Custom Manufacture :The US MoCRA guidelines have become the most important regulatory framework for every cosmetics manufacturer, private label brand, contract manufacturer, and cosmetic exporter looking to sell products in the United States. With the implementation of the Modernization of Cosmetics Regulation Act (MoCRA), the FDA cosmetics regulations have significantly tightened, making MoCRA compliance mandatory for all cosmetic businesses. MoCRA has strengthened product safety, facility oversight, labeling accuracy, fragrance allergen disclosures, cosmetic product listing, cosmetic facility registration, and record-keeping requirements. Any company aiming to grow in the U.S. cosmetics market must understand and follow the complete US MoCRA guidelines to avoid penalties, recalls, and regulatory action.
What Are the US MoCRA Guidelines?
The US MoCRA guidelines were created to improve cosmetic safety, quality, transparency, and monitoring of all cosmetic products sold in the U.S. These FDA MoCRA regulations focus on strict cosmetic product listing, facility registration, safety substantiation, GMP compliance, cosmetic labeling requirements, MoCRA adverse event reporting rules, fragrance allergen disclosure rules, and FDA inspection and recall authority. The purpose of MoCRA is to ensure that cosmetic brands maintain proper documentation, provide safe formulations, follow quality control processes, and prevent misbranded or adulterated cosmetic products from entering the U.S. market.
Cosmetic Product Listing Under MoCRA
Under the US MoCRA guidelines, every cosmetic company must submit a complete cosmetic product listing to the FDA. All cosmetic products already in the market must be listed within one year of MoCRA’s enactment, while products launched after MoCRA must be listed within 120 days of marketing. The responsible person must update each product listing annually. This FDA cosmetic product listing requirement ensures complete transparency and helps the FDA track every cosmetic product being sold in the U.S. market. Failing to comply with the MoCRA product listing requirement can restrict companies from marketing cosmetic products in the USA.
Cosmetic Facility Registration Requirement
The cosmetic facility registration mandate is another major requirement under the US MoCRA guidelines. All existing cosmetic manufacturing facilities must register with the FDA by December 29, 2023, while new facilities must register within 60 days of starting operations. The registration must also be renewed every two years. The FDA uses the facility registration data to monitor compliance, inspect manufacturing conditions, and ensure that cosmetic products are produced under safe and hygienic environments. Without proper MoCRA facility registration, a company cannot legally manufacture or market cosmetics in the U.S.
Safety Substantiation for Cosmetic Products
MoCRA requires brands to maintain complete safety substantiation records to prove that their cosmetic products are safe for use. This includes scientific data, tests, toxicology reports, stability studies, and evaluations carried out by qualified experts. Safety substantiation is a crucial part of the FDA MoCRA compliance framework because it ensures that every cosmetic product marketed in the U.S. is scientifically backed and does not pose a health risk. Under the US MoCRA guidelines, no cosmetic product can be sold without adequate safety evidence.
Cosmetic Good Manufacturing Practices (GMP Compliance)
The US MoCRA guidelines also make GMP for cosmetics mandatory. Cosmetic manufacturing facilities must follow strict Good Manufacturing Practices to avoid contamination, maintain hygiene, improve production quality, and reduce the risk of adulterated cosmetic products. The FDA MoCRA GMP rules ensure that every product is produced in a controlled environment with proper documentation, quality systems, and consistent manufacturing standards. Without following cosmetic GMP compliance, a brand cannot meet the required FDA cosmetics regulations under MoCRA.
Updated Cosmetic Labeling Requirements
One of the most important areas under the US MoCRA guidelines is the updated cosmetic labeling requirements. Every cosmetic label must clearly mention consumer contact information such as a domestic address, phone number, or email for reporting adverse events. The label must also include fragrance allergen disclosures, as MoCRA makes it mandatory to separately highlight allergens identified by the FDA. Professional-use cosmetic products must also be clearly labelled for licensed professionals only. These MoCRA labeling requirements ensure transparency and help consumers make safe choices while using cosmetic products.
