Frequently Asked Questions

Do I need to register my cosmetic facility with the FDA?

Yes. Under MoCRA, most cosmetic manufacturing and processing facilities must register with FDA and renew every two years. Certain small‑business exemptions apply, but many contract manufacturers still need to register.

Do individual cosmetic products need to be listed?

Yes. You must submit a product listing for each marketed cosmetic, update it annually, and keep it aligned with your current formulas and labels.

What documentation is required to substantiate product safety?

Maintain written safety substantiation for each product (toxicological profiles, testing, expert assessments) and keep it readily retrievable.

What has to appear on cosmetic labels now?

Identity, net contents, responsible person contact, ingredient declaration (INCI), and any required warnings. MoCRA adds enhanced adverse event contact info and future updates (e.g., fragrance allergens) when finalized.

Who reports serious adverse events for cosmetics?

The “responsible person” (name on label) must capture and report serious adverse events and retain records (currently 6 years).

Are contract manufacturers responsible for MoCRA compliance?

Both the responsible person and the facility have obligations—quality agreements should allocate duties for safety substantiation, labeling, records, and AE handling.

Does MoCRA require GMPs for cosmetics?

Yes—FDA is moving toward mandatory GMPs. Start aligning SOPs, training, and documentation now to de‑risk inspections.

Can I make “free‑from” or “dermatologist tested” claims?

Yes, but claims must be truthful, not misleading, and supported by evidence. Avoid therapeutic/drug claims.

How often should I review my labels?

At least annually, and whenever formulas, claims, or regulations change.

How does MoCRA affect influencers and private labelers?

If your name is on the label, you’re the “responsible person” and inherit MoCRA duties for listing, safety substantiation, labeling, and adverse events.