By Todd Harrison and Melanie English, Venable LLP10.16.23
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is poised to revolutionize the U.S. Food and Drug Administration’s (FDA’s) regulation of the cosmetics industry. A subtitle of the Food and Drug Omnibus Reform Act passed in late 2022, MoCRA is the most significant expansion of FDA’s authority to regulate cosmetics since the passage of the Federal Food, Drug, and Cosmetics Act in 1938.
When MoCRA goes into effect, cosmetics companies will be subject to more statutory and regulatory requirements, and to greater scrutiny from regulators and the plaintiffs’ bar. This article summarizes the statute’s requirements, expected increases in enforcement, and what you can do to prepare.
The “responsible person” in this context refers to the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product’s label. Each facility must only submit one registration, regardless of whether the facility manufactures or produces cosmetics for one person or for multiple persons. When a facility is initially registered, FDA will assign a facility registration number to the facility and a product listing number to each product. The product listing number will not be publicly available.
Facilities that existed on Dec. 29, 2022 will need to register with FDA by Dec. 29, 2023. Any facilities created thereafter will need to register within either 60 days after Dec. 29, 2023, or 60 days after first manufacturing or processing cosmetic products, whichever is later. Registration must be renewed every two years, and registration information must be updated within 60 days of any change.
Note that information in the current voluntary cosmetic registration program (VCRP) will not be transferred to the new system, because the information submitted under the old voluntary program is not the same as the information that will be required under MoCRA. FDA stopped accepting submissions to VCRP at the end of March 2023. However, the new systems are not yet open for the submission of registration and listing information. FDA is currently seeking comments on the proposed new electronic systems, and we recommend taking a look at their proposals and providing feedback before the systems are finalized.
It will be formula-specific, so one product sold under multiple brand names can be listed as a single product. Products that vary only by fragrance, color, flavor, or quantity may be listed together.
Products marketed on or before Dec. 29, 2022 will need to be listed by Dec. 29, 2023. If the product was first marketed after Dec. 29, 2022, it will need to be listed within 120 days of first being marketed in interstate commerce. Product listings must be updated annually.
As we mentioned, FDA has not yet completed the electronic submission system for product listing, but the agency is accepting comments on the proposed portal and accompanying forms.
• Death;
• A life-threatening experience;
• Inpatient hospitalization;
• A persistent or significant disability or incapacity;
• A congenital anomaly or birth defect;
• An infection;
• “Significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended under conditions of use that are customary or usual”; or
• Any medical or surgical intervention that based on reasonable medical judgment is required to prevent the above-mentioned outcomes.
Infections and “significant disfigurement” did not previously qualify as serious adverse events that would need to be reported to FDA, but now they will need to be reported. All serious adverse events associated with the use of cosmetics products, and any further information about the adverse event received within a year of the initial report, will need to be reported to FDA within 15 business days. Information related to adverse event reports must be maintained for 6 years, excepting certain small businesses that will only need to maintain data for 3 years.
A cosmetic product is considered “safe” if it can be demonstrated that the product and its ingredients are not injurious to users under the conditions of use prescribed on the label or under such conditions of use as are customary or usual. Minor and transient reactions or skin irritations will not necessarily be considered to render a product unsafe, though “minor and transient” is not currently defined.
Related to safety and safety substantiation, MoCRA requires FDA to develop a rule establishing and standardizing testing methods for detecting and identifying asbestos in talc-containing cosmetics products. The rule must be proposed by Dec. 29, 2023. FDA must also issue a report assessing the safety of the use of per- and polyfluoroalkyl substances (PFAS) in cosmetics by Dec. 29, 2025.
These high-risk products include cosmetic products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use, cosmetic products that are injected, cosmetic products intended for internal use, and cosmetic products that are intended to alter consumers’ appearance for more than 24 hours under customary and usual conditions of use that are not customarily or usually removed by the consumer.
There will also be exemptions to MoCRA requirements for certain facilities and products that are subject to drug and medical device regulations, since those facilities and products are already subject to stringent safety standards.
In addition to the new requirements that MoCRA imposes on cosmetics facilities and products, MoCRA significantly expands the FDA’s regulatory authority and ability to enforce those requirements. When MoCRA goes into effect, under certain circumstances, FDA will have the authority to access and copy certain records related to cosmetic products, mandatory recall authority, and the authority to suspend a facility’s registration.
Under MoCRA, if the agency has a reasonable belief that a cosmetic product or ingredient is likely to be adulterated such that the use of or exposure to the product presents a threat of serious adverse health consequences or death to humans, then FDA will—upon presentation of the appropriate credentials and written notice—have access to and copy all records related to the product or ingredient needed to assess the safety risk, within reasonable limits and acting in a reasonable manner.
