The Modernization of Cosmetics Regulation Act (MoCRA) has fundamentally changed the way cosmetics are regulated in the U.S. Starting in 2024–2025, every cosmetic product placed on the market in the U.S. must be properly registered (facilities) and registered (products) with the U.S. Food and Drug Administration (FDA).

Failure to comply may result in:

• Warning letters, enforcement actions, or import bans from the FDA

• Delays in market access

• Reputational risk with retailers and consumers

• Operational disruption if you reformulate your product or change the label

With our service, 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 on the U.S. market.

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

• Want to ensure MoCRA compliance without deploying internal regulatory resources

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

How it works – step by step

1. Onboarding & Info Gathering
   We request product details: name, intended use (skin care, makeup, etc.), full INCI ingredient list, images of labels, and manufacturing details.

2. Product Listing Submission
   We build Structured Product Labeling (SPL) files and submit them via Cosmetics Direct, including all required fields and verifications. This requires the Facility Registration.

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

4. Annual Update Cycle
   Every year, we review your lists, verify the information, and resubmit or confirm them with the FDA.

5. Change Management (if necessary)
   If you change your formula, redesign your packaging, or switch facilities, we must submit an update within 120 days to remain compliant.

Deadlines and Compliance

• Listing deadline for existing products: December 29, 2023

• Facility enrollment deadline: March 29, 2024

• Annual updates: required to maintain accuracy and compliance

• 120-day updates: mandatory for significant changes

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 up to date on FDA guidelines and policy changes.

• Low cost, high value
  With this subscription, you don’t need to hire full-time regulatory staff or pay 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 can handle the scale. As your line grows or changes, we adapt.

• Risk Mitigation
  With the right compliance, you reduce the risk of enforcement, fines, or market disruption.

Pricing and Terms

• Subscription rate: per product / year

• Billing: Annually in advance

• Included updates: Annual registration confirmation update

• Cancellation: You can cancel at the end of the year; products removed from the list will be removed according to your instructions.

FAQs

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

Q: What if I reformulate mid-year?
A: We will submit the required 120-day update for you, but major changes that are beyond our control (e.g., new raw materials requiring new safety assessments) may incur additional costs.

Q: Do all cosmetics need to be on the list?
A: Most do. Exceptions include products classified as true soap (not cosmetic soap) or certain small businesses that meet the exemption thresholds.

Q: Can I view the FDA portal?
A: Yes. We share the Cosmetics Direct interface and tell you what we’re submitting on your behalf.

Q: What if the FDA rejects my listing?
A: We help resolve deficiencies, resubmit the application, and maintain contact with the FDA to correct the issues.