JM NOT banned ....
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free skin care · Mon Nov 06, 2006 1:28 pm

I just phoned the company.

The company orginally experienced production problems because of the huge demand.

They created a new label and need FDA approval on the new label ... it has nothing to do with safety or efficacy. That's it - that's the hold up - need to get FDA approval on new packaging.

I work in medical device and biotech and yes, you do need FDA approval for labels and packaging. I worked on a number of packaging designs - you need to note dye numbers, type of paper stock, adhesive, etc. and have a ton of paperwork for labels, inner and outter boxes.

free skin care · Mon Nov 06, 2006 1:50 pm

I agree just talked to more vendors, and the products should be back in their hands early December at latest, or so they said. I made these calls just to make sure its not more testing.

free skin care · Mon Nov 06, 2006 1:57 pm

Rjez wrote:

They created a new label and need FDA approval on the new label ... it has nothing to do with safety or efficacy. That's it - that's the hold up - need to get FDA approval on new packaging.

I work in medical device and biotech and yes, you do need FDA approval for labels and packaging. I worked on a number of packaging designs - you need to note dye numbers, type of paper stock, adhesive, etc. and have a ton of paperwork for labels, inner and outter boxes.

I had no clue Rjez. Does every cosmetic label need to get FDA approval? For instance does a cleanser label need to get FDA approval? What about the label for something like ISC Super Serum, did that need to get FDA approval? What about a mascara label? I am not doubting you here I just want to make sure that I understand exactly what you are saying.

free skin care · Mon Nov 06, 2006 2:09 pm

Whew!!!!

free skin care · Mon Nov 06, 2006 2:18 pm

Well, every medicine which needs to be approved by the FDA, is approved with it's packaging (so if you change the packaging you need a new approval as well - i work for a big intl. packaging supplier). But as i mentioned, this is only for medicines and not for cosmetics... (we agreed in another thread in the past that JM eyelash stuff is somehow not a medicine and never has been approved by the FDA).

free skin care · Mon Nov 06, 2006 2:25 pm

well one vendor told me jm had a glitch in its last huge batch and never sent them out. They needed to redo the entire batch....so it could be that simple....

free skin care · Mon Nov 06, 2006 2:34 pm

TheresaL wrote:

Does every cosmetic label need to get FDA approval? For instance does a cleanser label need to get FDA approval? What about the label for something like ISC Super Serum, did that need to get FDA approval? What about a mascara label? I am not doubting you here I just want to make sure that I understand exactly what you are saying.

Believe me, when I did my first design for an inner pouch I was in for a rude awakening.

FDA can be extremely confusing because many times they're vague. For example, I've received a warning letter for a biotech website that I managed. But FDA has no official guidelines for websites. So, among other things - our Regulatory department would not allow linking to our company site to a physician's site because in doing so, we were liable for any claims by a physician. The link was considered a promotion to anything the physician said.

I'm not sure on OTC products (like mascara) but any cosmetics that make claims like Jan Marini are also considered drugs (hormone creams, antidandruff shampoos). Don't know ISC stuff but it might.

And, actually, I should clarify that when I said 'labeling' I meant the actual container. Labeling is also the 'claims'.

For the actual medical containers, yup, you need FDA approval. The straight labeling that isn't being sterilized or manufactured, FDA doesn't pre-approve but will send a warning letter if they have questions.

Warning letters come in all forms and most companies don't get too concerned.

Here's an example for displaying net quantity and how easy it is to get messed up: "The declaration must be distinct, placed in the bottom area of the panel in line generally parallel to the base on which the package rests, and in a type size commensurate with the size of the container as prescribed by regulation."

I also had to redo some collateral because FDA has now deemed 9 point font (but no specific font type) as the "minimum readability" for literature.

FDA also allows that a company need not reveal its trade secrets - if all the paperwork has been filed.

Okay - I know this is sort of rambling. I'll do another response with direct answers to your questions.

free skin care · Mon Nov 06, 2006 2:47 pm

Does every cosmetic label need to get FDA approval?

Quote:

"FDA's legal authority over cosmetics is different from other products regulated by the agency, such as drugs, biologics, and medical devices. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. However, FDA may pursue enforcement action against violative products, or against firms or individuals who violate the law."

Is Jan Marini Age Intervention Eyelash cosmetic or a drug?

Quote:

"Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs."

What about "cosmeceuticals"?

Quote:

"The FD&C Act does not recognize any such category as "cosmeceuticals." A product can be a drug, a cosmetic, or a combination of both, but the term "cosmeceutical" has no meaning under the law."

For instance does a cleanser label need to get FDA approval?
Wow .. you, uh, hit on the 'oddity'.

Quote:

"Soap is a category that needs special explanation. That's because the regulatory definition of "soap" is different from the way in which people commonly use the word."

I thought this was interesting:

Quote:

"If a product --
* consists of detergents or
* primarily of alkali salts of fatty acids and
* is intended not only for cleansing but also for other cosmetic uses, such as beautifying or moisturizing,
it is regulated as a cosmetic.

If a product --
* consists of detergents or
* primarily of alkali salts of fatty acids and
* is intended not only for cleansing but also to cure, treat, or prevent disease or to affect the structure or any function of the human body,
it is regulated as a drug.

If a product --
* is intended solely for cleansing the human body and
* has the characteristics consumers generally associate with soap,
* does not consist primarily of alkali salts of fatty acids,
it may be identified in labeling as soap, but it is regulated as a cosmetic."

free skin care · Mon Nov 06, 2006 2:54 pm

thanks Rjez!!! the lights coming on, and its making sense...grins!!!

free skin care · Mon Nov 06, 2006 3:07 pm

Rjez thanks for taking the time to answer my questions! Although you added a few questions to those that I asked I am glad that you did. I get the impression that you have had to deal with the regulations one time too many and hence the ramble. Wink

free skin care · Mon Nov 06, 2006 3:09 pm

MelissaMarie wrote:

thanks Rjez!!! the lights coming on, and its making sense...grins!!!

Actually, I'm sorry to be rambling all over the place but this is so exciting for me. For the first time ... I actually know what I'm talking about on this board!

Just a quick note about FDA. I'll bet most people don't realize this but many commercials you see on TV receive warning letters.

A few years ago a big pharma company spent $1M to run a commercial. They got a warning letter and pulled the commercial ... but this took over 30 days, enough time for them to consider the campaign a success.

FDA is getting so irritated that a few months ago they had a meeting to discuss marketing. Should companies be required to submit marketing collateral BEFORE being used publicly.

free skin care · Mon Nov 06, 2006 3:09 pm

Thank goodness! I am so glad you cleared that up. Smile

free skin care · Mon Nov 06, 2006 3:18 pm

Rjez wrote:

.... but any cosmetics that make claims like Jan Marini are also considered drugs (hormone creams, antidandruff shampoos).

Rjez I just noticed that you mentioned that Jan Marini makes a drug claim. I thought like lin23 mentioned above that we had sort of decided on some other threads that the Jan Marini product was not a drug and only a cosmetic which if this were the case would mean that it would not be subject to the strict FDA packaging requirements. But if what you say is true then it would be subject to the packaging requirements. Do I understand this correctly or am I missing something?

BTW I had the impression that you knew what you were talking about on other subjects too (example retinaldehyde product expert!).

free skin care · Mon Nov 06, 2006 4:14 pm

TheresaL wrote:

Rjez I just noticed that you mentioned that Jan Marini makes a drug claim.

I think they are making a drug claim but it depends on FDA and how they interpret the claims. There are whole departments that navigate the world of what we can and cannot say in medical marketing. (I couldn't use a photo of a man holding his back because we didn't have FDA approval to say "pain", as in 'helps back pain'. The photo was considered banned b/c it IMPLIED back pain).

Here's definition of cosmetic:

Quote:

"articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, eye and facial makeup preparations, shampoos, as well as any material intended for use as a component of a cosmetic product.

Drug definition:

Quote:

(A) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease..and (B) articles (other than food) intended to affect the structure or any function of the body of man or other animals"

Both cosmetic and drug:

Quote:

Products that are cosmetics but are also intended to treat or prevent disease, or affect the structure or functions of the human body, are considered also drugs and must comply with both the drug and cosmetic provisions of the law.

TheresaL wrote:

BTW I had the impression that you knew what you were talking about on other subjects too (example retinaldehyde product expert!).

nah ... I was just reposting from others, but thanks ... since I'm not working right now, it's nice to know someone thinks me is smart Laughing

free skin care · Mon Nov 06, 2006 10:06 pm

Rjez wrote:

... FDA can be extremely confusing because many times they're vague. For example, I've received a warning letter for a biotech website that I managed. But FDA has no official guidelines for websites.

Rjez wrote:

... There are whole departments that navigate the world of what we can and cannot say in medical marketing. (I couldn't use a photo of a man holding his back because we didn't have FDA approval to say "pain", as in 'helps back pain'. The photo was considered banned b/c it IMPLIED back pain).

Ladies, she's absolutely right. You have no idea how difficult it is to deal with anything relating to the FDA and often with federally-overseen anything (like the IRS for example)! You haven't lived until you've received a warning letter from a federal agency!