If the agency determines that there is 1) a reasonable probability that the cosmetic is adulterated or misbranded and 2) the use of or exposure to the cosmetic will cause serious adverse health consequences or death, and 3) the responsible person refuses to voluntarily cease product distribution and recall the cosmetic, FDA will be permitted to order that such person immediately cease distribution of the product at issue.
In extreme cases, if FDA determines that a cosmetic product manufactured or processed by a registered facility and distributed in the U.S. has 1) a “reasonable probability of causing serious adverse health consequences or death to humans” and the agency 2) “has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility,” FDA may suspend a facility’s registration.
There are statutory provisions for challenging FDA enforcement decisions, such as the opportunity to seek a voluntary hearing regarding a recall no later than 10 business days after the date of issuance of the order, or the opportunity to participate in an informal hearing regarding a suspension no later than 5 business days after the issuance of the order.
Regardless of the methods companies have to push back, however, FDA’s expanded enforcement authority, when combined with the new statutory and regulatory requirements, will lead to added scrutiny of cosmetics companies related to their ingredients and claims.
MoCRA does not permit structure-function claims regarding skin health on cosmetic products, so between the additional scrutiny and the continued limitations on structure-function claims, we may expect FDA to issue more warning letters to cosmetics companies related to their advertising claims going forward.
We may also expect MoCRA to be followed by new state laws and regulations. MoCRA preempts states from establishing requirements for cosmetics that differ from what is required by MoCRA, but states will still be permitted to limit or prohibit the use of ingredients in cosmetics, and to require compliance with preexisting state cosmetic product ingredient reporting requirements such as California’s Proposition 65.
New York is already considering proposed legislation to ban certain cosmetics ingredients, including parabens and PFAs. The new state and federal requirements will likely lead to increased plaintiff challenges to cosmetic ingredients and claims.
Comments already posted to regulations.gov include suggestions that the agency add further categories to its list of proposed cosmetics categories, suggestions related to clarifying the registration and listing process, requests for clarification of how to identify the “responsible party,” and much more.
The agency will be reading comments, and some may well be included in the agency’s final regulations implementing MoCRA. If you have feedback for the agency on any of these proposals, the comment period is your best chance to make your voice heard.
Additionally, cosmetics companies should begin preparing to implement MoCRA's requirements now. They can begin to prepare for facility registration and product listing by identifying which of their facilities may need to be registered. This should include preparing a list of the company’s cosmetic products, their ingredients, and when they were first marketed.
Companies should set up registration and listing policies and standard operating procedures, and develop reporting and compliance policies for updating product listing and notifying FDA of product changes and new products being marketed.
Companies can prepare for reporting and recordkeeping requirements by updating current adverse event reporting procedures, and by reviewing safety and toxicity claims along with support for those claims. Small businesses should examine whether or not they will be excluded from certain MoCRA requirements. It is also a good time for cosmetic companies to review current GMP practices and recall insurance coverage.
A new world in cosmetic product regulation is coming, and there is no time like the present to prepare.
About the Authors: Todd Harrison is Partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com. Melanie English is an Associate at Venable's Food and Drug Law practice. Prior to joining Venable, she was an intern at the U.S. Department of Transportation (USDOT), where she reviewed and edited regulations for the Office of Regulation within the Office of the General Counsel. During law school, English was a staff editor on the New York University School of Law Moot Court Board. She was also a Venable summer associate.
When MoCRA goes into effect, cosmetics companies will be subject to more statutory and regulatory requirements, and to greater scrutiny from regulators and the plaintiffs’ bar. This article summarizes the statute’s requirements, expected increases in enforcement, and what you can do to prepare.
Facility Registration
MoCRA will require facilities located inside the U.S. or abroad that engage in the manufacturing or processing of a cosmetic product for distribution in the U.S. to register with FDA. The owner or operator of those facilities will need to provide a variety of information to the agency, including the brand names under which all cosmetics products manufactured or processed in the facility are sold, the product category or categories of those products, and the identity of the responsible person for each product.The “responsible person” in this context refers to the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product’s label. Each facility must only submit one registration, regardless of whether the facility manufactures or produces cosmetics for one person or for multiple persons. When a facility is initially registered, FDA will assign a facility registration number to the facility and a product listing number to each product. The product listing number will not be publicly available.
Facilities that existed on Dec. 29, 2022 will need to register with FDA by Dec. 29, 2023. Any facilities created thereafter will need to register within either 60 days after Dec. 29, 2023, or 60 days after first manufacturing or processing cosmetic products, whichever is later. Registration must be renewed every two years, and registration information must be updated within 60 days of any change.
Note that information in the current voluntary cosmetic registration program (VCRP) will not be transferred to the new system, because the information submitted under the old voluntary program is not the same as the information that will be required under MoCRA. FDA stopped accepting submissions to VCRP at the end of March 2023. However, the new systems are not yet open for the submission of registration and listing information. FDA is currently seeking comments on the proposed new electronic systems, and we recommend taking a look at their proposals and providing feedback before the systems are finalized.
