Daniel T. McKillop
Partner
201-896-7115 dmckillop@sh-law.comHow the Cosmetics Industry Should Prepare for Increased FDA Oversight Under MOCRA
Author: Daniel T. McKillop|February 10, 2023
The Modernization of Cosmetics Regulation Act of 2022 (MOCRA) overhauls the U.S. Food and Drug Administration’s (FDA) regulatory framework for cosmetics and expands its oversight over the industry...
How the Cosmetics Industry Should Prepare for Increased FDA Oversight Under MOCRA
The Modernization of Cosmetics Regulation Act of 2022 (MOCRA) overhauls the U.S. Food and Drug Administration’s (FDA) regulatory framework for cosmetics and expands its oversight over the industry...
The Modernization of Cosmetics Regulation Act of 2022 (MOCRA) overhauls the U.S. Food and Drug Administration’s (FDA) regulatory framework for cosmetics and expands its oversight over the industry...
The Modernization of Cosmetics Regulation Act of 2022 (MOCRA) overhauls the U.S. Food and Drug Administration’s (FDA) regulatory framework for cosmetics and expands its oversight over the industry. The sweeping legal changes will not only impact traditional cosmetics companies, but also the growing cannabis cosmetics market.
New MOCRA Requirements for Cosmetics Companies
MOCRA amends Chapter VI of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and represents the first major update to cosmetics regulations since 1938. Congress enacted the new law on December 29, 2022, as part of the Omnibus Appropriations Act.
The cosmetics industry has grown significantly over the past several decades. Under the FD&C Act, cosmetics are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” The definition includes skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, tanning lotions, and deodorants, as well as any substance intended for use as a component of a cosmetic product.
Overall, MOCRA aims to align FDA oversight over the cosmetics industry with other industries under the agency’s purview. Its new regulatory requirements cover areas ranging from product manufacturing to labeling to safety. Below is a brief overview of several key provisions:
Facility Registration and Renewal
MOCRA requires cosmetic product manufacturing facilities to register with the FDA. The law specifically provides that “[e]very person that, on the date of enactment of the MCRA, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States shall register each facility with the Secretary…”
The term “facility” includes “…any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.” Facilities that solely perform labeling, relabeling, packaging, repackaging, holding, and/or distributing cosmetic products are not required to register. However, if facilities that perform “packaging” and “repackaging” fill product containers with a cosmetic product, they are required to register.
Existing facilities must register with the FDA within one year of enactment; meanwhile, new facilities that manufacture or process cosmetic products for distribution in the U.S. after the enactment date must register within 60 days of marketing a product or 60 days after the deadline for registration, whichever is later. Existing registrations must be renewed every other year.
Product Listing
Under MOCRA, responsible persons, which are defined as the “manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product,” must list each cosmetic product with the FDA. Each listing must include the product ingredients and information about where the cosmetic product is manufactured.
Responsible persons must submit existing product listings no later than one year after enactment. Going forward, new products marketed after the enactment date must be listed within 120 days of marketing. Companies must annually renew product listings with any updates.
Good Manufacturing Practices
MOCRA requires the FDA to establish good manufacturing practices for cosmetic manufacturing facilities that are consistent, to the extent practicable and appropriate, with national and international standards. The agency must issue a proposed rule within two years of enactment, and a final rule within three years of enactment. In establishing the regulations, MOCRA directs the FDA to “take into account the size and scope of the businesses engaged in the manufacture of cosmetics, and the risks to public health posed by such cosmetics, and provide sufficient flexibility to be practicable for all sizes and types of facilities to which such regulations will apply.”
Labeling Requirements
Product labels must be updated to include a domestic address, domestic phone number, or electronic contact information where a responsible person can receive adverse event reports. Professional cosmetics products must also state that only licensed professionals may use the product. New labeling requirements will take effect two years after the date of enactment.
MOCRA also requires the FDA establish new regulations under which fragrance allergens must be disclosed on a cosmetic product’s label. The FDA must issue a proposed rule within 18 months after the date of the enactment, with the final ruling issued no later than 180 days after the public comment period ends.
Safety Substantiation
MOCRA mandates that companies maintain records supporting adequate safety substantiation for their cosmetic products. The term “adequate substantiation of safety” is defined to mean “…tests or studies, research, analyses or other evidence or information that is considered, among [qualified experts], to be sufficient to support a reasonable certainty that a cosmetic product is safe.”
Enforcement and Mandatory Recalls
MOCRA provides the FDA with several new enforcement tools. Should the FDA determine that a cosmetic product has a reasonable probability of causing serious adverse health consequences or death to humans, and other products manufactured by the facility may be similarly affected, the FDA may suspend the facility’s registration.
The FDA is authorized to mandate recalls if it determines there is a reasonable probability that a cosmetic is adulterated or misbranded and exposure to the product will cause serious adverse health consequences or death. MOCRA also authorizes the FDA to request a written list of all ingredients in a cosmetic product’s fragrances or flavors if it believes an ingredient or combination of ingredients has caused serious adverse events. The ingredients list must be provided within 30 days of FDA’s request.
