MoCRA Put a Named Person Behind Every Cosmetic Sold in the US. We Have Never Received an Adverse Event Report, and That Isn't Reassuring.

This is the one article in this series with no product attached to it. There is nothing to recommend at the end and nothing to link. It is about the paperwork behind everything else we sell, and about a number of ours that is zero.

Until 2022, cosmetics in the United States were governed by a statute written in 1938. No registration, no product listing, no mandatory reporting of anything. A cosmetic company could exist entirely outside the regulator's knowledge unless something went badly wrong in public.

Then Congress rewrote it.

Who the responsible person is

The statute defines it precisely, and the definition is worth reading slowly because it decides who carries the duties. The responsible person is "the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act".

So it is not defined by who makes the product, or who profits from it. It is defined by whose name is printed on the label.

That responsible person lists the product with FDA, keeps the ingredient information current, holds the safety substantiation records, and receives and forwards the adverse event reports.

Registration sits separately with the facility that manufactures or processes, renewable every two years. Two different obligations landing on two potentially different companies.

Fifteen business days

The reporting clock is the part with teeth. A responsible person who receives information about a serious adverse event has 15 business days to report it to FDA, and must include a copy of the product label. If further information about that event arrives within a year, it goes in within 15 business days of arriving.

Fifteen business days is three weeks. It is a duty written on the assumption that reports arrive, get logged, and get acted on, by a company with a process for the first of those.

Note what the law does not do. There is no pre-market approval for an ordinary cosmetic in the US, no dossier reviewed before sale, nothing resembling Korea's review of functional cosmetics. MoCRA is a records-and-reporting regime, not an approval regime. The safety judgement stays with the company; what changed is that the company now has to be able to show its work and has to speak up when something goes wrong.

Zero reports, and what that is evidence of

We have received no adverse event reports. Not serious ones, not minor ones, not a single email from anyone saying a product we sold them made their skin worse.

Fifty-six products. We would love to read that as a result. It is not one.

Think about what a person actually does when a cream stings for three days. They stop using it. Maybe they leave a two-star review somewhere, maybe they mention it to a friend, and then they move on. Almost nobody writes to the shop, because writing to the shop has never been how this works and because there is rarely an obvious place to write to.

Which means our zero is measuring the absence of a channel, not the absence of events. We publish ingredient screening scores for every product, we publish the ingredients we flag, we publish our own mistakes most weeks — and we have never once put a line on a product page saying "if this reacted, tell us, here is what we will do with that".

Nor do we know, with certainty, where we sit in the definition above. Our products carry manufacturer labels in Korean. Whether that makes us a distributor whose name appears on the label, in the sense the statute means, is a question about our own labelling that we have not had determined. We are not going to guess at it in public.

What our screening found

The practical takeaway

If a cosmetic hurts you, tell somebody. That sounds obvious and almost nobody does it. The person to tell is whoever's name is on the label, because under US law that is the party carrying the reporting duty, and FDA takes reports directly as well.

A serious adverse event has a statutory meaning — it covers things like disfigurement, hospitalisation and persistent impairment, not a product you disliked. But you do not need to work out which category you are in before saying something. Companies are supposed to sort that out, and they cannot sort out what they never hear.

Look for who is named on a product you buy from overseas. Cross-border retail is exactly where the responsible-person question gets murky, and a shop that cannot tell you who holds that role has told you something about how carefully it has thought about the question. Including, this week, us.

We publish how we screen every product and what the score does and does not include, which now visibly excludes anything that happens after purchase. Which label claims carry weight and which ones carry nothing are the closest companions to this one. Our method lives on the awards page.