses for which it is being marketed . . . How can products containing CBD be sold in the US?
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The anti-commandeering rule is based on the Tenth
Amendment and was most fully articulated by the U.S.
Supreme Court in New York v. United States, 505 U.S.
144 (1992). There, the Court found unconstitutional a
federal statute that ordered the states to either develop
their own methods for responsibly disposing of
radioactive waste generated within state boundaries or
to become financially responsible for the presence of
such waste within their borders. In reaching this result,
the Court succinctly stated that “Congress may not
simply ‘commandee[r] the legislative processes of the
States by directly compelling them to enact and enforce
a federal regulatory program.”
https://www.cobar.org/Portals/COBAR/TCL/Dec%202018/CLDec18_Features_Cannabis.pdf
Anti-Commandeering Rule:
If Placing CBD in Food is Illegal, Why are so Many Companies Doing it?
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Recent publication (October 2021) by the FDA:
https://www.fda.gov/news-events/public-health-
focus/cannabis-derived-products-data-acceleration-plan
FDA intends to focus on the following:
Review of Online COAs;
Developing “Safety Signal Detection for Online Data;”
Developing Real-Time Online Surveillance Tools for safety
signaling;
Developing Automated processes and technical solutions
to evaluate online product landscape;
Evaluating Online Safety Misinformation; and
Determining the Impact of Healthcare providers
perceptions on usage and safety.
Is the FDA changing the focus of enforcement?
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CBD P roduct S a les
30
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Each State or Indian Tribe which has adopted a
hemp program may adopt its own rules and
regulations for the sale of products.
For Example:
WV Title 61 Series 30 governs Hemp Products.
Hemp Product means any product derived from,
or made by processing hemp plants or plant
parts, that are prepared in a form available for
commercial sale.
In order to sell a Hemp Product in WV to
someone else in WV, you must properly grow it,
or purchase it from a licensed grower, register it
and pay the registration fees annually, and sell it
at a properly licensed retail entity that has
registered. 61 CSR 30.4
Sale of the Product-Intrastate
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• Are the rules different if the product is sold on an
intra vs. interstate basis?
• The rules can be different, especially if the product
violates Federal laws or Regulations.
• Unless your product is produced under the USDA
plan, it is governed by State or Tribal law and the
registrations and sales are generally governed
therein. However, if you sell across state lines, you
must also comply with Federal Law and Regulation.
• This begs the question of whether you must comply
with Federal Law if you sell on an interstate basis.
What are the requirements to sell a CBD product interstate?
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FDA & F TC Enforcement of CBD P roduct s
33
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FDA Warning Letter Examples
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2019
• FDA issued 22 warning letters (including 15 in November
2019) advertising and marketing claims for CBD products
that violated the FDCA
• Multiple warning letters issued by FTC (independently or
jointly with FDA) regarding false or misleading
advertising claims for CBD products
2020
• 12/17/20 FDA/FTC announced crackdown on deceptive
claims in the growing CBD product market against sellers
claiming their product treated serious health conditions
including cancer, heart disease, hypertension,
Alzheimer’s disease, etc. https://www.ftc.gov/news-
events/press-releases/2020/12/ftc-announces-
crackdown-deceptively-marketed-cbd-products
2021
FTC announces actions in which sellers will pay $30,000 in
consumer redress. State “Seller . . Should know better. . . .”
https://www.ftc.gov/news-events/press-releases/2021/05/ftc-
announces-latest-enforcement-action-halting-deceptive-cbd
FDA & FTC Enforcement
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FDA Enforcement
36
• Issues identified by the FDA include:
• Products marketed for infants and children, a vulnerable patient population that may be at greater risk for adverse reactions due to differences in the ability to absorb, metabolize, distribute or excrete CBD
• Addition of CBD to foods, which is an unapproved food additive in violation of the FDCA
• Marketing of CBD products as dietary supplements in violation of the FDCA
• Use of CBD in food consumed by food-producing animals, which raises concerns about the safety of human food products (e.g. meat, milk, and eggs) due to a lack of data establishing safe CBD residue levels
• March 2020 press release indicates that FDA’s focus is “unlawful CBD products that pose a risk of
harm to the public”
• “evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors the agency intends to take into account in prioritizing enforcement decisions”
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FTC Enforcement
37
• Issues identified by the FTC include:
• “Illegal to advertise that a product can prevent, treat, or cure human disease without competent and reliable scientific evidence to support such claims”
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The Dragontree Apothecary LLCApril 28, 2020
38
• CBD products labeled and marketed as a dietary supplement
• Unsubstantiated medical and health claims on the product
labels
• https://www.fda.gov/inspections-compliance-enforcement-
and-criminal-investigations/warning-letters/rooted-
apothecary-llc-585312-10102019
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• What Claims did Dragontree make/
What statements appeared on the
product label:
The Dragontree Apothecary LLC
“Instead of synthetic chemical that can have safety
concerns, this blend uses the best of nature to help
calm the inflammation and pain of teething, while also
promoting sleepiness for your little one.”
