In an ever-evolving regulatory landscape, cosmetics companies must navigate a complex web of requirements to ensure compliance. The Modernization ofCosmetics Regulation Act of 2022 (MoCRA) has introduced significant changes to the Federal Food, Drug, and Cosmetic Act, transforming how the cosmetics industry operates in the United States. As a result, understanding and adhering to these new regulations is crucial for cosmetic businesses to thrive in the market.
This article aims to provide a comprehensive guide to MoCRA compliance for cosmetics companies, particularly small businesses. We will delve into the key requirements under MoCRA, including good manufacturing practices, facility registration, product listing, and the role of the responsible person. Additionally, we will outline the steps necessary to register your facility and list your cosmetic products, discuss exemptions and specific considerations, and highlight the importance of monitoring cosmetic ingredients and reporting serious adverse events.
Understanding MoCRA and FDA Compliance
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly expands the FDA’s authority to regulate cosmetics[1]. MoCRA aims to strengthen oversight of cosmetic products by establishing premarket review and reporting requirements for ingredients used in the manufacturing process[2]. The act targets hazards and risks, including significant underreporting of adverse health events and lack of communication on chemical ingredients and product use risks[2].
Overview of MoCRA
MoCRA applies to all cosmetics manufacturers, importers, marketers, and distributors, as well as all types of cosmetic products[2]. The act requires manufacturers to adhere to strict current GoodManufacturing Practices (cGMPs), ensuring that the manufacturing process is documented and facilities are regularly inspected and monitored by the FDA[2]. Additionally, all ingredients used in cosmetics products must be certified as safe and properly labeled[2].
Key provisions of MoCRA include:
- Adverse event reporting within 15 business days[2]
- Facility registration with the FDA before December 29, 2023[2]
- Product listing submission to the FDA before December 29, 2023[2]
- Safety substantiation records maintained by responsible persons[2]
FDA’s Expanded Authority Under MoCRA
MoCRA provides new authorities to the FDA, including:
Authority | Description |
|---|---|
Records Access | If certain conditions are met, FDA can access and copy certain records related to a cosmetic product, including safety records . |
Mandatory Recall Authority | If the agency determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and the use of or exposure to the cosmetic will cause serious adverse health consequences or death, FDA has the authority to order a mandatory recall if the responsible person refuses to do so voluntarily . |
The act also establishes new requirements for the industry, such as adverse event reporting, facility registration, product listing, and safety substantiation[1]. Furthermore, MoCRA requires the FDA to establish regulations for Good Manufacturing Practices for facilities that manufacture cosmetic products, fragrance allergen labeling requirements, and standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products[3].
Key Requirements for MoCRA Compliance
MoCRA introduces several key requirements for cosmetics companies to ensure compliance[1]. These include facility registration, product listing, and safety substantiation[1].
Facility Registration Requirements
Under MoCRA, manufacturers and processors must register their facilities with the FDA and renew their registration every two years[2]. The FDA has the authority to suspend a facility’s registration if it determines that a cosmetic product manufactured or processed by the facility has a reasonable probability of causing serious adverse health consequences or death to humans[2].
Product Listing Requirements
The responsible person must list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually[2]. A single listing submission for a cosmetic product may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents[2].
Safety Substantiation Requirements
Companies and individuals who manufacture or market cosmetics have a responsibility to ensure the safety of their products[2]. A responsible person is required to ensure and maintain records supporting adequate safety substantiation of their cosmetic products[2]. Manufacturers can use relevant safety data that is already available to support the safety of their products[2]. Animal testing is not a requirement for marketing a cosmetic product[2]. However, it’s important that all data used to support safety are derived from scientifically robust methods[2].
In addition, MoCRA requires that industry comply with regulations that the FDA will establish for:
- Good Manufacturing Practice (GMP) requirements for facilities that manufacture cosmetic products[2]
- Fragrance allergen labeling requirements[2]
- Standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products[2]
By adhering to these key requirements under MoCRA, including good manufacturing practices, facility registration, product listing, and safety substantiation, cosmetics companies can ensure compliance and maintain the safety of their products for consumers[1].
Steps to Register Your Facility and List Products
To ensure compliance with MoCRA, cosmetics companies must register their facilities and list their products with the FDA[1]. This process involves several key steps that require careful preparation and attention to detail[1].
Preparing for Registration
Before beginning the registration process, cosmetics manufacturers should gather all necessary information[1]. This includes:
- Facility details, such as address and contact information[1]
- Product formulations and ingredient lists[1]
- Brand names and product categories[1]
Establishing robust record-keeping practices is essential to ensure the accuracy of submitted information[1].
