In this Beyond Compliance training webinar, get the most critical updates on regulations for CBDs and hemp use in edibles, beverages, and nutritional supplements from Eric Edmunds, JD, of The Acheson Group.

1. Title: CBD Regulations: Critical Updates, Trends & Strategies Food Companies Need to Know
Presented By: Eric Edmunds, JD, The Acheson Group
Date: August 21, 2019
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5. TRAINING TOPIC
Presented By: Eric Edmunds, JD
The Acheson Group
CBD Regulations:
Critical Updates,
Trends & Strategies
Food Companies Need to Know
Beyond Compliance Webinar Series

6. OBJECTIVES ● Overview of CBD Sources and Regulatory Background
● Responsibilities of Federal Agencies
● Regulatory Movement at Federal Level
● State Programs and Regulations
● Enforcement
● Considerations Moving Forward
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7. Cannabis, Hemp, THC, and CBD
● Plant of the Cannabaceae family
● Many biologically active compounds
○ Delta-9-tetrahydrocannabinol (THC)
○ Cannabidiol (CBD)
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8. 2014 Farm Bill
● “Industrial hemp” means the plant Cannabis
sativa L. and any part of such plant, whether
growing or not, with a delta-9
tetrahydrocannabinol (THC) concentration of not
more than 0.3 percent on a dry weight basis
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9. 2014 Farm Bill
● “Agricultural pilot program” means a pilot
program to study the growth, cultivation, or
marketing of industrial hemp
○ Authorized state departments of agriculture
and institutions of higher education to grow
hemp under certain conditions
○ Still unclear restrictions on hemp commerce,
including transportation and sales
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10. 2018 Farm Bill
● “Hemp” means the plant Cannabis sativa L. and
any part of that plant, including the seeds thereof
and all derivatives, extracts, cannabinoids,
isomers, acids, salts, and salts of isomers,
whether growing or not, with a delta-9-
tetrahydrocannabinol (THC) concentration of not
more than 0.3 percent on a dry weight basis
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11. 2018 Farm Bill
● Amended Controlled Substances Act (CSA)
○ Excludes “hemp” from definition of marijuana
○ Excludes THC in hemp from the term
“tetrahydrocannabinols” in Schedule 1 of
CSA
● Removed hemp from DEA oversight (in many
cases)
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12. 2018 Farm Bill
● Remove hemp from CSA
● Phase-out of the industrial hemp pilot program of
the 2014 Farm Bill
● Allows States and Indian tribes to regulate hemp
production
○ Or operate under USDA plan
● Ensure free flow of hemp in interstate commerce
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13. 2018 Farm Bill Limitations
● States and Indian tribes can still enact and
enforce laws regulating the production of hemp
that are more stringent than Federal law
○ Cannot block transit of hemp
● Felons may be subject to 10-year ineligibility
restriction
● Maintains authority of FDA to regulate hemp and
hemp products under applicable laws
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14. 2018 Farm Bill Limitations
● Hemp may be grown:
○ With a valid USDA-issued license
○ Under a USDA-approved State or Tribal plan
○ Under 2014 Farm Bill Pilot Program
■ Until 12 months after USDA establishes
hemp plan
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15. USDA
● Provided option for importing seed
○ Phytosanitary certificates for pests and seed
origin
● Drafting hemp regulations
○ Expected by fall of 2019
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16. USDA - Draft Hemp Regulations
● Record land information used for hemp
production
● Procedure for testing THC content
● Procedure for disposal of violative plants
● Enforcement procedures
● Random annual inspection of hemp producers
● Review of unapproved jurisdictions
● Certification that state or Indian tribe has
resources to fulfill duties of approved plans
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17. What about other sources of CBD?
● Bioengineered yeast that produces cannabinoids
○ Enzymatic process that turns sugar into
cannabinoids
○ THC, CBD, and more!
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18. FDA - Hemp and CBD
● Drugs
● Dietary Supplements
● Food and Beverage
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19. FDA - Drug
● Epidiolex
○ Purified form of CBD
○ Treatment of Lennox-Gastaut or Dravet syndromes
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20. FDA - Drugs
● Marinol and Syndros
○ Active ingredient dronabinol
○ Treatment of anorexia associated with
weight loss in AIDS patients
■ Synthetic THC
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21. FDA - Drug Exclusion Rule
● Applies to food and dietary supplements
● Active drug ingredients
● New drug for which substantial clinical investigations
have been instituted and have been made public
