Re: We got bashed

[Guest guest]

Thanks for coming back to answer questions, Dr. Pilcher. You're a

brave man.

> 1.We didn't go after FDA approval because the active ingredient is

> already on the FEMA (Flavor and Extract Manufacturers Assoc) GRAS

> (Generally Recognized as Safe) list and is approved already by the

> FDA as a food additive. Members of the Quadrinone family occur

> naturally in plants, particularly in nut oils.

For FDA-approved prescriptives, I thought the key was demonstrating

that an ingredient is more effective than placebo in treating a

condition. A safety profile must be filed, and the FDA will not

approve (or will recall) something that is shown to be dangerous, but

a drug doesn't need to be safe to be approved -- just efficacious.

Besides, even if it's regarded as GRAS and FDA-approved as a food

additive, you're using it as a topical agent. Also, the FDA-approved

digitalis occurs naturally in plants.

> 2.The formulation as it now stands has been proven to be non-

> irritating, non-sensitizing, and non-comedogenic by an independent

> preclinical testing service.

But that's for normal skin, right? ceans are notorious for their

sensitive skin, which behaves differently with respect to

ingredients, combinations of ingredients, and likelihood for

developing sensitivity to ingredients with use, than does normal skin.

Matija, my understanding is that, surprisingly, mineral oil is

actually non-comedogenic (for normal skin).

Marjorie

Marjorie Lazoff, MD

>

> > I agree that it's good to be skeptical while giving Dr. Pilcher

the

> > chance to answer questions which we did here. I have some

questions

> > on why they didn't go after FDA approval or if the mineral oil in

> the

> > formula could cause breakouts. I don't think it's wrong to ask

> > questions based on the evidence presented.

> >

> > At any rate, I saw that Cutanix will cost $65 for 2 ounces though

> you

> > can get samples. If it works that's great. However like Patty

said

> we

> > have to ask questions so we don't literally get burned like I

have

> > from so many products that were supposed to help, but didn't.

> >

> > Take care,

> > Matija