Adverse Event Reports
Under MOCRA, responsible persons must submit to the FDA any report received of a serious adverse event associated with the use, in the United States, of a cosmetic product manufactured, packed, or distributed by such person. The adverse event report must be accompanied by a copy of the label on or within the retail packaging of the cosmetic product and must be submitted to the FDA no later than 15 business days after the report is received.
Additionally, if a responsible person receives new and material medical information related to the report within one year of the initial report, it must submit the information to FDA within five business days of receiving it. Adverse event records must be maintained for six years, unless a small business exception applies.
Small Business Exemption
MOCRA provides certain exemptions to small businesses, which are defined as those with average gross annual sales for the previous three-year period totaling less than $1,000,000. Small business exemptions, however, are not available to any responsible person or facility engaged in manufacturing cosmetic products that regularly come into contact with eye, are injected, that are intended for internal use, or that alter the appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer.
Impact on the Cannabis Industry
As we have discussed in prior articles, the 2018 Farm Bill legalized hemp derivatives, such as CBD, that contain less than 0.3% THC. Congress left it up to the states to establish their own regulatory schemes governing the growth, processing, and distribution of hemp and hemp-derived products. To date, the FDA has treated cannabis and cannabis-derived compounds under the FD&C Act as it would any other compound found in cosmetics.
MOCRA may shift the regulatory landscape as it contains provisions preempting state laws with respect to facility registration, product listing, good manufacturing practices, record keeping, recalls, adverse event reporting, and safety substantiation. This means that cannabis companies must comply with MOCRA, as well as the FDA’s implementing regulations, rather than existing state laws in these areas.
For the cannabis cosmetics market, the impact of MOCRA may be both positive and negative. The safety substantiation requirement will allow cannabis companies to inform to consumers that their CBD cosmetic products have been tested for safety. On the other hand, companies will have to expressly inform the FDA that its products contain cannabinoids, which could open them up to increased scrutiny, particularly should the FDA believe that companies are marketing the products as “drugs” rather than cosmetics by making therapeutic or disease claims. Given that it is unclear how state and FDA regulations may change in the wake of MOCRA, the cannabis industry should stay on top of legal updates.
Next Steps for Cosmetics Companies
MOCRA is scheduled to take effect on December 29, 2023, although the FDA must enact new rules to implement several key provisions. We encourage cosmetic companies and other entities potentially impacted by MOCRA to become familiar with its requirements and monitor the FDA rulemaking process. In light of the complexity of the new regulatory framework, it is certainly advantageous to consult with experienced legal counsel. Relying on the experience of attorneys from our Cannabis, Business, and Regulatory Compliance teams, Scarinci Hollenbeck is uniquely positioned to help cosmetics companies, including those in the cannabis industry, meet their new obligations.
If you have questions, please contact us
If you have any questions or if you would like to discuss the matter further, please contact Dan McKillop, or the Scarinci Hollenbeck attorney with whom you work, at 201-896-4100.
How the Cosmetics Industry Should Prepare for Increased FDA Oversight Under MOCRA
Author: Daniel T. McKillop
The Modernization of Cosmetics Regulation Act of 2022 (MOCRA) overhauls the U.S. Food and Drug Administration’s (FDA) regulatory framework for cosmetics and expands its oversight over the industry...
The Modernization of Cosmetics Regulation Act of 2022 (MOCRA) overhauls the U.S. Food and Drug Administration’s (FDA) regulatory framework for cosmetics and expands its oversight over the industry. The sweeping legal changes will not only impact traditional cosmetics companies, but also the growing cannabis cosmetics market.
New MOCRA Requirements for Cosmetics Companies
MOCRA amends Chapter VI of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and represents the first major update to cosmetics regulations since 1938. Congress enacted the new law on December 29, 2022, as part of the Omnibus Appropriations Act.
The cosmetics industry has grown significantly over the past several decades. Under the FD&C Act, cosmetics are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” The definition includes skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, tanning lotions, and deodorants, as well as any substance intended for use as a component of a cosmetic product.
Overall, MOCRA aims to align FDA oversight over the cosmetics industry with other industries under the agency’s purview. Its new regulatory requirements cover areas ranging from product manufacturing to labeling to safety. Below is a brief overview of several key provisions:
Facility Registration and Renewal
MOCRA requires cosmetic product manufacturing facilities to register with the FDA. The law specifically provides that “[e]very person that, on the date of enactment of the MCRA, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States shall register each facility with the Secretary…”
The term “facility” includes “…any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.” Facilities that solely perform labeling, relabeling, packaging, repackaging, holding, and/or distributing cosmetic products are not required to register. However, if facilities that perform “packaging” and “repackaging” fill product containers with a cosmetic product, they are required to register.
Existing facilities must register with the FDA within one year of enactment; meanwhile, new facilities that manufacture or process cosmetic products for distribution in the U.S. after the enactment date must register within 60 days of marketing a product or 60 days after the deadline for registration, whichever is later. Existing registrations must be renewed every other year.
Product Listing
Under MOCRA, responsible persons, which are defined as the “manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product,” must list each cosmetic product with the FDA. Each listing must include the product ingredients and information about where the cosmetic product is manufactured.
