Re: Regulations

[Guest guest]

On Mon, 25 Aug 2003 12:52:17 -0700 (PDT), Jeannie Harrington wrote:

>I have ran across a particular safety statement from FDA regarding testing of

products several times, each time I contacted FDA to verify the information.

Each time I was told

that the statement did not have to appear on my product. Every time I come

across that statement I get concerned about it over and over again. Can someone

please inform

me on the regulations pertaining to the following statement.

>

>The safety of this product has not been determined.

21 CFR 740.10 Labeling of cosmetic products for which adequate substantiation of

safety has not been obtained.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=740.10

(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.

( An ingredient or product having a history of use in or as a cosmetic may

at any time have its safety brought into question by new information that in

itself is not

conclusive. The warning required by paragraph (a) of this section is not

required for such an ingredient or product if:

(1) The safety of the ingredient or product had been adequately substantiated

prior to development of the new information;

(2) The new information does not demonstrate a hazard to human health; and

(3) Adequate studies are being conducted to determine expeditiously the

safety of the ingredient or product.

© Paragraph ( of this section does not constitute an exemption to the

adulteration provisions of the Act or to any other requirement in the Act or

this chapter.

Maurice

--------------------------------------------------------

Maurice O. Hevey

Convergent Cosmetics, Inc.

http://www.ConvergentCosmetics.com

-------------------------------------------------------

[Guest guest]

On Mon, 25 Aug 2003 12:52:17 -0700 (PDT), Jeannie Harrington wrote:

>I have ran across a particular safety statement from FDA regarding

testing of products several times, each time I contacted FDA to

verify the information. Each time I was told

that the statement did not have to appear on my product. Every time

I come across that statement I get concerned about it over and over

again. Can someone please inform

me on the regulations pertaining to the following statement.

>

>The safety of this product has not been determined.

21 CFR 740.10 Labeling of cosmetic products for which adequate

substantiation of safety has not been obtained.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?

FR=740.10

(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.

( An ingredient or product having a history of use in or as a

cosmetic may at any time have its safety brought into question by new

information that in itself is not

conclusive. The warning required by paragraph (a) of this section is

not required for such an ingredient or product if:

(1) The safety of the ingredient or product had been adequately

substantiated prior to development of the new information;

(2) The new information does not demonstrate a hazard to human

health; and

(3) Adequate studies are being conducted to determine

expeditiously the safety of the ingredient or product.

© Paragraph ( of this section does not constitute an exemption

to the adulteration provisions of the Act or to any other requirement

in the Act or this chapter.

Maurice