Due to regulatory changes triggered by the 2018 Farm Bill, the use of hemp and CBD in food and beverage products will now be addressed by the FDA. This webinar clarifies which hemp and CBD products are legal in the US and unpacks the implications for interstate commerce. By drawing insightful comparisons to the way the FDA ruled on the drug Epidiolex, Eric Edmunds, JD, Food Safety Director at The Acheson Group, illuminates the path that the FDA is most likely to follow regarding its future handling of hemp-derived products that are used in food and dietary supplements in the United States.

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Agenda
HELPFUL TIPS
Informal but professional format
Ask Questions (Q&A at end)
Only panelists are displayed
Recording link will be shared
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WHAT WE WILL COVER
FSMA News & Updates
FDA Focus: Hemp and CBD
Audience Q&A

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Presenters
Brian Sharp
President
Eric Edmunds, JD
Food Safety Director

6. FSMA NEWS

7. FSMA FOCUS

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2014 Farm Bill
State Pilot Programs for Industrial Hemp
2018 Farm Bill (December 20, 2018)
Removal of Industrial Hemp from Controlled Substances Act (CSA)
Drug Enforcement Administration (DEA)
FDA: Hemp and CBD

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Industrial Hemp
“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.”
FDA: Hemp and CBD

10. FDA Public Statement
Unlawful to introduce food or dietary supplements containing CBD or THC
into interstate commerce, or to market CBD or THC products regardless of
whether the substances are hemp-derived
Drug approval of Epidiolex
Previous warning letters
Drug claims
Used to prevent, diagnose, treat, or cure diseases
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FDA: Hemp and CBD

11. Pathways to legal sales
Formal drug approval process
FDA does have authority to allow the use of a pharmaceutical ingredient to
food or dietary supplements
Some foods can be derived from parts of the hemp plant that may not
contain CBD or THC
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FDA: Hemp and CBD

12. Evaluation GRAS petitions of three hemp seed-derived ingredients
Hulled hemp seed
Hemp seed powder
Hemp seed oil
FDA determination of “no questions” about conclusion that these ingredients are GRAS
under their intended use
Do not naturally contain THC
Contain only trace amounts of THC and CBD
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FDA: Hemp and CBD

13. Historical examples?
 Red rice yeast and lovastatin vs. Hemp and CBD
 1987 approval of lovastatin
 2018 approval of Epidiolex
 FDA enforcement of dietary supplements containing lovastatin (1997)
 Legal battle followed, and declared dietary supplements did not contain natural levels of
lovastatin and could not be considered a dietary supplement
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FDA: Hemp and CBD

14. Future of Hemp and CBD products
Naturally derived hemp products with out any individual compounds or component
amplification will likely be considered GRAS
FDA recognizes substantial public interest in the topic, and intends to hold public meetings
and evaluate its duty to protect public health and take enforcement actions when necessary
Major issues to consider now:
Sources of hemp derived products and final product evaluation
Broad/Full Spectrum Hemp Oil
Items determined to be GRAS
CBD Oil
Claims made on product labels and potentially misleading information
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FDA: Hemp and CBD

15. Q & A

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