Re: Claims and Ingredients

[Guest guest]

Interesting point and well made. I am in complete agreement.

, AKA theSoapLady

> I have been following this thread for quite some time and I must

ask

> this question.

>

> TDF is selling an " ingredient " with claims that it can reduce

> cellulite. She is not selling a finished product...but an

> ingredient that has certain claims.

>

> I went to Croda's site and if you go into their Sederma section,

you

> will see many ingredients with all sorts of claims and all sorts of

> studies (pictures or graphs included in most of them).

>

> Now, Croda doesn't seem to have a problem making such claims. Why

> is it wrong for TDF to do the same? I am a little confused as to

> what wrong was done.

>

> Di

[Guest guest]

In a message dated 9/6/2004 3:06:43 AM Eastern Standard Time,

bethmhaskins@... writes:

> Now, Croda doesn't seem to have a problem making such claims.

perhaps it is because they did conduct studies and did have valid results

with the LIPOCARE to make claims of cellulite reduction? I had understood that

to be a requirement

for making a claim...a valid and approved research study to substantiate the

claim...

Andree

[Guest guest]

In a message dated 9/6/2004 8:24:12 PM Eastern Standard Time,

diana34@... writes:

So are the studies done with caffein not valid?

I do not know...

....and I have not read the literature on caffeine quoted in the posts to the

group...and I am not sure I have to expertise to judge them accordingly even

if I do...

the LIPOCARE (from Sederma/Croda) product from the prebuy I did is not just

(only) caffeine- it also contains a Chinese herb, a co-enzyme...other

ingredients... the studies conducted in France by Croda/Sederma in support of

the

claims of their product are based on their own mix of ingredients, and we did

the

prebuy on this for sharing the LIPOCARE product for personal use to list

members- after all of us had such good results from using a creme/lotion made

with

the LIPOCARE...we were not out to prove any results quoted in their research

or to re sell the product to the public...although I can say from my own use

that the LIPOCARE product was very effective for me...and I am glad I used it!

Andree

[Guest guest]

> All of the ingredients that any company sells whether it be

> extracts or an ingredient that claims it can help with the the

> reduction of cellulite " can " be sold. However, at the point where

> that ingredient goes into a product with such claims and then sold,

> that is where the FDA steps in. Am I wrong?

You ask a very good question. The regulations of the FD & C Act apply

not only to the drug and cosmetic products themselves but also to the

ingredients and " articles intended for use as a component " of drugs

and cosmetics. Hence, if I open a website and sell bags of white

powder for use in your lotions and creams, the FDA has oversight over

those bags of white powder upon the offer of those bags into the

market place, as well as over your lotions and your creams.

And if I sell an " ingredient " with claims that it affects the

structure or function of the body, or that it's useful in the

diagnosis, cure, mitigation, treatment, or prevention of disease, then

according to the FD & C Act, it's an article/ingredient being sold as a

drug. And, because I made the claims, the " ingredient " doesn't stop

being a drug with respect to my actions whether you buy it to smear on

your face, or add it to your lotions or use it to paint your gazebo.

Further, if you (and others) purchase this " ingredient " from me with

the idea or intention that your lotions will now be able to affect the

structure or function of the body or what have you -- even if you

purchase it for personal use only, then not only does this tend to

affirm that I'm selling a drug, but your lotions may themselves be

considered drugs as well.

> So are the studies done with caffein not valid?

Validity of a study is generally not discussed in or estimable through

the study abstracts. The full study text, perhaps even acquiring the

supporting data, may be needed to better weigh validity. I would be

cautious in making claims based on study abstracts. Your formulation

will likely not match that used in a particular study, and hence the

relevance of such study to your lotions and creams may not carry the

significance implied in any claims. If you have a particular study in

mind, perhaps someone will have some comments.

[Guest guest]

> So are the studies done with caffein not valid?

Hi ,

Croda/Sederma has conducted a scientific studies which back up their

cosmetic claim that LIPOCARE reduces the appearance of cellulite aka " orange

peel effect " . This is a cosmetic claim, not a drug claim, and has been

substantiated by there own testing. So yes, this is a valid COSMETIC claim

of appearance.

Pam

>

> Di

>

>

> > In a message dated 9/6/2004 3:06:43 AM Eastern Standard Time,