Working on facial hair growth solution: FDA compliance?

Hey guys, my name is Paul and thank you for accepting my request to join this wonderful community.

I am working with cosmetic scientists to find the best active(s) that promote hair growth. The end product will be marketed for appliance on men's beards, and will thus promote facial hair growth with consistent application. Whatever the ingredient is, will already have had many clinical studies on them for efficacy and safety so it's GRAS.
I would like to market this as a cosmetic instead of a drug to avoid the complicated process of a New Drug Application.


There exists many similar products like this on Etsy, eBay, Amazon, and other eCommerce stores like "Dollar Beard Club" and "Vitabeard". They have been on the market for some time now and have gained substantial popularity.

However, the FDA defines drugs as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease...and articles (other than food) intended to affect the structure or any function of the body of man or other animals." Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, or revitalize cells. (FD&C Act)

Under this definition, many of these products are in violation under CFR- Title 21 Sec. 310.527.

If these brands are this successful in their business, then I would like to do the same. These products all tend to have the same citation: "These statements have not been evaluated by the Food and Drug Aministration. This product is not intended to treat, cure, prevent or diagnose any disease."

.Does that citation alone make the product a "cosmetic"?
.Are there certain ingredients that cannot be marketed as a cosmetic? (i.e, minoxidil 5%)?
.Any guidelines/tips on "claim phraseology"? ("Boosts beards", "Beard enhancement", "Beard grower")
.Should I hire the cosmetic scientist first? And then market it as a cosmetic?
.Anything else I should know?

Thank you.

Comments

  • BelassiBelassi Member
    edited October 2016
    Anything else I should know?
    Yes. You're wasting your time, unless you include the prescription drug, Minoxidil.
    Cosmetic Brand Creation. Concept to name to IMPI search to logo and brand registration. In-house graphic design inc. Pantone specs. Cosmetic label and box design & graphics.
  • Bill_TogeBill_Toge Member, Professional Chemist
    a product like that would be regarded as a medicine anywhere in the world - the fact that other branders use weasel words to try and sell their products as cosmetics doesn't make them legally compliant or in any way defensible

    you could certainly try to sell it as a cosmetic, but if it blew up in your face and you ended up being taken to court over it you'd only have yourself to blame
    UK based formulation chemist. Strongest subjects: hair styling, hair bleaches, hair dyes (oxidative and non-oxidative) I know some stuff about: EU regulations, emulsions (O/W and W/O), toothpaste, mouthwash, shampoos, other toiletries
  • Yes. You're wasting your time, unless you include the prescription drug, Minoxidil.

    Could you provide some value to the discussion? There exists a large number of scientific research behind certain plant extracts, compounds, etc. that show effective hair growth abilities. The final ingredients in this cosmetic product may not replace minoxidil usage, but could certainly help and improve the benefits alongside with minoxidil.

  • a product like that would be regarded as a medicine anywhere in the world

    A medical drug would be defined as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

    I don't believe this solution derived from natural extracts would have anything to do with medicine.

  • Some value? Yes. About 3 years ago I held beliefs similar to yours. I obtained many costly extracts of this and that. Trichogen, what a joke that is, just for starters. None of the test panel showed any effect of anything. After a couple of years ... do you really think you are going to come up with something when a whole world of cosmetics companies devote their efforts to it and come up with nothing?
    Cosmetic Brand Creation. Concept to name to IMPI search to logo and brand registration. In-house graphic design inc. Pantone specs. Cosmetic label and box design & graphics.
  • MicroformulationMicroformulation Member, Professional Chemist
    edited October 2016
    @Belassi is absolutely correct in every point.

    Hair loss or slowed growth is alopecia, a disease state. As soon as you propose a physiological response vice a Cosmetic (hence visusal), it becomes a drug. You can play with the semantics but it doesn't change that root fact.
    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.
  • None of the test panel showed any effect of anything. After a couple of years ...

    @Belassi , thanks for responding. Are you stating that there exists no natural ingredients that will show "any" hair growth effects when there are hundreds of clinical studies on these ingredients that are shown to have hair growth effects? Jojoba oil, peppermint oil, apple polyphenols, copper peptides, and other extracts have all been researched and according to the findings, they are potential agents for hair growth. A few cosmetic scientists I am communicating with are familiar with these ingredients and efficacy as well.

    How is it that you can make a simple statement and regard all of the clinical studies as illegitimate? I suppose you may have formulated wrong, because that is quite a bold assertion to make.

    Kind regards,


    Paul L

  • Hair loss or slowed growth is alopecia, a disease state.

    Microformulation  Thanks for your input.

    Alopecia is actually associated with hair loss or the thinning of hair. Alopecia barbae is the sudden hair loss of the beard. This is not something I am intending to treat.

    To clarify, beard growth in males is largely a result of the androgen receptors on the hair follicles of the face. Technically, all males and females have "beards" due to the presence of vellus hairs. These vellus hairs are the result of androgen receptors, more specifically DHT, and other genetic factors.

