Regulatory Open Forum

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  • 1.  FDA and CBD use in cosmetics

    Posted 25-Feb-2019 12:18
    Fellow Rappers,

    As we would all expect, the beauty industry would be jumping on the opportunity to add CBD in their products.  The laws concerning CBD are still a bit foggy and while I have read several articles and visited FDA's site, much is said about THC and little is said of CBD.  Does anyone have any insight as to where exactly FDA stands as it relates to the use of CBD in cosmetics, especially when it comes to such claims are wrinkle reduction etc.? Since there are several "drug" benefits of CBD, I imagine they would regulate such products even though they are "beauty products, with beauty claims".


    Any bit of info would be great!


    Regards,
    Laura

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    Laura HoShue
    Regulatory Compliance Specialist
    Las Vegas, Nevada
    USA
    ------------------------------


  • 2.  RE: FDA and CBD use in cosmetics

    Posted 25-Feb-2019 15:14
    Be very careful with CBD in this case Laura.  CBD was tested and recently approved for use in an Rx drug that is used for certain forms of seizures in epileptic patients.  Could get you into more issues than you want to consider.​

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    Victor Mencarelli
    Director Regulatory Affairs
    United States
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    Original Message


  • 3.  RE: FDA and CBD use in cosmetics

    Posted 26-Feb-2019 09:06
    Victor,

    Thank you!! I read several articles on CBD and have instructed the team that it is NOT to be considered unless of course they wish to file for a drug application.  That said, interestingly, the derivative of the cannabis like the cannabis seed oil, hemp seed oil, etc., seem to be OK and in Canada it has is a restricted use for cosmetics.  I have seen several other beauty products with the hemp seed oil so we should be good on that end.  I have therefore recommended that if we are to go this route, that is with the hemp seed oil and since we have to list the scientific name in the ingredients list, we need to stress that the product is both THC-free and CBD-free.  

    As always, thank you for the feedback Victor.  You and I are on the same page.


    Cheers,
    Laura

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    Laura HoShue
    Regulatory Compliance Specialist
    Las Vegas, Nevada
    USA
    ------------------------------

    Original Message


  • 4.  RE: FDA and CBD use in cosmetics

    Posted 28-Feb-2019 13:29
    Hi Laura, 

    This area is a regulatory minefield! Constantly changing... 

    After the passage of the Farm Bill in December appeared to make any cannabinoid derived from hemp legal, Commissioner Gottlieb immediately issued a statement on the status of cannabis-derived compounds, pulling them back in the realm of the FDA.

    However, he also announced that some parts of the plant (that do not contain THC or CBD) would be ok (this may help you):

    It should also be noted that some foods are derived from parts of the hemp plant that may not contain CBD or THC, meaning that their addition to foods might not raise the same issues as the addition of drug ingredients like CBD and THC. We are able to advance the lawful marketing of three such ingredients today. We are announcing that the agency has completed our evaluation of three Generally Recognized as Safe (GRAS) notices related to hulled hemp seeds, hemp seed protein and hemp seed oil and that the agency had no questions regarding the company's conclusion that the use of such products as described in the notices is safe. Therefore, these products can be legally marketed in human foods for these uses without food additive approval, provided they comply with all other requirements and do not make disease treatment claims.

    Yesterday, he announced that FDA will be holding a public hearings on CBD in food products in April. There is a huge grey economy in CBD products crying out for some sort of regulation. The gap between what is on the label and what is in the jar is enormous. 

    In Canada, Health Canada put all phytocannabinoids (including CBD) on the Prescription Drug List on the day of cannabis legalization (Oct. 17, 2018) and only the parts of the cannabis plant that     do not meet the definition of cannabis are allowed in natural health products:
      • Non-viable seeds or roots of the cannabis plant
      • Mature cannabis stalks without leaves, flowers, seeds, or branches
      • Fibre derived from such a stalk
      • Hemp derivatives that are compliant with the Industrial Hemp Regs
      • Must not contain more than 10 parts per million THC, or phytocannabinoids that have been isolated or concentrated

    So there's a bunch of products that contain hemp oil, hemp protein or hemp seed. But CBD products are regulated under the Cannabis Act. Health Canada plans to allow edibles, extracts and topicals containing CBD this October (2019), but producers can't make any health claims unless they go through the prescription drug pathway. 

