What is MoCRA? The 2026 Cosmetic Brand Guide

On average, people use between 6 and 12 cosmetic products every single day. Moisturizers, shampoo, makeup, perfume, nail polish, etc. And for decades, the regulations governing those products hadn't changed since 1938.

That changed in December 2022 when the Modernization of Cosmetics Regulation Act, better known as MoCRA, was signed into law. It's the most important update to the FDA cosmetics regulation in over 80 years, and if you sell cosmetic products in the United States, it applies to you.

So, what is MoCRA, what does it require, and what do you need to have in place as a cosmetic brand in 2026?

That's exactly what we’ll cover in this guide.

What Does MoCRA Stand For?

MoCRA stands for the Modernization of Cosmetics Regulation Act of 2022. President Biden signed it into law in December 2022 as part of the Consolidated Appropriations Act of 2023.

The law updates the Federal Food, Drug, and Cosmetic Act, which has governed cosmetics in the US since 1938. It gives the FDA new powers to regulate cosmetic products and the facilities that make them.

Before MoCRA, a lot of what the FDA asked cosmetic brands to do was optional. There was no requirement for facility registration and no requirement to report adverse reactions. Recalls were voluntary. MoCRA makes all of that mandatory.

When Does MoCRA Go Into Effect?

MoCRA took effect on December 29, 2023. But not everything started at the same time. Here are the events and the deadlines that occurred between 2023 and 2025:

• December 29, 2023: Brands needed proof that their products were safe before selling them in the US

• July 1, 2024: Facility registration and product listing enforcement began. The FDA gave brands extra time after the original deadline to get set up on the new Cosmetics Direct portal

• December 29, 2024: Brands had to update their labels to list fragrance allergens and include contact information for reporting adverse events

• December 29, 2025: The FDA was required to publish its final rules on Good Manufacturing Practices for cosmetic facilities

If you are selling cosmetic products in 2026, all of these deadlines have passed. This means MoCRA compliance isn't something you're getting ready for. It's something you are expected to already have in place.

What Does MoCRA Require?

1. Facility Registration

Every facility that makes or processes cosmetic products sold in the United States must be registered with the FDA. This includes facilities both inside and outside the US. Registration needs to be renewed every two years.

The FDA can also suspend a facility's registration if it believes a product made there could cause serious harm. If that happens, the facility cannot sell or distribute cosmetic products in the US until the problem is fixed.

2. Product Listing

Every cosmetic product sold in the US must be listed with the FDA. The responsible person, who is the manufacturer, packer, or distributor whose name appears on the label, must submit this listing and update it annually. 

The listing needs to include the product name, brand name, ingredient list, product category, and the date it first went on sale.

You can submit facility registrations and product listings through the FDA's Cosmetics Direct portal.

3. Adverse Event Reporting

MoCRA introduces mandatory adverse event reporting for cosmetics for the first time. If a serious adverse event involving one of your products occurs, the responsible person must report it to the FDA within 15 business days of becoming aware of it.

A serious adverse event includes death, a life-threatening experience, hospitalization, significant disfigurement, such as serious rashes, second or third-degree burns, major hair loss, infections, birth defects, or anything that requires medical treatment to prevent those outcomes.

Records of adverse events must be kept for six years. The FDA can also ask to see those records during an inspection.

4. Safety Substantiation

Before you sell a cosmetic product in the US, you need to have evidence that it is safe. MoCRA defines this as tests, studies, research, or other information that experts agree is enough to confirm the product is safe when used as directed.

Products without this evidence are considered adulterated, which means they cannot legally be sold in the US. This is why testing your ingredients and finished products with an accredited laboratory is an important part of MoCRA compliance.

5. FDA MoCRA Labelling Requirements

The FDA MoCRA labelling requirements bring several new rules for cosmetic brands. Labels must now include a US address, phone number, or online contact method so consumers can report adverse events. 

Professional cosmetic products, the kind used only by licensed professionals, must now meet the same labelling rules as regular consumer products, including listing all ingredients.

Under MoCRA section 3505, which covers fragrance allergen labelling, brands must list every fragrance allergen in the product on the label. Products that do not meet these labelling rules are considered misbranded and cannot be sold legally in the US.

6. Good Manufacturing Practices

MoCRA requires the FDA to set mandatory GMP rules for cosmetic manufacturing facilities. The final rule was due by December 29, 2025. 

