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11. In making the two previous determinations about THC, why did FDA conclude that THC is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act? In making the two previous determinations about CBD, why did FDA determine that substantial clinical investigations have been authorized for and/or instituted, and that the existence of such investigations has been made public?

6. What is FDA’s reaction to states that are allowing cannabis to be sold for medical uses without the FDA’s approval?

Regulatory Resources

[3] Hayatbakhsh, et al. Birth Outcomes associated with cannabis use before and during pregnancy. Pediatric Research. 2012; 71 (2): 215-219.

10. Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?

FDA Communications

The study of cannabis and cannabis-derived compounds in clinical trial settings is needed to assess the safety and effectiveness of these substances for the treatment of any disease or condition. FDA’s December 2016 Guidance for Industry: Botanical Drug Development provides specific recommendations on submitting INDs for botanical drug products, such as those derived from cannabis, in support of future marketing applications for these products. The agency’s July 2020 draft guidance, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry, highlights quality considerations for anyone wishing to conduct clinical research in this area, particularly those who are less familiar with the FDA.

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Cannabidiol or CBD is made legal—under specific circumstances

Second, there will be significant, shared state-federal regulatory power over hemp cultivation and production. Under section 10113 of the Farm Bill, state departments of agriculture must consult with the state’s governor and chief law enforcement officer to devise a plan that must be submitted to the Secretary of USDA. A state’s plan to license and regulate hemp can only commence once the Secretary of USDA approves that state’s plan. In states opting not to devise a hemp regulatory program, USDA will construct a regulatory program under which hemp cultivators in those states must apply for licenses and comply with a federally-run program. This system of shared regulatory programming is similar to options states had in other policy areas such as health insurance marketplaces under ACA, or workplace safety plans under OSHA—both of which had federally-run systems for states opting not to set up their own systems.

One big myth that exists about the Farm Bill is that cannabidiol (CBD)—a non-intoxicating compound found in cannabis—is legalized. It is true that section 12619 of the Farm Bill removes hemp-derived products from its Schedule I status under the Controlled Substances Act, but the legislation does not legalize CBD generally. As I have noted elsewhere on this blog CBD generally remains a Schedule I substance under federal law. The Farm Bill—and an unrelated, recent action by the Department of Justice—creates exceptions to this Schedule I status in certain situations. The Farm Bill ensures that any cannabinoid—a set of chemical compounds found in the cannabis plant—that is derived from hemp will be legal, if and only if that hemp is produced in a manner consistent with the Farm Bill, associated federal regulations, association state regulations, and by a licensed grower. All other cannabinoids, produced in any other setting, remain a Schedule I substance under federal law and are thus illegal. (The one exception is pharmaceutical-grade CBD products that have been approved by FDA, which currently includes one drug: GW Pharmaceutical’s Epidiolex.)

Redefining Urban and Suburban America

This week, Congress agreed to the final version of the 2018 Farm Bill, and President Trump is expected to sign the legislation within days. But this is not your typical farm bill. While it provides important agricultural and nutritional policy extensions for five years, the most interesting changes involve the cannabis plant. Typically, cannabis is not part of the conversation around farm subsidies, nutritional assistance, and crop insurance. Yet, this year, Senate Majority Leader Mitch McConnell’s strong support of and leadership on the issue of hemp has thrust the cannabis plant into the limelight.

However, the new Farm Bill does not create a completely free system in which individuals or businesses can grow hemp whenever and wherever they want. There are numerous restrictions.

12 things we know (and don’t know) about Bernie Sanders’s marijuana proposal

The allowed pilot programs to study hemp (often labeled “industrial hemp”) that were approved by both the U.S. Department of Agriculture (USDA) and state departments of agriculture. This allowed small-scale expansion of hemp cultivation for limited purposes. The 2018 Farm Bill is more expansive. It allows hemp cultivation broadly, not simply pilot programs for studying market interest in hemp-derived products. It explicitly allows the transfer of hemp-derived products across state lines for commercial or other purposes. It also puts no restrictions on the sale, transport, or possession of hemp-derived products, so long as those items are produced in a manner consistent with the law.

McConnell understood much about this issue. First, he knows hemp doesn’t get you high and that the drug war debate that swept up hemp was politically motivated, rather than policy-oriented. Second, Kentucky—the leader’s home state—is one of the best places to cultivate hemp in the world, and pre-prohibition the state had a robust hemp sector. Third, the grassroots interest in this issue was growing in Kentucky, and McConnell knows that his role as Senate Majority Leader hangs in the balance in 2020, as does his Senate seat as he faces re-election that same year. McConnell emerges from the Farm Bill as a hemp hero, but advocates should be hesitant to label him a cannabis champion; Leader McConnell remains a staunch opponent of marijuana reform and his role in the Senate could be the roadblock of Democratic-passed legislation in the 116 th Congress.