•“This blend also works great for jaw and TMJ
dysfunction pain.”
•“Lavender . . . Antidepressant properties and
Analgesic properties . . .”•“Pain relief . . ..”
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Dragontree Warning Letter:
“As FDA stated in an announcement regarding a warning
letter on July 23, 2019, “while we recognize the potential
opportunities and significant interest in drug products
containing cannabis and cannabis-derived compounds like
CBD, protecting and promoting public health remains our
top priority.”[2] The Agency continues to be concerned
about the proliferation of products asserting to contain
CBD that are marketed for therapeutic or medical uses
without having been reviewed for safety and effectiveness
by the FDA as is required by law and to protect the public
health. There are many unanswered questions about the
science, safety, effectiveness and quality of unapproved
products containing CBD. Without this information, we are
unable to ensure that these products will not cause harm to
people who use them. With the exception of Dronabinol,
Epidiolex, Marinol, and Syndros, no product containing
cannabis or cannabis-derived compounds (either plant-
based or synthetic) has been approved as safe and effective
for use in any patient population.
The Agency is particularly concerned that you market
unapproved new drugs for uses in infants and children.
Such products include, but are not limited to, “Teeth/TMJ –
Essential Oil + CBD Infusion” and “Ears – Essential Oil +
CBD Infusion.” Your products have not been evaluated by
the Agency for safety, effectiveness, and quality. The use of
untested drugs can have unpredictable and unintended
consequences, especially in vulnerable populations.”
https://www.fda.gov/inspections-compliance-enforcement-
and-criminal-investigations/warning-letters/rooted-
apothecary-llc-585312-10102019
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BIOTA Biosciences LLCApril 9, 2020
41
• Selling and marketing unapproved injectable drug products,
including “Canabidiol (CBD) Complex,”
“Cannabidiol+Curcumin,” and “Curcumin Complex”
• Misbranded because labeling fails to bear adequate
directions for use
• https://www.fda.gov/inspections-compliance-enforcement-
and-criminal-investigations/warning-letters/biota-
biosciences-llc-605164-04092020
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• Claims made on website:
⎯ “Oil will drastically reduce the need for opioid-based pain relief and eliminate global opioid epidemic. . . “
⎯ “Instant relief for patients that are symptomatic of inflammatory auto-immune diseases”
⎯ Bypass liver absorption completely making CBD immediately 100% bioavailable …. Delivers 100% CBD directly into your blood stream … Deliver high concentrations of CBD unattainable with the oral or inhalation route“
BIOTA Biosciences LLC
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Biota Warning Letter:
“Your “Cannabidiol (CBD) Complex,” “Cannabidiol+Curcumin,” and
“Curcumin Complex” products are drugs under section 201(g)(1) of
the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in
the diagnosis, cure, mitigation, treatment, or prevention of disease,
and/or intended to affect the structure or any function of the body. . .
.”
Your “Cannabidiol (CBD) Complex,” “Cannabidiol+Curcumin,” and
“Curcumin Complex” products are not generally recognized as safe
and effective for the above referenced uses and, therefore, the
products are “new drugs” under section 201(p) of the FD&C Act, 21
U.S.C. 321(p). New drugs may not be legally introduced or delivered
for introduction into interstate commerce without prior approval
from the FDA, as described in sections 301(d) and 505(a) of the FD&C
Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the
basis of scientific data and information demonstrating that the drug
is safe and effective. There are no FDA-approved applications in
effect for any of the above-named products.