Once those rules were enacted, any product made in a facility that does not follow GMPs will be considered adulterated.

GMPs cover documentation, facility maintenance, equipment standards, staff training, raw material handling, production processes, and complaint management. 

If you work with a contract manufacturer, check that they are already meeting GMP standards.

7. Mandatory Recall Authority

Before MoCRA, all cosmetic recalls in the US were voluntary. That has changed.

The FDA now has the power to order a mandatory recall if it believes a cosmetic product is adulterated, misbranded, or could cause serious harm or death.

This means that brands can no longer quietly manage a safety issue without the FDA stepping in.

Why MoCRA is Important in 2026

The FDA can now suspend facility registrations, order mandatory recalls, and review your safety and adverse event records. These are not future possibilities. They are happening now.

Consumers are also paying more attention to what goes into their products. 

Brands that can demonstrate MoCRA compliance, with registered facilities, tested ingredients, and clear labels, build more trust with buyers. Brands that cannot are at a disadvantage.

The cost of non-compliance is also high. Your products can be pulled from sale. Your facilities can lose their registration. 

In essence, a recall or suspended registration will cost you far more than getting compliant ever would.

Who Is Exempt From MoCRA?

Small businesses are exempt from some MoCRA requirements, specifically the GMP rules, facility registration, and product listing. 

To qualify, a business must have average gross annual cosmetic sales in the US of less than USD 1 million over the previous three years.

But these exemptions do not apply if the business makes products that:

• Regularly touch the mucus membrane of the eye

• Are injected

• Are for internal use

• Are meant to change someone's appearance for more than 24 hours under normal conditions of use

Small businesses that do qualify for exemptions are still required to keep adverse event records. Their retention period is three years instead of six.

How MoCRA Changes Things for Cosmetic Brands

The USA Modernization of Cosmetic Regulation Act MoCRA changes how cosmetic brands operate. Here’s how:

• More clarity: 

Getting MoCRA compliant costs money. Facility registration, product listing, safety testing, label updates, and GMP readiness all require investment. 

But the upside is that MoCRA cosmetics regulations are now clearly defined. Brands know exactly what is expected of them.

• Better ingredient control: 

Under the Modernization of Cosmetics Regulation Act of 2022, MoCRA, brands have to assess every ingredient for safety and be able to back that up with evidence. 

There is no longer any room to use an ingredient and hope for the best. If you cannot substantiate the safety of what is in your product, it should not be in your product.

• Standardized labelling across the board: 

FDA MoCRA cosmetics labelling rules now apply to all cosmetic products sold in the US, including professional products that previously had different standards. 

Every label needs to list ingredients, disclose fragrance allergens, and provide a way for consumers to report adverse events. This creates a more consistent experience for consumers and reduces the risk of a brand being caught off guard by a misbranding violation.

• Better brand reputation: 

MoCRA cosmetics compliance is becoming a trust signal. Consumers who care about what goes into their products are starting to ask questions that brands were not always required to answer before. 

Being able to show that your facility is registered, your products are listed, your ingredients are tested, and your labels are accurate puts you in a stronger position than brands that cannot.

• The FDA has more power: 

Under MOCRA FDA cosmetics rules, the agency can now access your records, suspend your facility registration, and order a mandatory recall. 

This is a different level of oversight than the industry has ever operated under. If you treat compliance as optional, you are taking on real risk.

How to Prepare for MoCRA Compliance

Since all major MoCRA deadlines have already passed, the focus in 2026 is on ensuring everything in your brand is in order. Here is a practical checklist for cosmetic brands:

1. Register your facility: If you manufacture or process cosmetic products sold in the US and your facility is not yet registered through the FDA's Cosmetics Direct portal, that should be your first priority. MOCRA cosmetic registration is mandatory, and operating without it puts your entire product line at risk

2. List all your products: Every product you sell in the US must be listed with the FDA, including its ingredients. If your product lineup has changed since you last updated your listings, make them current. Product listings need to be updated annually

3. Review your labels: Check every label against the FDA MoCRA labelling requirements. Does your label include a US contact address or phone number? Does it list all fragrance allergens? Does your professional cosmetic product now include full ingredient disclosure? If any of these are missing, your products are technically misbranded

