Regulatory Open Forum

 View Only
  • 1.  Non-FDA requirements - cannabis

    This message was posted by a user wishing to remain anonymous
    Posted 17-Feb-2017 13:23
    This message was posted by a user wishing to remain anonymous

    A company is planning to create a new product line of topical products based on the cannabis and cannabinoid trends.  In discussing testing of the raw material oil to ensure no psychoactive materials are in the material a testing lab told the company that they would need a DEA license.  Several questions to the group:

    1. Does the company need a DEA registration if they are ensuring that the products they sell do not contain any psychoactive materials at analytically detectable levels?

    2. Are there any further registrations that the company should consider obtaining prior to working with this material?

    3. Is there an accepted list that DEA, FDA or any other federal agency has established of psychoactive substances that would be considered cannabinoids and listed under CSA?

    4. Can anyone provide me with the general requirements to obtain and maintain a DEA registration and license should that be a requirement here?

    Thanks for your help!



  • 2.  RE: Non-FDA requirements - cannabis

    Posted 18-Feb-2017 08:43
    This looks like one of those questions that can't be given a clear-cut answer on a message board, at least not without a large amount of further detail.

    My experience with topical products which deposit substances into the body can be considered cosmetics, drugs, devices and even pesticides depending on the exact nature of the substance and the intended effect.

    Breaking it down, there are two things that need to be looked at carefully:

    1) what is the intended effect ?

    2) is there some regulation which makes the manufacturer's intentions irrelevant?

    Regulation of cannabis is relatively new, so it may be difficult to find regulatory professionals who speak from experience.

    It appears that the relevant regulation is 21 CFR 1308.35

    CFR - Code of Federal Regulations Title 21

    which exempts extracts from the cannabis plant as long as those extracts do not contain "*any* amount of tetrahydrocannabinols (THC)" and are "Not used, or intended for use, for human consumption."

    Since this is a topical product, it IS intended for human consumption. What this hinges on for my money is the word "any," which I find surprisingly vague. Does "any" mean the same thing as below "analytically detectable levels?" This looks like one for legal minds to tackle.

    This document in the Federal Register describes a new code for extracts of marijuana which contain one or more cannabinoids as opposed to previously established codes, so the relevant code appears to depend on exactly what is being extracted.

    Establishment of a New Drug Code for Marihuana Extract

    ------------------------------
    Jean Bigoney PHD, RAC
    Managing Member
    Nu Device Consulting LLC
    Murphy NC
    United States
    ------------------------------



  • 3.  RE: Non-FDA requirements - cannabis

    Posted 18-Feb-2017 13:11
    My experience is very limited, but my impression so far is that, when it comes to a product's regulatory status,  people dealing with cannabis and other "natural" products tend to focus too much on the ingredients and not enough on the intended use, just as non-RA medical device professionals sometimes focus too much on the physical device.  While there may be some exceptions, my experience so far also indicates that the regulatory status of ANY product (i.e., whether it will be regulated as a drug, device, food, cosmetic, etc,) is determined by intended use, including the MOA by which that use is achieved, not by its ingredients, materials, or components.

    There are often separate requirements for the ingredients or materials, and a focus on  these requirements sometimes seems to obscure the bigger regulatory picture, which is the regulatory requirements applicable to the finished product. 

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 4.  RE: Non-FDA requirements - cannabis

    Posted 20-Feb-2017 13:39
    Oops... reading/posting on the fly.  Ignore!

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 5.  RE: Non-FDA requirements - cannabis

    Posted 21-Feb-2017 09:06
    1. and 4. The DEA registration regulations don't go into that much detail with respect to who needs to register and who doesn't.  Instead, it focuses more on the activity that you're performing with respect to the controlled substances.  If you're going to manufacture things from a controlled substance you're probably at least storing the controlled substances.  In my experience, if the substance is a controlled substance, and you're doing something that requires a registration for it, you may need to register.  

    2. The state in which you operate may require additional registrations - DEA and the State boards of pharmacy usually work hand-in-hand for things like registration and diversion.  Otherwise, we would have to know more about your situation, what you're planning on making, etc.  

    Alas, I'm not sure about #3, aside from the CSA itself (and I don't recall off the top of my head the level of detail into which the schedules go).  As someone mentioned above, the regulation of cannabis is a bit fluid at the moment, so this may need a bit more interaction with the different agencies than normal.  

    I hope that this helps!

    ------------------------------
    Sarah H. Stec, JD, RAC (EU)
    Associate
    Squire Patton Boggs (US) LLP
    Washington, DC
    USA
    ------------------------------



  • 6.  RE: Non-FDA requirements - cannabis

    Posted 21-Feb-2017 13:41
    Hello there... hopefully this post will help.

    We are in a rec/med legal state, however, NO state which has legalized either med or rec is compliant with Federal laws. The DEA is a federal agency. Cannabis in any form is a Schedule 1 product. Schedule 1 substances are scheduled as such because they have a) shown now scientifically-based therapeutic benefit and b) they are highly likely to be abused. I am NOT here to debate the these points, just to lay out the facts. The DEA regulates all scheduled products.

    The DEA will not license anyone in the rec/med industry to handle schedule 1 products. The only facilities with schedule 1 licensing would be university and government programs which are involved with heavily monitored research.

    If you have a DEA license as a business and ask for a schedule 1 - be prepared for some heavy scrutiny, a decline and close monitoring of your activities. If you do not yet have a DEA license... you will not get one for schedule 1. If you have a DEA license and want to test rec/med, you are jeopardizing your business.

    All that said, depending on your state, you may be able to perform testing as a cannabis only lab until the federal government decides to check you out. Remember too, that unless your state has instituted banking regulations that allow cannabis companies bank access, you will be receiving cash-payments. That is a very unusual activity for a testing laboratory... so your bank will be interested and is obligated to report cash-heavy accounts (if they are FDIC insured). If you receive any percent of your income as a business from a federally illegal enterprise, your assets can be held in investigations.

    Also, if your testing products are sent to you by any mail/fedex/ups carrier that is a violation of inter-state commerce which pops you into federal jurisdiction.

    I think that above answers #1 pretty well.

    #2 would be addressed to your state agency that regulates cannabis operations (including hemp).

    #3 No... anything derived from cannabis is schedule 1; the DEA just came out and reiterated their stance on CBD oil in the last month or so.

    #4 if you still think that this is a good idea, just go to the DEA website. It is pretty self-explanatory.

    Remember, the only way to ensure that something like the THC level might be below the state HEMP level is to test. Until testing is complete, it is all the same thing.

    Even though the Obama administration instructed the AG to de-prioritize cannabis activities in states with legal programs, that action was NOT LAW. The new administration's AG is not likely to continue this relaxed consideration. Also, DEA districts are authorized to address situations in their jurisdictions as they deem necessary. DEA can and will enforce federal law.


    ------------------------------
    Jennifer Travis

    ------------------------------