CHAPTER IV U.S. Legal Landscape
U.S. Legal Relationship between Marijuana and Industrial Hemp
Mature stalks; fiber made from mature stalks; oil or cake made from seeds; compounds, Cannabis plant and all parts and manufactures, salts, mixtures, preparations derivatives except non-marijuana or derivatives of the foregoing parts and derivatives (except resin extracted from mature stalks); sterilized seeds
Sis-
Non-Industrial Hemp
« Manufacture, distribution, dispensing « No CSA controls Cannabis plant and all parts and and possession controlled under CSA derivatives except industrial hemp * No Farm Bill exception to CSA * Farm Bill exception to CSA moot
Industrial Hemp * Manufacture, distribution, dispensing « No CSA controls and possession controlled under CSA
Cannabis plant and any part with THC (but subject to Farm Bill exception) concentration not more than 0.3% on F . . ; ; a dry weight basis « Farm Bill exception to CSA controls: « Farm Bill exception to CSA moot
state-legal cultivation by an institution of higher education or a state department of agriculture for research
Industrial hemp can be used to produce CBD oil, an extract of the cannabis plant with a high concentration of cannabidiol (CBD) but little or no psychoactive THC. CBD oil is believed to have a range of medicinal benefits and therapeutic applications. Some have argued that the Farm Bill federally legalizes the production and sale of CBD oil. However, it is unclear whether CBD oil produced from industrial hemp is itself considered industrial hemp (the CSA defines marijuana by reference to the cannabis plant, parts of the plant and derivatives of the plant, whereas the Farm Bill exception to the CSA defines industrial hemp by reference only to the plant and parts of the plant, but does not men- tion derivatives). Even if CBD oil is considered industrial hemp and may be lawfully produced under the Farm Bill, only institutions of higher education and state departments of agriculture are authorized to produce it, and then only for purposes of agricultural or academic research; thus the Farm Bill likely does not create a CSA exception broad enough for large-scale commercial production and distribution of CBD oil within the United States.
Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act (FD&C Act) is a federal law enacted in 1938 (and since amended multiple times) that authorizes the FDA to regulate the safety and effectiveness of drugs and medical devices and the safety of food, tobacco products and cosmetics. The FD&C Act prohibits the “adulteration or misbranding” of any drug, medical device, food, tobacco product or cosmetic (which the act generally refers to as “articles”) in interstate commerce and prohibits interstate commerce in any such adulterated or misbranded article. The FD&C Act also prohibits the “introduction or delivery for
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