The Public Record · Exhibit C
They invoked an emergency. The mortality data tells a different story.
01 — When 7-OH Actually Arrived
Independent sources converge: concentrated/semi-synthetic 7-OH exploded into the U.S. market between late 2023 and early 2025.
Analysts date the market flood to "since late 2023," marking the entry of explicitly concentrated 7-OH items sold separately from whole-leaf kratom.
A 6-month forensic inventory identified 304 distinct 7-OH and MP products in circulation. Most were semi-synthetic extracts or synthetics, not the natural leaf.
"The rise of novel, semi-synthetic 7-hydroxymitragynine products," posted online in Addiction — Smith, Boyer, Grundmann, McCurdy, Sharma flag the emerging category and the saturation pace.
The Colorado Forensic Science Research and Evaluation (CFSRE) lab first isolates and identifies 7-OH in seized drug materials, marking the formal entry into law-enforcement detection networks.
The United Nations Office on Drugs and Crime flags novel high-concentration 7-OH products "emerged since 2024," particularly in the United States, in a global early warning signal.
02 — What Overdose Deaths Did
7-OH market saturation (2024–early 2025) vs. CDC final and provisional overdose-death data.
03 — The Honest Caveats
None of these caveats disappear when you ignore them. Read all three before you cite this page.
Opioid-specific deaths fell from 79,358 (2023) to 54,045 (2024) largely because fentanyl-involved deaths declined. Federal agencies credit naloxone access, treatment expansion, prevention funding, and a shifting fentanyl supply composition. 7-OH is not a documented driver of the drop. No causal link exists in the literature or in overdose attribution data.
Most labs did not test for 7-OH by name until roughly 2025. The FDA concedes this likely under-counted 7-OH's presence in earlier poisonings and overdoses. So the statement "we don't see 7-OH deaths" partly reflects "we weren't measuring them." The FDA's own report acknowledges this gap — making it impossible to know whether 7-OH harms were under-reported. Both "it's not there" and "we can't see it" cannot be true at once.
7-OH's metabolite overlaps with mitragynine, and toxicology labs struggle to distinguish them — making post-mortem attribution genuinely difficult. Deaths involving kratom alkaloids may be assigned to other substances or left unattributed. The FDA's own assessment flags this as a source of uncertainty. Speed of scheduling does not resolve this measurement problem; it just bypasses the process designed to surface it.
04 — The Argument
By the government's own timeline, 7-OH saturated the market in 2024 — the same year overdose deaths fell to a four-year low. The FDA also says we likely under-counted 7-OH deaths because labs weren't testing for it. Both cannot carry an emergency.
You cannot simultaneously declare an "imminent hazard" urgent enough to skip the normal process and admit you weren't measuring it. Emergency scheduling demands evidence of imminent harm. The mortality record doesn't show it — and the government's own caveat says it can't yet see it.
That's not an emergency. That's a reason to use the ordinary, reviewable process.
And there's a fourth data point: The thin record already documented in the main filing. No confirmed deaths from 7-OH alone. About 53 poison-control calls over a three-month period. Little seizure or trafficking data. The case leans heavily on animal receptor-binding studies and theoretical opioid potency — not real-world harm statistics.
The question the comment window exists to answer: Did the government meet its own standard for emergency action?
05 — The Counter-Signal
This matters for context. It's not a death metric — it's an exposure report. The distinction is crucial.
The Texas Poison Center Network reported 192 kratom/7-OH exposures by late August 2025, compared to 107 in all of 2024 and 122 in all of 2023. In Washington state, roughly 1,800 kratom-related exposures were reported by early August 2025, with approximately ⅓ involving 7-OH extracts. These numbers are real and reflect rising product availability.
Poison-center calls are not deaths. They are exposure reports — many non-emergent, many users seeking baseline information. Exposure calls increased because 7-OH availability increased. That's a rational correlation. But calls ≠ fatalities, and the absence of a mortality spike during rising exposures is itself a data point worth sitting with.
The Bottom Line
The record is clear. The question stands. The comment window opens Monday.