Responsible persons must submit existing product listings no later than one year after enactment. Going forward, new products marketed after the enactment date must be listed within 120 days of marketing. Companies must annually renew product listings with any updates.
Good Manufacturing Practices
MOCRA requires the FDA to establish good manufacturing practices for cosmetic manufacturing facilities that are consistent, to the extent practicable and appropriate, with national and international standards. The agency must issue a proposed rule within two years of enactment, and a final rule within three years of enactment. In establishing the regulations, MOCRA directs the FDA to “take into account the size and scope of the businesses engaged in the manufacture of cosmetics, and the risks to public health posed by such cosmetics, and provide sufficient flexibility to be practicable for all sizes and types of facilities to which such regulations will apply.”
Labeling Requirements
Product labels must be updated to include a domestic address, domestic phone number, or electronic contact information where a responsible person can receive adverse event reports. Professional cosmetics products must also state that only licensed professionals may use the product. New labeling requirements will take effect two years after the date of enactment.
MOCRA also requires the FDA establish new regulations under which fragrance allergens must be disclosed on a cosmetic product’s label. The FDA must issue a proposed rule within 18 months after the date of the enactment, with the final ruling issued no later than 180 days after the public comment period ends.
Safety Substantiation
MOCRA mandates that companies maintain records supporting adequate safety substantiation for their cosmetic products. The term “adequate substantiation of safety” is defined to mean “…tests or studies, research, analyses or other evidence or information that is considered, among [qualified experts], to be sufficient to support a reasonable certainty that a cosmetic product is safe.”
Enforcement and Mandatory Recalls
MOCRA provides the FDA with several new enforcement tools. Should the FDA determine that a cosmetic product has a reasonable probability of causing serious adverse health consequences or death to humans, and other products manufactured by the facility may be similarly affected, the FDA may suspend the facility’s registration.
The FDA is authorized to mandate recalls if it determines there is a reasonable probability that a cosmetic is adulterated or misbranded and exposure to the product will cause serious adverse health consequences or death. MOCRA also authorizes the FDA to request a written list of all ingredients in a cosmetic product’s fragrances or flavors if it believes an ingredient or combination of ingredients has caused serious adverse events. The ingredients list must be provided within 30 days of FDA’s request.
Adverse Event Reports
Under MOCRA, responsible persons must submit to the FDA any report received of a serious adverse event associated with the use, in the United States, of a cosmetic product manufactured, packed, or distributed by such person. The adverse event report must be accompanied by a copy of the label on or within the retail packaging of the cosmetic product and must be submitted to the FDA no later than 15 business days after the report is received.
Additionally, if a responsible person receives new and material medical information related to the report within one year of the initial report, it must submit the information to FDA within five business days of receiving it. Adverse event records must be maintained for six years, unless a small business exception applies.
Small Business Exemption
MOCRA provides certain exemptions to small businesses, which are defined as those with average gross annual sales for the previous three-year period totaling less than $1,000,000. Small business exemptions, however, are not available to any responsible person or facility engaged in manufacturing cosmetic products that regularly come into contact with eye, are injected, that are intended for internal use, or that alter the appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer.
Impact on the Cannabis Industry
As we have discussed in prior articles, the 2018 Farm Bill legalized hemp derivatives, such as CBD, that contain less than 0.3% THC. Congress left it up to the states to establish their own regulatory schemes governing the growth, processing, and distribution of hemp and hemp-derived products. To date, the FDA has treated cannabis and cannabis-derived compounds under the FD&C Act as it would any other compound found in cosmetics.
MOCRA may shift the regulatory landscape as it contains provisions preempting state laws with respect to facility registration, product listing, good manufacturing practices, record keeping, recalls, adverse event reporting, and safety substantiation. This means that cannabis companies must comply with MOCRA, as well as the FDA’s implementing regulations, rather than existing state laws in these areas.
For the cannabis cosmetics market, the impact of MOCRA may be both positive and negative. The safety substantiation requirement will allow cannabis companies to inform to consumers that their CBD cosmetic products have been tested for safety. On the other hand, companies will have to expressly inform the FDA that its products contain cannabinoids, which could open them up to increased scrutiny, particularly should the FDA believe that companies are marketing the products as “drugs” rather than cosmetics by making therapeutic or disease claims. Given that it is unclear how state and FDA regulations may change in the wake of MOCRA, the cannabis industry should stay on top of legal updates.
Next Steps for Cosmetics Companies
MOCRA is scheduled to take effect on December 29, 2023, although the FDA must enact new rules to implement several key provisions. We encourage cosmetic companies and other entities potentially impacted by MOCRA to become familiar with its requirements and monitor the FDA rulemaking process. In light of the complexity of the new regulatory framework, it is certainly advantageous to consult with experienced legal counsel. Relying on the experience of attorneys from our Cannabis, Business, and Regulatory Compliance teams, Scarinci Hollenbeck is uniquely positioned to help cosmetics companies, including those in the cannabis industry, meet their new obligations.
If you have questions, please contact us
If you have any questions or if you would like to discuss the matter further, please contact Dan McKillop, or the Scarinci Hollenbeck attorney with whom you work, at 201-896-4100.
