US FDA Moves to Further Regulate Marijuana Products

US Food and Drug Administration [FDA] announced a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.

The public hearing will be held on May 31, 2019, from 8 a.m. to 6 p.m. Submit requests to make oral presentations and comments at the public hearing by May 10, 2019. Electronic or written comments will be accepted until July 2, 2019. 

Cannabis is a plant of the Cannabaceae family and contains more than 80 biologically active chemical compounds. The most commonly known compounds are delta-9- tetrahydrocannabinol (THC) and cannabidiol (CBD). Parts of the Cannabis sativa plant have been controlled under the Federal Controlled Substances Act (CSA) since 1970 under the drug class ‘‘Marihuana’’ (21 U.S.C. 802(16).1 ‘‘Marihuana’’ is listed in Schedule I of the CSA due to its high potential for abuse, which is attributable in large part to the psychoactive effects of THC, and the absence of a currently accepted medical use for marijuana in the United States. Cannabis and cannabis-derived products have been the subject of increasing interest by consumers, industry, researchers, the public, and regulators. Regulatory oversight of products containing cannabis or cannabis-derived compounds is complex and involves multiple Federal and State agencies. 

The legality of cannabis has been changing over time at both the State and Federal levels. Currently, 33 States and Washington, DC, allow ‘‘medical’’ use of marijuana under State law and 14 additional States have State law ‘‘medical’’ programs that are limited to CBD products. In addition, 10 States and Washington, DC, have legalized marijuana for recreational use under State law, and 13 additional States have decriminalized recreational marijuana possession under State law in some form. 

NJ Governor Pat Murphy has advocated  for the legalization of recreational marijuana products NJ. Recently a proposed bill was withdrawn before the legislature could vote on it as there were not enough favorable votes. In the meantime Governor is reworking the legislation and is expanding the distribution of medical marijuana products. Business have been concerned that injured workers who are performing work and using medical marijuana may be impaired and suffer accidents.

NJ workers' compensation courts have approved the use of medical marijuana for palliative care. Employers have been held liable for such payments as compensable medical treatment. 

At the Federal level, the Agriculture Improvement Act of 2018, Public Law 115–334 (the 2018 Farm Bill), was signed into law on December 20, 2018. Among other things, this new law changes certain Federal authorities relating to the production and marketing of hemp, defined as the plant 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. These changes include removing hemp from the CSA, which means that cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under Federal law. 

FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the FD&C Act. FDA has taken action against companies illegally selling cannabis and cannabis-derived products that put the health and safety of consumers at risk. For example, FDA has issued warning letters to companies illegally selling CBD products that were intended to prevent, diagnose, mitigate, treat, or cure serious diseases, such as cancer, and that had not obtained new drug approvals. Selling unapproved drug products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk as the marketing of unproven treatments raises significant public health concerns. Patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases.

The FDA proposed regulation demonstrates that the marijuana safety controversy is far from over. Whether the cure, and it what form, is worse than the disease will yet be the subject of further discussion and debate.

1. Under the CSA, the term ‘‘marihuana’’ means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such a term does not include hemp or the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination. 

2. Federal Register / Vol. 84, No. 64 / Wednesday, April 3, 2019 / Proposed Rules

3. https://www.fda.gov/NewsEvents/PublicHealth

See also:
New Jersey workers' compensation judge has ordered this municipality to cover the cost of a municipal employee's medical marijuana

NJ Expands Access to Medical Marijuana to Include Common Work-Related Conditions

NJ Governor Murphy Signs Executive Order Mandating Review of Medical Marijuana Policy

NJ Calls for Big Increase in Number of Medical Marijuana Dispensaries (NJ Spotlight 4/2/2019) 

CBR Is Everywhere, but Scientist Still Don't Know Much About It (NY Times 2/25/19)

Legalized marijuana: Opportunity or time bomb? Part 1  (Property Casualty 360 4/1/19)

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Jon L. Gelman of Wayne NJ is the author of NJ Workers’ Compensation Law (West-Thomson-Reuters) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thomson-Reuters). For over 4 decades the Law Offices of Jon L Gelman 1.973.696.7900 jon@gelmans.com has been representing injured workers and their families who have suffered occupational accidents and illnesses.