Re: Testing for a lotion formula

[Guest guest]

In a message dated 1/16/04 9:22:35 AM Eastern Standard Time,

admin@... writes:

> If I come up with my own lotion formula or tweak one of Angie's

> formulas what testing requirement do I have to keep from

> putting " This product has not been laboratory tested " on the label?

>

> Am I correct in assuming that the testing would have to be done on

> each and every batch I make regardless of the amount?

>

>

Hi ,

I'm not sure I understand what you mean by " testing requirement " . The FDA

doesn't have a testing requirement, but does have recommendations and guidelines

about manufacturing cosmetics. Maurice has recently posted this information

and I believe it can also be found in the files section. The bottom line is

that the manufacturer of any cosmetic product is responsible for his/her

product.....following GMP, labeling guidelines, etc. I've heard varying

interpretations of 'the warning statement' and will leave it to Maurice and

others to

respond on that issue.

Angie

The Herbarie

Natural Source Ingredients for Toiletries & Cosmetics

http://www.theherbarie.com

[Guest guest]

In a message dated 1/16/04 9:22:35 AM Eastern Standard Time,

admin@... writes:

> If I come up with my own lotion formula or tweak one of Angie's

> formulas what testing requirement do I have to keep from

> putting " This product has not been laboratory tested " on the label?

>

> Am I correct in assuming that the testing would have to be done on

> each and every batch I make regardless of the amount?

>

>

Hi ,

I'm not sure I understand what you mean by " testing requirement " . The FDA

doesn't have a testing requirement, but does have recommendations and guidelines

about manufacturing cosmetics. Maurice has recently posted this information

and I believe it can also be found in the files section. The bottom line is

that the manufacturer of any cosmetic product is responsible for his/her

product.....following GMP, labeling guidelines, etc. I've heard varying

interpretations of 'the warning statement' and will leave it to Maurice and

others to

respond on that issue.

Angie

The Herbarie

Natural Source Ingredients for Toiletries & Cosmetics

http://www.theherbarie.com

[Guest guest]

Maurice, I read what you posted in the files section and thats what

made me think of this. From reading it I know there are no

requirements to test the product but it is recommended. But I also

got the impression that if you don't test the product you must state

this on your label so the consumer knows they are purchasing a

product that has not been tested. Is this correct?

So I guess what I'm asking is what level of testing needs to be done

to, for example lotion, so you don't have to put a waring statement

on the label?

> In a message dated 1/16/04 9:22:35 AM Eastern Standard Time,

> admin@a... writes:

>

> > If I come up with my own lotion formula or tweak one of Angie's

> > formulas what testing requirement do I have to keep from

> > putting " This product has not been laboratory tested " on the

label?

> >

> > Am I correct in assuming that the testing would have to be done

on

> > each and every batch I make regardless of the amount?

> >

> >

>

> Hi ,

> I'm not sure I understand what you mean by " testing requirement " .

The FDA

> doesn't have a testing requirement, but does have recommendations

and guidelines

> about manufacturing cosmetics. Maurice has recently posted this

information

> and I believe it can also be found in the files section. The

bottom line is

> that the manufacturer of any cosmetic product is responsible for

his/her

> product.....following GMP, labeling guidelines, etc. I've heard

varying

> interpretations of 'the warning statement' and will leave it to

Maurice and others to

> respond on that issue.

>

> Angie

>

> The Herbarie

> Natural Source Ingredients for Toiletries & Cosmetics

> http://www.theherbarie.com

>

>

>

[Guest guest]

Maurice,

I'm feeling a little stupid right now but I have to ask you this and

maybe I'm reading to much into it but I just want to make sure I am

doing everything on the up and up.

It feels like this is a catch 22. First we have:

Although the Food, Drug & Cosmetic Act does not specifically mandate

animal testing for cosmetic safety, FDA strongly urges cosmetic

manufacturers to conduct whatever tests are appropriate to establish

that their cosmetics are safe. In the United States, manufacturers

bear a responsibility to ensure their products are safe for consumer

use.

The above statement tells me it is recommended but not required.

Then we have:

21 CFR 740.10 Labeling of cosmetic products for which adequate

> substantiation of safety has not been obtained.

>

Which tells me that you are required to prove the safety of the

product but no specific action to be taken to prove it. The only way

I can think of proving the safety of the product is by testing it

which is the opposite of what they state in the first paragraph.

I am using only approved ingredients in my products and working in a

sanatary, well maintained area designated solefully for the purpose

of making bath and body products but I don't send any samples off to

a lab for testing. My hands, counters, and containers are all wiped

with alcohol before ever mixing anything. Most of my products are

made when ordered. Some are made ahead of time for my store but

they don't stay on the shelf for very long.

After spending many years working at a nuclear site and dealing with

soil and water sampling I have leared that the rules and regulations

are often interpreted differently depending on who is doing the

interpreting.