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54 The US-Israel Legal Review 2019
US: CANNABIS LAW
Secretary of Agriculture. Penalties for violations
under the state and federal plans are nearly
identical. For negligent violations, the producer
must correct the conduct and periodically report
to the state for a period of two years. There are no
criminal penalties for negligent violations, even if
the violation involves producing Hemp with a THC
content of more than 0.3 percent. However, repeat
offenders will be referred to the state’s chief law
enforcement officer or the US Attorney General.
For now, until one year after the federal
government establishes a federal plan, the 2014
FarmBill remains in effect. That said, nothing in the
2018FarmBill suggests the2014FarmBill prohibits
selling Hemp-CBD. We recommend operating under
existing state laws regarding Hemp-CBD where
possible and modifying operations as state and
federal plans are approved.
FDA TAKES OVER FROM DEA
The 2018 Farm Bill provides the US Secretary of
Agriculture with the sole authority to develop
regulations and guidelines for the production
of Hemp, and requires that such regulations be
promulgated “as expeditiously as possible.” This
shifts enforcement and regulatory authority away
from the DEA to the Food and Drug Administration
(FDA). The bill also expressly states that it does
not prohibit interstate Hemp commerce, and
forbids states from prohibiting the transportation
or shipment of Hemp or Hemp products, including
Hemp-CBD, through the state if produced in
accordance with the 2018 Farm Bill. This includes
states that have not adopted their own plans.
Finally, the bill does not affect the FD&C Act or the
authority of the Commissioner of Food and Drugs
to promulgate regulations under the Act. This
means Congress explicitly preserved the FDA’s
current authority to regulate products containing
cannabis or cannabis-derived compounds under
the FD&C Act.
KEY LAW: FOOD DRUG AND COSMETIC ACT
The FD&C Act establishes a comprehensive
federal scheme for the regulation of food, drugs
and cosmetics, among other products. Included in
that scheme is a prohibition against introducing
new drugs into interstate commerce without
first meeting certain regulatory approvals. The
act also prohibits the introduction of adulterated
or misbranded drugs into interstate commerce.
Following the passage of the 2018 Farm Bill, the
FDA issued a statement clarifying its position on
the regulation of products that contain cannabis
and cannabis-derived products.
The statement starts by saying the FDA will treat
“products containing cannabis or cannabis-derived
compounds” as it does any other FDA-regulated
product, regardless of the source of the substance. It
goes on to recognize the “growing public interest” in
cannabis and cannabis-derived products, including
CBD, and the potential opportunities that presents.
The FDA also promises it will “continue to take steps
to make the pathways for the marketing of these
productsmore efficient,” but thismay take as long as
18-24 months, according to a recent report.
WATCH HEALTH CLAIMS
It is worth noting that the statement asserts that
“cannabis and cannabis-derived products claiming
in their marketing and promotion materials that
they are intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of diseases
(such as cancer, Alzheimer’s disease, psychiatric
disorders and diabetes) are considered new drugs
or new animal drugs and must go through the
FDA drug approval process for human or animal
use before they are marketed in the US” It also
emphasizes that it is unlawful under the FD&C Act
to introduce food containing added CBD or THC
into interstate commerce, or to market CBD or THC
products as, or in, dietary supplements … because
both are active ingredients in FDA-approved drugs
Companies wishing tomarket
Hemp or Hemp-derived CBD
products must ensure they
contain nomore than a 0.3
percent concentration of THC.