FDA MoCRA Compliance

Overview

The Modernization of Cosmetics Regulation Act (MoCRA) is the most significant update to US cosmetics regulation in decades. It requires cosmetics manufacturers, processors, packers, and holders to register their facilities with the FDA, list their products, and maintain safety records. Formuley's compliance tools help you track your MoCRA obligations and check formulas against current FDA regulations. This feature is available on the Pro plan and above.

Accessing the Compliance Dashboard

Navigate to Compliance in the sidebar to open the compliance dashboard at /compliance. The dashboard displays an overview of your formulas' compliance status, including counts for compliant formulas, those with warnings, and non-compliant formulas. From here you can run checks against multiple regulatory markets including the United States.

MoCRA Facility Registration

Formuley tracks your MoCRA facility registration status through the following stages:

• Draft -- you are preparing your registration information but have not yet submitted it.
• Pending -- your registration has been submitted and is awaiting confirmation.
• Registered -- your facility is actively registered with the FDA.
• Renewal Due -- your registration is approaching its renewal deadline. The FDA requires annual renewal.
• Expired -- your registration has lapsed and needs immediate attention.

You can set your facility type to match your role in the supply chain: manufacturer, processor, packer, or holder. Formuley sends reminders as your renewal date approaches so you do not miss the deadline.

Running a Compliance Check

1. Go to the Compliance dashboard and click Run Compliance Check, or navigate to a specific formula.
2. Select the formula you want to check.
3. Choose US as your target market (you can also check against EU, UK, CA, and AU simultaneously).
4. Formuley scans every ingredient in your formula against the FDA regulatory database.
5. Review the results. Each ingredient receives a status indicating its regulatory standing.

Ingredient Regulatory Status

When Formuley checks your formula, each ingredient is classified according to its FDA regulatory status:

• Allowed -- the ingredient is permitted for use without restrictions.
• Restricted -- the ingredient is allowed but subject to concentration limits or specific conditions of use.
• Prohibited -- the ingredient is banned from cosmetic use in the US market.
• Color Additive -- the ingredient is regulated as a color additive and must be from an FDA-approved batch.
• GRAS -- the ingredient is Generally Recognized As Safe.
• Drug Active -- the ingredient may cause the product to be classified as an over-the-counter drug rather than a cosmetic, requiring different regulatory treatment.

Alert Severity Levels

Compliance check results use severity levels to help you prioritize issues:

• Error (red) -- a prohibited ingredient or critical violation that must be resolved before selling the product.
• Warning (yellow) -- an ingredient near its concentration limit or a condition that needs your attention.
• Info (blue) -- informational notes about ingredient classifications or documentation recommendations.

What MoCRA Requires

Formuley's compliance checks help you stay on top of core MoCRA requirements:

• Facility registration with the FDA, renewed annually.
• Product listing for each cosmetic product you manufacture or distribute.
• Adverse event reporting procedures.
• Safety substantiation records demonstrating your products are safe under labeled conditions.
• Good Manufacturing Practice (GMP) adherence. GMP documentation is available on the Lab tier and above.
• Labeling compliance including accurate ingredient declarations. Use the Label Generator to create compliant labels.

Tips

• Run compliance checks every time you modify a formula, especially when substituting ingredients.
• Keep your facility registration status updated in Formuley so renewal reminders are accurate.
• If an ingredient is flagged as a drug active, consult a regulatory professional before proceeding -- the product may require FDA drug approval.
• For EU market compliance, see EU Cosmetics Regulation.