FDA discusses regulation of cannabidiol in the USA
Amid the popularization of CBD, the US equivalent of Anvisa, the Food and Drug Administration (FDA), held its first public hearing on cannabidiol (CBD) last Friday (31). The cannabis derivative has already become a craze in the country, creating a billion-dollar industry. Therefore, the FDA is studying how to regulate CBD products and believes that the substance can no longer be sold as a dietary supplement. Those interested in the topic can submit suggestions to the entity until July 2.
Many Americans are using CBD to treat everything from menstrual cramps to insomnia. Cannabis companies are selling various products like sodas, cookies, and bath salts with cannabidiol, even online. These products are different from medical marijuana and are non-psychoactive since they do not contain THC. According to a New York Times report, the FDA has been skeptical of this industry but is facing strong pressure from the US Congress to ease access to plant derivatives.
At the FDA hearing that filled the entity's auditorium in Washington, many researchers agreed that CBD has various health benefits. However, many argued that more studies are needed before making any decisions. Speakers mentioned issues with adulterated CBD products, the presence of pesticides and heavy metals, as well as inconsistent levels of the substance. The potential for addiction was also raised.
The new US agricultural law passed in 2018 lifted restrictions on hemp, a variety of cannabis used in the industry. It ceased to be considered a controlled substance. However, the Food and Drug Administration quickly asserted its authority in the matter.
According to Dr. Norman Sharpless, FDA Commissioner, some compounds found in cannabis, specifically CBD and THC, have been approved as drugs. The Federal Food, Drug, and Cosmetic Act prohibits adding drugs to human or animal food in interstate commerce.
"It means that, under current law, CBD and THC cannot legally be added to food or marketed as a dietary supplement. We have concluded that, for (these products) to be used safely, a prescription or medical supervision is needed to help protect against potential dangerous use. THC and CBD are no exception," wrote the commissioner in an article published on the FDA website.
The entity has not set a timeline to regulate CBD products, and this debate is expected to continue in the coming months. Thirty-three US states have already legalized marijuana for medical use, and recently, Illinois became the 11th state to legalize recreational use of the plant.
"We hope that this meeting and the comments sent to our audience will help us as we try to address this issue in an informed manner. This hearing is an important step in our ongoing evaluation of cannabis and cannabis-derived compounds in FDA-regulated products," wished the commissioner.
In Brazil, Anvisa takes first step to regulate cannabis cultivation
Meanwhile, here in Brazil, it is on the agenda of the next meeting of the Collegiate Board of the National Health Surveillance Agency (Anvisa) on Tuesday (11) to potentially open a public consultation on the cultivation of medicinal cannabis in Brazil. This is the first step to regulate the cultivation of the plant in the country.
There are two proposals for public consultation. One is about the "technical and administrative requirements for the cultivation of Cannabis spp. for medicinal and scientific purposes." The other "establishes the specific procedure for the registration and monitoring of medicines based on Cannabis spp., its derivatives, and synthetic analogs."