In December last year, President Joe Biden signed the Modernization of Cosmetics Regulation Act (MoCRA), the most significant expansion of the United States Food and Drug Administration’s oversight of cosmetics in over 80 years, into law. It gives the FDA recall authority and mandates beauty companies list products and register facilities with the agency, adhere to good manufacturing practice (GMP) and fragrance labeling requirements, and appoint a responsible person to report serious adverse events, among other regulatory obligations.
In the beauty industry, there’s fear that MoCRA could place undue burdens on small businesses. Recognizing that possibility, the FDA is exempting businesses with average gross annual sales from cosmetics amounting to less than $1 million over the past three years. While the FDA originally set a Dec. 29 deadline for product listing and facility registration, the deadline has been moved to July 1 next year, affording beauty entrepreneurs who may struggle with navigating the regulatory thicket a little more time to prepare.
Still, we were wondering whether they’re concerned about MoCRA’s impacts on their brands that typically don’t have enough money floating around to hire sizable in-house regulatory teams. So, for the latest edition of our series asking questions relevant to indie beauty, we asked 33 brand founders and executives the following question: How do you think MoCRA will affect you specifically and smaller beauty brands generally?
-
Keith Cornelius Jr. President, Maison 276 First and foremost, consumer protection is a critical and necessary aspect of our consumer economy. That said, new regulation often results in companies increasingly becoming litigation targets. In instances of frivolous litigation, smaller companies tend to be less equipped to defend themselves which ultimately results in increased costs throughout many supply chain components.
-
MoCRA will likely impact both my brand and other smaller beauty brands in a few different ways. On one hand, it has the potential to create more opportunities for us by promoting fair competition and building stronger consumer trust through transparency, but, on the other, there would obviously be an increase in operational costs for brands as it pertains to compliance and regulations.
Smaller brands might face challenges adjusting, but it could also lead to a fairer landscape by weeding out unfair market practices, ultimately benefiting consumers and encouraging innovation in the long run.
- KRISTIN MOORE Founder and Creative Director, Satva Botanicals
We are a small, but mighty team. Due to this, MoCRA does not have a high impact on us directly at this time due to some exemptions for smaller brands. However, we are growing, and I do have both hopes and concerns for us and for other smaller beauty brands.
We don’t know all of the details from the FDA yet, so it is hard to pinpoint the exact costs associated, but I have attended the FDA’s MoCRA meetings thus far and mapped out what our requirements might look like. I am definitely concerned about the costs associated with the rollout.
For small beauty brands, the challenges will be placed on compliance at a cost, where larger companies likely have the budget and workforce to execute or are perhaps already working with foreign markets where most of these requirements are already in place.
Additionally, small brands are nimble when it comes to innovation and pivots, and this will potentially be stifled by the added cost and workload of a small team with limited resources. On the other hand, I do appreciate that the FDA is finally moving forward to overall raise our standards in the U.S. for safety and transparency.
Satva was founded on the cornerstone of transparency and trust, and I believe once MoCRA is fully onboarded, it will set the precedent for other brands that make claims to be clean, safe or natural to really prove themselves.
- ANISHA VINJAMURI Founder and CEO, UMM Skincare
For our company, MoCRA laws are not expected to have a significant impact. We have already established partnerships with manufacturing facilities that strictly adhere to all the necessary FDA and GMP regulations.
Additionally, we have a robust system in place for compliance with labeling protocols. Therefore, our current operations are well-prepared to meet the requirements outlined in MoCRA.
However, it's essential to recognize that MoCRA will pose substantial challenges for emerging beauty brands. The days of organically growing a beauty business from a home-based setup are coming to an end due to the increased regulatory demands. Many of today's highly successful multimillion-dollar beauty businesses were after all once started in the garages of the founder's homes.
This challenge extends beyond compliance issues. It also affects aspects such as packaging and labeling design. Meeting both aesthetic standards and labeling compliance can be an uphill battle for smaller brands, making it harder for them to establish a foothold in the industry.
If these emerging brands have access to capital or industry relations/connections, it's definitely going to be an easier path compared to a company like UMM, which did not have either option when we founded.
