MoCRA Compliance Consulting

For beauty brands, private-label owners and repackagers

If your name is on the label, MoCRA puts responsibilities on you, even when someone else makes the product. We find out exactly what applies to your products and build what you need to meet it.

Book a free intro call

Who this is for

Brand owners who are the "responsible person" whose name appears on the label
Private-label brands whose products are filled by a contract manufacturer
Relabelers and repackagers
Small brands unsure whether a small-business exemption applies

The problem it solves

The Modernization of Cosmetics Regulation Act (MoCRA) is the biggest expansion of FDA authority over cosmetics since 1938. It added facility registration, product listing, safety substantiation, serious adverse event reporting, recordkeeping and new labeling requirements.

Certain small businesses may qualify for exemptions from some requirements, but safety, labeling and adverse-event responsibilities still apply, and some product types never qualify. Most brands we talk to aren't sure which rules are theirs and which belong to their manufacturer.

What you receive

Applicability assessment: a written summary of which requirements apply to your products, your role and your sales, including an exemption check
Registration and listing plan: who registers the facility, who lists each product, and what each filing needs
Safety substantiation review: what evidence you have, what's missing, and how to document it
Adverse event procedure: intake, investigation, the 15-business-day reporting timeline and recordkeeping
Label review: required statements and the contact information consumers need to report problems
Private-label roles map: a one-page split of responsibilities between you and your manufacturer

How an engagement works

Free intro call. Fifteen minutes to learn about your products and where you sell.
Assess. We map what applies to you and where the gaps are.
Build. We create or fix the documents, processes and filings you need.
Stay ready. Optional ongoing support as products, suppliers and rules change.

Questions brands ask

Does the small-business exemption apply to me?

It may. FDA describes exemptions for certain small businesses from facility registration and product listing, but they don't cover every product type, and they don't remove safety, labeling or adverse-event duties. We check your products and numbers in the assessment.

Who is the responsible person?

The manufacturer, packer or distributor whose name appears on the label. For private-label products, that's usually the brand.

My contract manufacturer says they handle compliance. Am I covered?

Partly, at most. Facility registration belongs to the facility, but product listing, safety substantiation and adverse-event reporting sit with the responsible person. We map who owns what.