Italian Hair Loss Lotion To Hit The Market In 2016

[Trouse]

I really don't think commercializing this will take that long. Maybe to get everything going full steam with a marketing initiative and all that but they'd still be able to sell it online before that all falls into place.

Remember this treatment has gotten no steam from the media. It will be very popular in Italy but in the US, less than 1 percent of hair loss sufferers will even know it exists for the first 6 months- a year. It's the same couple dozen people checking this thread everyday, that should buy us some time at least.

 

[hairblues]

Omg 2016 become 2017? then 2017 comes we wait until 2018...it would be better to wait other treatments aiming for 2018 like histogen

it was always discussed as sometime in 2017 never assumed it was going to be 2016 maybe first few pages thats it

 

[hairblues]

I appreciate you citing relevant information. In a previous post, I did mention that OTC monographs are a potential route to avoid FDA approval, but it would still require an approval process, albeit shorter.
As for the cosmetic guidelines you listed, they are only relevant if the lotion isn't advertised as having the ability to regrow hair. If it is labeled as such, it is automatically classified as a drug. A cosmetic cannot under any circumstance claim that it grows hair.

How long an approval process? do you actually know or are you guessing at this?

How do you NOT know that FIDIA is already finished with trials and doing the approval process now?

I find it interesting that FIDIA and DR Brotzu are wanting to release it as a cosmetic--a pharmaceutical company and an esteemed Dr and inventor/scientist who have top lawyers in this field working for them--you think you are going to know more than these people?

People who have their masters in international business and know all the laws backwards and forwards?

I just don't understand your logic.

what exactly are you saying? that it wont be available in 2017/2018?

 

[hairblues]

Omg 2016 become 2017? then 2017 comes we wait until 2018...it would be better to wait other treatments aiming for 2018 like histogen

it was almost always assumed by early posters in this thread end of 2017.

the trials did not even start until May/June 2016.

 

[AnArcticTaco]

What I'm saying is it is illegal in the United States for a cosmetic product to claim that it regrows hair and not also be considered a drug. By illegal I mean it is against the law. It does not require a degree in business to understand that. I hope Fidia has a way to circumvent any regulatory hurdle, but bottom line is that in the USA, it will be a drug. Whether or not Fidia has been concurrently having the product reviewed for over the counter monograph approval remains to be seen.

I do not know the specifics of European cosmetic regulation. The articles you may have read citing the cosmetic goals perhaps are focused on just the European market. Because I repeat: A cosmetic cannot claim to grow hair in the united states without being considered a drug.

Is Minoxidil considered a drug since it also claims the same? I know it used to be prescription only so I guess that would make sense.

 

[Pavi]

Is Minoxidil considered a drug since it also claims the same? I know it used to be prescription only so I guess that would make sense.

It is a drug

 

[jc3303]

There are cosmetics that claim re growth. Just go on amazon, even though a majority are just bs essential oils.

 

[SmoothSailing]

To me it seems it will be classified as a drug in the US at least. Read the following page, even an anti dandruff shampoo must be considered a drug.

http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm

An antidandruff treatment is a drug because its intended use is to treat dandruff...
. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims.

If these products are classified as drugs I can't imagine Brotzus lotion won't be.

What this means exactly I'm not sure. I mean does every new anti dandruff shampoo need to be trialed for years?

 

[potato87]

But even if it is a drug we will find a way of shipping it to you! nothing is impossible.

 

[That Guy]

CETA starts taking effect next year.

Take that, you American peasants!

 

[DrizzyD]

Wait so your telling me shitty *** rogaine and even any basic head and shoulders shampoo are considered drugs and not cosmetics? Both make claims that the FDA considers worthy of classification as a drug, but both sit in every single target, Walmart, and grocery store in the nation. Were these products subject to the same approval as a drug I'm genuinely curious.

 

[SmoothSailing]

Wait so your telling me shitty *** rogaine and even any basic head and shoulders shampoo are considered drugs and not cosmetics? Both make claims that the FDA considers worthy of classification as a drug, but both sit in every single target, Walmart, and grocery store in the nation. Were these products subject to the same approval as a drug I'm genuinely curious.

Best I could find was this statement on head and shoulders.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

https://www.drugs.com/otc/104092/head-and-shoulders-clinical-strength.html

My guess is that so long as the product complies with particular standards for a shampoo or for anti dandruff properties then it doesn't need to go through an approval process.

Hopefully Brotzus lotion can somehow make use of this. Maybe it's mostly about the ingredients?

 

[Fahad]

Im tired of this sh*t wtf i mean they almost find a cure for HIV but for hairloss they r not even close

 

[Stupidon]

Im tired of this sh*t wtf i mean they almost find a cure for HIV but for hairloss they r not even close

No they don't and they are far from it.

 

[Grasshüpfer]

You can buy ____ing meth on the internet. So i assume if the lotion works we will get it one or the other way.

 

[Royaume]

@7th sense, any news concerning bellicapelli?

 

[Fahad]

No they don't and they are far from it.

1. Dude if u dont know ur american FDA or wotever is testing a new HIV treatment which is so so much better treatment than what the world have right now nd the actor charlie sheen is one of the ppl who r testing it

 

[DrizzyD]

@SmoothSailing @Barbe a papa oh so if there is no problem with getting it shipped in from Europe then who gives a sh*t about FDA approval. If this lotion is effective and side free then f*** I'll pay extra to get this from Europe the hell do I care I just want to maintain my damn hair.

 

[SmoothSailing]

@SmoothSailing @Barbe a papa oh so if there is no problem with getting it shipped in from Europe then who gives a sh*t about FDA approval. If this lotion is effective and side free then f*** I'll pay extra to get this from Europe the hell do I care I just want to maintain my damn hair.

I will much prefer if I can buy it legitimately, but no doubt whatever classification it ends up being I will get my hands on it somehow as soon as it hits markets.

 

[hairblues]

What I'm saying is it is illegal in the United States for a cosmetic product to claim that it regrows hair and not also be considered a drug. By illegal I mean it is against the law. It does not require a degree in business to understand that. I hope Fidia has a way to circumvent any regulatory hurdle, but bottom line is that in the USA, it will be a drug. Whether or not Fidia has been concurrently having the product reviewed for over the counter monograph approval remains to be seen.

I do not know the specifics of European cosmetic regulation. The articles you may have read citing the cosmetic goals perhaps are focused on just the European market. Because I repeat: A cosmetic cannot claim to grow hair in the united states without being considered a drug.

If it is a drug i believe it is a drug made up of already 3 components that are already FDA approved.

SO if it is a drug 'here' and you need a prescription...So what?

You seem to be inferring this is going to be some huge delay.