Upgrade to Pro — share decks privately, control downloads, hide ads and more …

BEMA Convention 2019 - BakingWith Cannabis and CBD

BEMA
June 18, 2019

BEMA Convention 2019 - BakingWith Cannabis and CBD

Baking with Cannabis and CBD presentation provided by William Bogot, Esq. of Rothschild LLP at BEMA Convnetion 2019

BEMA

June 18, 2019
Tweet

More Decks by BEMA

Other Decks in Education

Transcript

  1. Baking with
    Cannabis &
    CBD

    View full-size slide

  2. © 2019 Fox Rothschild
    BAKING WITH CANNABIS AND CBD
    William Bogot, Esq.
    Partner, Fox Rothschild LLP

    View full-size slide

  3. The Controlled Substance Act (CSA)
    • The CSA establishes a comprehensive federal scheme to
    regulate controlled substances.
    • The CSA makes it unlawful to “manufacture, distribute, or
    dispense, or possess with intent to manufacture, distribute, or
    dispense any controlled substance . . . .”
    • Restrictions on the manufacture, distribution, and possession of
    a controlled substance depend on the “schedule” in which
    Congress has placed the drug.

    View full-size slide

  4. The CSA and “Marijuana”
    • From its inception, the CSA classified both “marijuana” and THC as
    Schedule I controlled substances.
    • Definition of “marijuana” (pre-2018 Farm Bill):
    – “[A]ll parts of the plant Cannabis sativa L., whether growing or not; the
    seeds thereof; the resin extracted from any part of such plant; and every
    compound, manufacture, salt, derivative, mixture, or preparation of such
    plant, its seeds or resin.”
    • Excludes: “the mature stalk of such plant, fiber produced from such stalks, oil or cake
    made from the seeds of such plant, any other compound, manufacture salt,
    derivative, mixture, or preparation of such mature stalks (except the resin extracted
    therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of
    germination.”

    View full-size slide

  5. Hemp v. Marijuana
    Cannabis Sativa L.
    (Plant)
    Hemp Marijuana
    Cannabinoids Cannabinoids
    THC < 0.3% CBD THC > 0.3% CBD

    View full-size slide

  6. Cannabidiol (CBD) Generally
    • Unlike THC, which gives users the “high” feeling, CBD is non-psychoactive.
    • Although the data is mixed, CBD may have potential clinical effects on anxiety
    disorders, movement disorders, cognition and pain.
    • CBD can be ingested/applied in multiple different ways, including:
    – Tinctures (essentially droplets of CBD-infused alcohol placed under tongue)
    – Capsules
    – Oil
    – Inhalation of smoke or vapor
    – Infused food/drink
    – Cream
    • At least one report suggests that the hemp-CBD market alone is poised to hit $22
    billion by 2022.

    View full-size slide

  7. 2014 Farm Bill
    • 2014 Farm Bill
    – Notwithstanding the Controlled Substances Act . . . or any
    other federal law,an
    institution of higher education (as defined in section
    1001 of title 20) or a state department of agriculture
    may grow or cultivate industrial hemp if—
    • (1) the industrial hemp is grown or cultivated for purposes of
    research conducted under an agricultural pilot program
    or other agricultural or academic research . . .
    • The 2014 Farm Bill defines “agricultural pilot program”
    as “a pilot program
    to study the growth, cultivation, or marketing of
    industrial hemp . . .”
    • The 2014 Farm Bill defines “industrial hemp” as the
    “plant Cannabis sativa
    L. and any part of such plant, whether growing or not,
    with a delta-9
    tetrahydrocannabinol concentration of not more than
    0.3 percent on a dry
    weight basis.”
    – DEA enacted regulations that seemed contrary, then tried to
    walk it back

    View full-size slide

  8. 2018 Farm Bill
    • 2018 Farm Bill
    1. Removed “hemp” from CSA definition of “marijuana”
    • Defines “hemp” as “the plant Cannabis sativa L. and any part of that plant,
    including the seeds thereof and all derivatives, extracts, cannabinoids, isomers,
    whether growing or not, with a [THC] concentration of not more than 0.3
    percent on a dry weight basis.”
    2. Gave primary regulatory authority to states
    • If a state does not regulate, then federal regulations govern
    3. Forbids states from interfering with interstate shipment of hemp
    4. Does not affect the Food, Drug, and Cosmetic Act, among other
    things, as well as the authority of the FDA to promulgate regulations
    and guidelines under the FD&C Act

