MoCRA in 2026

Registration Is Only the Beginning

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly expanded FDA’s authority over cosmetics and created new obligations for many cosmetic companies.

For businesses that entered the market after MoCRA’s enactment, one of the most common misconceptions is that facility registration and product listing equal FDA approval.

They do not.

FDA recently reiterated that it does not issue certificates or other documents verifying compliance with cosmetic facility registration or product listing requirements. FDA expressly states that registration and listing are not an approval program or promotional tool.

What Did MoCRA Change?

MoCRA represents the most significant expansion of FDA’s cosmetics authority since the FD&C Act was enacted in 1938.

Among other things, MoCRA added requirements and authorities concerning:

Facility registration;
Product listing;
Serious adverse-event reporting;
Safety substantiation;
Records access;
Mandatory recalls;
Good manufacturing practices; and
Other aspects of cosmetic oversight.

The result is a materially different regulatory environment for cosmetic manufacturers, processors, responsible persons, and brands.

Facility Registration

Manufacturers and processors of covered cosmetic products generally must register their facilities with FDA and renew registration every two years.

FDA’s current materials state that it has authority to suspend a facility’s registration under specified circumstances involving a reasonable probability of serious adverse health consequences or death and concerns that the problem may extend beyond an isolated product.

This creates a meaningful operational consequence: facility registration is not merely paperwork.

Product Listing

A responsible person generally must list each marketed cosmetic product with FDA and provide required information, including product ingredients. Product listings must be updated annually.

The “responsible person” is generally the manufacturer, packer, or distributor whose name appears on the product label.

Brands therefore need to understand exactly which entity bears the statutory responsibility.

Registration Is Not FDA Approval

FDA’s September 2026 announcement is particularly important for companies that receive requests from retailers, distributors, investors, or other business partners for “FDA certificates.”

FDA states that it does not provide:

Certificates proving cosmetic facility registration;
Certificates proving product listing;
Letters verifying registration;
Letters verifying listing; or
Documents stating that a facility or product is “FDA approved” based on registration or listing.

The assignment of a registration or listing number likewise does not mean FDA has approved the facility or product.

Safety Substantiation

MoCRA also established an affirmative obligation concerning safety substantiation.

FDA explains that responsible persons must ensure and maintain records supporting adequate safety substantiation for cosmetic products. FDA does not prescribe one universal testing protocol for every cosmetic product or ingredient, and animal testing is not required as a condition of marketing a cosmetic.

This means companies should establish a defensible safety-substantiation file appropriate to the product.

The absence of a single mandated test does not mean the absence of a safety obligation.

Serious Adverse Events

MoCRA requires responsible persons to report serious adverse events associated with cosmetic products to FDA within 15 business days.

FDA explains that additional medical information received within one year of the initial report must also be submitted within 15 business days.

Companies should therefore have an internal process for:

Receiving complaints;
Identifying potential adverse events;
Determining whether an event meets the statutory definition of “serious adverse event”;
Escalating the matter internally; and
Making required FDA submissions.

Waiting until an adverse event occurs to establish the process can create unnecessary risk.

Mandatory Recall Authority

MoCRA also gives FDA mandatory recall authority in specified circumstances.

If FDA determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and exposure will cause serious adverse health consequences or death, and the responsible person does not voluntarily cease distribution or recall the product, FDA has authority to order a mandatory recall.

That represents a substantial expansion of FDA’s cosmetics enforcement authority.

Small-Business Exemptions

MoCRA contains exemptions from certain registration, listing, and GMP requirements for qualifying small businesses.

But the exemptions are not universal.

FDA identifies several categories of products for which the exemptions do not apply, including certain products that regularly contact the eye’s mucous membrane, injected products, products intended for internal use, and products intended to alter appearance for more than 24 hours under customary conditions of use.

Companies should therefore determine whether an exemption actually applies to the specific business and products at issue.

The Bottom Line

MoCRA compliance is substantially broader than obtaining a registration number.

Cosmetic companies should have a regulatory system addressing:

Registration + Product Listing + Safety Substantiation + Adverse Events + Labeling + Manufacturing + Records + Recall Preparedness.

The companies best positioned for FDA scrutiny are those that build these systems before a problem arises.

Garg Law advises cosmetic and beauty companies on MoCRA compliance, FDA registration and listing, safety substantiation, adverse events, labeling, claims, and FDA enforcement matters. For more information or questions on FDA cosmetic compliance and enforcement matters, please contact info@garg-law.com.