[HuskyBeard]

Could you link it? I don’t know where I’m supposed to find that

[HuskyBeard]

@Belassi Sounds interesting. Are you going to fund this through the NDA process? I’d be astounded if you actually persisted enough with whatever formulation you’ve come up with, to pay 1 million dollars and wait 10 years. 

[HuskyBeard]

If I am “tagged”, then during the 15 day grace period, I could simply remove the non-compliant claims. This is what SkinBiology did. 

I spoke to them on the phone and they informed me that they had to edit their whole website and remove much of their claims. Their business is still up and running and has been for years. 

[HuskyBeard]

@Microformulation @Perry
Thanks for the input.

Of course I too find it unethical for a brand to lie and deceive its customers and that is not what I want.

Through claims, I would like to promote the idea that this product could grow beard hairs, based on the available information on the ingredients mechanisms of actions.

About 3-4 extract ingredients have been suggested to have mechanisms of action similar to that of minoxidil (vasodilation, anagen induction, etc.) And some of these extracts have even been compared favorably to that of minoxidil. 

Although this limited information isn’t “proof” that this formulation would work, it suggests the possibility. This doesn’t substantiate the claims legally, of course. But to the consumer, this information is logical and promising enough. If these extract ingredients have been suggested to promote hair growth through various studies, then the topical application of a carefully designed formulation with said ingredients would likely produce more hairs on the face than the body’s natural hair growth rate. Some may experience extreme benefits and no benefits. And some may experience side effects, which is another topic.

To the users who report no benefits, a full refund is given. 

[HuskyBeard]

@Perry Back to what you were saying, by the logic of big companies and congress and lawyers not caring about the smaller company, my cosmetic business could ultimately succeed small scale (a comfortable living).

The cosmetic would imply beard growth but not directly state this. The intention would still be to create a formulation that grows hairs. 

If the bigger people only care about big money, why would they bother suing? If they did “tag’ me, why couldn’t I just abide and decide to switch up my marketing? 

I have contacted several hair growth companies who have been tagged by the FDA and asked them what had happened. They report that they just simply had to change their marketing and remove some of their claims. 

No harm no foul.

[HuskyBeard]

@Bobzchemist Very interesting. Would a consumer survey like this have to be setup in a certain manner? Would I have to hire a legal person to write up this survey? Or could it be sufficient enough to just write up a google survey document and have my email subscribers fill it out?

[HuskyBeard]

@Perry Well I’ve heard from several members in this group that the number of reports against smaller businesses and their claims are being tagged more and more often. This is what the consultant and regulator told me as well.

Thanks for your advice! It does seem that it is indeed possible to enter this market.

[HuskyBeard]

@Belassi
I know, I probably am. It’s just that the regulator’s words gave me such a different perspective on the technicality of advertising and the such. I guess I’m just making excuses. 

[HuskyBeard]

@Microformulation
Is there a guideline for words/descriptions that may be used for cosmetic purposes? I know the definitions but it’s quite ambiguous what claims “fly too close to the sun”.

Are these claims “safe”?
-Moisturizes
-Nurtures
-Helps cultivate
-Rich in antioxidants
-Healthy
-Gives you a better beard
-improves/enhances
-Freshens/revitalize

[HuskyBeard]

@Belassi
Thanks for the advice! I’ll keep that in mind. 

[HuskyBeard]

Hey @Perry, thanks for your tips! I do think their advice is situated on a “worst case scenario”. 

At the moment I have completely given up hope on any beard growth product, despite me believing several ingredients may have a significant impact on hair growth. It’s just quite risky and I’d be shooting myself in the foot in the long run.

However, I do want to formulate something for the beard, such as a beard oil or beard balm. There are many of these products on the market. It’s quite known that a mixture of carrier oils and essential oils can be used on the beard and most agree that they benefit from it. 

Could I purchase a few amber glass bottles, buy a bulk inventory of each castor oil and essential oil, and mix/dilute them appropriately at my kitchen and sell it? 
According to the regulatory expert, even this is not a good idea, because there is no “proof” that my mixture would have any desired effects, and would therefore be deceptive advertising. 

While I may not be “important” enough in the eyes of lawyers/FDA auditors, the cracking down on small businesses/mom and dad shops are growing exponentially. This favors Congress and big businesses and is likely that they are conspiring to rule this industry. 

[HuskyBeard]

@Microformulation Yes I do remember having that discussion with you. Hair growth would be an impossible feat to pursue unless I go through the process of a NDA, which would be completely out of the question for a startup. 

The regulatory expert advised me that I couldn’t even make a beard oil, which is a multimillion dollar market, without going through a series of studies/tests to determine if the formulation “conditions/softens/moisturizes the beard. He declared that every single claim for any product would have to be substantiated which I find quite ridiculous. Then it would have to be tested for safety and other things. 

Is this accurate? Could I not even replicate a simple formulation of argon oil, jojoba oil, and peppermint essential and market that as a beard oil that is healthy for the beard without having to conduct $10k+ studies? Because while some ingredients/monographs might have been conducted on scalp hair, I doubt there is any information regarding beard hair.

Any implication on hair growth is completely outside of my intentions now as I don’t even want to deal with potential lawsuits. I would just like to start some beard oils without having the headache of claiming “illegal” copy for the product.

[HuskyBeard]

Could you explain to me a little bit more about cosmetic raw distributors not complying with FDA cosmetic claims?

Are you saying that different formulators can make different “kinds” of redensyl, and thus create a less effective result?
And why is it wrong to assume since Induchem made a statement in their pdf, i can make it?

I know I am naive in this matter, but I’ve been researching on some similar hair growth companies and a very few amount of them have had FDA warnings on them and their claims. I’ve followed up with them and they’ve said they just simply removed some of the claims, and that they are still in business and are still selling their cosmetics. No fines, no legal involvement, just compliance.

[HuskyBeard]

Hey @Microformulation , thanks for responding to my second posting!

Yes you are right claim substantiation is a difficult process but my strategy was to market more on the benefits of having a beard and the “social need” of growing a beard as it is trending.

Redensyl has won a cosmetic silver award in Europe I believe, so I was going to market about that. Also redensyl has a PDF file made by the manufacturer and that PDF includes test results and the science behind why it “could” promote hair growth. All of my claims will be based on that PDF.

I’ve also noticed that other cosmetics with redensyl all state the same claims based on that PDF.

Thoughts?

[HuskyBeard]

@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.

[HuskyBeard]

@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”

[HuskyBeard]

@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.

[HuskyBeard]

@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

[HuskyBeard]

@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.

[HuskyBeard]

@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!

[HuskyBeard]

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.

[HuskyBeard]

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

[HuskyBeard]

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.

[HuskyBeard]

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.