    View full-size slide

  9. 2018 Farm Bill: Interstate Transportation
    • (a) RULE OF CONSTRUCTION – Nothing in this title or an
    amendment made by this title prohibits the interstate commerce
    of hemp (as defined in section 297A of the Agricultural
    Marketing Act of 1946) or hemp products
    • (b) TRANSPORTATION OF HEMP AND HEMP PRODUCTS -
    No State or Indian Tribe shall prohibit the transportation or
    shipment of hemp or hemp products produced in accordance
    with subtitle G of the Agricultural Marketing Act of 1946
    through the State or the territory of the Indian Tribe, as
    applicable

    View full-size slide

  10. 2018 Farm Bill: Interstate
    Transportation
    (cont.)
    • What constitutes hemp or hemp products produced in accordance with
    subtitle G under 2018 Farm Bill?
    – Hemp grown with a valid USDA issued license
    • Waiting for USDA regulations to be issued in the fall and licenses provided
    – Hemp grown under a USDA-approved State or tribal plan
    • Waiting for USDA regulations to be issued in the fall and state plans to be approved
    – Hemp grown under the 2014 Farm Bill
    • This provisions expires one year after the USDA issues its 2018 Farm Bill regulations
    – Big Sky Scientific v. Idaho State Police, et al.
    • Lower Court relied on 2018 Farm Bill and lack of federal regulatory plan to prohibit trucking of
    hemp through Idaho
    • Appeal reasserts 2014 Farm Bill
    – Question as to whether 2014 Farm Bill allows commercial activity

    View full-size slide

  11. 2018 Farm Bill: Interstate
    Transportati
    on (cont.)
    • State laws enacted post-2018 Farm Bill generally allow hemp
    products produced in their states to be sold commercially both
    within and outside their states (e.g., Illinois Industrial Hemp Act
    and regulations, 8 Ill. Admin. Code 1200.90(c)).
    • June 13, 2019 U.S. Postal Service Notice allowing the shipment
    of hemp derived CBD oil and CBD other products through the
    U.S. mail.

    View full-size slide

  12. FDA Implications for Interstate Commerce
    • Federal Food, Drug, and Cosmetic Act (FD&C Act)
    – 2018 Farm Bill preserved the FDA’s current authority to regulate
    products containing hemp-CBD under the FD&C Act.
    – FDA issued a statement on hemp-CBD products that reiterated
    treatment of CBD as a “drug” and not a “dietary supplement” under the
    FD&C Act, but suggested that this may change in the near future.
    • Epidiolex
    • Sale of a “drug,” including food containing the “drug,” requires FDAregulatory
    approval

    View full-size slide

  13. FDA Implications for Interstate
    Commerce
    (cont’d)
    • Federal Food, Drug, and Cosmetic Act (FD&CAct)
    – The FDA statement recognized “growing public interest in [CBD],” as well as
    “the potential opportunities that cannabis or cannabis-derived compounds
    could offer...”
    – The FDA statement committed to making the pathways for marketing CBD
    products more efficient.
    – FDA’s April Q & A distinguishes and applies differing interstate commerce
    standards for hemp-based food products, hemp-based CBD food products,
    dietary supplements and cosmetics. (https://www.fda.gov/news-events/public-
    health-focus/fda-regulation-cannabis-and-cannabis-derived-products-
    questions-and-answers)

    View full-size slide

  14. FDA Implications for Interstate
    Commerce
    (cont’d)
    • FDA Enforcement
    – FDA enforcement priorities appear to be focused on vendors that are making
    serious health claims about their CBD products.
    • For example, “CBDs are effective against MRSA”
    – In those cases, the FDA issued warning letters.
    – FDA warning letters typically allow for post-warning compliance without
    penalty or fine.
    • FDA’s May 31 meeting

    View full-size slide

  15. © 2019 Fox Rothschild
    William Bogot, Esq.
    312-517-9205
    [email protected]
    FOX ROTHSCHILD, LLP
    California | Colorado | Connecticut | Delaware | DC | Florida | Georgia |
    Illinois | Minnesota | Nevada | New Jersey | New York | North Carolina |
    Pennsylvania | South Carolina | Texas | Washington

    View full-size slide