Nationwide: FDA's MoCRA cosmetic rules, what they mean if you sell skincare

Key facts:

• MoCRA (2022) expanded FDA authority over cosmetics: facility registration, product listing, adverse-event reporting, safety substantiation, and recall authority.
• On February 11, 2026, the FDA updated its Cosmetics Direct portal ahead of biennial registration renewal.
• Manufacturers and processors register facilities. A responsible person lists each marketed product.
• It's most relevant to med spas selling retail or private-label skincare.

What is MoCRA?

The Modernization of Cosmetics Regulation Act of 2022 gave the FDA broader authority over cosmetics. It added requirements for facility registration, product listing including ingredients, serious adverse-event reporting, safety substantiation, records access, and mandatory recall authority. On February 11, 2026, the FDA updated its Cosmetics Direct submissions portal to help facilities prepare for biennial registration renewal. See the FDA update and the MoCRA overview.

Does this apply to a med spa?

It depends on your relationship to the products you sell. If you only resell another company's finished, already-listed products, the manufacturer usually carries the registration and listing duties. If your practice's name is on the label, you market a private-label line, or you're involved in manufacturing, distribution, or listing, you may be a responsible person with obligations of your own. There are exemptions for some small businesses.

What it means for your med spa

Map your retail and private-label products to a responsible person. Keep supplier documentation showing who manufactures, labels, and lists each product, and set a clear path for routing adverse reactions and complaints to the right party.

FAQs

What is a responsible person under MoCRA?

The party responsible for listing a cosmetic product with the FDA, typically the manufacturer, packer, or distributor whose name is on the label.

Does selling retail skincare automatically trigger MoCRA registration?

Not necessarily. Reselling finished, already-listed products usually keeps the obligation with the manufacturer. Private-label or own-brand products are where duties can attach to you.

Fresh Clinics helps med spa owners keep their retail and product operations compliant. Learn more about Fresh Clinics membership.