MoCRA in Motion: Current Recap, New Draft Guidance, and What’s Coming Next Artwork

Intertek's Assurance in Action Podcast Network

Welcome to the Intertek Podcast Network, Assurance in Action, your hub for quality insights and information from our Intertek experts. Learn what our people are saying about important industry trends ranging from food safety standards to supplier management and everything in between! With new and recurring guests, we are poised to provide you the knowledge needed to enhance your business processes, operations, and safety.

All Episodes

Intertek's Assurance in Action Podcast Network

MoCRA in Motion: Current Recap, New Draft Guidance, and What’s Coming Next

January 29, 2026 • Intertek Assuris • Season 9

A major shift is reshaping the U.S. cosmetics industry. In the latest episode of Assurance in Action, we dive into the Modernization of Cosmetics Regulation Act (MoCRA) and what it means for brands, manufacturers, importers, and distributors.

Joined by Intertek Assuris experts Ashli and Alexandra, we unpack the key requirements, risks, and opportunities to help you understand requirements and maintain compliance.

Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris
Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

00:19 --> 00:57
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Hey everyone, and welcome back to the Assurance in Action podcast. Today we’re diving into one of the biggest regulatory shifts the U.S. cosmetics industry has seen in decades , the Modernization of Cosmetics Regulation Act of 2022, or MoCRA. If you make, import, distribute, or label cosmetics for the U.S. market, this law touches you in some way.

I’m joined by Alexandra, who has extensive experience in toxicology and navigating safety, regulatory, and compliance requirements. Alexandra, thanks for being here.

00:57 --> 01:05
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

Thanks, Ashli! I’m excited to be here. MoCRA is a big topic, and an important one, so I’m glad we’re taking the time to break it down.

01:05 --> 01:36
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

And that’s exactly the goal today, practical clarity. We’ll start with what MoCRA is and why it matters, walk through the key requirements, and then wrap up with the new FDA draft guidance on records access that just came out. So let’s start at the top.

So, as I understand it, MoCRA isn’t totally new to the scene as it was signed into law at the end of 2022, but we’re still seeing companies scramble. Why is this such a landmark change?

01:36 --> 02:07
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

Because it’s the most significant update to U.S. cosmetic regulation since 1938. For decades, cosmetics were largely self-regulated compared to drugs or food. MoCRA fundamentally changes that by giving FDA new authority, mandatory facility registration, mandatory product listing, access to records, mandatory adverse event reporting, and eventually enforceable GMPs.

02:07 --> 02:16
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Ok, so this isn’t just more paperwork, it’s a shift in how FDA oversees cosmetics?

02:16 --> 02:33
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

Exactly. FDA now has recall authority, facility suspension authority, and expanded inspection powers. That alone changes the risk profile for companies that haven’t historically interacted much with FDA.

02:33 --> 02:43
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

And one detail people sometimes overlook is that FDA itself reorganized. Why does that matter?

02:43 --> 03:03
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

The Office of Cosmetics and Colors moved under the Office of the Chief Scientist. That’s a signal that FDA is treating cosmetics more like a science-driven, risk-based regulatory area, similar to food and drugs. It also centralizes MoCRA implementation, which means more consistency, but also more scrutiny.

03:03 --> 03:12
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

So companies should expect inspections and enforcement to feel more formal than in the past.

03:12 --> 03:13
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

Absolutely.

03:13 --> 03:28
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Let’s talk definitions, because MoCRA hinges on a few very specific ones. Let’s start with who is the “responsible person.”

03:28 --> 03:48
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

The responsible person, or RP, is the manufacturer, packer, or distributor whose name appears on the product label. This is the entity FDA holds accountable, for listing, safety substantiation, adverse event reporting, and records retention.

03:48 --> 03:51
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

And what about facilities?

03:51 --> 04:11
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

A facility is any establishment that manufactures or processes cosmetic products for U.S. distribution. That includes foreign facilities and importers’ establishments, but it excludes retailers and salons that don’t manufacture or process products.

04:11 --> 04:19
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

It sounds to me like that definition alone pulls a lot of contract manufacturers into scope.

04:19 --> 04:25
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

It does, especially those who previously thought the brand owner handled everything.

04:25 --> 04:36
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

What about small business exemptions, it seems those have caused a lot of confusion. Can you clarify or provide any insights?

04:36 --> 05:01
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

Small businesses may be exempt from facility registration and GMP requirements if they average under $1 million in U.S. cosmetic sales over three years, but that exemption disappears if they make certain higher-risk products, like eye-area cosmetics, injected products, or products intended to alter appearance for more than 24 hours.

