MoCRA 101: How To Comply With The New FDA Laws
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the biggest regulatory shake-up in the US cosmetics industry to date.
Whether you are just getting started with your business, or are established as a small beauty brand, this act could radically change how you formulate, track, and label your cosmetics going forward.
For brands consistently earning over $1 million in sales, formulating from home is no longer a viable option for your business.
So where do you go from here?
Our in-depth guide below outlines a summary of MoCRA and explains how it could impact your business. We provide step-by-step guidance on how you can comply with the legislation by working with a MoCRA-compliant beauty lab instead of formulating at home.
What Is The Purpose Of MoCRA?
The Modernization of Cosmetics Regulation Act of 2022 falls under Subtitle E in the Consolidated Appropriations Act, 2023, which is available to read in full here. The Act was approved by Congress in 2022, however the exact requirements are still subject to change as of Q1 2024.
The Act is primarily concerned with enhancing safety provisions, improving product traceability, and bringing the US cosmetics industry closer in line with cosmetics regulations across the globe.
The legislation is partially based on the ISO 22716 - an international standard for Good Manufacturing Practices (GMP) developed by the International Organization For Standardization. This ISO standard outlines a universal management system for the proper production, storage, and shipment of cosmetics.
What Does The Act Require Of The Manufacturer?
The Act places new legal requirements on ‘Responsible Persons’, which the FDA defines as “the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product.” As outlined by The Society of Chemical Manufacturers and Affiliates (SOCMA), these responsibilities include (but are not limited to):
Adhering to the FDA’s full ‘Good Manufacturing Practices’ (GMP) for cosmetics. The draft guidance was provided in 2013 (with provisions similar to the ISO 22716 standards), and we can expect the FDA to release its full guidelines before the end of 2024
Mandatory manufacturing and processing facilities registration with the FDA
Registering each cosmetic product with the FDA every year
Maintaining records (including tests and studies) that show with reasonable certainty that a cosmetic product is safe for use
Notifying the FDA of any reports of serious adverse events
Updating labels to include contact information for reporting serious adverse events and to include fragrance allergen information
Due to these requirements, in most cases, it is no longer feasible for successful brands to produce cosmetics at home. However, there are some exemptions for smaller businesses.
Is My Business Exempt From Some Of These Requirements?
As explained by The Society of Chemical Manufacturers and Affiliates, brands with average gross sales (in the US) over the previous 3 years of less than $1 million are not legally required to follow the Good Manufacturing Practices (GMP), facility registration, and product listing requirements outlined in the Act.
However, the FDA explains that this sales revenue exemption does not apply in all cases.
For example, there is no exemption for cosmetics that regularly come into contact with the mucus membrane of the eye with normal use. According to Glossy, the FDA currently claim that this includes mascara, eyeshadow, liquid eyeliner, eye makeup remover, and false eyelash adhesive. As noted in a 2022 study, many common eye makeup products trigger adverse effects on the ocular surface of the eye, including the conjunctiva.
Products that are injected, intended for internal use, and those that alter appearance for more than 24 hours (for example hair dye) are also not exempt.
Additionally, there is no exemption at all for small brands when it comes to maintaining records and reporting serious adverse events.
How Can My Small Business Comply With MoCRA?
MoCRA means it’s no longer feasible for successful small beauty brands (defined as earning over $1 million in average gross US sales over the previous 3 years) to make their products at home.
It’s time to level up and partner with a professional lab that has the expertise and resources to create high-quality cosmetics in full compliance with MoCRA legislation, including all of the future Good Manufacturing Practices (GMP) requirements.
Working with a professional manufacturer not only helps you comply with this new legislation, but it’s also an opportunity to scale production safely, expand your product range, and safety test your products to professional standards.
Remember - not all beauty labs are created equal. If you want to sell high-quality products, you need to take the time to find a manufacturer that meets your quality expectations and falls within your price range.
At Genie Supply, we specialize in working with small home-to-lab beauty brands like yours! Learn more about the logistics of moving from at-home formulating to working with a lab in our full guide here.
Identifying The Best Manufacturing Method For Your Brand
There are two crucial steps to take before you begin the manufacturer selection process:
Draft a short-term and long-term plan outlining the future direction of your brand.
Based on these plans, identify the most suitable manufacturing method(s) for your product range moving forward. This is important as not all suppliers will offer your preferred manufacturing process.
If you are unsure about the direction you want to take, evaluate the performance of your current product range first:
Are you earning a good profit margin on each product?
Are you meeting your sales targets for each SKU?
What are your key best sellers?
Which products are underperforming?
