Warning Statement (Was Labs For Testing Lotions & Creams)

March 4, 2000

> we do not need to

> add the warning label about it not being tested, unless we make

> medical claims like, " prevents sunburn " , etc.

Unfortunately, that statement is incorrect. The regulation, found at 21 CFR

section 740.10 says:

" Labeling of cosmetic products for which adequate substantiation of safety has

not been obtained.

(a) Each ingredient used in a cosmetic product and each finished cosmetic

product shall be adequately substantiated for safety prior to marketing. Any

such ingredient or product whose safety is not adequately substantiated prior to

marketing is misbranded unless it contains the following conspicuous statement

on the principal display panel:

'Warning -- The safety of this product has not been determined.' "

Making medical claims has nothing to do with whether the warning statement is

required. It's required for cosmetics period, whether or not medical/drug type

claims are made.

I am in the process of preparing a legal memo that provides a high level

overview of the FDA's, EPA's, CPSC's and FTC's regulation of cosmetics and

toiletries products. This memo will not address every single issue that can

arise in the scope of a business...no one memo could. But if you could use a

general summary of the regs as they apply to cosmetics, it should prove helpful.

If you would like a copy, please let me know by sending a PRIVATE email.

Donna

" What Did You Put On Your Skin Today? "

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