The Registration Process
Cosmetics companies have several options for submitting their facility registrations and product listings:
Submission Method | Description |
|---|---|
Cosmetics Direct | An FDA-provided SPL authoring tool that simplifies the submission process |
Electronic Submissions Gateway (ESG) | An online portal for submitting registrations and listings |
SPL Xforms | An alternative SPL authoring software |
Paper Submissions | FDA strongly encourages electronic submissions, but paper forms (FDA 5066 and FDA 5067) are available |
To facilitate the registration process, owners or operators of facilities must obtain an FDA Establishment Identifier (FEI) number before submitting their registration[1]. The FEI Search Portal can help determine if an entity already has an assigned FEI number[1].
Annual Product Listing Updates
After initial registration, a responsible person must list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually[2]. A single listing submission may include multiple cosmetic products with identical formulations or formulations that differ only in colors, fragrances, flavors, or quantity[2].
By following these steps and adhering to FDA guidance, cosmetics companies can successfully navigate the facility registration and product listing requirements under MoCRA[1]. Staying informed about compliance dates and any updates to the registration process is crucial for maintaining compliance and ensuring the safety of cosmetic products[1].
Exemptions and Specific Considerations
MoCRA provides exemptions for certain small businesses from Good Manufacturing Practices (GMP), facility registration, and product listing requirements[1]. To qualify for the small business exemption, a business must meet two criteria: a maximum annual revenue amount and restrictions on the types of cosmetic products manufactured[3].
Small Business Exemptions
The small business exemption applies to businesses with average gross annual sales of cosmetic products in the U.S. less than $1,000,000 (adjusted for inflation) for the previous 3-year period[4]. However, this exemption does not apply to businesses that manufacture or process specific cosmetic products, such as:
- Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use[1][4]
- Products that are injected[1][4]
- Products that are intended for internal use[1][4]
- Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use[1][4]
Product-Specific Exemptions
In addition to the small business exemption, MoCRA also provides exemptions for certain products and facilities that are subject to requirements for drugs and devices[1]. These exemptions are specific to the type of product and the regulatory requirements they must meet.
It is important to note that even if a business qualifies for the small business exemption, it is still required to:
Requirement | Description |
|---|---|
Adverse Event Contact Information | Provide contact information on the cosmetic label |
Serious Adverse Event Reporting | Report serious adverse events to the FDA within 15 business days |
New Medical and Other Information | Report new medical and other information for serious adverse events within 1 year |
| Record Keeping | Keep records of adverse events for 3 years |
Fragrance Allergen and Professional Use Labels | Update labels to include fragrance allergens and professional use information |
Understanding the exemptions and specific considerations under MoCRA is crucial for cosmetics companies, particularly small businesses, to ensure compliance with the new regulations[4]. By carefully reviewing the criteria for the small business exemption and product-specific exemptions, companies can determine their obligations and take the necessary steps to meet the requirements set forth by the FDA[2].
Conclusion
The Modernization of Cosmetics Regulation Act of 2022 has transformed the regulatory landscape for cosmetics companies in the United States. By understanding and adhering to the key requirements under MoCRA, such as good manufacturing practices, facility registration, product listing, and safety substantiation, businesses can ensure compliance and maintain consumer safety. Small cosmetics companies should carefully review the criteria for exemptions to determine their obligations and take necessary steps to meet FDA requirements.
Staying informed about compliance dates and updates to the registration process is crucial for cosmetics manufacturers and marketers. By navigating the complex web of regulations and prioritizingproduct safety, the cosmetics industry can thrive while protecting consumer health and well-being. As the regulatory landscape continues to evolve, businesses must remain vigilant and adaptable to maintain compliance and success in the market.
Need assistance with your cosmetic registration?
FAQs
What Does MoCRA Entail for Cosmetic Manufacturers?
MoCRA, for the first time, grants the FDA the power to mandate the registration of facilities that manufacture cosmetic products and to require the submission of product listings, which includes detailing the ingredients used in these products.
How Does the FDA Regulate Cosmetics?
The FDA does not approve cosmetic products or their ingredients before they hit the market, except for certain color additives. However, cosmetic companies must ensure their products are safe, correctly labeled, and free of banned substances. They must also comply with restrictions on certain ingredients.
Can You Summarize MoCRA’s Impact on Cosmetics Regulation?
MoCRA enhances the FDA’s oversight of the cosmetics industry by introducing the authority to recall products, mandating facility registration, and enforcing improved product labeling. Although it represents progress, the law does not oblige the FDA to evaluate or limit the use of potentially harmful chemicals in cosmetics.
Which Agency Oversees Cosmetic Safety in the United States?
The Food and Drug Administration (FDA) is the federal agency responsible for regulating cosmetic products and their ingredients in the USA. This authority stems from the 1938 Federal Food, Drug, and Cosmetic Act (FFDCA), which addresses the adulteration and misbranding of cosmetic products.
References
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