    With this said, a "slow" growing beard is not a disease state. It is not alopecia. The only time alopecia is associated with beards, is when sudden patches of hair start to fall off on your beard. This is termed as "alopecia barbae".


    Hope this helped.


  • Bill_TogeBill_Toge Member, Professional Chemist
    @HuskyBeard on the other contrary, it would be an "article (other than food) intended to affect the structure or any function of the body of man", which puts it firmly into the medicines category
    UK based formulation chemist. Strongest subjects: hair styling, hair bleaches, hair dyes (oxidative and non-oxidative) I know some stuff about: EU regulations, emulsions (O/W and W/O), toothpaste, mouthwash, shampoos, other toiletries
  • My view is that the most important aspect here is being put on one side:

    "Does it work?"

    I have seen the hair that grows as a side effect of treatment with Minoxidil for its intended use (hypertension).
    I ain't beard hair by any means - more like the fluff on a baby's bum. Worst thing is, it falls out when the treatment stops.

  • MicroformulationMicroformulation Member, Professional Chemist
    Nonetheless, you are attempting a physiological change, which is a drug claim. It doesn't matter if your product is a Pharmacological agent, an herbal product or even the sweat of sugarplum fairies! It is a disallowed claim.

    As many have mentioned, if this were a viable claim, someone would have utilized it.

    Sorry to burst your bubble, but your reliance of the limited studies is a bit naive. You will see this as you evolve in the field. I think @Belassi has been helpful in relaying his progression from a naturalistic bias towards the "natural" products  to a Science based realism. He is not being negative and in fact is giving you good advice. "...I suppose you may have formulated wrong..." disregards this journey.

    Just because someone gives you a fact based rebuttal of your marketing based paradigm, they are not being unhelpful Your response came off as petulent and has kept you from seeing the great advice that experienced Formulators in the field offered to you gratis.
    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.
  • BobzchemistBobzchemist Member, PCF student
    The products being sold for this purpose are getting away with it both because they use "weasel words" to describe how their products work AND because - surprise, surprise - they have proof that their products do not actually work.

    If their products worked, they would be selling an unapproved new drug and would be shut down.

    If you have a product that actually speeds hair growth, the FDA will consider it a drug. Period. Selling it without a NDA will potentially put you in a world of hurt. Natural vs. synthetic is irrelevant.

    There are only two choices to keep from being sued/prosecuted into oblivion - sell something that doesn't work and pretend that it does, or sell something that does work with the proper safety and efficacy testing and file a NDA. 
    Robert Zonis, Sr. Formulation Chemist, Beaumont Products "All opinions and comments expressed are my own, have no relation to Beaumont Products, are fully copyrighted, and may not be used without written permission."
  • @johnb
    Well I am leaving that question to the cosmetic chemists I am interviewing. They will do the scientific research and come up with a list of potential ingredients to include in the end formulation. They won't be doing testing however, as the clinical studies will do the "talking".

    I'm hoping they will not screw me over and actually have a promising formulation that will be effective.
    And minoxidil does wonders for the beards. There is a huge community of young adults who put this on their face and see good results within 3 months. The results will fall out though if you discontinue usage. Application of minoxidil to result in a permanent beard (a beard full of terminal hairs) takes approximately a year. So it is very important to be consistent with application and then gradually quit application instead of suddenly stopping. There's only one scientific study shown on minoxidil's affects on the beards, however all of the anecdotal reports have good results! Like me, I've grown a pretty solid beard from just two months of usage, of course i will have to keep applying until around next year for the beard to transition into terminal stage! :)
  • @Microformulation
    There exists hundreds of shampoos/conditioners/beard oils that have phrases like "restores hair", "promotes fuller head of hair", "fuller stronger hairs". Some are even being sold at Walmart or hair salons. These have been on the market since forever and they are still making money. If anything, Etsy, eBay, and Amazon allow hair growth products to be sold on their stores and nothing is stopping them. These products are manufactured from China or made at home. I am not talking about whether or not the product works, I am simply saying that the FDA isn't invested in this because all of these products should've been taken down already. You're right I am very naive in this field and am looking for explanations.

    One cosmetic chemist told me that I can first market my product as a cosmetic, and if the effects are extremely remarkable, then it will "move" into the drug category, which I will then have the funds to do that. But now, my funds only allow me to make a cosmetic.

    As an entrepreneur I want to know why and how, not short simple rebuttals. That's just the way my mind works and I hope to not come off as petulant.

    Thanks again for your contribution to this discussion.
  • MicroformulationMicroformulation Member, Professional Chemist
    You are welcome.

    My last piece of advice. Don't use a Cosmetic Chemist as your go to source of specialized advice. We specialize and you must seek an appropriate expert. For example, I recently did some work with CBD oils. My assertion throughout was that my expertise revolved around including these materials in a stable formulation with nice skin properties, NOT the actual effectiveness of the CBD oils. Claims substantiation is a specialty and in fact there are several laboratory providers that provide this service. It is not a core Cosmetic Science function. It is the same with Regulatory compliance. Granted we can speak to the topic, but in the end you will need a regulatory expert. Regulatory compliance is not a core Cosmetic specialty, arguably something we have exposure to, but that is all.

