18. How can patients gain access to cannabis or cannabis-derived products for medical use through expanded access?
 Trezza, et al. Effects of perinatal exposure to delta-9-tetrahydrocannabinol on the emotional reactivity of the offspring: a longitudinal behavioral study in Wistar rats. Psychopharmacology (Berl) 2008; 198(4): 529-537.
Hemp seeds are the seeds of the Cannabis sativa plant. The seeds of the plant do not naturally contain THC or CBD. The hemp seed-derived ingredients that are the subject of these GRAS notices contain only trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant. Consumption of these hemp seed-derived ingredients is not capable of making consumers “high.”
Research and Expanded Access
FDA relies on applicants and scientific investigators to conduct research. The agency’s role, as laid out in the FD&C Act, is to review data submitted to the FDA in an application for approval to ensure that the drug product meets the statutory standards for approval.
A. FDA is aware that unapproved cannabis or cannabis-derived products are being used for the treatment of a number of medical conditions including, for example, AIDS wasting, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and cancer and chemotherapy-induced nausea.
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. The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), permits veterinarians to prescribe extralabel uses of approved human and animal drugs for animals under certain conditions. Extralabel use must comply with all the provisions of AMDUCA and its implementing regulation at 21 CFR § 530. Among other limitations, these provisions allow extralabel use of a drug only on the lawful order of a licensed veterinarian in the context of a valid veterinarian-client-patient relationship and only in circumstances when the health of an animal is threatened or suffering, or death may result from failure to treat.
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Warning letters dated 4 February 2016 were published by the FDA to their web site, and the manner in which the agency alleged the CBD manufacturers were in violation of the FDC Act (i.e., marketing their products as dietary supplements) was clearly described:
Another commonly reproduced bit of verbiage held (without substantiation) that the impetus behind the FDA actions was a drug company’s interest in CBDs:
Despite lengthy edits, the article remained factually inaccurate, claiming that the FDA asserted CBD oils were “adulterated products”:
Several examples of such labeling or marketing were included in the letters, many of which clearly appeared to violate the cited regulations:
The original article contained several links that readers might have presumed corroborated its claims. The first relevant link was to a 19 February 2016 article which in no way indicated that the FDA had banned CBDs; it simply reported on warning letters sent by the FDA to CBD oil manufacturers with respect to “impermissible” label claims:
The next link pointed to a nearly month-old article published by the Cannabusiness web site on 22 February 2016. Cannabusiness‘ coverage appeared to describe CBDs labeled and marketed in a manner that violated FDA labeling regulations:
On 20 March 2016, the disreputable alternative health web site Natural News published an article claiming the Food and Drug Administration (FDA) had “just” outlawed cannabidiol (CBD) oils by claiming that “all plant molecules now belong exclusively to Big Pharma”: