FDA's proposed $2000 fee for cosmetics manufacturers

[Guest guest]

Hi Everyone:

 

This is the feared-for follow up to the Globalization info I wrote about

last year. Yes, the Guild and Cropwatch did manage to stop IFRA from

adopting the amendment without public input and so our efforts were

successful on that end. As warned, 2008 is the year Global Harmonization

was to kick in, and it has.

 

Of course, the voluntary GMP registration is already in place, no fee,

AFAIK:

http://www.cfsan.fda.gov/~dms/cos-regn.html

 

If passed, this legislation will effectively put many out of business -

they just can afford it, especially if they have a tiny business selling

to farmer's markets, local stores, etc. Here are some links, and I'd

love to hear back from you on this. I'm contacting others in the

industry to see what we will do about this. More later.

 

http://www.usatoday.com/printedition/money/20080418/fda18.art.htm

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2008/04/fda-globalizati.html

http://www.cosmeticsdesign-europe.com/news/ng.asp?n=85308-fda-regulation-legisla\

tion-cosmetics

and sort of related, but in a wacky niche all by itself: Indian Supreme

Court rules Vaseline a Drug not a Cosmetic

http://www.hindu.com/thehindu/holnus/002200805162171.htm

 

--

- perfumes, aromatics, classes,

consultation

 

 

 

 

 

 

 

 

[Guest guest]

In regard to the new proposals on cosmetics regs I am a bit puzzled.

The 2006 idea was an entirely voluntary register, yet the 2008

proposals seem compulsory.

 

My general impression is that these proposals like the ones we have in

Europe, are only as good or bad as the enforcement of them. Here in

the UK despite many years of stringent EEC and UK laws on cosmetics,

enforcement with small suppliers is weak. Some people get regular

visits from Trading Standards, while others still make cosmetics in

their kitchen sink and never get any visits from enforcement agencies.

In other countries in Europe enforcement is non-existant and even

outrageous medicinal claims are made on web sites in France without

any action against them.

 

I can see a potential big problem with this sentence:

" (The CIR is an independent, industry-funded panel of scientific

experts that regularly assesses the safety of numerous cosmetic

ingredients and publishes its findings " .

That means you could end up with the same kind of cretins as we have

on the European advisory committees and in the US based IFRA now, they

only understand the chemistry of single ingredients which leads to

major problems over natural extracts.

 

In the European regulations they do not require a manufacturer to pay

a license fee, but I know that those who comply with the regulations

end up paying far more than $2000 to get their facilities approved and

products certified.

 

I do find the US scene disconcerting in that people with no knowledge

of cosmetics safety or proper production techniques at the moment get

away with putting dangerous products on the market. Some kind of

regulation is needed, but Federal regulations will always be overkill.

 

Martin Watt

http://www.aromamedical.com

 

ATFE2 , Anya <anya wrote:

>

> Hi Everyone:

>

> This is the feared-for follow up to the Globalization info I wrote

about

> last year. Yes, the Guild and Cropwatch did manage to stop IFRA from

> adopting the amendment without public input and so our efforts were

> successful on that end. As warned, 2008 is the year Global

Harmonization

> was to kick in, and it has.

>

> Of course, the voluntary GMP registration is already in place, no fee,

> AFAIK:

> http://www.cfsan.fda.gov/~dms/cos-regn.html

>

> If passed, this legislation will effectively put many out of business -

> they just can afford it, especially if they have a tiny business

selling

> to farmer's markets, local stores, etc. Here are some links, and I'd

> love to hear back from you on this. I'm contacting others in the

> industry to see what we will do about this. More later.

>

> http://www.usatoday.com/printedition/money/20080418/fda18.art.htm

>

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2008/04/fda-globalizati.html

>

http://www.cosmeticsdesign-europe.com/news/ng.asp?n=85308-fda-regulation-legisla\

tion-cosmetics

[Guest guest]

Oh please, the FDA is so full of it. They're about as overworked as

the Social Services Agencies here in America here which is why you

have a bunch of greedy lowlifes making a business out of fostering

kids and why you have so many kids winding up dead because of it.

The meatpacking industry here is getting away with murder breaking a

multitude of codes because they hire undocumented workers and they

don't train them properly and the FDA doesn't even have enough agents

to control a slaughter house. There have been salmonella outbreaks

in friggin' peanut butter a number of times just to let you know how

crappy things are in the food industry. The drug companies pay them

bookoo bucks to look the other way while they put dangerous drugs on

the market. The only time the FDA is able to do their job is the

same when any government agency is able to do their job is when a

reporter finds a gross negligence and then they jump in and act like

Superman. Then they want to whine on camera about how overworked and

understaffed they are, which is the truth. Give me a break. I had a

co-worker who rode the bus with a lady who worked for the FDA in

downtown L.A. and she told me for weeks she thought the woman was

homeless because she look so unkept.

 

After the films I saw in my Microbiology class of what goes on in

meatpacking plants, watching Fast Food Nation, I'm gonna be scared of

by the proposal of $2000, I'm taking a anti-seizure/migraine drug for

cluster headaches which the doctor informed was " new " and which they

do not " know " the long-term affects (they got that through the FDA

with a little green didn't they).

 

This is nothing but smoke and mirrors to shut up a consumer group who

got a rash and scare off a few kitchen witches because I guarantee

you that the FDA cares about as much about this as they do about me

stubbing my toe last night and I'm not about to get my dandruff up

about it. They're like AOL cancellations with two agents manning the

guns on this one, and a PR firm writing up a bunch scare material.

 

But anywho, I'm a stark raving banshee right now and I admit it and

they just happen to be getting the butt of my wrath, so luckily I

have a cousin who works in the field and I can find out exactly where

all this is going.

 

Michele

 

ATFE2 , " Martin Watt " <aromamedical wrote:

>

> In regard to the new proposals on cosmetics regs I am a bit puzzled.

> The 2006 idea was an entirely voluntary register, yet the 2008

> proposals seem compulsory.

>

> My general impression is that these proposals like the ones we have

in

> Europe, are only as good or bad as the enforcement of them. Here in

> the UK despite many years of stringent EEC and UK laws on cosmetics,

> enforcement with small suppliers is weak. Some people get regular

> visits from Trading Standards, while others still make cosmetics in

> their kitchen sink and never get any visits from enforcement

agencies.

> In other countries in Europe enforcement is non-existant and even

> outrageous medicinal claims are made on web sites in France without

> any action against them.

>

> I can see a potential big problem with this sentence:

> " (The CIR is an independent, industry-funded panel of scientific

> experts that regularly assesses the safety of numerous cosmetic

> ingredients and publishes its findings " .

> That means you could end up with the same kind of cretins as we have

> on the European advisory committees and in the US based IFRA now,

they

> only understand the chemistry of single ingredients which leads to

> major problems over natural extracts.

>

> In the European regulations they do not require a manufacturer to

pay

> a license fee, but I know that those who comply with the regulations

> end up paying far more than $2000 to get their facilities approved

and

> products certified.

>

> I do find the US scene disconcerting in that people with no

knowledge

> of cosmetics safety or proper production techniques at the moment

get

> away with putting dangerous products on the market. Some kind of

> regulation is needed, but Federal regulations will always be

overkill.

>

> Martin Watt

> http://www.aromamedical.com

>

> ATFE2 , Anya <anya@> wrote:

> >

> > Hi Everyone:

> >

> > This is the feared-for follow up to the Globalization info I wrote

> about

> > last year. Yes, the Guild and Cropwatch did manage to stop IFRA

from

> > adopting the amendment without public input and so our efforts

were

> > successful on that end. As warned, 2008 is the year Global

> Harmonization

> > was to kick in, and it has.

> >

> > Of course, the voluntary GMP registration is already in place, no

fee,

> > AFAIK:

> > http://www.cfsan.fda.gov/~dms/cos-regn.html

> >

> > If passed, this legislation will effectively put many out of

business -

> > they just can afford it, especially if they have a tiny business

> selling

> > to farmer's markets, local stores, etc. Here are some links, and

I'd

> > love to hear back from you on this. I'm contacting others in the

> > industry to see what we will do about this. More later.

> >

> > http://www.usatoday.com/printedition/money/20080418/fda18.art.htm

> >

> http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2008/04/fda-

globalizati.html

> >

> http://www.cosmeticsdesign-europe.com/news/ng.asp?n=85308-fda-

regulation-legislation-cosmetics

>