Screen a formula for US and MoCRA requirements

What you will accomplish

You will run Formuley's US screening, review ingredient and product-classification flags, and use its MoCRA reminder and checklist as an external-work prompt. Formuley organizes rule matches and missing obligations; a qualified regulatory reviewer still owns legal interpretation, registration, listing, substantiation, and release judgment.

Before you start

Confirm the saved formula, percentages, intended cosmetic use, claims, product category, and target market. Gather current raw-material identities and supplier documents. US-only compliance checking is available on Maker and higher tiers. Selecting the EU or another non-US market requires Pro or higher, and additional regions outside the core US and EU pair require Business or higher.

Run the US screening

1. Open the formula check. Go to /compliance/check/[formulaId].
2. Select US. Add EU or another available market only when the product will also be reviewed there.
3. Choose Draft guidance during development. Use it as an early screening pass while formula or evidence work remains open.
4. Choose Release review for a release candidate. Supply the structured product and evidence context requested by the workflow.
5. Run the check. Inspect the US result, issue severity, rule sources, and any follow-up action.

Review FDA-related findings

The current US service can flag prohibited or restricted cosmetic ingredients, color-additive approval or certification scope, and ingredients or claims that may raise over-the-counter drug classification questions.

1. Confirm each matched identity. Similar names, grades, and mixtures can require different analysis.
2. Review restricted-use context. Compare the formula percentage and intended use with the cited condition.
3. Review color-additive flags. Verify permitted use, certification status when applicable, and the exact supplied color.
4. Escalate drug-classification questions. Do not treat an informational or warning result as a final cosmetic-versus-drug decision.
5. Verify the governing source. Use current FDA material and qualified review before changing claims or releasing the product.

Use the MoCRA reminder and checklist

When a US formula contains ingredients, Formuley adds an informational reminder that MoCRA may require FDA facility registration and product listing. The supporting checklist identifies these external obligation areas:

• facility registration
• product listing
• adverse event reporting
• GMP

This is a reminder and checklist only. Formuley does not track facility-registration status, store registration stages, run a renewal tracker, or determine whether an obligation is complete. It also does not submit an FDA registration or product listing. Complete and verify those actions in the appropriate FDA system and retain the resulting evidence under your own regulatory process.

1. Review the reminder. Decide which obligation applies to the responsible business and product.
2. Assign an external owner. Name the person or qualified regulatory reviewer responsible for each applicable item.
3. Complete the external action. Use the official FDA workflow rather than marking the Formuley screening result as proof of submission.
4. Retain evidence. Store confirmation, correspondence, procedures, and records in the system your regulatory program controls.
5. Recheck before release. Verify that the formula, claims, label, and external MoCRA obligations are aligned.

Complete the release review

1. Resolve confirmed formula failures. Correct prohibited uses, over-limit conditions, or unsupported classifications before release.
2. Resolve evidence gaps. Attach or reference the identity, testing, color-additive, claim, and market evidence required by your process.
3. Route ambiguous items to a qualified regulatory reviewer. Keep the decision and rationale with the release record.
4. Treat Pass as screening evidence. Do not treat it as FDA approval or final release authorization.

Check your work

• US was selected for the intended formula and product category.
• Each ingredient, color-additive, or drug-classification flag has a documented disposition.
• The MoCRA reminder and checklist have an external owner and supporting evidence where applicable.
• No Formuley status is being used as proof of FDA registration, product listing, or renewal.
• A qualified regulatory reviewer has verified the final US and MoCRA release position.

If something does not look right

• If an ingredient is misidentified, correct the raw-material identity and rerun the screening.
• If a color-additive result is incomplete, verify the exact color, use, and certification evidence outside the formula record.
• If a claim may change the product classification, pause cosmetic release review and obtain qualified advice.
• If you expected a facility-registration status page, use the external FDA record instead; Formuley provides no facility tracker.
• If Release review is blocked, provide the missing evidence or human decision rather than relying on Draft guidance.

Next steps

• Generate and verify the INCI declaration
• Build a label from reviewed release snapshots
• Run EU market screening