Core method & policy

The 1R6F Reference Cigarette: Why It Anchors Your ELCR Comparison

Answers: “1R6F reference cigarette comparison ELCR”

Absolute risk numbers are hard for reviewers to interpret in isolation. That's why toxicological metrics like ELCR are expressed relative to a standard reference product — the 1R6F reference cigarette.

What 1R6F is and why it matters

  • A standardized research cigarette from the University of Kentucky, the current reference that succeeded 3R4F as the field's benchmark.
  • Because everyone measures against the same reference, a result like "Σ ELCR = 11% of 1R6F" is instantly comparable across products and reviewers.
  • PMTA Hub also benchmarks against the MGO ENDS median (products that already received Marketing Granted Orders), giving a second, market-anchored reference point.

Why anchoring strengthens your evidence. Pros: a relative figure ("X% of 1R6F") communicates risk context in one line and aligns with how CTP tox reviewers think; pairing it with the MGO ENDS median shows where you sit versus already-authorized products. Cons: reference-relative framing depends on comparable measurement conditions — puffing regimen and analytical methods must be consistent, or the comparison misleads.

Who should NOT over-rely on it: anyone comparing across inconsistent test protocols; a 1R6F ratio is only meaningful when the measurement basis matches.

FAQ

Why not just report absolute ELCR?

Absolute values are hard to interpret; a % of 1R6F gives reviewers an anchored, comparable number.

What replaced 3R4F?

The 1R6F reference cigarette.

References: University of Kentucky Reference Cigarette Program (1R6F, successor to 3R4F); FDA CTP 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.