Misbranded Drugs
Your “Cannabidiol (CBD) Complex,” “Cannabidiol+Curcumin,” and
“Curcumin Complex” products are also misbranded within the
meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in
that their labeling fails to bear adequate directions for use. “Adequate
directions for use” means directions under which a layperson can use
a drug safely and for the purposes for which it is intended. (See 21
CFR 201.5.) The aforementioned products are offered for conditions
that are not amenable to self-diagnosis and treatment by individuals
who are not medical practitioners; therefore, adequate directions for
use cannot be written so that a layperson can use these drugs safely
for their intended purposes. FDA-approved prescription drugs that
bear their FDA-approved labeling are exempt from the requirements
that they bear adequate directions for use by a layperson. However,
your products are not exempt from the requirement that their
labeling bear adequate directions for use, 21 CFR 201.100(c)(2) and
201.115, because no FDA-approved applications are in effect for them.
The introduction or delivery for introduction into interstate
commerce of these misbranded drugs violates section 301(a) of the
FD&C Act, 21 U.S.C. 331(a).
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CBD Meds, Inc.
44
FTC announced crackdown on deceptive claims in CBD
products against six sellers making scientifically
unsupported claims to treat things including cancer, heart
disease, hypertension, Alzheimer’s and others.
https://www.ftc.gov/news-events/press-
releases/2020/12/ftc-announces-crackdown-deceptively-
marketed-cbd-products
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Claims made on website:
CBD effectively treats, prevents, or mitigates serious diseases
and conditions like artery blockage, cancer, glaucoma, autism,
and schizophrenia, among many others.
The respondents also falsely represented that some of the
efficacy claims were scientifically proven or that the U.S.
government has confirmed the health benefits of CBD.
CBD Center LLC
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CBD Meds, Inc. Action:
“The Federal Trade Commission, having reason to
believe that CBD Meds, Inc., a corporation . . . ,
(collectively, “Respondents”), have violated the
provisions of the Federal Trade Commission Act, and
it appearing to the Commission that this proceeding
is in the public interest, alleges: . . .
CBD Meds, Inc., “To induce consumers to purchase
their products, . . . have disseminated or have
caused to be disseminated advertisements for their
CBD products. Respondents promoted CBD
products through the websites CBDMEDS.org and
G2Hemp.com, and through social media such as
YouTube. These advertisements have contained the
following representations or statements, among
others, that CBD can treat, prevent or mitigate
various serious medical conditions or diseases:
A. . . . Research on the benefits of cannabidiol
(CBD) is well documented by the U.S.
government via the NCBI (National Center for
Biotechnology Information) and the U.S.
National library of Medicine. We have
compiled six (6) therapeutic properties of CBD
with links below. Our government explains in
great detail the scientific explanation for each of
the following properties of cannabidiol: . . . “
https://www.ftc.gov/system/files/documents/cases/
202_3080_cbd_meds_complaint.pdf
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© 2021. ALL RIGHTS RESERVED
10 Key Ta keaways Re la ted to th e Regu la t ion of Cannab i s P roduct s
47
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10 Key Takeaways Related to the Regulation of Cannabis Products
48
1. Cannabis products are impacted by Federal and
State Laws and Regulations. In order for the
products derived from hemp to be legal, they must
originate and be processed and sold in compliance
with State and Federal Laws and Regulations.
Marijuana is not legal federally. Some states have
legalized Marijuana and presently the Omnibus
Spending Bills prohibit the prosecution of state
legal marijuana programs by the Department of
Justice.
2. Both the Federal and some State FDA laws exist
and compliance with labeling and packaging laws
in both are required.
3. Food, Drugs and Cosmetics may not be
misbranded.
4. Food, Drugs and Cosmetics may not be
adulterated.
5. Incorporating an approved drug into a food drug
or cosmetic may cause it be become adulterated
and is prohibited in some circumstances. **The
CBD in Epidiolex may or may not be the same
approved drug as is in the CBD in products on the
shelves.
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10 Key Takeaways Related to the Regulation of Cannabis Products Cont.
49
6. You should implement and maintain a process for
monitoring product safety in order to anticipate
potential regulatory action.
7. You should develop and implement a robust claims
review process for labeling, packaging, and
advertising.
8. You should develop a process for quickly
evaluating and responding to enforcement actions
by FDA, FTC and other enforcement agencies
9. You should know and understand state and
federal regulations on the sale of all products,
including registration fees.
10. There are current enforcement changes that have
been published by FDA.