Hemp provision in 2014 Farm Bill seen as opening the way for research

By R. Scott Nolen

Posted July 11, 2018

Shape of a marijuana leaf inside a yellow caution sign More than half the country has legalized marijuana use in one form or another.

The decriminalization movement that started with California in 1996, when it was the first to establish a medical marijuana program, has given birth to a legally ambiguous cannabis market with a projected value of $25 billion by 2025.

Despite the dramatic shift in public opinion and state policies over the past two decades, little conclusive evidence exists concerning the short- and long-term health effects of a drug that, according to one nationwide survey, was used by 22.2 million Americans during a 30-day period in 2014.

One explanation for the lack of cannabis research is the federal classification of cannabis as a schedule I controlled substance. The most restrictive of the Controlled Substances Act categories, schedule I applies to drugs with no known medical benefits and a high potential for abuse, such as heroin and LSD.

The farm bill passed by Congress in 2014 included a provision that legalized the growing and cultivating of industrial hemp for research purposes under certain conditions. The law defined industrial hemp as all parts of the marijuana plant (Cannabis sativa L.) containing less than 0.3 percent tetrahydrocannabinol. THC is one of 104 cannabinoids identified in the marijuana plant and the substance responsible for the psychotropic experience in human users.

Laws regulating the approval process for prospective pharmaceutical products and the criteria to conduct research on such products were not amended, however. Neither did any change occur in the Controlled Substances Act itself, which governs the manufacture, distribution, and dispensing of controlled drug products.

Those wishing to study the effects of cannabis or cannabinoids must navigate a challenging process that may involve the National Institute on Drug Abuse, Food and Drug Administration, Drug Enforcement Administration, offices or departments in their state's government, state boards, their home institution, and potential funders.

Some researchers have viewed the process as sufficiently onerous that it dissuades them from proceeding, while others have negotiated it successfully. In late June, the FDA approved Epidiolex, the nation's first drug derived from marijuana, for the treatment of seizures associated with two rare and severe forms of epilepsy in humans.

Still other researchers are studying cannabis in animal patients without explicit FDA and DEA approval, but in a manner they contend complies with federal and state law.
Clinical studies

are here

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