    Cheers
    Karen




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    Karen Long RAC
    Vancouver BC
    Canada
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    Original Message


  • 5.  RE: FDA and CBD use in cosmetics

    Posted 28-Feb-2019 16:09
    Karen,

    Thank you for the feedback, like you, I found that information quite helpful for the purposes of our product, and stressed to the team that CBD is by no means an option.  

    As is the case in Canada, CBD is prohibited in cosmetics and the cannabis sativa is restricted as indicated in your message.  This will be interesting to follow as everyone seems to want to jump on the bandwagon.  


    As always, thank you all for the information!


    Cheers,
    Laura

    ------------------------------
    Laura HoShue
    Regulatory Compliance Specialist
    Las Vegas, Nevada
    USA
    ------------------------------

    Original Message


  • 6.  RE: FDA and CBD use in cosmetics

    Posted 22-Apr-2019 15:33
    Thank you Karen! Excellent!

    ------------------------------
    Laura HoShue
    Regulatory Compliance Specialist
    Las Vegas, Nevada
    USA
    ------------------------------

    Original Message


  • 7.  RE: FDA and CBD use in cosmetics

    Posted 23-Apr-2019 08:40

    Hi Laura!

    'Tis I again!  Another watch point for CBD is even in the US - with the passage of the Farm Bill of 2018 federal law has been further defined to allow for things like CBD of hemp-derivation.  However, several states (notably TX, ID and some of the western states) still consider the use of any cannabinoid including CBD from any source as illegal within their state.  And unfortunately, based on the wording of the Farm Bill the states will retain the right to further regulate in this are provided they don't regulate in ways that would make federal law impossible to comply with.  So in this arena, if a state outlaws the use of CBD for example within its own state, provided they don't outlaw transport of the material through the state (note I said transport not sale) then the state likely will be allowed to regulate in whatever way the state legislature and regulatory agencies deem fit.  However, if they regulate transport of material through the state, that is where you will see fights.  More importantly, the states can also argue that the Farm Bill allows for the transport and production of such materials from businesses that have "obtained a license either from USDA or from an agency and through a system in their state approved through the USDA".  As far as I know currently, no state or federal licenses have been issued at this point...

    Just FYI - in the last few weeks I have seen several reports of at least 1 state actively raiding facilities within the state over this!
    ​



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    Victor Mencarelli
    Director Regulatory Affairs
    United States
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    Original Message


  • 8.  RE: FDA and CBD use in cosmetics

    Posted 23-Apr-2019 09:34
    Hi Victor!! I am happy to hear from you.  That is great information! It is so important that we are aware of the laws even at the state level.  Such examples like knowing whether the transport of the CBD is even allowed within the state is also very crucial.  Wow.  

    Thank you again for such insightful feedback!!!


    Cheers,
    Laura

    ------------------------------
    Laura HoShue
    Regulatory Compliance Specialist
    Las Vegas, Nevada
    USA
    ------------------------------

    Original Message


  • 9.  RE: FDA and CBD use in cosmetics

    Posted 12-Jul-2019 09:07
    At the public meeting in May, the FDA panel had several questions about the purpose of CBD in cosmetics. These same questions were raised by the FDA Office of Cosmetics at recent public conferences in May and June. CBD is permitted, as long as it is safe as used, makes no therapeutic claims and has a legitimate cosmetic purpose. FDA has said they will ask, during inspections, what is the function and why is it being added.

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    Jennifer R. Martin
    Director - Regulatory Affairs
    United States
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    Original Message


  • 10.  RE: FDA and CBD use in cosmetics

    Posted 22-Jul-2019 09:48
    Great information Jennifer, thank you! 



    Cheers,
    Laura

    ------------------------------
    Laura HoShue
    Regulatory Compliance Specialist
    Las Vegas, Nevada
    USA
    ------------------------------

    Original Message


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