MoCRA Compliance and Formulation for US Personal Care Brands
MoCRA compliance means meeting the FDA's cosmetics rules under the Modernization of Cosmetics Regulation Act of 2022: facility registration, product listing, safety substantiation, adverse event reporting, and labeling. Health and Beauty Partners gives US personal care brands advisory support on those rules, plus formulation work led by our Chief Formulating Officer.
What Does MoCRA Compliance Require of My Brand?
MoCRA is the biggest change to US cosmetics law since 1938. For most brands, it comes down to five areas, plus rules that keep evolving.
Facility Registration
Facilities that make or process cosmetics sold in the US, including facilities outside the US, register with the FDA and renew every two years.
Product Listing
The brand named on the label lists each product and its ingredients with the FDA. New products are listed within 120 days of launch, and listings are updated every year.
Safety Substantiation
You keep records, such as tests, studies, and expert review, showing each product is safe to use as intended.
Adverse Event Reporting
Serious adverse events, such as hospitalization, infection, or significant disfigurement, are reported to the FDA within 15 business days. Records of every report are kept for six years.
Labeling
Every label carries a US address, a US phone number, or an electronic contact such as a website, where consumers can report problems.
Rules That Keep Evolving
MoCRA lets the FDA add rules and guidance over time, so what's required keeps changing. We track what's new and what it means for your products, so nothing catches you off guard.
How Our MoCRA Compliance Advisory Works
We review where your brand stands, show you the gaps, and help your team close them. Most of the work is getting the right records in place and keeping them current.
Our compliance work is advisory. We aren't attorneys or legal counsel. We work alongside your attorney or regulatory counsel when a legal opinion is needed.
- Facility registration and product listing guidance
- Ingredient review
- Safety substantiation support
- Labeling and claims review
- Adverse event process setup
- Audit and retailer readiness
Formulation Development Led by Dan Pont
Dan Pont, our Chief Formulating Officer, has more than seven years in product formulation. In prior work, he has created products for award-winning brands, with products featured at QVC, Ulta, Walmart, Costco, and more.
His job on your project is simple to say and hard to do: a product that performs the way you want, made the same way every batch.
What Dan Covers
- Custom formulation for new products and line extensions
- Benchmarking, developing your own version of a product direction
- Ingredient optimization
- Stability guidance, and pH and preservation review
- Bill of materials and batch record support
- Troubleshooting products that aren't performing
- Technical review when your formula moves to a new manufacturer, including cosmetic formula ownership →
Does MoCRA Cover Europe?
No. MoCRA is a US law. Selling cosmetics in the EU and the UK follows separate rules, and being MoCRA-compliant doesn't carry over.
What Europe Asks For
In general terms: a Responsible Person based in the market, a product safety report, a product information file, notification before sale, compliant labels, and a check of your ingredients against local restrictions. The UK runs its own parallel system.
MoCRA doesn't cover Europe. See how EU and UK expansion works →
EU and UK Responsible Person Services
We're building this service now. Today, we assess your readiness and help you close the gaps before you sell in Europe.
Who This Work Is For
Compliance and formulation work fits best as part of a bigger move: a launch, a manufacturer change, or a move into Europe.
A Good Fit
- US skincare, hair, body, and men's grooming brands
- Brands launching, leaving a manufacturer, or planning for Europe
- Brands with MoCRA gaps flagged by a retailer or an audit
Not a Fit Right Now
- Color cosmetics and supplements
- One-off formulation jobs with no launch, exit, or expansion path
- Pre-launch solo founders without funding
Want to know who you'd work with? Meet the people behind Health and Beauty Partners →
MoCRA and Formulation: Common Questions
Is Health and Beauty Partners legal counsel?
No. Our MoCRA compliance work is advisory. We help you understand the rules, find your gaps, and put the right records in place, and we work alongside your attorney or regulatory counsel when you need a legal opinion.
Does MoCRA apply to small brands?
Partly. Businesses averaging under $1 million a year in US cosmetics sales over the past three years, adjusted for inflation, don't have to register facilities, list products, or follow the coming GMP rules. That exemption doesn't cover products used near the eye, injected, used internally, or meant to change appearance for more than 24 hours. Adverse event reporting, safety substantiation, and labeling apply to everyone.
Does MoCRA compliance cover selling in the EU or UK?
No. MoCRA is a US law. The EU and the UK each have their own cosmetics rules, including a local Responsible Person, a safety report, and notification before sale. Our EU and UK expansion work covers readiness for those markets.
If we make our products in Europe, does MoCRA still apply to what we sell in the US?
Yes. A facility outside the US that makes cosmetics sold here has to register with the FDA and name a US agent, and following ISO 22716 doesn't exempt it. The brand on the label still lists each product. We plan for both sets of rules when production moves.
Who owns a formula you develop for us?
You do. Once you sign off on the final formula and it's paid for, we hand over the full formula and all development records. It's written into your agreement.
Do you take one-off formulation projects?
Usually not on their own. Formulation fits best as part of a launch, a manufacturer move, or a move into Europe, where we can see the product through to production. If that's where you're headed, let's talk.
Do you offer EU Responsible Person services?
Coming soon. Today, we assess your readiness for the EU and UK and help you close the gaps. We'll share details once the service is live.
Find Your Gaps Before a Retailer Does
Bring your product list and your manufacturer's details. On the call, we'll tell you where you stand on MoCRA and what to fix first.
HBP can be paid by manufacturing partners as well as a commission on your international sales. Both will be disclosed in your proposal. How we work and how we're paid →
Health & Beauty Partners · Based in Arizona, built for US brands · Make it · Sell it · Lead it