The United States “Modernization of Cosmetics Regulation Act” (MoCRA)

Our latest podcast is dedicated to the United States “Modernization of Cosmetics Regulation Act” (MoCRA), enacted on 29 December 2022. MoCRA is a meaningful reform, marking the most substantial change to the U.S. Cosmetics Regulation since 1938. It will definitely transform the cosmetics industry in the U.S.  Many obligations under MoCRA will come into force on 29 December 2023. For a clearer understanding of this major update to the U.S. Cosmetics Regulation, we discuss the main changes, new requirements, and deadlines for compliance. To learn more about this topic, stream our podcast now.

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Transcript

0:0:0.0 --> 0:1:19
 Lana Heurtault  Intertek
 Hello, everyone, and welcome to today’s podcast dedicated to the United States “Modernization of Cosmetics Regulation Act” (MoCRA), which was enacted on December 29th, 2022.

I am Lana Heurtault, from Intertek France, and I am with my colleague Heidi Reamer, from Intertek USA, who will answer some questions about this new U.S. Cosmetics Regulation law.

MoCRA is a meaningful reform, marking the most substantial change to the U.S. Cosmetics Regulation since 1938. It will definitely transform the cosmetics industry in the U.S. 

Many obligations under MoCRA will come into force on December 29th, 2023. For a clearer understanding of this major update to the U.S. Cosmetics Regulation, we’re going to discuss the main changes, new requirements, and deadlines for compliance.

To begin, can we talk about facility registrations and product listings, both of which will become mandatory under MoCRA? Who will be affected?

0:1:20--> 0:2:11
 Heidi Reamer  Intertek
 Of course. Any establishment that manufactures or processes finished cosmetic products that will be distributed in the U.S. is considered a “facility” under MoCRA. Facilities will have to register with the Food and Drug Administration (the FDA) even if they are not located in the U.S. 

Establishments that only perform labelling, packaging, holding, or distribution, as well as establishments that manufacture only cosmetic ingredients, are not considered “facilities” and are not affected by this new requirement. 

Regarding product listings, a responsible person will have to list each cosmetic product, including its ingredients, with the FDA. Multiple cosmetic products can be combined into a single, flexible listing if they have identical formulas or formulas that differ only by colour, fragrance, flavour, or quantity of contents.

0:2:12 --> 0:2:16
 Lana Heurtault  Intertek
 When will companies have to comply with MOCRA and how will they?

0:2:17 --> 02:57
 Heidi Reamer  Intertek
 Existing facilities will have to register their facility no later than December 29th, 2023. New facilities will have to register with the FDA within 60 days of initiating their manufacturing or processing operations. All facilities will need to renew their registrations biannually. 

Likewise, product listings for existing products must be submitted by the responsible person by December 29th, 2023. For new products, listings have to be submitted within 120 days of marketing. All product listings will need to be renewed annually.

The FDA will be opening new portals for facility registrations and product listings.

0:2:58 --> 0:3:04
 Lana Heurtault  Intertek
 You mentioned the “responsible person.” Who is the responsible person and what obligations do they have?

0:3:05 --> 0:4:24
 Heidi Reamer  Intertek
 Under MoCRA, the responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label. In addition to responsibilities related to product listings, the responsible person must collect any reports of health-related adverse events associated with the use of the cosmetic product and must maintain records for up to 6 years. Additionally, they must report to the FDA any serious adverse events associated with their cosmetic products within 15 days of learning about the issue. 

The responsible person must ensure the adequate safety substantiation of their cosmetic product and must maintain records of that substantiation. Substantiation in this context refers to tests, studies, research, analyses, and other evidence considered sufficient by qualified experts to demonstrate that the cosmetic product and its ingredients are not injurious to users under the conditions of use prescribed in the labelling or under typical conditions of use. 

Finally, by December 29th, 2024, the responsible person will be required to include—on the label of the cosmetic product—their domestic address, domestic telephone number, or electronic contact information in order to receive reports of adverse events.

0:4:25 --> 0:4:34
 Lana Heurtault  Intertek
 So, cosmetic labels will have to be updated under MoCRA, in addition to including the responsible person’s contact details. What else will be required?

0:4:35 --> 0:5:13
 Heidi Reamer  Intertek
 By December 29th, 2023, professional cosmetic product labels will have to include the same information that is currently required for cosmetic products intended for sale to consumers, plus a warning that only licensed professionals may use the product.

Additionally, fragrance allergens will have to be listed on the labels of cosmetic products. Pending rulemaking by FDA will determine which substances are considered fragrance allergens. 

The FDA will release a proposed fragrance allergen rule by the end of June 2024. The final publication of the law is expected within 180 days after the publication of the proposed regulation.

0:5:14 --> 0:5:21
 Lana Heurtault  Intertek
 I know that the FDA is required to implement a few actions linked to the MoCRA enactment. What are they?

0:5:22 --> 0:6:16
 Heidi Reamer  Intertek
 MoCRA requires the FDA to establish Good Manufacturing Practices (GMPs) consistent with national and international standards. Proposed GMP rules will be issued within 2 years of the enactment of MoCRA, so December 2024. The final GMP rule will be issued within 3 years after enactment, by December 2025. 

MoCRA requires the FDA to issue a public report no later than 3 years after the enactment of MoCRA to assess the use of perfluoralkyl and polyfluoralky substances (PFAS) in cosmetic products, and the scientific evidence regarding the safety of PFAS in these products.

The FDA will also have to issue regulations that establish, and require, standardized testing methods for detecting asbestos in talc-containing cosmetics. The proposed testing rule is expected in December 2023. The details of the content of this regulation are not yet known. 

06:17 --> 0:6:27
 Lana Heurtault  Intertek
 It seems that the FDA will have an important role to play under MoCRA. What will the FDA be allowed to do, for example, in terms of product recalls?

0:6:28 --> 0:7:21
 Heidi Reamer  Intertek
 The FDA may initiate a mandatory product recall if there is a reasonable probability that a cosmetic product is adulterated or misbranded or if the use or exposure to that product may cause serious adverse events.    

The FDA will have the authority to access certain company records related to a cosmetic product, including documentation of safety substantiation. 

The FDA will also be authorized to suspend a facility registration if the Agency determines that a cosmetic product manufactured by that facility has a reasonable probability of causing serious adverse health consequences. 

MoCRA will allow the FDA to inspect facilities and audit certain records deemed necessary to determine compliance with GMP.

So, although the FDA will not approve cosmetic products or their ingredients, with the enactment of the MoCRA, they will have more authority over cosmetics. 

0:07:22 --> 0:7:53
 Lana Heurtault  Intertek
 Thank you very much, Heidi, for your detailed insight about this new regulation. 

Although we are still waiting for some publications and more details surrounding MoCRA, companies can start preparing for compliance with this regulation now, and Intertek can support you in these efforts. From product listings to safety substantiation and labelling updates, our team of experts is standing by to help. 

This concludes today’s podcast. Thank you for listening and see you soon!