Re: Caffeine - still waiting ()

[Guest guest]

> I'm sharing information I've found about Caffeine. I'm not selling

> a new drug.

You have no authority to decide what's a drug and what's not. The FDA

defines what's a drug and what's not a drug by its intended use. If

you market a product " intended for use in the diagnosis, cure,

mitigation, treatment, or prevention of disease " or you market a

product " intended to affect the structure or any function of the body

of man or other animals " , then the FDA classifies it as a drug. [FD & C

Act, sec. 201(g)(1)]

Intended use is established by your claims stated on the product

labeling, in advertising, on the Internet, or in other promotional

materials, including this forum. An ingredient may also cause a

product to be considered a drug because it has a well known (to the

public and industry) therapeutic use. Product reputation and consumer

perception can also establish a product as a drug. In connection

with your marketing of this product, you have posted citations of its

use in treating Alzheimer's, preventing skin cancer, affecting how fat

is metabolized and/or stored in the body, and more.

You claim it's " sharing information " , but if you're selling a cosmetic

and not a drug, then the only information you should be sharing is how

your product relates to " cleansing, beautifying, promoting

attractiveness, or altering the appearance " . That's the domain of

cosmetics and nothing more. Citing medical journals does not relate

to your product's use as a cosmetic. Instead, it's identifying your

product as a drug.

> I don't understand the questions about it being safe for ANYONE to

> use?

If you make drug claims with respect to the marketing of your product,

if you lead people to believe that your product has benefits beyond

making you look pretty, then you need to establish to the FDA's

satisfaction that your product is safe and effective for use by the

general public.

Show me the panel of qualified experts as accepted by the FDA

establishing that caffeine is safe and effective for use by anyone

with respect to the claims you make in your marketing propaganda.

Show me the FDA monograph for caffeine with respect to the uses and

properties you connect to this product.

> Are there studies saying that it's NOT safe for anyone to use

> caffeine? If so, why isn't pulled from the shelves.

That's a question that needs to be answered by anyone who is making

drug claims in connection with the marketing of their caffeine

product. People who sell coffee aren't making drug claims when they

say it's good to the last drop. With respect to cosmetics, the FDA

requires that " each ingredient used in a cosmetic product and each

finished cosmetic product shall be adequately substantiated for safety

prior to marketing " -- or else you have to literally warn consumers

about your product and do so conspicuously. Failure to do means your

product may be classified as misbranded and subject to seizure. And

even if you attach a warning to it, it doesn't permit you to make drug

claims in connection with your product.

> I guess it's just like anything else, we have to weigh the pros and

> cons and make personal choices.

The FDA does not leave the decision as to how you are permitted to

market your product up to personal choice. It is a matter of public

safety and concern that we are discussing. The FDA does not consider

this a matter of buyer beware.

Finally, you have yet to establish the truth behind your claims that

" Many scientific studies carried out to date have confirmed the

slimming action of caffeine applied locally " ? Where is your evidence

that underlies your claim that " Scientific studies have proven the

slimming effects of caffeine applied locally " ? None of the information

you have posted, not one study, supports those claims. Whether it's a

drug or a cosmetic does not matter in this respect: if you cannot back

up your claims in connection with your marketing of this product, you

must remove them.

[Guest guest]

Bethmhaskins,

I'm not in any way trying to start an argument, just trying to

understand. When you said to , " the only information you

should be sharing is how your product relates to " cleansing,

beautifying, promoting attractiveness, or altering the appearance " .

Isn't that what said in her statement: " reduces the

appearance of cellulite " . Is this not a statement of altering the

appearance? It doesn't say that it WILL reduce the cellulite, only

that it will reduce the APPERANCE of cellulite. Therefore, if the

cellulite appeared to be reduced, isn't that " altering the

appearance " ?

Like I mentioned earlier……..just trying to understand. The FDA can

be soooooo vague in their statements.

, AKA theSoapLady

> > I'm sharing information I've found about Caffeine. I'm not

selling

> > a new drug.

>

> You have no authority to decide what's a drug and what's not. The

FDA

> defines what's a drug and what's not a drug by its intended use.