Product Listing
MoCRA will require companies to list each cosmetic product that they market in the U.S. with FDA. Listing will require the facility registration number of each facility where the cosmetic is manufactured or processed, the name and contact number of the responsible person for the product, the cosmetic category or categories the product falls within, a list of product ingredients including fragrances, flavors, and colors, and the product listing number if any was previously assigned.It will be formula-specific, so one product sold under multiple brand names can be listed as a single product. Products that vary only by fragrance, color, flavor, or quantity may be listed together.
Products marketed on or before Dec. 29, 2022 will need to be listed by Dec. 29, 2023. If the product was first marketed after Dec. 29, 2022, it will need to be listed within 120 days of first being marketed in interstate commerce. Product listings must be updated annually.
As we mentioned, FDA has not yet completed the electronic submission system for product listing, but the agency is accepting comments on the proposed portal and accompanying forms.
'MoCRA is the most significant expansion of FDA’s authority to regulate cosmetics since the passage of the Federal Food, Drug, and Cosmetics Act in 1938.'
Adverse Event Reporting and Recordkeeping
MoCRA will allow FDA to access all adverse event reports during inspections. Adverse events include “any health-related event associated with the use of a cosmetic product that is adverse.” MoCRA will also expand the definition of what constitutes a serious adverse event that must be reported to FDA. A “serious adverse event” under MoCRA will include any adverse event that results in:• Death;
• A life-threatening experience;
• Inpatient hospitalization;
• A persistent or significant disability or incapacity;
• A congenital anomaly or birth defect;
• An infection;
• “Significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended under conditions of use that are customary or usual”; or
• Any medical or surgical intervention that based on reasonable medical judgment is required to prevent the above-mentioned outcomes.
Infections and “significant disfigurement” did not previously qualify as serious adverse events that would need to be reported to FDA, but now they will need to be reported. All serious adverse events associated with the use of cosmetics products, and any further information about the adverse event received within a year of the initial report, will need to be reported to FDA within 15 business days. Information related to adverse event reports must be maintained for 6 years, excepting certain small businesses that will only need to maintain data for 3 years.
Safety Substantiation
MoCRA will require responsible persons for cosmetics products to maintain records supporting adequate safety substantiation for their cosmetics products, which should include “tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.”A cosmetic product is considered “safe” if it can be demonstrated that the product and its ingredients are not injurious to users under the conditions of use prescribed on the label or under such conditions of use as are customary or usual. Minor and transient reactions or skin irritations will not necessarily be considered to render a product unsafe, though “minor and transient” is not currently defined.
Related to safety and safety substantiation, MoCRA requires FDA to develop a rule establishing and standardizing testing methods for detecting and identifying asbestos in talc-containing cosmetics products. The rule must be proposed by Dec. 29, 2023. FDA must also issue a report assessing the safety of the use of per- and polyfluoroalkyl substances (PFAS) in cosmetics by Dec. 29, 2025.
Labeling Requirements
By Dec. 29, 2023, all product labels on cosmetics for professional use must state that they are for use only by licensed professionals. By Dec. 29, 2024, all cosmetic product labels must include contact information through which the responsible person for the product can receive adverse event reports. Finally, FDA is required to develop a rule requiring fragrance allergens to be identified on product labels. The agency must issue a proposed rulemaking for that rule by Jun. 29, 2024. The final rulemaking must be issued 180 days after the proposed rulemaking’s public comment period closes.Good Manufacturing Practice (GMP) Requirements
Before the passage of MoCRA, GMP requirements for cosmetics products manufactured or processed in the U.S. had always been voluntary. MoCRA requires FDA to establish mandatory GMP requirements for manufacturers and processors. FDA must publish a proposed rule for GMP requirements by Dec. 29, 2024, and a final rule by Dec. 29, 2025. Whatever rule is proposed must be consistent with national and international standards to the extent practicable and appropriate and must ensure that cosmetic products are not adulterated. Any cosmetic product that is manufactured without following GMP regulations will be considered adulterated.Exemptions
Some small businesses will be excluded from MoCRA’s GMP, registration, and product listing requirements, but those exemptions will not apply to manufacturers or facilities that manufacture or process certain high-risk cosmetics products.These high-risk products include cosmetic products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use, cosmetic products that are injected, cosmetic products intended for internal use, and cosmetic products that are intended to alter consumers’ appearance for more than 24 hours under customary and usual conditions of use that are not customarily or usually removed by the consumer.
There will also be exemptions to MoCRA requirements for certain facilities and products that are subject to drug and medical device regulations, since those facilities and products are already subject to stringent safety standards.