I worked with an attorney who did patent, trademark and copyright infringement work and we were in contact with the USPTO (United States Patent and Trademark Office) for a lot of things. They'd send letters that purported to explain their rules exactly, but mostly created more questions than answers. Amazingly vague at times! I think they sometimes want corporations and companies to "guess" at what falls within the guidelines, and then they issue their warnings when they determine there's been a violation. Its like Justice Potter Stewart of the U.S. Supreme Court attempting to explain “hard-core” por-nog-raphy (sorry, EDS edits that word and won't let me type it out correctly!) by famously saying, “I shall not ... attempt ... to define it ... but I know it when I see it.” Eh?

BTW, Rjez, I don't think you were rambling at all. Your posts were information-packed and as you and I both know, you can't make explaining anything relating to the federal goverment short and sweet! Very Happy

free skin care · Tue Nov 07, 2006 8:00 am

Rjez wrote:

I just phoned the company.
---
it has nothing to do with safety or efficacy.

Well, they would say that, wouldn't they? Laughing

Call me a cynical old woman, but I don't see ANY company, when speaking to an unknown person over the phone, admitting "Oh, yes, we have been forced to withdraw our product due to safety concerns, it will endanger your eyesight and all your eyelashes are going to drop off"

There's probably nothing wrong with the JM at all, but you won't get that kind of info from a phone call.
I know when my clients call I always tell them I'm flat-out busy, even though I'm sitting at the computer with a glass of wine reading EDS Laughing

free skin care · Tue Nov 07, 2006 10:10 am

appletini wrote:

Rjez wrote:

I just phoned the company.
---
it has nothing to do with safety or efficacy.

Well, they would say that, wouldn't they? Laughing

Exactly right - except for the fact that if it HAD been anything official by FDA ... there'd be a posted report by FDA - warning letter, recall, etc.

Also, Jan Marini would've referred all FDA questions to an official spokesperson. Among other things, when dealing with any questions about FDA - a company has policies and procedures because it's a huge legal minefield.

With all the recent press and huge interest - I would hope they're smarter than making up a story about FDA involvement.

free skin care · Tue Nov 07, 2006 10:58 am

luckily there is EDS, where we got all the stuff :P

free skin care · Tue Nov 07, 2006 11:32 am

I don't use this product and have read only some of the many threads here but I did check out the ingredients at the EDS store some time back. EDS lists "eyelash growth factor" as one. I did wonder if that ingredient was listed as such on the actual product, rather than the proper name?

If that is the case (?), maybe that is the cause of the "labelling problem". It would only take one disgruntled customer or business competitor to report to the FDA and then they would have a "labelling problem". As it's selling so well, I imagine they've got a few jealous competitors ?

My understanding was that "cosmetics" don't need to go through the stringent testing required by the FDA for new "drugs", but they ARE required to list all ingredients. Am I wrong on this?

free skin care · Tue Nov 07, 2006 12:08 pm

not to mention if there had been an fda ban, it would then have to be pulled from any shelf where its still available. Now I realize very few have it available, but it appears a few do.

free skin care · Tue Nov 07, 2006 1:40 pm

appletini wrote:

I did wonder if that ingredient was listed as such on the actual product, rather than the proper name?

FDA actually does allow for "trade secrets", but you need to submit paperwork.

appletini wrote:

My understanding was that "cosmetics" don't need to go through the stringent testing required by the FDA for new "drugs", but they ARE required to list all ingredients. Am I wrong on this?

You're right, but cosmetic products that make drug claims must adhere to guidelines for both. FDA says "Products that are cosmetics but are also intended to treat or prevent disease, or affect the structure or functions of the human body, are considered also drugs and must comply with both the drug and cosmetic provisions of the law."

It could be that JM is removing any drug claims so they can stay cosmetic. Or, it could also be filing the necessary paperwork, that 'eyelash growth factor' is a "trade secret".

Forgot to mention before, along with 15 years in medical device/biotech ... I got my start filing FDA submissions. I'm *so* used to reviewing FDA guidelines.

free skin care · Tue Nov 07, 2006 2:09 pm

As a cosmetic chemist, I know first hand that the ingredient labeling is very important when putting out a "cosmetic" consumer product. If the product does not affect "bodily function" in any way it can be considered a cosmetic, and not a drug. All of the ingredients MUST be listed on the label from most prevalent ingredient (highest percent loading) to the lowest loaded ingredient, in that order. If you see "Water" listed first, then it is the main component of that product and is usually very heavily loaded in that product. If the ingredient is loaded at just 1% or less, they can be listed in any order at the bottom of the list.

