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  • marketing a formula and claims

    Posted by Saba on January 10, 2022 at 9:13 pm

    I need a guidance here please. I did make a plant extract from mixing couple of plants when I was at college. Then I tested those extracts on ginea pigs by making an incision on their skin to see the healing effect. Then, I prepared that extract as an ointment, cream and gel. After applying them for 10 days twice a day, I noticed that there was no mark or a scar at all with the gel formula. Then by chance I used it for burn that I got. To my surprise, there was no scar what so ever.  Then, my family and friends started asking me to make for them and every time it is a winning. My question, how can I sell this product? Is it going to be a drug or cosmetic? How can I proceed to be selling this gel? 
    I really appreciate your help and expertise.

    Saba

    PhilGeis replied 2 years, 1 month ago 6 Members · 11 Replies
  • 11 Replies
  • ajw000

    Member
    January 11, 2022 at 12:38 am

    Anything claiming a “healing” property will need to list the drug facts. If you are making a claim it will need to be with ingredients that are FDA approved for the claim you are making. I would suggest visiting the FDA website and doing some study on labeling and claims requirements. Unfortunately I think you will find you will need to change your verbiage with marketing so that you aren’t making a claim. 

  • oldperry

    Member
    January 11, 2022 at 2:59 am

    Yes, it comes down to the way you word your claims and what you’re implying what the product does. Anything that affects the body biochemistry is a drug in the US. If you focus on making scars look better (not healing them) then you may be able to make it as a cosmetic. But if you are actually offering a drug active, even rewording your claims may not be enough.

  • Saba

    Member
    January 11, 2022 at 6:28 am

    Thanks for your input. Maybe I should say it’s a soothing, moisturizing gel, and make scars looks better as you suggested, Perry.

    On top of that, on the details description, I can write about each plant and it’s properties. 
    Also. I have to write that this gel is not intended to heal,  treat, or cure.
    Can I attach the pictures before and after the burn?

    If anymore suggestions, I really appreciate it. 

  • jaszangel

    Member
    January 14, 2022 at 4:48 am

    @Saba Would love to know when/where you’ll be selling this product! But in response, you most certainly can utilize your social proof for sell’s, which is a good way to show the effects and benefits without having claim issues. & a disclaimer would also be ideal. 

  • PhilGeis

    Member
    January 14, 2022 at 12:22 pm

    Pictures/plant decriptions implying drug effect are the same as the textual claim.  Boiler plate denial does not neutralize.
    As cosmetic - recall regulatory demands including ingredient labeling - what will be the appropriate name for this “extract”?
    Please also be aware of your affirmative safety  responsibility - toxicology and microbiology.

    I’m sure this would go under FDA’s radar.  But be aware, in this discussion you established product as drug - the FD&C Act addresses “intent.”  

  • Saba

    Member
    January 15, 2022 at 6:34 am

    thanks for the info

  • Saba

    Member
    January 15, 2022 at 6:38 am

    Hi jaszanGels, I’m not sure really. I just want to make sure that everything will be legal.

  • Saba

    Member
    January 15, 2022 at 6:52 am

    Pictures/plant descriptions implying drug effect are the same as the textual claim.  Boiler plate denial does not neutralize.
    As cosmetic - recall regulatory demands including ingredient labeling - what will be the appropriate name for this “extract”?
    Please also be aware of your affirmative safety  responsibility - toxicology and microbiology.

    I’m sure this would go under FDA’s radar.  But be aware, in this discussion you established product as drug - the FD&C Act addresses “intent.”  

    Hi PhilGeis,
    Do you mean I should search for the LD50 “leathal dose” for each ingredient or plant in the extract to see how toxic it is?
    Do you think that I have to write each and every plant extract I included in it? Maybe I should, but then everyone can copy it? right?

    I really don’t know how to deal with this?
    Should I ask a herbalist may be? 

  • PhilGeis

    Member
    January 15, 2022 at 11:24 am

    Appreciate your effort to take responsibility.
    Think about all the critcisms companies face - carcinogenicity, sensitization, the BS of endocrine disruption, etc.  I do NOT recommend EWG, but look at the safety considerations it uses in its (BS) safety assessments.

  • microformulation

    Member
    January 15, 2022 at 2:31 pm
    “Do you think that I have to write each and every plant extract I
    included in it? Maybe I should, but then everyone can copy it? right?”
    Yes, you have an obligation to reveal all components in the ingredient deck. It is to allow the consumer to make informed decisions.
  • PhilGeis

    Member
    January 15, 2022 at 3:06 pm

    Trade scret is possible but very, very rarely granted (reportedly once in last 20 years)
    https://www.fda.gov/cosmetics/cosmetics-labeling/trade-secret-ingredients

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