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FDA Regulated Cannabis Douglas MacKay, ND CV Sciences Scientific and Regulatory Affairs

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Page 1: FDA Regulated Cannabis - USP...GRAS NDIN FDA pre-market approval cGMP 21 CFR Part 117 21 CFR Part 111 21 CFR Part 211 Claims taste, aroma, nutritive value Structure/function claims

FDA Regulated CannabisDouglas MacKay, ND

CV Sciences

Scientific and Regulatory Affairs

Page 2: FDA Regulated Cannabis - USP...GRAS NDIN FDA pre-market approval cGMP 21 CFR Part 117 21 CFR Part 111 21 CFR Part 211 Claims taste, aroma, nutritive value Structure/function claims

A perfect storm is an event in which a rare combination of circumstances drastically intensifies the event

Cannabis sativa L.

• Evolving state laws

• Approved prescription drug

• Federally legal hemp (2018 Farm Bill)

• Research burdens down

• Research funding up

• Third party risk going down

• Canada

• Overall Zeitgeist shift

Page 3: FDA Regulated Cannabis - USP...GRAS NDIN FDA pre-market approval cGMP 21 CFR Part 117 21 CFR Part 111 21 CFR Part 211 Claims taste, aroma, nutritive value Structure/function claims

Supplement

Regs

Botanical

SafetyFood

Regs

Patent

LawProp 65

Rx Drug

Regs

IND

Exclusion

Zeitgeist

USDA

Regs

Page 4: FDA Regulated Cannabis - USP...GRAS NDIN FDA pre-market approval cGMP 21 CFR Part 117 21 CFR Part 111 21 CFR Part 211 Claims taste, aroma, nutritive value Structure/function claims

Cannabis sativa L.

BEFORE 2018 FARM BILL

Cannabis sativa L.

EXEMPT PARTSSterile seedsStalks(No Cannabinoids)

LEGAL HEMP FOOD PRODUCTS

• Hemp Seed Oil• Hemp Protein• Hemp Flour

HEMPAgricultural Commodity

Constituents include• CBD• No THC• Other Cannabinoids

MARIJUANAControlled SubstanceConstituents include• THC• CBD• Other Cannabinoids

0.3% THC

Cannabis sativa L.

AFTER 2018 FARM BILL

Page 5: FDA Regulated Cannabis - USP...GRAS NDIN FDA pre-market approval cGMP 21 CFR Part 117 21 CFR Part 111 21 CFR Part 211 Claims taste, aroma, nutritive value Structure/function claims

Terms • Cannabis sativa L.

• Hemp (< 0.3% THC)

• Marijuana (everything else)

• Cannabinoids

• CBD

• THC

• others

• Terpenes – fragrant volatile compounds providing aromatic flavor profile

• Hemp seed products

• Hemp seed oil, flour, protein

• fatty acids and protein

• cannabinoids absent

• Hemp extracts (hemp oil, CBD oil, full-, broad-spectrum)

• Each extraction method results in unique profile of bioactive compounds

• Highly purified and isolated CBD

Page 6: FDA Regulated Cannabis - USP...GRAS NDIN FDA pre-market approval cGMP 21 CFR Part 117 21 CFR Part 111 21 CFR Part 211 Claims taste, aroma, nutritive value Structure/function claims

HEMPAgricultural Commodity

MARIJUANAControlled Substance0.3% THC

USDA regulations

Hemp Food/Supplement/Cosmetic

Legal Hemp Products

State-Based RecreationalAnd Medical

Industries

Cannabis sativa L.

Prescription Drugs

May 31, 2019

Page 7: FDA Regulated Cannabis - USP...GRAS NDIN FDA pre-market approval cGMP 21 CFR Part 117 21 CFR Part 111 21 CFR Part 211 Claims taste, aroma, nutritive value Structure/function claims
Page 8: FDA Regulated Cannabis - USP...GRAS NDIN FDA pre-market approval cGMP 21 CFR Part 117 21 CFR Part 111 21 CFR Part 211 Claims taste, aroma, nutritive value Structure/function claims

FDA regulation allows a naturally derived ingredient to co-exist as conventional food, dietary supplement, and drug

✓ Intended use dictates safety, manufacturing standards, and marketing claims

CONVENTIONAL FOOD DIETARY SUPPLEMENT PRESCRITION DRUG

Page 9: FDA Regulated Cannabis - USP...GRAS NDIN FDA pre-market approval cGMP 21 CFR Part 117 21 CFR Part 111 21 CFR Part 211 Claims taste, aroma, nutritive value Structure/function claims

Dietary Supplement

* CBD synthetic or other source = different regulatory considerations

Hemp (<0.3% THC)

Botanical Dietary Ingredient

Hemp Seed Oil

Hemp Seed Protein/Flour

Hemp Extract• ETOH• CO2• Other Method

O.D.I.

