Do cosmetics have to be proven safe before sale?

Two claims circulate about US cosmetics and both are wrong. One says nothing is checked. The other says everything is approved. The regulation is a third thing, and it is short enough to read.

What it actually requires

The rule opens with an obligation, not a permission: “Each ingredient used in a cosmetic product and each finished cosmetic product shall be adequately substantiated for safety prior to marketing.”

That is not nothing. It is a duty that attaches before anything is sold, and it covers both the ingredients and the finished product, which are different questions.

And then the sentence that changes it

The obligation has an escape, printed in the same paragraph. A product whose safety is not adequately substantiated “is misbranded unless it contains the following conspicuous statement on the principal display panel: Warning —The safety of this product has not been determined.”

Now ask yourself when you last saw that sentence on a shelf.

Why the warning is invisible

No company wants it. The commercial cost of printing it is enormous, so the practical effect of the rule is not that unsubstantiated products carry a label. It is that manufacturers substantiate, or take the view that they have.

That last clause is where the rule gets soft. The regulation does not define what adequate substantiation is, does not require it to be filed with anyone, and does not have a pre-market review attached to it. The judgement is the manufacturer’s, and it is only examined afterwards if something goes wrong.

What this means when you are holding a product

Do not read the absence of the warning as a certificate. It tells you the company believes it has substantiated the product, which is a statement about the company’s opinion, not about a regulator’s finding.

What you can still read is the ingredient list, because a separate rule requires “a declaration of the name of each ingredient in descending order of predominance”, with the well-known exception that “fragrance or flavor may be listed as fragrance or flavor”.

That is why this site is built on ingredients and sources rather than on scores. The list is the part of the pack that is externally checkable, and the safety claim is the part that is not.

The honest summary

Cosmetics in the US are regulated, and the regulation is real. It is also mostly self-executing, which is a different thing from unregulated and a very different thing from approved.

The guide to what natural and clean legally mean covers the marketing vocabulary that grows in the space this rule leaves open.