Check my readiness
MoCRA Registration · FDA Cosmetic Compliance · U.S. Market Entry

Is your cosmetic product ready for FDA & MoCRA registration?

Product listing is only one part of MoCRA compliance. With FDA's cosmetic rules now in active enforcement in 2026, Sobel reviews your MoCRA facility registration, FDA product listing, labeling, and safety substantiation — then gives you a clear U.S. market-entry plan with your gaps and next steps.

  • See exactly which FDA & MoCRA requirements apply to your cosmetic
  • Cover facility registration, product listing, labeling & safety substantiation
  • Get clear next steps from a cosmetic regulatory consultant
Check my MoCRA readiness See what we review
Free, no-obligation review Your details stay confidential Reply within 1 business day
Trusted by regulated cosmetic & medical-device companies ISO 9001 certified
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Check your readiness · ~60 sec

This 60-second form is how you reach us. Answer 3 quick questions, add your details, and a specialist replies within 1 business day. There's no separate contact step.

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4Contact

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What best describes your current situation?

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What type of support may be needed?

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What stage is your product in?

This helps us tailor your assessment.

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A cosmetic regulatory specialist replies within 1 business day.

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Free, no-obligation review · Your details stay confidential · A specialist replies within 1 business day.

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A cosmetic regulatory specialist will reply within 1 business day with your recommended next steps — from a real person, not an automated sequence.

Want a head start? Have these ready if you can:
  • Product type and intended claims
  • Current markets and target U.S. launch timing
  • Labeling, formula / ingredient list, and any existing safety documentation
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Certified management system
4 markets
Brazil, USA, Europe & Canada
Recognized
Top regulatory consulting firm, Latin America, 2025
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Trusted by companies navigating regulated markets

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What we review

Three areas that decide your FDA & MoCRA registration

A practical review of the main FDA cosmetic compliance areas — facility registration, product listing, labeling, and safety substantiation — before you commit to selling, importing, or distributing in the U.S.

FDA + MoCRA readiness

What may apply, product listing vs. facility registration, Responsible Person needs, and ongoing obligations.

Product & documentation

Safety substantiation, labeling & claims, ingredient and formula documentation, and market-entry gaps.

Roadmap & next steps

A prioritized view of what to address before listing, import, distribution, or launch.

Is this for you?

Built for cosmetic teams entering the United States

For cosmetic brands, manufacturers, distributors, and exporters preparing to sell cosmetic products in the U.S. market.

Not a fit for product ideas, formulas, suppliers, courses, or private-label sourcing.

This service is for you if:

  • Your cosmetic product is developed or close to launch
  • You're preparing to sell, import, or distribute in the U.S.
  • You need clarity before listing or facility registration
  • You want to review labeling, claims, or safety substantiation
  • You want regulatory guidance, not a low-cost filing service
The risk

A listing-only approach can create hidden gaps

MoCRA is now in active FDA enforcement in 2026 — facility registration, product listing, and safety substantiation are mandatory, and facility registrations must be renewed every two years. Product listing alone doesn't replace a complete review of your facility, labeling, claims, and safety support.

!What companies often miss

  • ›FDA & MoCRA applicability review
  • ›Facility registration evaluation
  • ›Safety substantiation records
  • ›Labeling & claims review
  • ›Market-entry documentation

What it can cost you

  • Delayed launch timing
  • Lost distributor confidence
  • Disrupted import planning
  • Marketplace blockers
  • Rework and extra cost
The deliverable

Your FDA & MoCRA readiness review before U.S. launch

Sobel reviews your product, company scenario, and U.S. market-entry plan to identify which FDA and MoCRA requirements — facility registration, product listing, labeling, and safety substantiation — apply before you move forward. The outcome is a practical roadmap, not a generic checklist.

  • What may apply under FDA & MoCRA
  • Whether product listing or facility registration should be considered
  • Whether safety substantiation, labeling, and claims need review
  • Documentation gaps to address before market entry
Review my path
Cosmetic products prepared for FDA and MoCRA review
1 business dayspecialist reply
Specialist reviewing a cosmetic formulation in the lab
ISO 9001certified process
How it works

Start with what you already have

1

Share your product & U.S. launch plan

Product type, company structure, documentation, target channel, and timeline.

2

We review what may apply

Sobel evaluates the main FDA & MoCRA areas that may need attention.

