But what about the science? There’s no concrete evidence yet that CBD does anything for people who take it for some vague concept of “wellness.”
But, buyer beware. Products containing CBD may be everywhere in the US but – with one very specific exception – if you purchase it in any form you’ll be breaking the law in every single one of its 50 states. How is that possible if recreational marijuana has been legalised in nine states, you ask? The problem lies in a conflict between federal and state law, and with how people view two very different types of cannabis plant: marijuana and hemp.
There’s no concrete evidence yet that CBD does anything for people who take it for some vague concept of “wellness”
Gomez says when the Brightfield Group made its industry predictions earlier this year, “we raised plenty of eyebrows”. But, she says, three days later the media was reporting that Coca Cola was looking into the CBD industry and it suddenly made sense. “If you look at the total sum of CBD products being sold today and then add ‘big box’ retailers into the mix and the big pharmacies who are begging to enter. we expect to see a very rapid change.”
Based on a survey of 5,000 CBD users that Brightfield conducted this summer, millennials were the first to begin buying CBD products after various states legalised it
Grant describe these as clues to its potential use and the directions in which the medical community is moving but, he cautions, the science is not established.
There are currently no authorised CBD extracts or isolates on the market.
Applying for authorisation
If any business believes they have a significant history of consumption for their CBD extracts from before May 1997, they should follow the consultation process on the novel food page.
Safety of CBD products
The deadline applies in England and Wales. Novel foods regulations in Scotland are covered by Food Standards Scotland.
18. How can patients gain access to cannabis or cannabis-derived products for medical use through expanded access?
As discussed above (see Question #2), the 2018 Farm Bill removed hemp from the CSA. This change may streamline the process for researchers to study cannabis and its derivatives, including CBD, that fall under the definition of hemp, which could speed the development of new drugs.
13. What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?
Research and Expanded Access
The agency has and will continue to monitor the marketplace and take action as needed to protect the public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and that are being marketed for therapeutic uses for which they are not approved. At the same time, FDA recognizes the potential therapeutic opportunities that cannabis or cannabis-derived compounds could offer and acknowledges the significant interest in these possibilities. FDA continues to believe that the drug approval process represents the best way to help ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. The Center for Drug Evaluation and Research (CDER) is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug (IND) and drug approval process (see Question #16).
A. To conduct clinical research that can lead to an approved new drug, including research using materials from plants such as cannabis, researchers need to work with the FDA and submit an IND application to the Center for Drug Evaluation and Research (CDER). The IND application process gives researchers a path to follow that includes regular interactions with the FDA to support efficient drug development while protecting the patients who are enrolled in the trials. For research for use as an animal drug product, researchers would establish an investigational new animal drug (INAD) file with the Center for Veterinary Medicine to conduct their research, rather than an IND with CDER.
Conducting clinical research using cannabis-related substances that are scheduled by the DEA often involves interactions with several federal agencies. This includes: a registration administered by the DEA; obtaining the cannabis for research from NIDA, within the National Institutes of Health, or another DEA-registered source; and review by the FDA of the IND or INAD application and research protocol. Additionally:
Questions and Answers
3. Has FDA approved any medical products containing cannabis or cannabis-derived compounds such as CBD?
When this statutory prohibition applies to a substance, it prohibits the introduction into interstate commerce of any food to which the substance has been added unless FDA, in the agency’s discretion, has issued a regulation approving the use of the substance in the food (section 301(ll)(2) of the FD&C Act [21 U.S.C. § 331(ll)(2)]). To date, no such regulation has been issued for any substance.