Registration, and what it requires

Cosmetics went from one of the least administered categories to one with a registration regime, and the exemptions are widely misread as covering more than they do.

What MoCRA introduced

Facility registration and product listing with FDA, plus adverse event reporting and record keeping requirements.

Registration identifies the place where cosmetics are manufactured or processed. Listing identifies each product and its ingredients. Both are administrative rather than approvals: FDA does not approve a cosmetic before sale.

The small-business exemptions

There are genuine exemptions from facility registration and product listing for businesses below a defined size threshold.

They are real and they are worth understanding, because for a small brand they remove the two most visible obligations.

What the exemptions do not cover

Two things, and both are more consequential than the paperwork they relieve.

Safety substantiation applies to every business at every size. There is no exemption. A cosmetic must be substantiated as safe for its intended use whether you make ten units or ten thousand.

And the exemptions fall away entirely for products that are also drugs. Sunscreen, SPF makeup and medicated products sit under OTC drug requirements and are not eligible regardless of business size.

What to do now

Check the current threshold against your own turnover, because it is a number that moves and because growing past it is a quiet transition rather than an announced one.

Then build the substantiation file regardless: challenge test results, stability data in the actual packaging, ingredient safety information, and an assessment drawing them together. That file is the obligation the exemptions never touched, and it is also exactly what a wholesale buyer will ask for.

References