Pair this product analysis with updated target market research to make an informed decision about the future of your product line. This will help you identify the manufacturing process(es) you need from now on:
Do you want to keep your products exactly as they are, but need to partner with a manufacturer to comply with MoCRA and/or to scale up production? Contract manufacturing is your next step.
Is it time to switch up your product line entirely? Or maybe just add some additional products to your catalog? The MoCRA legislation is a good excuse to finally take the leap and make changes to your product range. In this case, look for manufacturers that offer preformulated products, custom product creation, or custom formulating.
At Genie Supply, we offer five different manufacturing processes in total - contract manufacturing, bulk, private label, custom product creation, and custom formulation. Learn more about each different manufacturing path in our full guide.
Can I Keep My Product Formula The Same While Moving From Home-To-Lab? Contract Manufacturing Explained
If you are satisfied with your current product range and don’t want to make any changes to your formula, then contract manufacturing is the next step for you.
Contract Manufacturing involves hiring a professional manufacturer to recreate your formula as closely as possible to your original recipe and instructions.
Once the formula replication process is complete, the beauty lab can manufacture your product at scale. Some manufacturers offer turnkey production with optional customized packaging and filling in addition to the formulating process.
At Genie Supply, we are experts in manufacturing cosmetics for small home-to-lab brands like yours. To ensure we get the replication of your formula as close as possible to the original, we will send you a sample while formulating for feedback.
There is no set MOQ on our contract manufacturing service (a small fee may apply under 5,000 units). We will also assign a dedicated project manager to oversee the contract manufacturing process for your brand. Learn more about our contract manufacturing services here.
Creating New-To-Market Products With A Professional Manufacturer
Are you ready to shake up your product offering? There are two main methods to create new-to-market products with a professional beauty lab: custom formulating and custom product creation.
Custom Formulating
If you are ready to disrupt the cosmetics market with original never-seen-before products, custom formulating is your next step. This process involves collaborating with a cosmetics manufacturer’s team of highly qualified chemists to create brand-new makeup or skin care from scratch.
At Genie Supply, we specialize in hybrid products, new product formats, novel chemical research, and making skin care ‘clean’. Learn more about our custom formulating services here.
Custom Product Creation
If the customization process appeals to you, but you don’t have the budget for custom formulating, consider custom product creation instead. This process involves adding a limited number of customizations on top of a manufacturer’s preformulated base formula.
At Genie Supply, we provide two separate custom product creation packages to suit a range of budgets. Learn more about our custom product creation process here.
Selecting Preformulated Beauty Products For Your Product Range
Do you want to expand your product range, but you don’t have the budget or time to fully custom-create a new product line? Private labeling is the next step for you. This process involves adding your own custom branding to a manufacturer’s preformulated products.
Although your products will not be unique, private labeling is a much less costly and less time-intensive process than custom formulating.
At Genie Supply, we offer over 60 clean and cruelty-free preformulated skin care and color cosmetic products on a private label or bulk basis. Order samples from our website here or view our full product catalog to learn more.
Finding A MoCRA Compliant Manufacturer For Small Beauty Brands
Now that you have a clear vision for the future of your brand, and have identified your preferred manufacturing processes, it’s time to search for a MoCRA-compliant beauty manufacturer.
A simple Google search is typically the best way to find manufacturers’ websites and evaluate a large number of potential suppliers all at once.
Potential search queries to try include:
‘Beauty manufacturer US’
‘Cosmetics producer based in the United States’
Learn more about finding a high-quality manufacturer in our full blog post.
While comparing manufacturers, consider the following criteria to find the best match for your brand:
Does this lab fit my budget?
Does this supplier offer my preferred manufacturing method(s)?
Is the manufacturer based in the US?
Does this manufacturer prioritize ethical and sustainable production with clean, vegan, and cruelty-free ingredients?
Are the product samples high quality?
Can they manufacture products within my brand’s niche?
Be sure to ask each lab on your shortlist about the steps they are taking to comply fully with MoCRA.
At Genie Supply, we fit all of the criteria above - and more. Learn more about your next steps in our full ‘need to know information’ guide.
In sum, MoCRA is changing the beauty industry as we know it in the US:
Brands consistently earning over $1 million in sales can no longer feasibly manufacture from-home
Compliance in many cases requires moving from at-home formulating to working with a professional beauty lab
Your first step is to decide on your future product range and identify the best manufacturing method to create your cosmetics going forward
Next, you need to look for a MoCRA-compliant lab that offers your preferred manufacturing method and can produce high-quality cosmetics within your budget
Are you ready to partner with a MoCRA-compliant beauty manufacturer? At Genie Supply, we specialize in high-quality clean cosmetics, and we offer five different manufacturing methods to provide maximum flexibility for your brand. Learn more by contacting our email: customerservice@geniesupply.com or calling: (812) 329 1105.
