Re: Claims and Ingredients

[Guest guest]

> 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.

It doesn't matter whether it's an ingredient or a finished product.

What matters is whether it's a drug being marketed.

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

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

> what wrong was done.

First of all, in our capacity as posters on this forum, we're not in

the position to declare anyone else to be " wrong " . We can, of course,

have opinions on the matter, and we're open to discussing it. I do

note that, despite the purported conversation with the FDA and the

report that " slimming " is apparently a drug claim, the website in

question continues to extoll the " slimming " effect of this

ingredient/product.

Second, we need to deal with specifics, and " such claims " is not

sufficiently specific to discuss. If you could point out where Croda

talks about or implies that LIPOCARE, for example, prevents skin

cancer, prevents Alzheimer's, cures the common cold or whatever,

perhaps we'd have something more to ponder. Nevertheless, even if

Croda does this or that, it doesn't mean anyone else should imitate

them. Everyone is responsible for their own actions. It's not a

valid defense to say, " but so-and-so does that too " . There's no

shortage of wrongdoing in this world that we can all point to as a

crutch to fall upon. And again, no one should be reading this and

thinking that I am claiming that Croda or anyone is engaging in

wrongdoing. I think it would be rather perilous to throw such

accusations around without a clear understanding, not to mention that

this forum is probably not the best place for that. The FDA and FTC

websites have links available for reporting violations.

[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]

Beth,

I guess by reading all the postings, I came to the conclusion that

what TDF was doing was not correct, thus coming to the conclusion

that it was wrong.

Pat did a fastbuy on the Lipocare and many of us happily purchased

it thru him because we know Pat as being an honest person and his

tests were enough to convince us (as well as the testing that Croda

did) to go into the buy with him and try it out for ourselves.

I think that it is safe to say that we can purchase ingredients that

make claims and see for ourselves if those claims are true...but not

sell the products the ingredient has been incorporated in.

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?

Di

> > 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.

[Guest guest]

Beth,

I guess by reading all the postings, I came to the conclusion that

what TDF was doing was not correct, thus coming to the conclusion

that it was wrong.

Pat did a fastbuy on the Lipocare and many of us happily purchased

it thru him because we know Pat as being an honest person and his

tests were enough to convince us (as well as the testing that Croda

did) to go into the buy with him and try it out for ourselves.

I think that it is safe to say that we can purchase ingredients that

make claims and see for ourselves if those claims are true...but not

sell the products the ingredient has been incorporated in.

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?

Di

> > 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.

[Guest guest]

So are the studies done with caffein not valid?

Di

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

> bethmhaskins@y... 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]

Hi, Di ...

Moisturizing or non drying are cosmetic claims, not drug ...

ANY ingredient claims like regenerates cells or in some way affects age

spots or other conditions, prevents anything, etc. are drug claims. Even if

rosehip oil has trans-retinoic acid, who are we to know and where are our

finished-product test results that prove that the product containing it helps

treat

medical conditions such as dermatitis, eczema or psoriasis? Yes, to claim

this without such protocol is illegal.

Natural or synthetic don't mean diddly to whether or not an ingredient does

or does not have cosmetic and/or drug potential. Soothing is a tricky,

on-the-fence claim ... ie, sooths discomfort related to dry skin may be okay,

but

sooths itch implies a drug active ...as do words like healing. So, to answer

your question, yes and no ... if someone has a burn and we mention for them

to put Aloe straight from their own plant ... I doubt the government will

send out the troops (and I'm no lawyer, either) ... but if we're selling

products with aloe and still mention it, we are insinuating that our products

will

have that perceived benefit. Also, if we offer them our products with aloe

for that burn, we then are making direct over-the-line implications.

-

[Guest guest]

Okay, so can I claim that something is moisterizing or non drying?

Is this not a claim?

Or...let's say I want to buy Rose Hip Oil. And I read the following:

" It is considered a cellular regenerative oil, also regenerates scar

tissue, attenuates wrinkles and age spots and helps to prevent and

fade stretch marks due to pregnancy and other factors. Rosehip seed

oil is a potent anti-inflammatory oil with polyunsaturated essential

fatty acids and trans-retinoic acid that helps when treating

dermatitis, eczema or psoriasis providing an immediate relief for

dry skin. These benefits are due to the high amounts of natural

trans-retinoic acid only to be found in such high proportion in

Rosehip seed oil. "

Is this illegal?

So any natural source whether it be Aloe straight from the plant or

Aloe Extract for example...we cannot mention the soothing or healing

qualities that many claim this plant exibits? If someone has a burn

and we mention for them to put Aloe straight from the plant...are we

committing an FDA crime for speaking this way?

Di

> If you have a particular study in

> mind, perhaps someone will have some comments.

I don't have any studies but I know there are some out there. It's

word of mouth for me since I have not use the ingredient. I went to

a convention last year and they brought up the Caffein subject and

there was a demo done so this is not a new subject. It's one I have

heard before, but haven't played with yet.

Di, again

> > 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