Cannabis & Hemp Research

CANNABIS / HEMP RESEARCHER DATABASE

FDA STATEMENT ON CBD FROM HEMP

The Controlled Substances Act criminalizes the possession, growing and use of Cannabis sativa without registration with the Drug Enforcement Administration for a schedule 1 controlled substance. Until the passage of the Agricultural Improvement Act of 2018 (Farm Bill), high THC cannabis and low THC cannabis aka hemp were both classified as a schedule 1 drug “marihuana.” While the Farm Bill did remove hemp, which is cannabis having a THC level no higher than 0.3%, from Schedule 1, hemp continues to be subject to signification controls and restrictions.

The purpose of this document is to provide guidance and direction with respect to cannabis and hemp to CSU administrators, researchers, and employees, as well as communication to the greater (public) community by providing FAQs. Questions about this topic can be directed to Linda Schutjer, Senior Legal Counsel, (970) 491‐6270

Frequently Asked Questions & Guidelines

Hemp Research

  1. What is hemp? Hemp is defined by the state of Colorado and the Farm Bill as the plant Cannabis sativa L. and any part of such plant with an average delta‐9 tetrahydrocannabinol ‐‐ or THC -‐ concentration of 0.3 percent or less, on a dry weight basis. Testing is done on hemp that has been through decarboxylation to “activate” any THC. Hemp now also includes hemp “extracts, cannabinoids and derivatives.”
  2. What is CBD?CBD stands for cannabidiol which is one of over 100 cannabinoids found in the cannabis plant, including hemp. Unlike THC, CBD does not have a psychoactive effect (i.e. the “high”). It appears to have other effects and it is contained in an FDA approved drug, Epidiolex, which is used to treat certain kinds of childhood epilepsy.
  3. Does the Federal Government have any jurisdiction over hemp now?The Farm Bill explicitly preserved the Food and Drug Administration’s (FDA) authority to regulate products containing cannabis, including hemp. Additionally, the DEA will assert jurisdiction over materials derived from high THC marijuana even if the materials themselves contain less that 0.3% THC.
  4. What does the FDA regulations provide with respect to hemp?The FDA has the authority under the Federal Food, Drug and Cosmetic Act and Section 351 of the Public Health Service Act to regulate products containing cannabis or cannabis-derived products. The FDA has statement that CBD and THC are active ingredients in an FDA approved drug (Epidiolex) and as such, it is illegal to introduce these ingredients into the food supply through interstate commerce or to market them as a dietary supplement. If a hemp derived product, including those containing CBDs, is marketed for human or animal use in such a way as to include claims of therapeutic benefit, absent FDA approval, that is a violation of law.
  5. What about animal food? I know that for example birdseed contains hemp seeds.The FDA has identified hulled hemp seeds, hemp seed protein and hemp seed oil as Generally Recognized as Safe. So, these materials can be freely used including in products that cross state lines, including animal and bird feed and even products for human consumption. Note that claims of health or other benefits may still not be used in marketing absent FDA approval.
  6. I still need to register with the Colorado Department of Agriculture to grow hemp?Yes. Registration and compliance with State law is still required. The Farm Bill specifies that state departments of agriculture must submit to the USDA a plan to license and regulate hemp cultivation. Upon approval of that plan, the state can them start issuing grow licenses.
  7. What hemp‐based research can be performed at CSU?At this time, there are no limits on hemp research at CSU so long as the material being used has a THC concentration of no more than 0.3 percent and was grown or derived from hemp that was lawfully grown. Research that involves growing hemp will require registration with the Colorado Department of Agriculture and compliance with their hemp testing program.
  8. Can I perform research that involves the consumption by humans or animal of hemp or hemp derived materials?Although food products containing hemp or hemp derived materials cannot be transported across state lines, there is nothing within the State of Colorado which limits research that involves consumption of hemp or hemp derived materials. Of course, appropriate IRB or IACUC approvals must be secured.
  9. Can CSU researchers or extension agents provide advice and assistance to non‐university hemp growers inside and external to the state of Colorado?CSU researchers and extension agents may provide advice to Colorado farmers cultivating hemp who are registered under the Colorado Department of Agriculture registration program; however, CSU researchers and extension agents may NOT assist cultivators of marijuana.
  10. CSU researchers use non‐CSU subcontractors to grow hemp for research purposes?Yes, as long as they are properly registered with the Colorado Department of Agriculture.
  11. CSU researchers obtain hemp products from third parties for research or analytical service purposes?Yes, provided the third party is properly registered with the Colorado Department of Agriculture or show that the products were derived from hemp that was lawfully grown.
  12. Can a CSU grower obtain viable hemp seed from any source?It would appear so. Historically the Colorado Department of Agriculture was responsible for importing seed into the US. It appears now that since hemp is no longer a scheduled drug, anyone should be able to import seed. Note that you may still need to obtain import licenses or other approvals. For example, the Animal and Plant Health Inspection Service (APHIS) will generally require an agricultural import permit and a phytosanitary certificate. There are no restrictions on the transport of hemp or hemp derived products across state lines if they were produced in compliance with the Farm Bill and state law.
  13. Can CSU researchers perform hemp research funded by industry?Yes, provided that the funding does not come from an entity or individual involved in the marijuana industry.
  14. Can CSU license intellectual property rights resulting from hemp research?Yes.

Marijuana Research

  1. Can CSU researchers perform marijuana research?

    Yes, but such research must be performed only after obtaining  a DEA schedule 1 registration of a controlled substance.

  2. Can CSU researchers provide marijuana samples, extracts, derivatives, or DNA materials to other labs at CSU or entities external to the university?

    No, unless such transfer occurs to another schedule 1 holder, and is otherwise permissible under state and federal rules.

  3. How can a CSU researcher apply for schedule 1 registration?

    Individual PIs may register with the DEA for a schedule 1 controlled substance by following the CSU procedures established through Environmental Health Services found online at   http://www.ehs.colostate.edu/WControlledSub/Home.aspx (see Chris Giglio for assistance).

  4. How long does it take to obtain DEA approval for a schedule 1 controlled substance?

    According to reports from CU and other institutions, the approval process is a lengthy process, sometimes requiring six to 12 months in total. CSU researchers interested in perform marijuana research should apply as soon as possible for a schedule 1 due to this time delay in approval. Grants awarded for marijuana research will be declined if the schedule 1 is not in place at time of award.

  5. Can CSU researchers perform research related to marijuana that does not require the handling of marijuana material?

    Yes, research or analysis on data, including economic analyses, human and animal clinical trials, and literature searches are allowable without a schedule 1 where marijuana does not come into the possession of the researcher.

  6. Can a CSU researcher who maintains a DEA schedule 1 permit handle hemp materials falling under the Final Rule or the Farm Bill in the same facility?

    Yes, provided that all schedule 1 rules and protocols are followed for those materials handled in such lab categorized as a schedule 1 controlled substance.

  7. Does CSU accept gifts from those in the marijuana industry?

    No, CSU cannot accept funds from the marijuana industry.