FDA To Assess Cannabis Benefits

By Mary Pat Luetke-Stahlman

May 31, 2019  - On Friday the United States Food and Drug Administration [FDA] held its first hearing (click here to read the agenda) to assess the safety and efficacy of cannabis products. Cannabis has been flooding the market over the last couple of years, and cannabis marketers have made dozens of health claims that include, but are not limited to, the following: pain relief, enhanced immune function, reduced symptoms of anxiety and depression, and protective effects against the development of certain cancers. The FDA states that “there is little known about how effective [cannabis products] are.”

Cannabis has two active ingredients, CBD (cannabidiol) and THC (tetrahydrocannabinol), and cannabis has been found in hundreds of products such as dog food, chocolate, dietary supplements, and even cosmetics. At the FDA hearing, Dr. Ned Sharpless opened with a statement that despite the widespread use of such products, “critical questions remain about [the] safety” of these products. The hearing was held for the general public to know that the FDA is working to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-deprived compounds.

The FDA established a docket for public comment on this hearing, which will remain open until July 2, 2019, and the docket number is FDA-2019-N-1482. Input can be submitted in electronic or hardcopy form, and the FDA has announced that “late, untimely filed comments will not be considered.” If you would like to submit your comments in hardcopy form, send it to this address: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

This is not the first time the FDA has been involved in cannabis-based discussions. According to Nadia Kounang on CNN, the FDA previously approved “a cannabis plant-derived, CBD-based, Epidiolex… to treat two severe and rare forms of epilepsy: Dravet Syndrome and Lennox-Gastaut syndrome.”

The liberalization by states and the growing popularity in the use of marijuana and CBD-related products is another reason the FDA has to be concerned. Hemp-derived CBD market is expected to hit between 15 to 20 billion dollars over the next five years and Jonathan Miller, general counsel for an industry-backed advocacy group called the U.S. Hemp Roundtable, emphasized it is important for the FDA to have a “regulatory handle on this.” Miller pointed to existing products that are bad or make false claims as the reason why the FDA “[has to] develop standards.”  

For those that use marijuana for medical reasons, understanding medical terminology can be challenging. According to Boulder Weekly, there is a group of interpreters working with Dr. Regina Nelson, the President of a nonprofit organization by the name of eCS Therapy Center that specializes in cannabis education, to pull together a video glossary of cannabis terminology in ASL. For further information about Sign of the Times Interpreters, check out their website (click here).