My personal advice for aspiring future beauty founders who don't have capital access beyond bootstrapping or industry relations is to start building those relationships now! This way, they can at the least avoid expensive mistakes during the learning curve and focus on efficient formulation, compliance and customer acquisition.
- Ariane Noji Founder, Contemplation
MoCRA seems to be causing a lot of anxiety for brands, but, at the end of the day, it's only helping to create safety standards around cosmetics. Since I have a background in product development, it's part of my job to try and keep up with all the standards, and I typically look at EU regulations when formulating because they have much stricter guidelines than here in the U.S.
That said, I built my product around safety and transparency. I also just have one product and fit within the small business exemption that MoCRA has in place, so there aren't any major implications for me right now. I do think that if smaller brands are not up to date on the guidelines of MoCRA or have a regulatory consultant to guide them on how to properly label their products, review their current ingredient lists or be prepared for product recalls.
They are going to run into issues which they might not be prepared for. This could cause great implications to their brands. It can definitely be daunting, especially for brands who have lots of SKUs, and cause a lot of extra unexpected work on their end that small brands aren't prepared for.
- Asher Hardt Director Of Operations, Skin Gym
I think just understanding the guidance provided and creating internal processes to ensure compliance across product development will be a big ask for some smaller beauty brands. I love the transparency MoCRA will provide both to the customer and from the manufacturers. Fully understanding the new requirements will be a learning process for most brands.
- RACHEL REID Founder, Subtl Staks
While the government regulation is new, consumers have been unofficially regulating cosmetics for years by demanding cleaner ingredients, ethical sourcing, safety reports, etc. At Subtl, we take transparency and consumer safety pretty seriously, as most indie brands do, so we'll be ready with all the proper paperwork.
My biggest concern is how the registration process will impact release timelines. Unlike Subtl, many indie brands do not have the budget to obtain large-scale manufacturers. However, just like the industry has changed and adjusted over the past few years, indie brands are known for their tenacity and will need to do a bit more due diligence regarding sourcing their suppliers and holding them accountable.
This may result in small price increases across the industry, but nothing extraordinarily major except safer brand usage guidelines. Indie brands using manufacturers will rely on their manufacturers to adjust their products accordingly, and again it may only result in release delays upon initial launch.
- YVE-CAR MOMPEROUSSE Co-Founder and CEO, Kreyol Essence
Like any new policy, the impact will be seen in the next few years as we understand the nuances. Given that a majority of brands work with a co-packer, they get to pass on the responsibility to their co-man. However, smaller indie brands are usually making products out of their kitchen, the way we did when we started.
Additionally, I find that many POC brands have their own manufacturing and processing facilities so that they can control the supply chain and manage COGS. MoCRA becomes another administrative task that someone must own.
Last year, we decided to hire an innovation director as part of our operations team, having someone look at MOCRA alongside our COO is our plan to stay in compliance and navigate the new waters.
- IAN BAEK Founder, Orgaid
Regulatory changes can have far-reaching effects on Orgaid and other smaller beauty brands. Since we manufacture our products directly in-house in California, we are well-prepared to meet any new regulations that may arise.
I am confident that they will ultimately benefit our brand by ensuring the production of safe and high-quality products and such regulations can also promote transparency and trust among consumers.
- ERIC DELAPENHA Founder, Strands Hair Care And The Hair Lab By Strands
We started this business with transparency and product safety as top priorities, and it is exciting that MoCRA will hold all companies in our industry accountable for consumer safety.
Our business practices around safety substantiation, recordkeeping and ingredient sourcing will not need to change significantly, but, as a growing company, we will rely on our established network of trusted external experts to ensure we are in compliance rather than bringing this role in-house.
While MoCRA offers relaxed requirements for smaller brands, we are forward thinking and setting ourselves up for compliance at any size.
- Daniel Isaacs Director of Research, Medik8
The introduction of MoCRA provides cosmetic brands with a set of standards to follow for all cosmetic and personal care products placed on the U.S. market, which can be legally enforced. MoCRA will be put into place over the next couple of years.
The new standards being introduced include compliance to good manufacturing standards, substantiation of product safety, reporting adverse product reactions, labeling fragrances and fragrance allergens, registration of our facilities and products and the introduction of the ability of the Federal Drug Administration (FDA) to recall products.
