Re: FDA label guidelines

[Guest guest]

Corrian, good questions. May I ask what kind of product you are labeling? I

would be interested in hearing other responses. I never felt the need to label

my soap, but on lotions and balms and stuff I put " not tested for safety " or

" not FDA tested " . Jan

FDA label guidelines

Can I say on my product label " heals dry, cracked skin " and still be

classified as a cosmetic rather than a drug? What if I say that it is helpful

for eczema? Can I just add the disclaimer- " this product is not intended to

diagnose, treat, cure, or prevent any disease? "

[Guest guest]

Hi, Corrina! I would advise against saying anything " heals. " A cosmetic changes

from a cosmetic to a drug (in the FDA's eyes, at least) anytime a claim is made

that the cosmetic causes a physiologic change. Most " healing " requires a

physiological change and not just a surface change. For example, saying a soap

is " moisturizing " does not imply that it causes a physiological change to the

skin; saying it cures eczema does. Does that make any sense? LOL

I'd still include the disclaimer, though.

If you can't figure out the guidelines, call the FDA and ask. They're wonderful

to work with!

pamela

[Guest guest]

How's this for cosmetic labeling?

" This product is an excellent moisturizer. Keeping skin well moisturized

has been shown to aid the healing of eczema. "

Re: FDA label guidelines

> Hi, Corrina! I would advise against saying anything " heals. " A cosmetic

changes from a cosmetic to a drug (in the FDA's eyes, at least) anytime a

claim is made that the cosmetic causes a physiologic change. Most " healing "

requires a physiological change and not just a surface change. For example,

saying a soap is " moisturizing " does not imply that it causes a

physiological change to the skin; saying it cures eczema does. Does that

make any sense? LOL

>

> I'd still include the disclaimer, though.

>

> If you can't figure out the guidelines, call the FDA and ask. They're

wonderful to work with!

>

> pamela

>

>

>

>

[Guest guest]

> How's this for cosmetic labeling?

> " This product is an excellent moisturizer. Keeping skin well

moisturized

> has been shown to aid the healing of eczema. "

Why don't you just say " soothes dry, itchy skin " ? The moment you

start implying that your product is a medical treatment (and that is

what you're implying there even though you are twisting the words to

try to get around the rules) you open yourself up not only to it being

interpreted as making claims under the drugs regulations, but you also

have the possibility that someone will use your product for a

condition that they should have taken to the doctor and have suffered

serious complications as a result.

Pat in Somerset, England

[Guest guest]

It's good! But I'd avoid the word " healing " completely. It's a dangerous one to

use. You might try something such as, " Keep skin well moisturized has been shown

to greatly benefit eczema. " That way, you don't make any claims and you don't

define what the " benefits " are. It's a good generic statement.

But ... call your FDA rep and ask him/her about it. That's the safest route to

take!

pamela

Re: FDA label guidelines

How's this for cosmetic labeling?

" This product is an excellent moisturizer. Keeping skin well moisturized

has been shown to aid the healing of eczema. "