4. Check your safety substantiation records: For every product you sell, you should have documentation supporting its safety. This includes testing data, research, or other scientific evidence. If that documentation is not in order, now is the time to get it sorted

5. Verify your manufacturing setup: Whether you manufacture in-house or through a contract manufacturer, your facility needs to meet FDA MoCRA cosmetics GMP standards now that the final rule has been issued. If you work with a third-party manufacturer, ask them directly whether they are GMP compliant under the modernization of cosmetics regulation act of 2022 MoCRA requirements

6. Set up an adverse event reporting process: Your team needs to know what counts as a serious adverse event under mocra fda cosmetics rules, who the responsible person is in your organization, and what the reporting process looks like. You have 15 business days from becoming aware of an event to report it to the FDA. That is not a lot of time if you do not have a process ready

Also, try to perform a GAP analysis by comparing your current systems against the full list of MoCRA cosmetic requirements and identifying where the gaps are. 

If you find any gaps, close them. Then update your internal procedures to ensure compliance is maintained going forward.

Wrapping Up

For cosmetic brands, we recommend one thing: Get your facility registered. Get your products listed. Make sure your labels are compliant. Have your safety documentation in order. And set up a proper process for adverse event reporting.

When you take these rules seriously, you will be in a stronger position with consumers, with retailers, and with regulators. 

If you run a cosmetic brand and want help thinking through your marketing and ecommerce strategy alongside your compliance obligations, get in touch with Pro Marketer and let's talk.

FAQs

1. What are the 5 main categories of cosmetic products?

The FDA recognizes several categories of cosmetic products. The five main ones are skin care products such as:

• Moisturizers, cleansers, and serums

• Hair care products such as shampoos, conditioners, and hair dyes

• Makeup and colour cosmetics such as foundation, lipstick, and eyeshadow

• Fragrance products such as perfume and cologne

• Personal care and grooming products such as deodorant, shaving cream, and nail polish

All of these fall under MoCRA cosmetics regulations if they are sold in the United States.

2. Does MoCRA apply to Canadian brands?

Yes. MoCRA applies to any brand that sells cosmetic products in the United States, regardless of where it is based. If your facility manufactures or processes cosmetics distributed in the US, it must be registered with the FDA under MoCRA. Your products must also be listed, your labels must meet FDA MoCRA labelling requirements, and you must have adequate safety substantiation in place. Being based in Canada does not exempt you from any of these requirements.

3. Who is a "responsible person" under MoCRA?

Under MoCRA, the responsible person is the manufacturer, packer, or distributor whose name appears on the cosmetic product label. 

This is the person or business that is legally responsible for meeting the requirements of the Modernization of Cosmetics Regulation Act of 2022 MoCRA, including product listing, safety substantiation, and adverse event reporting. 

If a serious adverse event occurs, it is the responsible person who must report it to the FDA within 15 business days.

4. Does MoCRA apply to small skincare brands?

It depends on the size of your business. Small businesses with average gross annual cosmetic sales in the US of less than USD 1 million over the previous three years are exempt from facility registration, product listing, and GMP requirements. 

However, they are still required to maintain adverse event records. The exemption also does not apply if you make products that come into contact with the mucus membrane of the eye, are injected, are for internal use, or are meant to change someone's appearance for more than 24 hours. 

If your brand has grown beyond the USD 1 million threshold, you are no longer exempt, and full MoCRA compliance is required.

5. What is the difference between MoCRA and VCRP?

VCRP stands for the Voluntary Cosmetic Registration Program, which was the system the FDA used before MoCRA. As the name suggests, participation was optional. 

Brands could choose to register their facilities and list their products, but there was no legal requirement to do so. MoCRA replaces the VCRP with a mandatory system. Registration is no longer a choice. It is a legal requirement, and selling products from an unregistered facility or failing to list products with the FDA is now a violation of federal law.

6. Do I need to update my Shopify product pages for MoCRA?

MoCRA's labelling requirements apply to the physical label on your product packaging, not directly to your Shopify product pages. 

However, your online store should accurately reflect what is on your label, including your full ingredient list, fragrance allergens, and contact information for reporting adverse events. 

If your physical labels have been updated to meet FDA MoCRA cosmetics requirements, your Shopify product descriptions should match. Inconsistencies between your label and your online listings can create confusion for consumers and could raise questions during an FDA review.