13. What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?
19. Can patients gain access to cannabis or cannabis-derived products for medical use through Right to Try?
There is an exception to section 201(ff)(3)(B) if the substance was “marketed as” a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD.
Questions and Answers
10. Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?
Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of this exclusion, and therefore might be able to be marketed as dietary supplements. However, all products marketed as dietary supplements must comply with all applicable laws and regulations governing dietary supplement products. For example, manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” (i.e., dietary ingredients that were not marketed in the United States in a dietary supplement before October 15, 1994) generally must notify FDA about these ingredients (see section 413(d) of the FD&C Act [21 U.S.C. § 350b(d)]). Generally, the notification must include information demonstrating that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. A dietary supplement is adulterated if it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury (see section 402(f)(1)(B) of the FD&C Act [21 U.S.C. 342(f)(1)(B)]).
2. How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?
A. General information about the import/export of drug products regulated by FDA can be found online here. The Drug Enforcement Administration (DEA) is the federal agency responsible for enforcing the controlled substance laws and regulations in the U.S. and, as such, should be consulted with respect to any regulations/requirements they may have regarding the import or export of products containing cannabis. Please see here for information about importing or exporting food ingredients.
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Dr Doherty believes cannabis-based products may help patients like Ben who have severe epilepsy but are not responding to more conventional treatments. However, he said that while worth trying, they are not a “silver bullet” or “miracle cures” .
Two years after it was announced, no cannabis-based product is available under the programme to treat patients with severe epilepsy, and no patients are registered with the access programme.
Four years ago, an official report recommended the establishment of an access programme for medicinal cannabis for patients with three conditions: severe epilepsy; spasticity associated with multiple sclerosis; and nausea and vomiting associated with chemotherapy. Legislation was passed in 2019 and work has been underway since on setting up the programme.
While CBD, another compound in cannabis, is proving to be relatively safe for patients under clinical supervision, the doctors point out that no products containing pure CBD have been accepted for use under the programme.
He suffers up to five seizures a day and spends up to 80 per cent of the time coming in or going out of seizures.
One drug, Epidyolex, has been licensed to treat a narrow spectrum of epilepsy-related cases but has yet to be approved for reimbursement, so patients have to fund their own treatment.
While one product has been approved for patients under the access programme, doctors treating epilepsy patients say it has a THC level that is too high to be a starting cannabinoid treatment for most people with the condition.