○ Investigation New Drug (IND) application
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22. FDA - Drug Exclusion Rule Exceptions
● Marketed as a dietary supplement or food before the
drug was approved?
○ Not for THC or CBD
● Other cannabis/hemp compounds?
○ Maybe
● Opportunity for a new rule to allow CBD use in
supplements/foods
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23. FDA - Dietary Supplements
● New Dietary Ingredient (NDI)
○ On the market after October 15, 1994
● Potential example from 1997 enforcement regarding
Red Yeast Rice
○ Lovastatin (cholesterol)
■ Supplements did not contain natural levels of
lovastatin
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24. FDA - Hemp and CBD in Foods
● Generally Recognized as Safe (GRAS)
Notification
○ Used in food before 1958
○ Consensus among qualified experts with
widely known information
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25. FDA - Hemp and CBD in Foods
● Food Additive Safety Determination
○ Private data submitted and evaluated by
FDA to determine safety of the ingredient
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26. FDA - Hemp and CBD in Foods
● FDA GRAS determination of “no questions” for these
ingredients under intended use
○ Trace amounts of THC and CBD
● GRAS
○ Hulled hemp seed
○ Hemp seed powder
○ Hemp seed oil
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27. FDA - Hemp and CBD in Animal Foods
● All animal food ingredients must go through food
additive petition or GRAS for the intended species
● Use Association of American Feed Control Officials
(AAFCO) publications
● No approved substances derived from hemp or formal
GRAS determinations at this time
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28. FDA - Hemp and CBD in Foods
● Potential example in fish oil?
○ Eicosapentaenoic acid (EPA) and Docosahexaenoic
acid (DCH) - active ingredient in Triglyceride
lowering drugs
○ Fish oil dietary supplements
○ Fish high in omega-3 fatty acids (salmon, tuna,
herring, etc.)
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29. FDA - Enforcement?
● History of warning letters
○ Claims to prevent, diagnose, treat, or cure serious
diseases
○ Marketed as dietary supplements or added CBD to
food
● Products cannot be adulterated or misbranded
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30. State Regulations for Hemp Cultivation
● Hemp programs in place under 2014 Farm
Bill, or underway pursuant to 2018 Farm Bill
○ Research vs. commerce confusion may
persist
○ All except Idaho, South Dakota,
Mississippi
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31. State Regulations for Cannabis Products
https://www.cannabisbusinesstimes.com/page/marijuana-legislative-map-cbt/
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32. State Regulations for CBD in Food
● Explicitly allow
○ Colorado
● Do not allow
○ California (legislation under consideration)
● Allows in certain applications
○ Washington
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33. State and Local Enforcement for CBD in Food
● Recognized some enforcement discretion
○ Differences between various state agencies and
local authorities
○ New York
■ Permissible in dietary supplements
■ NYC embargoed food and drink
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34. Regulatory Guidelines to Avoid Enforcement
Actions and Food Safety Issues
● Hemp and CBD supply-chain controls
○ Potency
○ Growing and manufacturing practices
■ Product drying and storage
○ Shipping and transport considerations
■ Still have risk of hemp vs. marijuana
investigation
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35. Regulatory Guidelines to Avoid Enforcement
Actions and Food Safety Issues
● Product Safety
○ Implement GMPs
○ 21 CFR 111-Dietary Supplements
○ 21 CFR 117-Human Preventive Controls
○ 21 CFR 507-Animal Preventive Controls
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36. Regulatory Guidelines to Avoid Enforcement
Actions and Food Safety Issues
● Labeling - DO NOT MAKE DRUG CLAIMS
○ “for chronic pain”
○ “effective in killing human breast cancer cells”
○ “linked to effective treatment of Alzheimer’s
disease”
○ “demonstrated to have properties to counteract the
growth or spread of cancer”
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37. Where Are We Going Next?
● State programs will continue to dominate “legal”
framework
● Congressional push for quick rulemaking or “formal
enforcement discretion”
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38. Where Are We Going Next?
● FDA action is slow moving but thorough
○ Public health considerations in dosing and multiple
exposures
○ Clarify consumer confusion on legality and terms of
use
■ Drugs, Dietary Supplements, and Foods possible
■ Full vs. Broad Spectrum vs. CBD Isolate vs.
Hemp oil
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39. Q & A

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