Deep-dive & application

The MGO ENDS Median: Benchmarking Your Product Against Already-Authorized Products

Answers: “MGO ENDS median benchmark PMTA authorized products”

Comparing your product to the 1R6F reference cigarette shows how it stacks up against combustion. But reviewers also want to know how it compares to products that already cleared the PMTA gate — the products with a Marketing Granted Order (MGO). That's the MGO ENDS median.

Why this second benchmark matters

  • 1R6F answers "better than a cigarette?" — necessary but not sufficient.
  • The MGO ENDS median answers "in line with products FDA already authorized?" — a market-anchored reference point.
  • Presenting Σ ELCR both as % of 1R6F and vs. the MGO ENDS median frames your product against both the risk ceiling and the authorized field.

Pros vs. cons. Pro: dual benchmarking pre-empts the reviewer's natural comparison and positions your product against the authorized field. Con: the MGO median reflects previously authorized products and evolving standards — it's a reference, not a guaranteed pass line.

Who should NOT over-rely on it: anyone treating "below the MGO median" as automatic approval; it's context, not a decision rule.

FAQ

What is the MGO ENDS median?

A benchmark built from ENDS products that received Marketing Granted Orders.

Why use two benchmarks?

1R6F shows risk vs. cigarettes; MGO median shows alignment with authorized products.

References: FDA CTP marketing-granted-order records; FDA HPHC/ELCR guidance.

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Disclaimer: PMTA Hub tools generate model-based supporting evidence for regulatory decision-making. They do not constitute, and do not guarantee, FDA or NMPA authorization. Modeled evidence is typically combined with a confirmatory study in a weight-of-evidence submission.