What MoCRA is
The Modernization of Cosmetics Regulation Act of 2022, known as MoCRA, is the most significant update to U.S. cosmetics regulation since the Federal Food, Drug, and Cosmetic Act of 1938. It gave the FDA new authorities over cosmetics and created new obligations for brands, manufacturers and others in the supply chain.
Key areas include facility registration, product listing, serious adverse event reporting, safety substantiation, labeling, recordkeeping and, in the future, good manufacturing practice regulations. The FDA also gained mandatory recall authority for cosmetics.
This guide is a plain-language overview for indie beauty founders thinking about fulfillment. It isn't legal advice. Regulations and FDA guidance change, and you should confirm your obligations with regulatory counsel or the FDA's own resources.
Who the responsible person is
Many MoCRA obligations fall on the responsible person. The responsible person is the manufacturer, packer or distributor whose name appears on the cosmetic product's label. For most indie beauty brands, that's the brand itself, even if a contract manufacturer makes the product.
The responsible person is responsible for product listing, adverse event reporting, safety substantiation and labeling requirements tied to adverse event contact information.
A 3PL that stores and ships your products is generally not the responsible person, because its name isn't on the label. That means your fulfillment partner can't take over your MoCRA obligations, though it can make some of them easier to meet.
Facility registration and product listing
MoCRA requires owners or operators of facilities that manufacture or process cosmetic products for U.S. distribution to register those facilities with the FDA. It also requires the responsible person to list each marketed cosmetic product, including its ingredients.
FDA guidance indicates that facilities that only label, relabel, package, repackage, hold or distribute cosmetics are not required to register. That generally means a 3PL that stores and ships finished products does not need to register as a cosmetics facility for that activity.
If you make products in your own studio, your studio may be a manufacturing facility. If a contract manufacturer makes them, it registers its facility. Product listing remains the responsibility of the brand as the responsible person, unless an exemption applies.
The small-business exemption
MoCRA includes an exemption for certain small businesses. Qualifying small businesses, generally those whose average gross annual sales of cosmetic products in the U.S. over the previous three years are below a threshold set in the law (with adjustments for inflation), are exempt from facility registration, product listing and the future good manufacturing practice requirements.
The exemption does not apply to certain products, even for small businesses. These include products that regularly come into contact with the mucous membrane of the eye under customary conditions of use, products that are injected, products intended for internal use and products intended to alter appearance for more than 24 hours under customary conditions of use, with removal by the consumer not part of those conditions.
Even if you qualify, the exemption doesn't cover everything. Small businesses still have obligations around safety substantiation, labeling and adverse event reporting.
Adverse event reporting and records
Under MoCRA, the responsible person must report serious adverse events associated with a cosmetic product used in the U.S. to the FDA within 15 business days of receiving the information. Serious adverse events include outcomes such as death, life-threatening experiences, hospitalization, significant disfigurement and certain other serious outcomes.
The responsible person must also keep records related to adverse events, with retention periods that differ for small businesses. These records cover all reports received, not just serious ones.
This is where fulfillment data becomes important. When a customer reports a problem, you need to know which lot they received and when. If your 3PL records lot numbers on each order, you can answer that quickly and see how many other customers received the same batch. That supports both your reporting obligations and your decisions about whether to hold or pull a lot.
Labeling requirements
MoCRA requires cosmetic labels to include domestic contact information, such as a U.S. address, U.S. phone number or electronic contact like a website, through which the responsible person can receive adverse event reports. This is in addition to existing labeling requirements such as ingredient declarations, net quantity and the name and place of business.
The law also anticipates requirements for fragrance allergen disclosure and labeling for professional-use products. Check current FDA guidance for the status of those rules.
Before sending inventory to a 3PL, it's worth confirming your labels meet current requirements. Relabeling inventory after it's in a warehouse is possible but costs time and money. A good 3PL can flag obvious issues at receiving, but label compliance is the brand's responsibility.
A practical MoCRA checklist for small brands
Turning MoCRA into day-to-day practice is mostly about records and habits. A simple checklist for indie beauty brands:
- Confirm whether you qualify as a small business and which of your products, if any, fall outside the exemption
- Confirm who manufactures each product and whether that facility is registered
- Check that labels include domestic contact information for adverse event reports
- Keep safety substantiation documentation for each product
- Set up a simple process for logging every adverse event report you receive, serious or not
- Make sure every production batch has a lot code printed on the product or packaging
- Choose a fulfillment partner that records lots on outbound orders and can hold a lot quickly
Revisit the checklist when you launch a new product type. Moving from lip products into eyeliner or a long-wear tint, for example, could change whether the small-business exemption applies to that product.
None of this needs to be complicated, but it does need to be deliberate. Brands that set up clean records early find it far easier to respond calmly if a customer ever reports a problem.
What a 3PL can and can't do
A 3PL can't register your products, file your adverse event reports or determine whether you qualify for an exemption. Those are your responsibilities as the responsible person.
What a good beauty 3PL can do:
- Capture lot numbers at receiving and record them on each shipped order
- Search which customers received a specific lot
- Place a lot on hold so it stops shipping while you investigate
- Pick dated products first-expired, first-out
- Support a recall or market withdrawal by identifying and pulling affected stock
- Keep clean receiving and inventory records
Those capabilities don't make you compliant on their own, but they make compliance much more practical, especially for small brands with many small production batches.
Frequently asked questions
Does my 3PL need to register under MoCRA?
Generally no. FDA guidance indicates facilities that only hold, label, package or distribute cosmetics are not required to register.
Are small beauty brands exempt from MoCRA?
Partly. Qualifying small businesses are exempt from facility registration and product listing for most products, but safety, labeling and adverse event reporting obligations still apply.
How quickly must serious adverse events be reported?
The responsible person must report serious adverse events to the FDA within 15 business days of receiving the information.