The Modernization of Cosmetics Regulation Act (MoCRA) has fundamentally changed how cosmetics are regulated in the the U.S. As of 2024–2025, every cosmetic marketed in the U.S. must be properly registered (facilities) and listed (products) with the U.S. Food and Drug Administration (FDA).

Failing to comply can lead to:

• FDA warning letters, enforcement actions, or import holds

• Delays in market access

• Reputational risk with retailers and consumers

• Operational disruption if your product reformulates or changes labeling

With our service, you let experts handle the entire process — from registration to annual updates — while you focus on your brand and sales.

What We Offer

Our subscription-based service includes:

Who Needs This

You should subscribe to this service if you:

• Sell cosmetics or personal care products in the U.S. market

• Are a manufacturer, brand owner, packager, or distributor (or work with them)

• Want to ensure MoCRA compliance without dedicating internal regulatory resources

• Plan to reformulate, rebrand, or launch new products regularly

How It Works — Step by Step

1. Onboarding & Info Gathering
   We request product data: name, intended use (skincare, makeup, etc.), full INCI ingredient list, label images, and facility details.

2. Product Listing Submission
   We build and submit Structured Product Labeling (SPL) files via Cosmetics Direct, including all required fields and verifications. The Facility Registration is required to do this.

3. Confirmation & Archiving
   Once submissions are accepted, we forward you confirmation and store the files in our archive.

4. Annual Update Cycle
   Each year, we review your listings, verify information, and re-submit or confirm with FDA.

5. Change Management (If Needed)
   If you alter your formula, redesign packaging, or change facilities, we file an update within 120 days to remain compliant.

Deadlines & Compliance Highlights

• Initial listing deadline for existing products: December 29, 2023

• Facility registration deadline: March 29, 2024

• Annual updates: required to maintain accuracy and compliance

• 120-day updates: mandatory when significant changes occur

Missing deadlines can result in regulatory consequences, import holds, or enforcement letters.

Why Choose Us

• Expertise & Reliability
  Our team knows MoCRA inside and out; we stay current on FDA guidance and policy shifts.

• Low Cost, High Value
  With this subscription you avoid hiring full-time regulatory staff or paying expensive legal fees.

• Transparent Process
  You get full visibility into submissions, confirmations, and status updates.

• Scalable & Flexible
  Whether you have 1 product or 100, we handle the scale. As your line grows or changes, we adapt.

• Risk Reduction
  With proper compliance, you reduce risk of enforcement, fines, or market disruption.

Pricing & Terms

• Subscription Rate: per product / year

• Billing: Annual in advance

• Included Revisions: Annual registration confirmation update

• Cancellation: You can cancel at year-end; discontinued products will be delisted per your instructions

FAQs

Q: Do I need this if I already comply with EU rules (e.g. PIF, CPSR)?
A: Yes. The EU PIF is valuable groundwork, but MoCRA requires a separate U.S. submission structure (facility registration, product listing, SPL files). We’ll use your existing data where possible to streamline the process.

Q: What if I reformulate mid-year?
A: We’ll file the required 120-day update for you, but major changes beyond our scope (e.g. new raw materials requiring new safety reviews) might incur extra cost.

Q: Are all cosmetics required to be listed?
A: Most are. Exceptions include items classified as true soaps (not cosmetic soaps) or certain small businesses meeting exemption thresholds.

Q: Can I see the FDA’s portal?
A: Yes. We’ll share the Cosmetics Direct submission interface and walk you through what we submit on your behalf.

Q: What if the FDA rejects my listing?
A: We’ll assist in resolving deficiencies, resubmit, and liaise with the FDA to correct issues.