FDA Cosmetics Compliance for Small Importers: Where to Start When You Have No Compliance Team

Running a small import or resale business means you are probably handling sourcing, customer service, and compliance yourself, often at the same time. When cosmetics are part of your product line, FDA Cosmetics rules under the FD&C Act and the Modernization of Cosmetics Regulation Act (MoCRA) 2022 apply to you, whether you have one SKU or fifty. The good news is that the requirements are specific enough to tackle in order, without needing a specialist on staff.

**What matters first**

Two things come before anything else: registering your facility with the FDA and listing your products. Under MoCRA, FDA Facility Registration and Product Listing with the FDA are the baseline. If you manufacture or contract-manufacture cosmetics for the US market, these two steps establish that your business and your products are on record. Skipping them leaves you exposed even if every other part of your operation is solid.

Alongside registration, make sure your full ingredient list is accurate and uses INCI names (the standard naming system for cosmetic ingredients). This list underpins your labeling and is something buyers and regulators may ask to see.

**What can wait, briefly**

You do not need a fully built-out quality system on day one. What you do need early, but can refine over time, is a Serious Adverse Event Reporting procedure — a documented process for what happens if a customer reports a serious reaction to your product. Having a basic version in place is enough to start; you can improve it as your business grows.

**The minimum you must get right**

Three things are non-negotiable under FDA Cosmetics requirements:

Get these three right and you have covered the core of FDA Cosmetics compliance. Everything else — refining your adverse event process, tightening supplier documentation, improving ingredient records — can be built out as you go.

If you import from multiple suppliers, it is worth checking their own documentation practices too, since gaps in their [supplier compliance](/supplier-compliance) often surface as gaps in yours.

For the full list of what applies to your products, see [FDA Cosmetics](/regulations/fda-cosmetics-fd-c-act), and consider using Complyra to keep your documentation organized as your product line grows.