6. What is FDA’s reaction to states that are allowing cannabis to be sold for medical uses without the FDA’s approval?
2. How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?
A. No. There are no other FDA-approved drug products that contain CBD. We are aware that some firms are marketing CBD products to treat diseases or for other therapeutic uses , and we have issued several warning letters to such firms. Under the FD&C Act, any product intended to have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. Drugs must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review. CBD was not an ingredient considered under the OTC drug review. An unapproved new drug cannot be distributed or sold in interstate commerce.
FDA is not aware of any evidence that would call into question its current conclusions that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.
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.
The debate over hemp CBD’s legal status continues after FDA sent eight warning letters to manufacturers of CBD dietary supplement and food products earlier this month. The warning letters cite impermissible health claims used to market the products, as well as CBD’s invalid status as a dietary ingredient due to its presence in two drug applications currently under consideration. On February 4, FDA sent warning letters to eight companies marketing CBD foods and dietary supplements, partially on the basis of impermissible medical claims used in marketing materials. These include suggestions that CBD may be used to reduce symptoms of schizophrenia, rheumatoid arthritis, diabetes, cancer, multiple sclerosis, and more.
Although the article was later substantially edited, its original version was republished verbatim to alternative news blog The Event Chronicle on 21 March 2016. The original article, which was credited to Natural News‘ “Health Ranger” Mike Adams, stated:
The FDA hasn’t banned the sale of cannabidiol oils because a drug company is interested in marketing them.
The relationship between digital articles and social media is such that a large share of the reading audience is exposed only to the headline of any given article and not its full text. One estimate from 2014 suggested that as many as four in ten people only read an item’s title, a figure which could be far higher when multiplied by Facebook. Thus, Adams’ claims led many to infer that the FDA had indeed issued an immediate, sweeping ban on CBDs (a product popular among chronic pain sufferers).
Notably, the FDA in no way issued a ban of any description on the sale of CBD oils. Rather, the agency stepped in to warn several manufacturers that their products could not be marketed or labeled as “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” without further FDA oversight. And as it happens, section 201(g)(1)(B) of the FDC Act pertains to the labeling of products under its governance:
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
It has some dangers, especially because there are so many products that haven’t been tested. For example, some CBD products have been promoted as good for pets, but there are also some CBD products that have caused liver damage to pets. In other words, do not give CBD products to your pet before consulting to a vet.
FDA outlaws CBD and hemp oil? No, the FDA does not outlaw CBD or hemp oil. However, it does not approve any CBD product promoted as a dietary supplement.
Does CBD have any Dangers?
Other than the aforementioned prescription CBD drug to treat two rare forms of epilepsy, the FDA has not approved any other CBD product. This stems from the lack of information about side effects, dosage and long-term effects caused by CBD.
Some CBD products are being marketed with unproven medical claims and are of unknown quality. These are the kind of products the FDA target, especially the ones that have been marketed as ‘food supplements’. Under federal law, it’s illegal to market any CBD product as a dietary supplement.
In conclusion, the FDA warns consumers to think carefully before consuming products that haven’t passed any quality controls. For example, claiming that it cures cancer or any other disease.