    Just because a product is sold on Ebay, Etsy or Amazon does not grant you permission to violate the regulations as well. While granted, the FDA does let a lot slip through, they are watching. There have been more violation letters this year than any year I can recall. In fact by July 1st, they had issued more in 2016 already than in all of 2015. If you get caught, you would have to bring all your web citations and packaging into compliance or face further censure.

    Just because someone gets away with a violation doesn't make it a good idea for you to attempt to do so also. A few streets over someone sucessfully kicked a door in and stole a big screen TV. But be assured, I will not be doing the same thing.

    In the end it comes down to your level of risk and your level of ethics. That simple. I again doubt you will see significant performance in this product. If it were possible, one of the Fortune 500 companies with an R&D budget thousands of times larger than yours would have already put it on the market.
    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.
  • @Bobzchemist so considering the world of cosmetic products, I would have a higher incentive to market an ineffective hair growth product to keep it as a cosmetic?
    what if the product were moderately effective?

    thanks
  • PerryPerry Administrator, Professional Chemist
    If the product is effective at all (moderately or more) it is an illegal drug. 

    If you are trying to build a legitimate business following the lead of people who are breaking the law is a terrible business plan.
  • BobzchemistBobzchemist Member, PCF student
    It's weird, but yes, if you want to sell a cosmetic in the US, you have a strong incentive to make sure that it does not work physiologically, and an almost equally strong incentive to imply (but not say outright) that it does work.

    Also, (and please consult with a lawyer, don't take my word for it) you're probably from a legal standpoint better off NOT doing any sort of claim substantiation/clinical testing at all.
    Robert Zonis, Sr. Formulation Chemist, Beaumont Products "All opinions and comments expressed are my own, have no relation to Beaumont Products, are fully copyrighted, and may not be used without written permission."
  • @Perry
    Who is to measure if the product is "moderately or more" effective?

    I know of one particular hair growth company that is being observed by the FDA. The FDA is dictating them to change their claims and remove more "science" out of their selling page. As far as I know, if they comply, their business is still running and no harm no foul.

    If my product works very effectively, then I will have to either: a.) change claims to "improves beard" or b.) go through process of cosmetic to new drug.
  • @Bobzchemist

    You mention that I am better off not doing any sort of claim substantiation/clinical testing at all. I don't really plan to unless my startup takes off and I form a company.

    What if I were to strip any claims from my cosmetic product, and just feature a graphic of a beard on it, and say "beard booster". "These statements have not been evaluated by the FDA"
  • @Microformulation

    Hi, thanks for your thorough explanation. Sorry for not responding promptly.

    I would like to know what you think the best steps for me to take are?
    Currently I am looking to hire a cosmetic chemist to formulate me a solution with ingredients that show promising scalp hair growth effects.
    Then have manufacturers develop this solution for me.
    The cosmetic product will have no "claims" on it, just a graphic of a beard implying that your beard will grow, but not explicitly stating that.

    Thanks for your time, and sorry if I came off petulant. This is my goal and I have been working very hard to make it a reality.
  • Reverting to my previous post on this: "Does it work".

    Your first steps ought to be acquiring intellectual property rights.

    If you don't do this then there is the strong possibility that anyone "in the know" about your invention/idea can/will steal it from you.
  • MicroformulationMicroformulation Member, Professional Chemist
    @HuskyBeard No problem at all.

    As many have pointed out (and I am sure that you may progress to see this as well), the benefits sometimes attached to the Natural products are exagerated to at least a large extent. I have always attributed this to "chemophobia" and "naturalistic fallacy" which is rampant in the smaller DIY adjacent market sector. Some never progress beyond this paradigm, but many will evolve and see that perhaps it is better to provide a root product based upon some realistic claims that can be attributed to valid plant based materials (perhaps conditioning, "volumizing", etc) and then as a marketing "campaign" later.

    The one truism (which you may not be ready to accept yet) is that a. if there were truly effective plant based products, the market would have utilized them by now. It is no accident that Rogaine has been a winner for Upjohn. And b. if a product did exhibit a true physiological effect it would become an OTC drug. Applying for a New Drug Application (NDA) is an expensive 6 figure process and the speed at which the FDA approves these NDA's is slow. I know these two points challenges your point and that is not my intent. Just put a pin in it and keep it in the back of your mind as your project progresses.

    Lastly, much as your Formulation will get revised and will change, so must your Marketing. Don't make the mistake of writing yorr Marketing goals in stone and refuse to revise it in regards to what the Science can provide. In that case you will either fail or alternatively make a product which you fly under the radar of compliance, hence engaging in snake oil.

    Good luck with your project and I wish you all the best.
    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.
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