While many U.S. brands will have to adapt to the new set of standards, as a British brand who complies with all EU and U.K. regulations already, we are well placed to fulfill all the requirements of the MoCRA. Our in-house manufacturing facility and agile operations team alongside our high-quality ISO standards will allow us to quickly adapt to any framework which MoCRA puts into place.
At Medik8, we welcome the introduction of set standards for all cosmetic products and believe that this will truly elevate the U.S. cosmetic market.
- NADINE RAMOS Founder, Blessed Bananas
I must admit it sounds daunting and costly at first glance, but I believe that it is high time for our industry to prioritize solid policies that ensure we consistently provide safe and effective products. While complying with MoCRA may seem like a challenging task, especially for independent brands like us, it ultimately presents a remarkable opportunity. Embracing and adapting to these policies will safeguard the quality of our products and reassure consumers that we are dedicated to their safety and satisfaction.
As a result, we can distinguish ourselves in the market and enhance our brand reputation. Let's face it, regulations may require additional resources initially, but they prevent potential legal issues and product recalls that could inflict even greater financial damage. Investing in compliance now will save us from costly pitfalls down the line. It is an investment in our future, our credibility and the trust of our valued customers.
- Priscila Fadul Founder, Lendava
For smaller brands, MoCRA means undergoing some changes. They will need to update their labels to ensure they comply with FDA rules, hire someone to manage the regulatory process, and update their websites or packaging to provide customers with a hotline to report any beauty-related issues. Maintaining records will become crucial in case of FDA audits.
In my view, these changes are a positive step forward. If a product isn't safe or is causing harm, reporting it and taking action, even if it means removing it from the market, is the right way to go. At Lendava, we've always been all about safety. Our manufacturing facility already meets the GMP certification, and our consistent focus has been on producing effective and environmentally responsible products.
These days, “clean” has become a big deal in the industry. Consumers want to know what's in their products, and they're pushing for transparency. Clean brands are working hard to offer products with well-thought-out, ethically sourced ingredients. They've been calling for more federal regulation to make sure products are safe and clear about what's inside.
So, these updated FDA regulations are going to level the playing field for everyone in the beauty industry. They'll boost safety, product quality, consumer confidence and trust. But it's important to remember that more regulation can also mean more costs and time for brands, which could potentially affect innovation, particularly among the small brands that are often the driving force behind industry innovation.
- MUNDI GATTIS Founder, Clean Mundi
As a small business, it is very important for us to stay aligned and compliant with MoCRA. Direct impacts for us will be listing fragrance allergens on our labels and registration of our products. We are pretty clear about the fragrances that we use in our products, which are listed on our site. These efforts have presented extra expenses since we are having to update all of our labels.
Oftentimes, there are a few people wearing multiple hats, juggling a lot of duties to run a successful business. The new MoCRA laws definitely pose a challenge for small businesses to stay compliant as well as incurring possible expenses that were not budgeted for.
Overall, MoCRA is going to impact the beauty industry in a very positive way such as regulating fragrances, tighter rules around formulation and requiring brands to be more transparent about ingredients. This will significantly increase formulations with better transparency and cleaner ingredients.
- STEPHANIE G-M Founder and CEO, Ouli's Ointment
Having started Ouli's Ointment in the EU, I don't feel like there will be much shift for brands that sell in the EU as a lot of the legwork is already done. Compliance is something that will weed out some brands that don't understand what is needed or have a background in the legal side of owning a business.
It may make it more challenging for brands to get on shelves until they have everything in place to do so. I think it's growth that we can all benefit from, adding longevity and trust to our brands.
- ADA POLLA CEO, Alchimie Forever
As always with any type of regulatory change, and assuming that smaller beauty brands do not have an official regulatory department (we do not), there are two key metrics that will be impacted: time spent on understanding the details of the changes needed (we have already spent a considerable amount of time on this, and will continue to as further clarifications are shared), and money to implement any required changes.
I imagine this will be similar to what we were through recently with Brexit. While this strains our resources, overall I convey to my team that we are all about embracing updates and improvements to cosmetics regulations as this overall helps with the consumers’ continued trust in beauty brands.