All hemp extracts are NDIs*products that were previously in the food supply legally did not contain meaningful amounts of cannabinoids because they were from seed or stalk

• CBD/CBDA • CBD Concentrated• CBD Standardized • CBD Highly Purified• CBD Isolate

Each finished dietary ingredient is unique• Safety data• Legal/regulatory considerations• NDI notification

FDA IND exclusion policy will distinguish supplement ingredients from drug ingredients

Page 10: FDA Regulated Cannabis - USP...GRAS NDIN FDA pre-market approval cGMP 21 CFR Part 117 21 CFR Part 111 21 CFR Part 211 Claims taste, aroma, nutritive value Structure/function claims

Conventional Food

Food Additive

Hulled Hemp Seed, Hemp Seed

Protein Powder, and Hemp Seed Oil

Hemp Extract• ETOH• CO2• Other Method

GRAS notified

• CBD/CBDA • CBD Concentrated• CBD Standardized • CBD Highly Purified• CBD Isolate

Each ingredient is unique• Safety data • Legal/regulatory

considerations• GRAS notified/self-

affirmed

FDA IND exclusion policy will distinguish food additive ingredients from drug ingredients. FDA may have additional limitations to ingredients allowed in the food supply as compared to supplements

Safety considerations with FDA food regulations• No ingredient ID testing• No ingredient

specifications• No potency testing• No age-restricted foods• No adverse event

reporting requirements• Matrix issues

Hemp (<0.3% THC)

Page 11: FDA Regulated Cannabis - USP...GRAS NDIN FDA pre-market approval cGMP 21 CFR Part 117 21 CFR Part 111 21 CFR Part 211 Claims taste, aroma, nutritive value Structure/function claims

CONVENTIONAL FOOD DIETARY SUPPLEMENT PRESCRITION DRUG

Raw material source Hemp Hemp Marijuana and Hemp

FDA Ingredient reg/safety standard

GRAS NDIN FDA pre-market approval

cGMP 21 CFR Part 117 21 CFR Part 111 21 CFR Part 211

Claims taste, aroma, nutritive value Structure/function claimsFDA approved

therapeutic claims

Scope of allowed cannabis ingredients

hulled hemp seed, hemp seed protein powder, and hemp seed oil

hemp extracts, hulled hemp seed, hemp seed protein powder, and hemp seed oil No limits

FDA regulation allows a cannabis derived ingredient to co-exist as conventional food, dietary supplement, and drug

✓ Intended use dictates safety, manufacturing standards, and marketing claims

Page 12: FDA Regulated Cannabis - USP...GRAS NDIN FDA pre-market approval cGMP 21 CFR Part 117 21 CFR Part 111 21 CFR Part 211 Claims taste, aroma, nutritive value Structure/function claims

State regulated recreational marijuana

• Full range of THC/CBD products, outside of FDA jurisdiction

• Limited to intra-state commerce

FDA regulated hemp products

• Food - hulled hemp seed, hemp seed protein powder, and hemp seed oil – isolated CBD?, hemp extracts?

• Dietary Supplements – USDA registered food fiber hemp extracts with NDINs – isolated CBD?

• Cosmetics – FDA compliant ingredients meeting cosmetic safety standard

FDA regulated prescription drugs

• Epidiolex and more

THREE DISTINCT CANNABIS PRODUCT CATEGORIES

The Future

1

2

3

Page 13: FDA Regulated Cannabis - USP...GRAS NDIN FDA pre-market approval cGMP 21 CFR Part 117 21 CFR Part 111 21 CFR Part 211 Claims taste, aroma, nutritive value Structure/function claims
Page 14: FDA Regulated Cannabis - USP...GRAS NDIN FDA pre-market approval cGMP 21 CFR Part 117 21 CFR Part 111 21 CFR Part 211 Claims taste, aroma, nutritive value Structure/function claims

Thank [email protected]

Douglas MacKay, ND

CV Sciences

SVP, Scientific and Regulatory Affairs


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