Mistakes made during promoting medical marijuana and the FDA oversight that keeps medical marijuana companies compliant

1. Non FDA Compliant Marijuana
Promotions
DARSHAN KULKARNI
PHARM.D, MS, ESQ
VICE PRESIDENT, REGULATORY
STRATEGY & POLICY
SYNCHROGENIX, A CERTARA COMPANY

3. Is this ok?
Your CEO Bob goes to a
medical cannabis
conference and discusses
their breakthrough Natural
Cannabis remedy that helps
with headaches.
Your CEO Anne, who is a
medical Doctor goes to the
American Diabetes
Association and talks about
the impact of medical
cannabis on depressing
rising blood sugar levels.
You have decided to
conduct clinical trials and
your CRO promotes the
amazing results your
CBD/THC therapy is having
on patients with pain.
Your CEO Bob goes to a
medical cannabis
conference and discusses
their breakthrough Natural
Cannabis remedy that helps
with headaches.

4. OUTLINE OF PRESENTATION
• Jurisdiction
• Examples of Problems
• Federal Law
• State Law
• Label v Labeling
• Who Says it, to Whom and Why
• Distinctions:
• Types of Advertisements
• Enforcement Actions

6. Claims Made
•“CBD .[has] anti-proliferative
properties that inhibit cell
division and growth in certain
types of cancer, not allowing
the tumor to grow.”
•“CBDs are effective against
MRSA (antibiotic-resistant
bug)”
•“Adding CBD oil as part of
your daily Alzheimer’s
medicine routine has a good
chance at delaying the
progression of the disease…”
“as a Type 1 diabetic, my
blood sugars have noticeably
leveled off.”
“[CBD] has antipsychotic
properties, which makes it
very useful for treating bipolar
disorder.”
The following are some of the
many ailments CBD oil can
potentially be therapeutic
for: asthma, Alzheimer’s
disease, arthritis, autism,
bipolar disorder, various types
of cancer . . .

7. Mission

8. What is a drug?
The term ‘‘drug’’ means
(A) articles recognized in the official United States
Pharmacopoeia, official Homoeopathic Pharmacopoeia of
the United States, or official National Formulary, or any
supplement to any of them; and
(B) articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man
or other animals; and
(C) articles (other than food) intended to affect the structure or
any function of the body of man or other animals; and
(D) articles intended for use as a component of any article
specified in clause (A), (B), or (C).
21 USC 321

9. • Prescription Drugs - OPDP
• Prescription Biologics - APLB
• Medical Devices - CDRH
JURISDICTION OVER ADS FOR TYPES OF PRODUCTS

10. JURISDICTION OVER TYPES OF ADS
OTC ProductsPrescription Products

11. State Laws around Medical Cannabis
Marketing
Pennsylvania
… a medical marijuana organization shall be consistent with the
Federal regulations governing prescription drug advertising and
marketing in 21 CFR 202.1
California
A person who participates in the illegal marketing of marijuana is
liable for civil damages caused by these actions.
Colorado
A Medical Marijuana Business shall not engage in Advertising that is
deceptive, false, or misleading. A Medical Marijuana Business shall
not make any deceptive, false, or misleading assertions or
statements on any product, any sign, or any document provided to a
consumer.

12. Label v Labeling
● FDA generally recognizes two types of labeling:
○ FDA-required labeling and
○ promotional labeling.

13. Labeling
● The U.S. Supreme Court has explained that the language
“accompanying such article” in the “labeling” definition is
interpreted broadly, to include materials that supplement or
explain an article. No physical attachment between the
materials and the article is necessary; rather, it is the
textual relationship between the items that is significant.
● Promotional labeling is generally any labeling, other than
the FDA-required labeling, that is devised for promotion of
the product.

14. 3 Factor Test
Who said it?
To Whom?
Why?

