MoCRA for Small Beauty Brands

The Modernization of Cosmetics Regulation Act of 2022 was the biggest change to US cosmetics law in more than eighty years. For a private label brand, most of it comes down to a short list of tasks. This is that list. It is a practical summary, not legal advice.

Two roles: the facility and the responsible person

MoCRA splits obligations between the facility that manufactures or processes the product and the responsible person — the manufacturer, packer or distributor whose name appears on the label. For a private label product with your brand on the label, the responsible person is normally you.

What the facility does

• Registers with the FDA, and renews the registration every two years.
• Manufactures under good manufacturing practice.
• Keeps batch records your product listing and any investigation can rely on.

What the responsible person (your brand) does

1. Product listing. List each product with the FDA, including its ingredients, and update the listing annually. A listing links your product to the facility that makes it.
2. Safety substantiation. Keep records that support the product is safe under its intended use. For a stock formula, much of this comes from the manufacturer’s data: ingredient safety, stability and preservative efficacy.
3. Adverse event reporting. Report serious adverse events to the FDA within 15 business days, and keep records of all adverse events for six years.
4. Label contact. Put a domestic address, phone number or electronic contact on the label so consumers can report problems.

Labels under MoCRA

The usual cosmetic label elements still apply — product identity, net quantity, ingredient list by INCI name in descending order, your name and place of business, warnings where required — plus the adverse event contact. Professional-use products and fragrance allergen labelling carry further requirements as FDA rules are finalised.

Is there a small business exemption?

Partly. Very small businesses (below a revenue threshold) are exempt from facility registration and product listing, but not from adverse event reporting, safety substantiation or labelling — and the exemption does not apply to certain product types, such as products that contact the eye or are injected. Check the current FDA guidance for your case.

What to ask your manufacturer for

• The full ingredient list for your listing and your label.
• The facility registration details to link your listing to.
• Stability and preservative-efficacy data for your formula.
• A batch certificate of analysis for each production run.
• Raw material safety data sheets and, for scented products, the fragrance allergen breakdown.

We supply these with our orders — see compliance. Selling in Europe as well? The EU needs a safety assessment and CPNP notification per formula; the same data package supports both.

The five-minute version

Your factory registers the facility. You list each product, keep safety records, report serious adverse events and put a contact on the label. Ask your manufacturer for the data up front and MoCRA becomes a checklist, not an obstacle.