05:01 --> 05:07
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Oh ok, so even though they may not be a huge company, they’re still not exempt from everything.

05:07 --> 05:18
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

Correct. Even small businesses must comply with adverse event reporting, safety substantiation, and labeling requirements. I am sure we will touch a bit more on safety substantiation later.

05:18 --> 05:25
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Now, let’s get practical. Facility registration, what’s required of the facilities?

05:25 --> 05:44
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

Every facility that manufactures or processes cosmetics for the U.S. must register through FDA’s Cosmetics Direct portal. You’ll need an FDA Establishment Identifier, or FEI number, first. That number becomes the backbone for both facility registration and product listing.

05:44 --> 05:52
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Ok, so once they have an FEI, is the registration one-and-done or are there additional requirements?

05:52 --> 06:01
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

No, they are not just one-and-done. Facilities must renew every two years and update FDA within 60 days of changes.

06:01 --> 06:08
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Got it. So if the product listing is on the responsible person. What does FDA expect?

06:08 --> 06:27
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

Each cosmetic product must be listed with ingredient information exactly as it appears on the label. FDA allows grouping for products with identical formulas or formulas that differ only by color, fragrance, or flavor, which is a huge efficiency if used correctly.

06:27 --> 06:34
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

And now with MoCRA is the Voluntary Cosmetic Registration Program officially out.

06:34 --> 06:47
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

Yes, MoCRA replaces it entirely and the FDA is no longer accepting VCRP submissions and will not transfer old data, requiring all companies to re-register through the new system.

06:47 --> 06:52
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Understood – and labeling changes are another big area with MoCRA, right?

06:52 --> 07:09
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

Yes, products must now include a domestic address, phone number, or electronic contact to receive adverse event reports. And fragrance allergen labeling is coming, FDA is aligning more closely with EU and UK approaches, though we’re still waiting on final implementation timelines.

07:09 --> 07:15
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

So, what I’m hearing is companies should start evaluating formulations now if they haven’t already.

07:15 --> 07:19
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

Definitely, waiting until enforcement begins will be painful.

07:19 --> 07:29
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Always better to be ahead of the curve. But I understand it is the adverse events that are where MoCRA’s teeth really show.

07:29 --> 07:48
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

Responsible persons must keep adverse event records for six years, three for qualifying small businesses, and serious adverse events must be reported to FDA within 15 days. Safety substantiation is also mandatory. If you don’t have it, the product is considered adulterated.

07:48 --> 07:55
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

And would an SDS be sufficient or do SDSs alone not cut it?

07:55 --> 09:38
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

Correct, and this is one of the biggest misunderstandings we still see. A Safety Data Sheet is designed for occupational safety and hazard communication, not for consumer safety under intended cosmetic use. FDA has been very clear that an SDS, by itself, is not considered adequate safety substantiation under MoCRA.

What FDA expects instead is scientific justification that shows a reasonable certainty of safety for the finished cosmetic product as it’s actually used by consumers. That typically means toxicological assessments of the ingredients, an evaluation of exposure, things like how much product is used, how often, whether it’s rinse-off or leave-on, and a consideration of vulnerable populations if applicable.

For some products, that may involve reviewing existing toxicology data, published literature, and regulatory precedents. For others, it may require a formal cosmetic safety assessment conducted by a qualified expert. The key point is that the safety substantiation has to be defensible, documented, and specific to the product, not just a collection of supplier documents, which we see often.

And importantly, those records must be maintained and made available to FDA if they request them. If FDA has a reasonable belief that a product is adulterated and you can’t produce that safety rationale, that’s where companies can quickly find themselves exposed from an enforcement perspective.

09:38 --> 10:00
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Ok, so now that you’ve brought me up to speed on what we already know about MoCRA, let’s touch on the new draft guidance FDA just released on records access. What should companies know, and what does this guidance help businesses understand?

10:00 --> 11:03
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

This draft guidance signals FDA’s current thinking on how it intends to exercise its authority to access records under MoCRA. It’s important to remember that this is still a draft document and should be closely monitored as it evolves, but its release gives brands valuable time to prepare for potential changes.

The guidance covers FDA access to records such as adverse event records, records related to serious adverse health threats, which are distinct from standard adverse event reports, and certain records FDA may request or review during inspections, including facility inspections of manufacturers and processors.

The guidance also lays out expectations around record retention, how confidential information is handled, and clarifies the potential implications if companies do not provide required records to FDA upon request.

