CBD, FDA, and Obstacles to Cannabis Marketing

BEGIN

CBD, FDA, and Obstacles to Cannabis Marketing

NOVEMBER 15, 2021

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

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• 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

DINSMORE & SHOHL LLP / © 2021. ALL RIGHTS RESERVEDDINSMORE & SHOHL LLP / © 2021. ALL RIGHTS RESERVED 3

What is the Difference Between Hemp and Marijuana?

DINSMORE & SHOHL LLP • LEGAL COUNSEL • DINSMORE.COM

© 2021. ALL RIGHTS RESERVED



Hemp S ource & Wh y I t M a tter s

4


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!


• 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.


• 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?





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


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


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?


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?


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:


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

DINSMORE & SHOHL LLP / © 2021. ALL RIGHTS RESERVED

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”?)


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.


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


(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





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);


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.



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;



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.)


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


Intended Use Claims

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• 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


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


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.


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?


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?


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?





CBD P roduct S a les

30


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


• 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?





FDA & F TC Enforcement of CBD P roduct s

33


FDA Warning Letter Examples


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


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”


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”


The Dragontree Apothecary LLCApril 28, 2020

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• 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


• 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 . . ..”

DINSMORE & SHOHL LLP / © 2021. ALL RIGHTS RESERVED 40

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


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


• 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


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).


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


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


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





10 Key Ta keaways Re la ted to th e Regu la t ion of Cannab i s P roduct s

47


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.


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.

Questions?

50

Alix Davis HarrisSenior Counsel, P&G

Jennifer K. Mason

Partner, Dinsmore

© 2021. ALL RIGHTS RESERVED.

D I N S M O R E & S H O H L L L P / L E G A L C O U N S E L

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