marketing a formula and claims

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

Comments

  • 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. 
  • PerryPerry Administrator, Professional Chemist
    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.
  • SabaSaba Member
    edited January 11
    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. 
  • @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. 
  • PhilGeisPhilGeis Member, Professional formulator
    edited January 14
    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."  
  • SabaSaba Member
    thanks for the info
  • SabaSaba Member
    Hi jaszanGels, I'm not sure really. I just want to make sure that everything will be legal.



  • SabaSaba Member
    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? 
  • PhilGeisPhilGeis Member, Professional formulator
    edited January 15
    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.


  • MicroformulationMicroformulation Member, Professional Chemist
    "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.
    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.
  • PhilGeisPhilGeis Member, Professional formulator
    edited January 15
    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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