40 mg of Mitragynine: The Policy Proposal and the Patent

Three Authors. One Patent. No Patent Disclosure.

The overlap is exact: policy authors Christopher R. McCurdy, Abhisheak Sharma, and Erin Berthold appear in the patent as Christopher Robert McCurdy, Abhisheak Sharma, and Erin C. Berthold. Elizabeth Maxwell is the fourth inventor; she is not a policy coauthor. [Patent record]

The published declaration begins:

Author EB was employed by Planted in Science Consulting, LLC.

It also discloses kratom-related expert-witness work by Oliver Grundmann and McCurdy. Its closing sentence says the remaining authors declared no commercial or financial relationships that could be construed as potential conflicts. The complete statement names neither this application nor any inventor revenue-sharing interest. The separate funding statement reports no financial support for the policy work or its publication. [Full declaration and funding statement]

Frontiers’ general policy, preserved in July 1 and October 1, 2026 snapshots, required authors to disclose actual and potential conflicts at submission, including interests that could be perceived as conflicts. It said disclosures belonged in the statements section and would appear in the published article. The reviewed general-policy text supplies a broad potential-conflict standard rather than a separate patent-specific relevance test. It does not reveal how editors assessed this particular application.

An invention concerning commercial mitragynine formulations could intersect with recommendations defining that market. Did Frontiers receive the patent information and decide it was irrelevant? Was information supplied but omitted from publication? The underlying declarations and editorial correspondence are needed before assigning responsibility or finding a violation.

The patent was public first

1. October 28, 2022Claimed priority: US provisional application 63/420,216.
2. October 30, 2023International application PCT/US2023/078192 filed.
3. May 2, 2024International application published as WO2024092269A1.
4. June 4, 2026US application published as US20260151446A1.
5. October 22, 2026Frontiers policy article published.

Dates: international record, US record, and journal publication history. The US publication also preceded the manuscript’s July 1, 2026 receipt.

Two documents, side by side

Swipe across the table to compare both documents →

Claim 6’s 40 mg figure is extract weight; Claim 11’s is mitragynine weight. Numerical overlap does not confer ownership of every 40 mg product. Claims request protection for specified compositions and methods.

Forty Milligrams of What?

A label measures the amount swallowed. Bioavailability measures the fraction reaching systemic circulation; systemic exposure also depends on the concentration over time. A milligram ceiling does not make different formulations pharmacokinetically equivalent.

The patent’s Example 4 and Table 5 compare an experimental capsule using extract described as 45% mitragynine with lyophilized kratom tea solution and OPMS Gold liquid extract. In male Sprague Dawley rats, reported absolute oral bioavailability was approximately 69%, 25%, and 41%, respectively.

• Different doses, normalized comparisons. The table lists 8 mg/kg mitragynine for the capsule, 5.7 mg/kg for tea, and 9.6 mg/kg for OPMS. Its dose-normalized AUC—the integrated blood-concentration measure—was 232.9, 83.7, and 136.1, respectively: approximately 2.8 times tea and 1.7 times OPMS for the capsule.
• Peak concentration also differed. Dose-normalized Cmax was 46.1 for the capsule, versus 11.1 for tea and 11.7 for OPMS—approximately fourfold higher.
• These are small animal experiments. Table 5 reports four animals per group. Different-dose comparisons and normalization do not establish equivalent human outcomes or constant dose proportionality. The patent narrative gives inconsistent exposure multipliers; these comparisons use the table.

Why the 40 mg canine capsule became 10 mg

Example 5 reports adverse signs in two of three dogs receiving the formulation in 40 mg capsules. At 3–4 mg/kg, one dog showed dysphoria, whining, restlessness, house-soiling, and refusal to eat; its owner withdrew it. Another, at 2 mg/kg, showed whining, restlessness, and reduced appetite. A third tolerated 1 mg/kg. Capsule strength was not an identical total dose for every dog.

The specification explicitly connects those reactions to reformulation. After a dog-owner dosing survey, the researchers selected a 10 mg capsule and diluted the original mixture with microcrystalline cellulose. Example 6 reports unchanged in vitro dissolution and further rat testing. This sequence does not prove that dose reduction alone resolved canine tolerability or establish a human safety threshold.

Would a 40 mg Ceiling Favor Their Patented Technology?