- KATE ASSARAF Founder, Dip
MoCRA is a long time coming—and rightfully so. I honestly am not sure how it will change my business, but any change is OK with me as long as it is in the name of consumer safety.
We recently not only joined The Good Face Project, but also made sure our products are Good Face-certified and -approved so customers know that a third party is looking at our formulas, ingredient percentages and claims to make sure they are consistently compliant.
It's actually the only certification we applied for so far because we felt it was so important. We are happy that the Good Face will alert us immediately if anything needs to change with our formulas as regulations change. That peace of mind is amazing.
- Calvin Quallis Founder, Scotch Porter
I think MoCRA will force brands to rethink their current and future formulations and their partnering manufacturers and, in turn, that may affect smaller brands depending on their budget and access to ingredients. Moving forward, I think all emerging beauty brands in general will need to keep a close eye on how MoCRA evolves and what future ingredients may or may not be allowed in formulations.
- Jeff Lee Co-Founder and CEO, DIBS Beauty
MoCRA compliance isn't just an upfront cost for indie beauty brands, especially if they're not able to claim the small business exemption, I think we'll see the real implications start to unfold after full implementation in the coming years as well as clarification on some of the FDA's draft guidance. It's a move in the right direction for the industry, but one that smaller companies will feel more acutely.
- ELINA WANG Co-Founder and CEO, ESW Beauty
MoCRA should not affect ESW Beauty. We pride ourselves on our nontoxic and vegan ingredients, cruelty-free practices and sustainable packaging. Our brand currently retails at Whole Foods Market, who hold themselves to strict guidelines following their Whole Foods Body Care Standard.
I believe that, for the beauty brands who do not comply to higher formulation standards, this new act can be an obstacle that they will encounter due to having to source new ingredients and potentially reformulate their products in order to comply.
In addition, manufacturers that are distributing to the United States must be registered within the FDA or update their registration. Our manufacturers comply already. However, the other brands with manufacturers who do not may now have new obstacles to encounter.
- ALEX MCINTOSH Co-Founder and CEO, Thrive Natural Care
We believe that MoCRA represents a positive initiative to standardize safety and quality controls within the cosmetics industry. It will require some additional upfront time and resources to make the required adjustments, but we think this will be a net positive for skincare consumers.
In Thrive's case and because a significant number of our products are OTC, our standards for manufacturing safety and quality are already high and so we are well-prepared for the forthcoming regulatory changes.
- DINA ROSENBLOOM CMO, Hairstory
We are an environment-forward company, so I'm completely on board with continuing to push for higher standards of safety and eco-consciousness, which is what, in my opinion, MoCRA does. I would like to see the boundaries pushed even further, looking to the U.K. and Europe as examples who are always ahead of us when it comes to formulations, ingredient restrictions, packaging guidelines and so on.
As it relates to Hairstory, I don't think it will affect us at all. We plan to aggressively pursue accreditations that ensure consumers feel confident in our claims surrounding our formulations and packaging.
In terms of the effects of MoCRA on small beauty brands in general, I think it keeps them true to what they need to do. Most of the small beauty brands that I've seen launch recently are already pushing boundaries of eco-consciousness, sustainability, packaging and ingredients, so I foresee MoCRA having more of an impact on larger established brands. It’s harder to steer a big ship, whereas smaller brands have the advantage of more flexibility.
- DEBI THEIS President, Henry Rose
Honestly, it doesn’t really affect Henry Rose. All of our products are formulated based on the strictest health and safety standards known today and disclose 100% of their ingredients.
We are the first and only fine fragrance brand to receive both EWG Verification and Cradle to Cradle certification. As for the implications on other beauty brands, we hope that it will open the door to greater ingredient transparency, not just with the FDA, but also with consumers. We all have a right to know what’s in the products we’re using.
- Gwen Salakaia Co-Founder, Senself
It was long overdue. The hype of skin care startup brands with no barriers of entry to the market gave us overly saturated beauty industry, with products available to hit the masses within few weeks and without enough safety control.
I think this will give brands certain break to carefully reexamine their assortment and formulas to propose something unique, innovative, well-thought-out, clean and safe for costumers.