'MoCRA preempts states from establishing requirements for cosmetics that differ from what is required by MoCRA; but states will still be permitted to limit or prohibit the use of ingredients in cosmetics, and to require compliance with preexisting state cosmetic product ingredient reporting requirements such as California’s Proposition 65.'
Increased Enforcement
In addition to the new requirements that MoCRA imposes on cosmetics facilities and products, MoCRA significantly expands the FDA’s regulatory authority and ability to enforce those requirements. When MoCRA goes into effect, under certain circumstances, FDA will have the authority to access and copy certain records related to cosmetic products, mandatory recall authority, and the authority to suspend a facility’s registration. Under MoCRA, if the agency has a reasonable belief that a cosmetic product or ingredient is likely to be adulterated such that the use of or exposure to the product presents a threat of serious adverse health consequences or death to humans, then FDA will—upon presentation of the appropriate credentials and written notice—have access to and copy all records related to the product or ingredient needed to assess the safety risk, within reasonable limits and acting in a reasonable manner.
If the agency determines that there is 1) a reasonable probability that the cosmetic is adulterated or misbranded and 2) the use of or exposure to the cosmetic will cause serious adverse health consequences or death, and 3) the responsible person refuses to voluntarily cease product distribution and recall the cosmetic, FDA will be permitted to order that such person immediately cease distribution of the product at issue.
In extreme cases, if FDA determines that a cosmetic product manufactured or processed by a registered facility and distributed in the U.S. has 1) a “reasonable probability of causing serious adverse health consequences or death to humans” and the agency 2) “has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility,” FDA may suspend a facility’s registration.
There are statutory provisions for challenging FDA enforcement decisions, such as the opportunity to seek a voluntary hearing regarding a recall no later than 10 business days after the date of issuance of the order, or the opportunity to participate in an informal hearing regarding a suspension no later than 5 business days after the issuance of the order.
Regardless of the methods companies have to push back, however, FDA’s expanded enforcement authority, when combined with the new statutory and regulatory requirements, will lead to added scrutiny of cosmetics companies related to their ingredients and claims.
MoCRA does not permit structure-function claims regarding skin health on cosmetic products, so between the additional scrutiny and the continued limitations on structure-function claims, we may expect FDA to issue more warning letters to cosmetics companies related to their advertising claims going forward.
We may also expect MoCRA to be followed by new state laws and regulations. MoCRA preempts states from establishing requirements for cosmetics that differ from what is required by MoCRA, but states will still be permitted to limit or prohibit the use of ingredients in cosmetics, and to require compliance with preexisting state cosmetic product ingredient reporting requirements such as California’s Proposition 65.
New York is already considering proposed legislation to ban certain cosmetics ingredients, including parabens and PFAs. The new state and federal requirements will likely lead to increased plaintiff challenges to cosmetic ingredients and claims.
What You Can Do
FDA is currently seeking public comments on its registration and listing electronic systems and on its draft guidance concerning registration and listing. Soon enough the agency will also be seeking comments on a proposed fragrance allergen rule and proposed GMP regulations.Comments already posted to regulations.gov include suggestions that the agency add further categories to its list of proposed cosmetics categories, suggestions related to clarifying the registration and listing process, requests for clarification of how to identify the “responsible party,” and much more.
The agency will be reading comments, and some may well be included in the agency’s final regulations implementing MoCRA. If you have feedback for the agency on any of these proposals, the comment period is your best chance to make your voice heard.
Additionally, cosmetics companies should begin preparing to implement MoCRA's requirements now. They can begin to prepare for facility registration and product listing by identifying which of their facilities may need to be registered. This should include preparing a list of the company’s cosmetic products, their ingredients, and when they were first marketed.
Companies should set up registration and listing policies and standard operating procedures, and develop reporting and compliance policies for updating product listing and notifying FDA of product changes and new products being marketed.
Companies can prepare for reporting and recordkeeping requirements by updating current adverse event reporting procedures, and by reviewing safety and toxicity claims along with support for those claims. Small businesses should examine whether or not they will be excluded from certain MoCRA requirements. It is also a good time for cosmetic companies to review current GMP practices and recall insurance coverage.
A new world in cosmetic product regulation is coming, and there is no time like the present to prepare.
About the Authors: Todd Harrison is Partner with Venable, which is located in Washington, D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on dietary supplement, functional food, biotech, legislative, adulteration, labeling and advertising issues. He can be reached at 575 7th St. NW, Washington, D.C. 20004, Tel: 202-344-4724; E-mail: taharrison@venable.com. Melanie English is an Associate at Venable's Food and Drug Law practice. Prior to joining Venable, she was an intern at the U.S. Department of Transportation (USDOT), where she reviewed and edited regulations for the Office of Regulation within the Office of the General Counsel. During law school, English was a staff editor on the New York University School of Law Moot Court Board. She was also a Venable summer associate.