3

We identify possible gaps

Documentation, labeling, claims, or safety-support gaps that affect your next steps.

4

You receive clear next steps

What to address before listing, import, distribution, or launch.

Why Sobel

Your cosmetic regulatory consultant for FDA & MoCRA

Focused on regulated products

We work in cosmetics, medical devices, and IVDs — not generic business consulting. Your review is handled by people who live in FDA and MoCRA.

Clarity before spend

We map what actually applies to your product first — so you don't pay for filings or steps you may not need.

Full FDA & MoCRA scope

Listing, facility registration, safety substantiation, labeling, claims, and Responsible Person obligations — reviewed together, not in isolation.

A plan you can act on

You leave with prioritized next steps you can actually execute — not a stack of regulatory jargon.

Who has been through this?

What teams that worked with Sobel say

"We hired Sobel to register a product that we export, and we obtained the certificate well ahead of schedule. The project was conducted professionally and completed on time. We recommend Sobel without hesitation."

AR
Abigail Rivera
Medulha Surgical · Mexico

"Sobel offered personalized and results-oriented service, with quick solutions. We look forward to working together on future projects."

AK
Andreas Kohl
CEO, Andratec
ISO 9001 Certified management system
Top Regulatory Consulting Firm — Latin America, 2025 (Healthcare Business Review)

Testimonials from Sobel clients, published on sobelconsult.com.

MoCRA & FDA cosmetic compliance FAQ

Frequently asked questions

In general, cosmetic products and ingredients don't require FDA premarket approval, except for color additives. However, companies are responsible for ensuring their products are safe, properly labeled, and compliant with applicable requirements.
Product listing may be required, but it shouldn't be treated as the entire process. Companies may also need to evaluate facility registration, safety substantiation, labeling, claims, Responsible Person obligations, and documentation.
MoCRA (the Modernization of Cosmetics Regulation Act) significantly expanded FDA oversight of cosmetics — introducing areas such as facility registration, product listing, safety substantiation, and adverse-event reporting. Whether and how it applies depends on your product, role, and activities, which should be assessed for your situation.
Yes. Sobel can review your regulatory path, documentation, labeling, claims, and applicable requirements before your product moves further into the U.S. market-entry process.
Depending on your structure and activities, a U.S.-based contact or Responsible Person may be relevant for certain obligations. We can assess your scenario and explain what may be required for your route to market.
Yes. Existing documentation can be useful, but it still needs to be assessed against U.S. FDA and MoCRA expectations. We can review what can be leveraged and what must be adapted for the U.S.
A clear recommendation on what may apply, key gaps, priority actions, and the next steps your company should take before moving forward with listing, import, distribution, or launch.
Under MoCRA, facilities that manufacture or process cosmetics for the U.S. market generally must register with the FDA, and their products must be listed. Sobel helps you confirm whether your facility and products are in scope, prepare the information FDA requires, and complete MoCRA facility registration and FDA cosmetic product listing correctly.
U.S. cosmetic labels must meet FDA requirements — including product identity, net quantity, ingredient declaration, the Responsible Person's contact details, and any required warnings. We review your labels and claims against current FDA cosmetic labeling requirements and flag what needs to change before you sell or import.
Yes. MoCRA facility registrations must be renewed every two years, and product listings kept up to date as your products or facilities change. Many companies that registered when enforcement began are now coming due in 2026 — we can review your status and keep your registration and listing current.
Yes. To import cosmetics to the USA, your products must still meet FDA and MoCRA requirements — facility registration, product listing, labeling, and safety substantiation. We review your route to market, U.S. Agent and Responsible Person needs, and documentation so your shipments aren't held up at entry.
Yes — the initial readiness review is free and carries no obligation. You'll receive a specialist's assessment of what may apply to your product and your recommended next steps, with no commitment to proceed and no sales pressure.
Yes. Sobel treats your product, formula, documentation, and company information as strictly confidential, handled within an ISO 9001-certified process. Your details are used only to assess your regulatory path and are never shared publicly.

Before you launch, know what FDA & MoCRA require

Check your cosmetic's FDA + MoCRA readiness — facility registration, product listing, labeling and safety substantiation — before moving forward with import, distribution, or marketplace plans.

Check my readiness

Free, no-obligation review · Confidential · A specialist replies within 1 business day.

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