News and information useful to Cleveland-Marshall College of Law students, faculty and staff.


FDA Holds Public Hearing & Opens Public Docket on Cannabis-Derived Compounds

graphic of CBD oilThe U.S. Food and Drug Administration (FDA) recently held a public hearing on cannabis-derived compounds, including cannabinoids, such as cannabidiol (CBD).  The hearing was prompted by industry confusion since the passage of the Agriculture Improvement Act of 2018 (AIA; Pub. L. No. 115-334).  The AIA excluded hemp from the statutory definition of marijuana (a controlled substance), and expanded the definition of hemp to “Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” [See The 2018 Farm Bill (P.L. 115-334): Summary and Side-by-Side Comparison, Congressional Research Service R45525, updated 2/22/19.]  The FDA continues to classify cannabis-derived compounds as “unsafe,” but the FDA has taken little action to remove such products from the marketplace.  The recent FDA public hearing provided a forum for “stakeholders to share their experiences and challenges with products containing cannabis and cannabis-derived compounds, including information and views related to the safety of such products, as well as to solicit input relevant to the agency’s regulatory strategy related to existing products.”  The FDA has also opened a public docket on regulations.gov, and the docket will be open until 7/16/19.  For additional information see the FDA Regulation of Cannabis and Cannabis-Derived Products page.

Research Resources for Your Summer Classes & Work

photo of law clerk using laptopThe C|M|Law Library provides a range of research resources that can help you do the best in your summer classes and at work.  You can contact us with research questions in-person during Research Services Hours, or via email or chat.  Our Research Guides provide information on and links to materials, websites, and databases addressing over 60 legal topics.  C|M|Law and CSU students can schedule a Research Consultation for in-depth assistance with topical legal research or when writing an upper-level paper or journal note.  C|M|Law students can also access Law Library Legal Research Seminars, which address major legal databases, terms and connectors searching, Bluebooking, administrative law, Federal legislative history, free web research, bioethics and scholarly writing.  Our Seminars are continuously available on the Westlaw TWEN platform.  If you want to earn points, complete that Seminar’s quiz.  When you earn 100 points, you are awarded a “Law Library Legal Research Letter of Recognition” and a Digital Badge, which you can post to your LinkedIn page.  Seminar points are good for the entire time you are here at C|M|Law, and you can earn multiple Letters of Recognition and Digital Badges.

Ohio Appellate Court Rules Frozen Embryos Are Not “Persons”

Photo of Ohio 8th District Court of Appeals buildingThe Eighth District Court of Appeals of Ohio recently ruled that frozen embryos are “not capable of independent survival” and “not considered to be persons under the law.” [See Penniman v. Univ. Hosps. Health Sys., Inc., 2019-Ohio-1673.]  The case is related to the March 2018 loss of over 4,000 frozen eggs and embryos after the malfunction of a storage tank at the University Hospitals Health Systems (UHHS) Fertility Center.  The plaintiffs-appellants, Wendy and Rick Penniman, lost one or more of their embryos in that storage tank malfunction, and had “sought a declaratory judgment that human life begins at conception and thus their embryos constitute persons under Ohio law in order to pursue a wrongful death claim against UHHS.”  The Court affirmed the judgment of the Cuyahoga County Court of Common Pleas dismissal of the Penniman’s declaratory judgment action.

CDC Clarifies Guidelines for Prescribing Opioids for Chronic Pain

Photo of 2 opioid prescription bottlesThe U.S. Centers for Disease Control and Preventions recently released a letter clarifying its 2016 Guideline for Prescribing Opioids for Chronic Pain.  The letter is actually dated 2/28/19, and was written by Deborah Dowell, MD, Chief Medical Officer, CDC National Center for Injury Prevention and Control, and a co-author of the 2016 Guideline.  The clarification letter addresses concerns of physicians caring for patients with cancer, sickle cell disease, and other serious illnesses.  Treatment options for pain are often being limited by laws or denied by insurers who say they are following the 2016 Guideline.  In her letter, Dr. Dowell restates that the 2016 Guideline “provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.” [My underline.]  She then notes “Because of the unique therapeutic goals, and balance of risks and benefits with opioid therapy in such care, clinical practice guidelines specific to cancer treatment, palliative care, and end of life care should be used to guide treatment and reimbursement decisions regarding use of opioids as part of pain control in these circumstances.”  Dr. Dowell also cites “useful guidance” documents, including the American Society of Clinical Oncology Management of Chronic Pain in Survivors of Adult Cancers, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Adult Cancer Pain, and the National Heart, Lung, and Blood Institute’s Evidence Based Management of Sickle Cell Disease Expert Panel Report.

Hemp, Cannabidiols and the FDA

image of cannabis leaf & cbd oilThe Agriculture Improvement Act of 2018 became Public Law 115-334 on 12/20/18.  Title XII Section 12619 of this act removed hemp and “tetrahydrocannabinols in hemp” from the Controlled Substances Act (CSA).  [Tetrahydrocannabinols (THC) are a cannabinoid subclass, as are Cannabidiols (CBD).]  Also on 12/20/18, Scott Gottlieb, the Food and Drug Administration (FDA) Commissioner, issued a Statement on the agency’s regulation of products containing cannabis and cannabis-derived compounds.  The 12/20/18 Statement acknowledges hemp’s removal from the CSA, but goes on to state “Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds….  We’ll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products….  The FDA will continue to take steps to make the pathways for the lawful marketing of these products more efficient.”  State lawmaker and public confusion on the legal status of CBD ensued.  On 1/15/19, Oregon Senators Ron Wyden and Jeffrey A. Merkley wrote Gottlieb asking the FDA “to immediately update federal regulations governing the use of certain hemp-derived ingredients in food, beverages or dietary supplements.”  On 2/19/19, Maine Congresswoman Chellie Pingree and 11 other Representatives wrote Gottlieb “to swiftly provide guidance on lawful pathways for food products containing hemp-derived CBD in interstate commerce.”  The FDA has not yet issued additional guidance, and Gottlieb recently announced his resignation effective 4/5/19.