15. Promotion
● All communications must ALWAYS be for a labeled use.

16. • Disease Awareness/ Help Seeking Ad
• Reminder Ad
• Product Claim
TYPES OF ADVERTISEMENTS

17. HELP SEEKING AD
Do you have intractable seizures?
Do you have 2-4 seizures within a 24 hour period?
Do your seizures not respond to medications?
There is help.
Talk to your doctor for options that may be right for you
443 Aramingo Ave,
Philadelphia, PA

18. • NOT a product ad
• Regulated by FTC
• Does not show a drug
• Shows symptoms
without identifying
product
• Can name a
company/phone/
website
• Recommends talking
to HCP
HELP SEEKING AD
Goal:
Increase awareness of disease
Do you have intractable seizures?
Do you have 2-4 seizures within a 24 hour period?
Do your seizures not respond to medications?
There is help.
Talk to your doctor for options that may be right for you
443 Aramingo Ave,
Philadelphia, PA

19. WHAT’S WRONG HERE?
HELP SEEKING AD
Do you have 2-4 seizures within a 24 hour period?
Do your seizures not respond to medications?
There is help.
Talk to your doctor for options that may be right for you
443 Aramingo Ave,
Philadelphia, PA
Do you have intractable seizures?
For all your medical
cannabis needs

20. REMINDER AD
443 Aramingo Ave,
Philadelphia, PA
215.312.4482
Talk to your doctor about the
Zibos sour diesel strain?
For all your medical
cannabis needs

21. REMINDER AD
• Focuses on the
product name.
• Does not
describe/name/hint at
the condition.
Goal:
Remind existence of Rx
443 Aramingo Ave,
Philadelphia, PA
215.312.4482
Talk to your doctor about the
Zibos sour diesel strain?
For all your medical
cannabis needs

22. WHAT’S WRONG HERE?
REMINDER AD
Do you have 2-4 seizures within a 24 hour period?
Do your seizures not respond to medications?
There is help.
Talk to your doctor about Zibos sour diesel strain that may be right for you
443 Aramingo Ave,
Philadelphia, PA
Do you have intractable seizures?
For all your medical
cannabis needs

23. PRODUCT CLAIM AD
443 Aramingo Ave,
Philadelphia, PA
215.312.4482
Curing your intractable
seizures
For all your medical
cannabis needs
Zibos Sour Diesel has been known to cause sleepiness, hunger and
may result in unexpected seizures from time to time.

24. PRODUCT CLAIM AD
● Risks & Benefits
● Name + Amt. in each
unit
● Substantiated claims
● Risks
● Cant be
false/misleading
● Fair balance
● Includes material facts
● Risk disclosure varies
depending on medium
● Prescription only
● Brief Summary
● Ask your Doctor...
● Source of Further
information
Goal:
Inform about Drug
443 Aramingo Ave,
Philadelphia, PA
215.312.4482
Curing your intractable seizures
For all your medical
cannabis needs
Zibos Sour Diesel has been known to cause sleepiness, hunger and
may result in unexpected seizures from time to time.
For further information call 1888-222-1577 Ask your Doctor for information that is right for you
10mg

25. PRODUCT CLAIM AD
WHAT’S WRONG HERE?
443 Aramingo Ave,
Philadelphia, PA
215.312.4482
Curing your intractable seizures
For all your medical
cannabis needs
Zibos Sour Diesel has been known to cause sleepiness, hunger and
may result in unexpected seizures from time to time.
For further information call 1888-222-1577 Ask your Doctor for information that is right for you
10mg

26. Xeno, Inc
Is this ok?
A customer writes a
comment on your
facebook page and talks
about how your product
helped his son manage
his Fabrys disease.
Your CEO Dr. Bob goes to
a medical cannabis
conference and discusses
their breakthrough Natural
Cannabis remedy that
helps with headaches.

27. • Omissions
• Broadening
• Unsubstantiated Claims
• Overstatements
• Inadequacy
• Misleading
• Failures
• Miscellaneous
MAJOR ENFORCEMENT FINDINGS

28. • Omission of Indication
and Risk Information
• Omission / Minimization
of Risk Information
• Omission of
Material Fact
OMISSIONS

29. • Broadening of Indication
BROADENING
Headaches
caused post
intractable
seizures

30. • Unsubstantiated Safety
Superiority Claims
• Unsubstantiated Efficacy
Superiority Claims
• Unsubstantiated Convenience
Superiority Claims
• Unsubstantiated Claims
• Unsubstantiated Comparative
Claims
UNSUBSTANTIATED
Cannabis

31. • Overstatement of Efficacy
OVERSTATEMENT
“Cannbis cured epilepy for patients who were resistant to drugs”

32. • Misleading Product
Claim Promotion
• Misleading Patient
Preference Claims
MISLEADING

33. • Letters noting violations
• Warning Letters
• Fines
• Seizure
• Injunction
• Prosecution of the Company
• Criminal Prosecution of Individuals
ENFORCEMENT OPTIONS