| Term | Definition | Can You Sell It? |
|---|---|---|
| Marketing Granted Order (MGO) | FDA has formally authorized this specific product for marketing. | ✓ Yes — fully authorized |
| PMTA Under Review (Accepted & Filed) | Application has been accepted and is being evaluated. May fall under enforcement discretion per May 2026 guidance. | ⚠ Enforcement discretion — not authorization |
| PMTA Submitted | Company filed an application. May not have been accepted for review yet. | ✗ No — unauthorized |
| FDA Registered | Facility or company is registered with FDA. Administrative requirement only. | ✗ No — irrelevant to product status |
| FDA Compliant | Marketing buzzword. No official regulatory definition. | ✗ No — meaningless |
| Marketing Denial Order (MDO) | FDA reviewed and denied authorization. Product cannot be legally marketed. | ✗ No — denied |
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