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:
The safety of the ingredient or product had been adequately substantiated prior to development of the new information;
The new information does not demonstrate a hazard to human health; and
Adequate studies are being conducted to determine expeditiously the safety of the ingredient or product.
Paragraph (b) 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.
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