Obviously, it comes with disadvantages of more paperwork, fees and lengthy procedures, but, on the other side, there are consumers who deserve transparency and safety.
Senself already has a regulatory affairs agent in Europe and U.K. to ensure compliance across different countries. Since we started operating, all our products are formulated with EU and U.K. regulatory compliance. Of course, it takes more work, but we think it’s the right way to go.
- JAMES PARK President, Herbivore Botanicals
These regulations are a win for the consumer. They deserve quality products with accurate labeling. For most brands, this translates into an incremental workload for the product development and regulatory teams.
For Herbivore, we are distributed internationally (for example, regulators in EU have long required product registrations), so it won't translate into a big change in the workload.
- Meghan Maupin CEO, OurX
MoCRA will not have a significant impact on our operations because we have made safety and testing a top priority for the brand from the beginning. We work with labs that already practice GMP (good manufacturing practice) and safety substantiation.
Black women are at higher risk of cancer than those who have not had exposure to products like chemical hair relaxers. Our mission at OurX is to put the needs of the tightest textures first, which includes creating efficacious and safe formulations for this consumer.
- Karen Barner CEO, Cay Skin
At Cay, most of our products are sunscreens. Complying with the OTC monograph rules means that we are meeting the intent and guidelines of MoCRA: adverse event tracking and reporting, record keeping, notification, GMPs and safety substantiation, and have the processes to support compliance with MoCRA for our few cosmetic products. We have started including fragrance allergens on our labels to meet the Dec. 29, 2025 deadline.
For smaller brands that are not in compliance with the existing FDA guidelines, MoCRA will force them to make the effort and spend the money to meet the requirements. That said, the lack of regulation of and preemption for raw materials is going to be the biggest challenge. These state initiatives to regulate raw materials are creating a patchwork effect throughout the U.S. and, if this continues, will make it very difficult to have one formula and package just for the U.S.
- Brittany Lo Founder, Beia
MoCRA will affect us as an indie brand as we create new products since we will need to register them with the FDA, which is a process we have not had to do before.
Thinking about other small beauty brands and the industry as a whole, I think this has the potential to completely change the startup landscape as it will likely raise the barrier to entry for emerging beauty founders by adding a regulatory step that is both cost and time intensive and requires a degree of expertise that was not required before.
While I think this is a positive change for consumer safety, I do think it will pose challenges for small beauty brands like mine who now need to learn a new regulatory language and invest in these regulations as well.
- Gerard Camme President and CEO, Element Eight
We’ve had our eye to this for a while. We’re in great shape both internally and externally with our formulations. There should be minimal impact, but we’re unique in that we’re an indie brand with a very seasoned veterans on the team. That helps.
- Julian Addo Founder and CEO, Adwoa Beauty
We work with great labs who are ahead of the game, so I don’t think it will affect me at all. We are prepared to get the necessary certifications to be a transparent and compliant brand for our customers.
Adwoa beauty products were EU compliant from day one, and we have our certifications for Canada and the EU. We regularly review our formulas to ensure consumer safety.
For smaller brands who are not looking around the corner, it will definitely be a challenge and another financial burden. This has been in conversation for many years, so hopefully brands in beauty, no matter the size, have been paying attention.
- SANDRA VELASQUEZ Founder, Nopalera
We are fortunate to have a chemist on board who keeps us current. We formulated our products to be Credo Clean, so we are tuned in. In general, I think it’s positive to have clear regulations and guidelines.
- ELENA FRANKEL Co-Founder, Flyte.70
The constant, rapid changes happening in the beauty industry are very hard for small brands from a financial standpoint to keep up with. I do think we need better regulations, not just for ingredients and products, but also for vague marketing terminology as well as they do in the EU.
- THEODORA NTOVAS Founder, Yasou
I’m not sure, but if it really is to make cosmetics safer, I’m good with that. I take pride in my brand Yasou and should I have an ingredient that is now known to not be clean, I would want to know and address that right away.
I guess it’s just another way of making sure everything I’m using is kosher to what I think and what I am promoting to the public and my customers.
If you have a question you’d like Beauty Independent to ask beauty entrepreneurs and executives, please send it to editor@beautyindependent.com.
Leave a Reply
You must be logged in to post a comment.