State representatives are urging for the Food and Drug Administration to provide significant leadership on handling cannabidiol-infused products. The move comes after the FDA held its first public meeting last May 31st after the agency warned manufacturers of making unwarranted health claims.
The 10-hour meeting was attended by stakeholders of CBD companies, as well as representatives from different government agencies. The meeting was meant to discuss possible ways to safely and adequately manufacture, sell, and market CBD products. While not clear regulations are made, the need for a regulatory framework is agreed by all parties. The FDA previously committed to creating such structure, though it would take some time for completion.
Proponents and Regulations
Florida Department of Agriculture and Services Secretary Brenda Morris raised the issue of unclear regulation regarding CBD products. The ‘anything is allowed’ environment is a result of what she called ‘a patchwork of laws’ for the products.
Representative Pam Miles of the Virginia Department of Agriculture added the lack of proper scientific proof of CBD’s effects as a cause for regulation. According to the representative, this lack of available scientific research and impacts cause some states to struggle with CBD retail.
Several health advocates also expressed concern over the lack of such research to substantiate the therapeutic claims of CBD. These include allegations of treating illnesses like epilepsy, Alzheimer’s, and dementia.
Proponents of CBD, however, are arguing that the FDA should not ban hemp-derived CBD-infused food and supplements. These proponents cite the 2018 Farm Bill as legal ground, where hemp and its variations are legalized. Other supports recommended these products to add under the existing network for dietary supplements. Products under this network are intended for non-medical use.
There was even a mention of efforts from the legislation to create laws to regulate CBD products in the absence of FDA guidelines. While the bill does legalize the production of hemp, a former FDA commissioner points out that the term ‘production’ was not adequately defined. This missing definition leaves the term open for interpretation, thus having the Congress form the regulation would seem a plausible option.
Currently, the sale and marketing of foods and dietary supplements infused with CBD between states are prohibited by the FDA. Cannabis and hemp are first labeled as illegal by the FDA before approval as food and supplements. Due to this circumstance, the agency advised that CBD cannot be marketed both as a drug and a food or supplement.
Despite current rules by the FDA, the agency does recognize the potential health benefits. A couple of drugs were approved for prescription use, including Epidolex, which contains CBD.
Cannabis Use in the US
The use of cannabis has found a significant change in the US over recent years. It started as an illegal drug in the country under the Controlled Substances Act of 1970. The drug was then classified as a Schedule I substance with no accepted medical use and a high potential for abuse.
From the late 1990s, efforts to legalize the use of marijuana, both for medical and recreational, have gone full-swing. The Rohrabacher – Farr amendment in 2014 protected individuals acting per state medical cannabis laws from federal persecution. While Cole memorandum enacted in 2013, allowed for commercial distribution of the drug following the state law. Federal law regarding recreational use is currently uncertain, as the memo was rescinded in 2018 by the US Attorney General.
As of 2019, 33 states, along with four US territories, have legalized the medical use of cannabis. On the other hand, recreational use is authorized in 10 states, as well as two territories.