The U.S. Food and Drug Administration is set to take a step ahead in the long-awaited decision for regulating cannabidiol or CBD. The federal law passed the Farm Bill in December 2018 removing hemp derived cannabinoid from the list of Controlled Substances. The substance has been gaining popularity ever since and is now being used as an alternative treatment for medically prescribed drugs.
Despite the federal law allowing CBD with 0.3% THC, the FDA had strict regulations against the compound. It allowed only one drug containing CBD which is used to treat epilepsy. However, companies and retailers were seen infusing cannabinoid in a wide variety of products irrespective of the ban by the Food and Drug Administration.
From CBD infused beer, coffee, tea, burgers, pizza, gummy bears, chocolates to CBD based beauty oils, creams, tinctures, ointments and much more, CBD is the most trending substance currently in the U.S. market. The CBD product craze has exploded into a frenzy never before seen in the supplement industry.
Erika Edwards at Nbcnews tells, On Friday, the FDA will hold its first public hearing on cannabis and cannabis related products, discussing about the regulatory framework that needs to be implemented in the coming months if they approve of cannabinoid and its products.
The goal of the hearing is to gather information on a wide range of topics related to products containing cannabinoid and its compounds. Dozens of interested parties are scheduled to discuss about the subject, including doctors, consumers and members of the cannabis industry.
Business leaders cross their fingers in hope of a positive decision inclined towards the legalization of cannabis.This would allow them to make different CBD based products and sell it to the consumers directly without worrying about prosecution.
Andrew Shao, interim senior Vice President of scientific and regulatory affairs at the Council for Responsible Nutrition, a trade association for dietary supplements said that this was definitely setting a new precedent. Shao also said that this is an important step which involves a number of stakeholders, including lawmakers and members of Congress are looking forward to this meeting to inform the pathway forward for cannabinoid.
The FDA’s principal deputy commissioner, Dr. Amy Abernethy, recently sent out a string of tweets regarding CBD, writing in part: “We are reviewing available databases and medical literature about CBD’s safety. Thus far, the data appear insufficient.”
She further tweeted saying what would happen if you eat CBD infused food? Or use a CBD infused skin cream and use other CBD related products on the same day? What if you use these products daily for a week or a month or even longer?
It has been observed and concluded that CBD alone does not cause the users to get “high”. Marijuana’s high comes from a different compound known as THC, or tetrahydro cannabinoid which has psychoactive properties. The maximum concentration of THC allowed in a product by the federal law in the U.S. is 0.3% which ensures a safe experience without producing any mind-altering effects.
People have been inhaling or ingesting CBD in the form of recreational marijuana for many years. The only difference now is that CBD has been isolated as an ingredient and is being incorporated into supplements and various products post the farm bill. But the legalization has certainly raised experts to question the compound’s safety and its after effects.
Dr. Pieter Cohen, who studies drug ingredients in the marketplace at the Harvard Medical School and the Cambridge Health Alliance said that they don’t really know the effects of CBD when it comes to safety. Cohen also said that they don’t have a mechanism in the U.S to effectively regulate supplements to ensure that those products infused with CBD are safe for consumption.
Some companies promote and market their products as a way to treat severe ailments such as insomnia, anxiety, chronic pain, epilepsy, Alzheimer’s and even cancer. The FDA had issued warning letters jointly with the FTC to 3 companies for marketing their products as a cure to Cancer. These marketing campaigns draw out people and make them believe in the product more than any pharmaceutical drug.
Lawmakers are also concerned for the younger generation which is being lured into the cannabinoid space by offering CBD infused gummy bears, chocolates and other edible products. While majority of the claims made by CBD remain unproven, there are a significant number of registered cases where patients showed improvement in their health after taking CBD oil only for a few weeks.