Listen to the 1st episode of our Assurance in Action 3-part podcast series on Cosmetic Regulations in the United States. Our latest podcast is dedicated to the updates to the United States “Modernization of Cosmetics Regulation Act” (MoCRA). 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 the regulation, stream our podcast now.
Follow us on- Intertek's Assurance In Action || Twitter || LinkedIn.
Listen to the 1st episode of our Assurance in Action 3-part podcast series on Cosmetic Regulations in the United States. Our latest podcast is dedicated to the updates to the United States “Modernization of Cosmetics Regulation Act” (MoCRA). 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 the regulation, stream our podcast now.
Follow us on- Intertek's Assurance In Action || Twitter || LinkedIn.
00:17 --> 00:43
Speaker 1
Welcome to Intertek’s Assurance in Action podcast!
My name is Rachel Mezza, Project and Quality Manager with Intertek’s US Home & Personal Care group, and I’ll be your host for this episode.
Today, I am sitting with Heidi Reamer, Manager of Toxicology on our team. We will discuss updates on the “Modernization of Cosmetics Regulation Act” otherwise known as “MoCRA”.
00:43 --> 00:45
Speaker 2
Thank you for having me, Rachel!
00:45 --> 01:09
Speaker 1
Welcome Heidi!
So, we know that MoCRA was the first major change to US cosmetics regulations since 1938. Under the regulation, cosmetics companies must meet new requirements for reporting, labelling, and more.
I heard that the deadline for meeting these requirements was pushed from December 2023 to July 2024. Is that true?
01:09 --> 01:26
Speaker 2
Well, it’s partly true. The compliance deadline for only the facility registration and product listing requirements was pushed to July 1st 2024.
01:26 --> 01:27
Speaker 1
Okay, can you tell me more about facility registration?
01:27 --> 02:25
Speaker 2
Sure! Facilities that manufacture or process cosmetics products that are sold in the US must register with the FDA.
We’ve learned that facilities will first need to request an FDA Establishment Identifier (or FEI). Once they have their FEI number, they can register with the FDA as a cosmetics facility.
I should mention that some companies may already have an FEI number, for example if they manufacture over-the-counter drugs. In these cases, there is no need to request an additional FEI number. The existing one can be used.
The FDA has already opened an electronic submission portal, called Cosmetics Direct, that is used for facility registration. Facilities have until July 1st to register and will need to renew their registration every two years. If any changes to the registration occur, the facility will have 60 days to update their registration.
Intertek can request FEI numbers and complete facility registrations on behalf of cosmetics facilities.
02:25 --> 02:31
Speaker 1
So, what type of information is included in the Facility Registration?
02:31 --> 02:52
Speaker 2
Registration information includes:
• The facility’s name and contact information;
• The name of the facility’s owner and/or operator;
• A list of brand names of the cosmetics products that are manufactured or processed at the facility; and
• The product categories and responsible person for each cosmetics product manufactured at the facility.
02:52 --> 02:59
Speaker 1
What about facilities located outside of the US? Do these requirements also apply to them?
02:59 --> 03:24
Speaker 2
Yes, if a facility manufactures cosmetics that are sold into the US, then they must obtain an FEI number and register with the FDA as a cosmetics facility.
Additionally, facilities located outside of the US are required to have a US Agent. The US Agent can be a person or business physically located in the US, like Intertek, that is able to interface with the FDA.
03:24 --> 03:31
Speaker 1
Thank you for clarifying, Heidi.
You also mentioned product listings. Can you tell me more about those?
03:31 --> 04:04
Speaker 2
Definitely.
The Responsible Person must list each of their cosmetics products with the FDA. Under MoCRA, “Responsible Person” means the manufacturer, packer, or distributor of a cosmetics product whose name appears on the product label. So, in other words, the brand.
Product Listings are submitted through the Cosmetics Direct portal. Responsible Persons have until July 1st to list their products and will need to renew the listings annually. This is also something that Intertek can help with.
04:04 --> 04:10
Speaker 1
And what is included in the Product Listing? What information will brands have to provide?
04:10 --> 04:37
Speaker 2
Sure, a Product Listing includes:
• The name and contact information of the Responsible Person/Brand.
• The name of the cosmetics product and the cosmetics category that the product falls into; and
• A list of ingredients
o Though note that the listing does not require the percentage of each ingredient—just the list of ingredients.
It also includes the FEI number of each facility where the product is manufactured or processed.
04:37 --> 04:46
Speaker 1
That’s interesting. What if a brand doesn’t manufacture their own products. For example, if they use a contract manufacturer. How would that work?
04:46 --> 05:21
Speaker 2
The Responsible Person will need to obtain the FEI number from each contract manufacturer that manufacturers or processes their product for them.
In fact, the Responsible Person’s name, the product categories, and the FEI number must match exactly between the Facility Registration and Product Listing. The Responsible Person and the Facility will need to coordinate to make sure this information is consistent between them.
The FDA released a helpful Guidance for Industry document, called Registration and Listing of Cosmetic Product Facilities and Products, which is available on the FDA website.
05:21 --> 05:34
Speaker 1
Thanks for that Heidi.
You said that it was only partly true that that the deadline for compliance was pushed from December 2023 to July 2024. What do you mean by that?
05:34 --> 05:45
Speaker 2
Ah, yes. What I meant was, while the product listing and facility registration compliance deadlines were pushed to July, other MoCRA requirements are already in force.
05:45 --> 05:48
Speaker 1
Ah, I see. And which requirements do you mean?
05:48 --> 07:00
Speaker 2
There are several.
The first to mention is Adverse Event record keeping and reporting. Responsible Persons must retain records for up to six years following any adverse event associated with their product. They must also report any serious adverse event associated with their product to the FDA within 15 business days. This can be done through the FDA’s MedWatch 3500A Form.
Secondly, Responsible Persons must already be ensuring that their cosmetic product and the ingredients in the product are safe. There is no one-size-fits all approach to safety substantiation, but it may include research or tests on individual ingredients and/or the whole product. Importantly, the Responsible Person must keep records showing that the safety of their product was substantiated. We will cover this topic in more detail in our next cosmetics podcast.
Lastly, there is also a labelling change that has already come into force. Professional cosmetics product labels must have the same information that is required for cosmetics products intended for sale to general consumers, in addition to a warning that only licensed professionals may use the product.
07:00 --> 07:03
Speaker 1
Got it. Thank you, Heidi, for clarifying.
07:03 --> 07:29
Speaker 2
Of course.
There is an upcoming labelling change that should be considered as well. By December 29, 2024, Responsible Persons will be required to include a domestic address, domestic telephone number, or electronic contact on the product label that is used to receive adverse event reports. If a website is used, it should link to a specific adverse event reporting page, not a generic site.
07:29 --> 07:44
Speaker 1
Wow, it sounds like cosmetics and personal care companies might have their hands full under MoCRA: potential label changes, adverse event record keeping, facility and product listings, and safety substantiation.
07:44 --> 07:59
Speaker 2
Yes, there are certainly many obligations for companies to meet. But Intertek can support companies with all aspects of MoCRA compliance. We are here to help!
Our next podcast will go more in depth into Safety Substantiation and what it means under MoCRA.
07:59 --> 08:05
Speaker 1
Looking forward to it!
Thank you, Heidi, for all the insight on MoCRA compliance.
08:05 --> 08:08
Speaker 2
It’s my pleasure. Thank you for having me, Rachel!