The FDA will definitely come after you if you don't have the ingredients list correctly done on the product. You can however list a "proprietary" ingredient by some special company code name. My personal opinion on this is that I don't like it. The code name tells nothing about the ingredient and leaves the consumer in the dark. I'm hoping the FDA will do away with this loophole in the future.

One other thing that has to be put on the label is any functional claims made about the product. And, if it is a cosmetic, this must be carefully worded. A functional claim for a cosmetic cannot state that it repairs or changes any bodily function. That is a drug claim and will get the company in trouble.

As far as this thread is concerned, if the Jan Marini people are saying they have a label problem, then I'm betting very strongly that they have left an ingredient out of the label, or they are being told to "describe" the coded ingredient more thoroughly or correctly. For the FDA to come in to a company and create a stir like this, something MAJOR must be wrong at this time. The FDA usually is slow to react and often looks the other way on minor infractions. Rarely do they come in and slap a company on the wrists like this.

John

free skin care · Tue Nov 07, 2006 5:16 pm

John C. Hill wrote:

As a cosmetic chemist, I know first hand that the ingredient labeling is very important when putting out a "cosmetic" consumer product. If the product does not affect "bodily function" in any way it can be considered a cosmetic, and not a drug. All of the ingredients MUST be listed on the label from most prevalent ingredient (highest percent loading) to the lowest loaded ingredient, in that order. If you see "Water" listed first, then it is the main component of that product and is usually very heavily loaded in that product. If the ingredient is loaded at just 1% or less, they can be listed in any order at the bottom of the list.

The FDA will definitely come after you if you don't have the ingredients list correctly done on the product. You can however list a "proprietary" ingredient by some special company code name. My personal opinion on this is that I don't like it. The code name tells nothing about the ingredient and leaves the consumer in the dark. I'm hoping the FDA will do away with this loophole in the future.

One other thing that has to be put on the label is any functional claims made about the product. And, if it is a cosmetic, this must be carefully worded. A functional claim for a cosmetic cannot state that it repairs or changes any bodily function. That is a drug claim and will get the company in trouble.

As far as this thread is concerned, if the Jan Marini people are saying they have a label problem, then I'm betting very strongly that they have left an ingredient out of the label, or they are being told to "describe" the coded ingredient more thoroughly or correctly. For the FDA to come in to a company and create a stir like this, something MAJOR must be wrong at this time. The FDA usually is slow to react and often looks the other way on minor infractions. Rarely do they come in and slap a company on the wrists like this.

John

none of could even say their being slapped on the wrist by the FDA. The FDA has not, as of yet, issued anything regarding this..I'd hardly call diff information (all of it being guessed at) since were all hearing diff reasons, as any valid information regarding this. When the fda issues a warning that this product is bad..then they've been slapped. This company has also been all over the talk shows and news with this product. Its the world wide rage...me thinks in my little brain, that creates some attention and focus towards them, some great, some bad, esp by their competition (meaning they could say complain to the fda alot)...I guess I am just trying to say we don't know whats happened.

I also don't think this is going to hurt her sales at all, but I do hate loving a product, I can't get my hands on, makes me not love the company very much.

free skin care · Tue Nov 07, 2006 5:39 pm

I agree with MelissaMarie.

It is not a requirement to list all ingredients. Yes, it is a requirement to list ingredients in % order - but it is easy enough to claim an ingredient as a trade secret. I've never had problems with any of my companies - it just means a ton of paperwork.

You can put a functional claim on a cosmetic - that's when FDA considers it a "cosmetic and also drug" and must follow guidelines for both cosmetic and drug.

If FDA felt an ingredient was not listed - they'd send a warning letter. It's also public notice and would've been in the weekly newsletters.

If FDA wanted to know what the secret ingredient is - JM would have to file paperwork on why 'eyelash growth factor' was a trade secret. blah, blah, blah answering the criteria for 'trade secret'.

If FDA had requested a recall - I wouldn't be able to walk to a spa tomorrow to purchase a tube ... which I am doing Razz

No WAY have their hands been slapped ...

free skin care · Thu Nov 09, 2006 9:33 am

Rjez wrote:

It is not a requirement to list all ingredients. Yes, it is a requirement to list ingredients in % order - but it is easy enough to claim an ingredient as a trade secret. I've never had problems with any of my companies - it just means a ton of paperwork.

Really? I find it hard to believe that the FDA allows cosmetic companies to leave off ingredients from their labelling.. If that is the truth I would probably hesitate to purchase any US-produced cosmetics. I know that some countries allow ingredients to be left off if the quantities are minute (which even that I dont like), but just because an ingredient is a trade secret does not seem right somehow... (or maybe my rose colored glasses are just coming off...)

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