MoCRA Adverse Event Reporting
The US MoCRA guidelines require the responsible person to report any serious adverse event associated with a cosmetic product within 15 business days. All additional medical information related to the adverse event must be submitted for up to one year. Brands must maintain adverse event records for six years, though small businesses are required to keep records for three years. This strict MoCRA adverse event reporting system allows the FDA to track safety-related issues and ensure that cosmetic products do not pose health risks.
Fragrance Allergen Disclosure Requirement
Under the US MoCRA guidelines, all fragrance allergens identified by the FDA must be clearly disclosed on product labels. Brands are required to thoroughly evaluate ingredients and conduct safety assessments to prove that these allergens do not cause harm. This MoCRA fragrance allergen disclosure is extremely important for consumer safety, transparency, and regulatory compliance.
Record-Keeping Requirements Under MoCRA
Another major part of the FDA MoCRA guidelines is the mandatory record-keeping requirement. Brands must maintain all product records, safety data, and adverse event documentation for six years. Small businesses must maintain records for three years. The FDA has full authority to inspect records and verify MoCRA compliance. Proper documentation is essential to avoid penalties under the US MoCRA regulations.
FDA Recall Authority and Enforcement
MoCRA gives the FDA the power to enforce both voluntary and mandatory recalls. If a cosmetic product is found to be adulterated, contaminated, misbranded, improperly labeled, or unsafe, the FDA can request the responsible person to stop distribution and recall the product. If the responsible person refuses, the FDA can issue a mandatory recall order. This makes MoCRA recall authority one of the most powerful regulatory tools for ensuring cosmetic product safety.
Facility Suspension Under MoCRA
Under the US MoCRA guidelines, the FDA can suspend a cosmetic facility’s registration if the products manufactured there may cause serious adverse health consequences. A suspended facility cannot legally manufacture or distribute cosmetic products in the U.S. until compliance is restored. This provision ensures strict enforcement of FDA MoCRA compliance across manufacturing operations.
MoCRA Small Business Exemption
The MoCRA small business exemption applies to companies with less than USD 1 million in annual cosmetic sales in the U.S. These businesses are exempt from facility registration, GMP requirements, and product listing. However, they must still maintain adverse event records for three years and follow safety requirements. This exemption supports small-scale manufacturers while still ensuring consumer safety under the US MoCRA guidelines.
The US MoCRA guidelines represent the biggest regulatory shift for the cosmetics industry in decades. Any brand planning to enter or expand in the U.S. market must ensure full MoCRA compliance, including product listing, facility registration, GMP adherence, labeling updates, safety substantiation, allergen disclosure, and record-keeping. Understanding and implementing these FDA cosmetics regulations is essential for safe, legal, and successful cosmetic product marketing in the United States.
HCP Wellness – Your Trusted MOCRA-Ready Cosmetic & Toothpaste Manufacturing Partner
For beauty and personal care brands across the USA, Europe, Middle East, and Asia looking for a reliable cosmetic manufacturer, cosmetic exporter, or MOCRA-compliant toothpaste manufacturer, HCP Wellness stands as a fully equipped partner for private label and contract manufacturing. We support USA importers and global distributors who want high-quality skincare, haircare, oral care, and personal care products that meet strict regulatory standards, including US MOCRA requirements. At HCP Wellness, we offer complete end-to-end solutions—from custom formulation development, active-based innovation, fragrance creation, and stability testing, to packaging sourcing, label design, printing, and final filling & packing. Our team delivers retail-ready, shelf-ready, export-ready products with fully customized branding options. Whether you need a MOCRA-certified toothpaste exporter, a USA-focused cosmetic manufacturer, or a partner to build your entire product line from idea to finished goods, HCP Wellness ensures quality, compliance, and exceptional support at every step.
