The short answer is no. You also have a jurisdiction issue with the DEA as well. See FDA's latest comments / posting on the issue
13. Can products that contain THC or cannabidiol (CBD) be sold as dietary supplements?
A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, respectively. Under those provisions, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under 21 U.S.C. § 355 (section 505 of the FD&C Act), or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. FDA considers a substance to be "authorized for investigation as a new drug" if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA's regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.
There is an exception to sections 201(ff)(3)(B)(i) and (ii) 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. For more information on this provision, including an explanation of the phrase "marketed as," see Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
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 sections 201(ff)(3)(B)(i) and (ii) 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 called our conclusions into question.
Ref: FDA and Marijuana: Questions and Answers . Accessed on March 19, 2018.
| Fda |
remove preview |
|
| FDA and Marijuana: Questions and Answers |
| How is marijuana therapy being used by some members of the medical community? Why hasn't the FDA approved marijuana for medical uses? Is marijuana safe for medical use? How does FDA's role differ from the role of other federal agencies when it comes to the investigation of marijuana for medical use? |
| View this on Fda > |
|
|
.
------------------------------
[Robert] [Falcone]
[Integris3Biosolutions]
[Bedminster] [NJ]
[US]
------------------------------
Original Message:
Sent: 18-Mar-2018 10:10
From: Susan Jackson
Subject: Hemp seed oil softgels
Is there a reference either with USDA or FDA on hemp seed oil and the maximum allowed of CBD or THC as a contaminant. Example most states that manufacture hemp have A maximum of 0.3% THC . This is where this amount is not considered to be illegal for hemp.
Is there any federal reference ?
Sent from my iPhone