If you plan to sell in the United States, MoCRA compliance is now part of the job. MoCRA, the Modernization of Cosmetics Regulation Act, is the biggest change to US cosmetics rules in almost a century, and it applies to small indie brands, not just the big players. The good news is that most of it is manageable, especially when your manufacturer already operates to these standards.
MoCRA compliance: what the law actually requires
MoCRA took effect in 2022 and gave the FDA real authority over cosmetics for the first time. In plain terms, MoCRA compliance means every cosmetic sold in the US must be made in a registered facility, listed with the FDA, and backed by safety records. For a founder, that turns “anyone can launch a skincare line” into “anyone can, but there is paperwork behind it.”
The four things that matter for a small brand
- Facility registration. The facility that manufactures your product must be registered with the FDA. If you work with a US-ready manufacturer, this is already handled on their side.
- Product listing. Each product and its ingredients must be listed with the FDA.
- Safety substantiation. You need records showing your product is safe. A good manufacturer provides the formulation and testing documentation that supports this.
- A responsible person. Every product needs a named responsible person whose contact details appear on the label and who handles adverse-event reports.
Why your manufacturer does most of the heavy lifting
This is where the choice of manufacturer changes everything. When you produce with a facility that is already GMP certified and set up for FDA and MoCRA requirements, the registration, documentation, and safety records are built into the process rather than something you scramble to assemble later. At Formyoule we manufacture for both Canadian and US brands, so the compliance groundwork is part of how we work, not an afterthought.
What to do next
You do not need to become a regulatory expert. You need a manufacturer who takes MoCRA compliance seriously and hands you the documentation you will be asked for. If you are planning a US launch, that is the single most important box to tick early.
Frequently asked questions
Do I need to register with the FDA myself? Your manufacturing facility handles its own registration. As the brand, you are typically responsible for product listing and naming a responsible person, which a good partner will walk you through.
Does MoCRA apply to small brands? Yes. There are some exemptions for very small businesses, but the safety and labeling expectations still shape how you should launch.
Can a Canadian manufacturer make products for the US market? Yes, as long as the facility meets US requirements. A North American lab set up for both markets lets you sell on either side of the border without switching suppliers.
Planning a US or Canadian launch? Book a free intro call and we will walk you through what your product needs.