What requirement applies to cosmetics regarding market entry, unlike prescription drugs?

Answer

Cosmetics do not require pre-market approval.

Cosmetics are regulated distinctly from drugs, primarily in the pre-market phase. Articles intended for cleansing, beautifying, promoting attractiveness, or altering appearance through application to the body, as defined for cosmetics, do not need to undergo the lengthy and expensive pre-market approval process required for new therapeutic drugs. However, this lack of pre-approval does not grant complete freedom; the FDA retains the authority to take regulatory action against cosmetics if they are found to be adulterated (containing harmful ingredients) or misbranded (having misleading labeling). Intervention also occurs if a cosmetic's labeling makes unauthorized claims that effectively transform it into an unapproved drug.

What requirement applies to cosmetics regarding market entry, unlike prescription drugs?

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