11:03 --> 11:17
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

So, FDA is essentially telling industry, “Here’s how we plan to use the authorities granted to us under MoCRA,” while giving businesses a clearer sense of what to expect?

11:17 --> 11:42
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

Exactly. It’s about transparency and predictability. And importantly, FDA is actively asking for comments. This gives companies and industry associations an opportunity to weigh in on what’s practical, what may be challenging for the industry, and how the final guidance can be implemented in a workable and realistic way.

11:42 --> 11:54
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Ok, so not only is it a guidance but a way for those affected by MoCRA to have an input as well – not like the parental “just because I said so”, but it provides them a way to give some input too.

11:54 --> 11:58
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

Yeah, that is one way you can look at it.

11:58 --> 12:25
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Great—thanks for helping make that clear for our listeners. Now, to wrap things up with what’s coming next under MoCRA, I want to touch on a few areas where there’s been some confusion. Labeling changes and fragrance allergens, in particular, seem to keep shifting, and we’ve heard a lot of different dates over the past year. So where do things actually stand now?

12:25 --> 13:15
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

You’re right, the timeline has moved. FDA announced in September that they now expect to release the fragrance allergen regulation in May 2026. Originally, the statutory deadline pointed to June 2024, so this is a meaningful delay.

What’s important for companies to understand, though, is that a delay doesn’t mean the requirement is going away. FDA has been very clear that fragrance allergen disclosure remains a core MoCRA requirement, and this will be inline with other parts of the world. The additional time appears to be about aligning the rule with scientific data, international approaches like the EU and UK allergen frameworks, and the practical realities of implementation.

13:15 -->13:28
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

So, this isn’t a situation where the FDA is backing off, it’s more or less taking more time than was originally anticipated to ensure they are getting it right?

13:28 --> 13:54
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

Exactly. And companies shouldn’t treat this as a pause button. This is actually a valuable window to start evaluating fragrance compositions, working with suppliers on allergen transparency, and understanding what potential label changes could look like down the road. Waiting until the rule is finalized will put companies in a very reactive position.

13:54 --> 14:05
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

And what about GMPs? I hear there is even less clarity there. What comments can you make on that guidance?

14:05 --> 14:49
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

That’s because FDA has not provided an update on when GMP guidance will be released. We know GMP requirements are coming, they’re explicitly written into MoCRA, but there’s currently no revised timeline or draft guidance available.

From a risk standpoint, that uncertainty makes preparation more important, not less. FDA has stated that cosmetic GMPs will align with national and international standards, so companies that already have documented quality systems, clear procedures, training, and inspection readiness will be far better positioned when those requirements are finalized.

14:49 --> 15:03
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

So again, the delay can be seen more as a time of opportunity for businesses to start getting their ducks in a row and not as much of a “wait and see” situation.

15:03 --> 15:22
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

Correct, “wait and see” is not the best approach. This is the phase where proactive companies can significantly reduce future compliance risk and be ahead of the curve instead of scrambling once enforcement begins, which we all know happens. We want to avoid that!

15:22 --> 15:40
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

So, my final thought before we close and the key takeaway is that MoCRA is still evolving. Between upcoming guidance, future rulemaking, and continued clarification from FDA, this is not a one-and-done compliance effort.

15:40 --> 16:07
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

Exactly. This is an ongoing journey. We’re actively tracking new guidances, implementation updates, enforcement trends, and the nuances that come with how FDA applies MoCRA in practice. As things evolve, we’ll continue to break them down in a practical way so companies can understand not just what is changing, but what it actually means for their day-to-day operations.

16:07 --> 16:23
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Yes, and we will continue sharing those insights, with you, our listeners, through future podcasts like this one, webinars, and other educational sessions, so you can stay informed without having to decipher everything on your own.

16:23 --> 16:49
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

And of course, if questions come up that are specific to your products, your facilities, or your role as a responsible person, you can always reach out to our team directly. Having those conversations early can make a huge difference in reducing risk and avoiding surprises. You can think of us as your MoCRA translators… minus the confusing footnotes.

16:49 --> 16:59
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Perfect note to end on. Alexandra, thank you so much for walking me through MoCRA and being my translator for today

17:00 --> 17:03
Speaker 2 – Alexandra Minich, Toxicologist, Program Manager, Regulatory Market Access, Intertek Assuris

My pleasure, thank you for having me.

17:03 --> 17:18
Speaker 1 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

And thanks to everyone listening and remember if MoCRA feels like a lot, you’re not alone, but the good news is, you don’t have to navigate it solo. We’ll keep tracking the updates, translating the guidance, and turning regulatory chaos into something manageable.

Thanks everyone!