The patent’s preferred concentrated-extract formulation cannot simply be treated as a traditional leaf product. Nor does a pharmaceutical formulation automatically fall under the paper’s botanical serving ceiling.

Section 3.3 applies its primary recommendation to leaf and Category 1 traditional preparations. It also suggests the same recommendation might apply to certain extracts containing no more than 40 mg mitragynine per serving, with mitragynine above 40% of total alkaloids and 7-hydroxymitragynine below 0.01% of final dry weight. It calls for chemical-integrity evidence, safety data, and new dietary ingredient notifications for Category 2 and 3a extract sellers.

Section 3.3 cites existing survey and clinical literature but supplies no new analysis deriving 40 mg as a unique threshold. That makes the evidentiary basis for this precise ceiling a question the authors should answer.

The conditional extract recommendation creates a possible route for qualifying embodiments, not proof that this invention qualifies. The patent’s ingredient composition, extraction process, intended use, and safety evidence would need evaluation. Claim 8’s mitragynine composition and the canine disease-treatment methods also require analysis separate from the botanical category.

The paper recommends drug regulation for Category 3b isolates inconsistent with natural alkaloid ratios and Category 4 synthetic or chemically altered products. For an embodiment regulated as a drug, the direct argument that a botanical ceiling favors it would not apply. An indirect hypothesis is that restricting unapproved isolates could redirect demand or investment toward pharmaceutical development. The application provides neither drug approval nor evidence that such a shift would benefit this technology.

No actual competitive benefit—or deliberate selection of 40 mg to benefit the invention—has been established. The outstanding question is whether the framework adequately addresses formulation-dependent exposure and whether readers should have been told about the inventors’ stake while assessing it.

Ownership is documented. Payments are not.

The US record lists University of Florida Research Foundation, Inc. as original and current assignee; the international record lists the university and Foundation. Google Patents labels the US application “Pending” and the international record “Ceased.” Its assignee and legal-status labels are qualified database listings, not an independent chain-of-title or prosecution audit. The international label does not establish that national applications have ended.

UF’s revenue-distribution guidance says inventors are entitled to a share of Foundation revenues when an invention is licensed. That establishes an institutional mechanism for financial benefit. It does not establish these inventors’ specific contracts, present payments, or allocation of any future income.

Searches by application number, title, and formulation terms did not locate a public licensing announcement or commercial product tied conclusively to this family. Private licenses may not be publicly announced. Licensees, commercialization, and family-specific royalty arrangements remain unknown. A published application establishes none of them, and is not a granted patent or an approved product.

Federal funding adds a public-accountability question

The patent’s government-support statement identifies NIH R01 DA047855 and UH3 DA048353 and states that the government has certain rights in the invention. That ties public support to the invention; it does not establish that NIH funded the policy article, which reports no support.

42 CFR Part 50, Subpart F requires institutions conducting covered Public Health Service-funded research to obtain relevant significant-financial-interest disclosures, review them, and manage and report identified financial conflicts. Patent-related interests can enter that review upon receipt of income.

An important exclusion applies: §50.603 excludes certain remuneration paid by the investigator’s institution to its current employees or appointees, including institution-assigned intellectual property and royalty-sharing agreements. UF Policy 1-003 also excludes university-assigned intellectual property and related royalty-sharing agreements from its significant-financial-interest definition, while providing research review and management procedures for covered interests.

These rules cannot be converted into a finding of noncompliance from an inventor listing. Their application depends on appointments, financial arrangements, research relationships, and institutional determinations. Journal disclosure is a separate obligation. Public funding makes transparent management a legitimate accountability issue; the unresolved question is what UF and Frontiers reviewed, under which standards.

Questions the Authors and the University Should Answer

• To McCurdy, Sharma, and Berthold: Was the patent disclosed to Frontiers before publication? Please identify the declaration and date.
• To Frontiers: Did the journal evaluate the patent as a potentially relevant intellectual-property interest? Why does the published statement not identify it?
• To the inventors and Foundation: Do McCurdy, Sharma, or Berthold have contractual rights to future licensing revenue or royalties?
• To the Foundation: Has this technology been licensed, optioned, or commercialized?
• To the policy authors: What independent scientific evidence supports precisely 40 mg per serving and two servings daily?
• To the policy authors: Did you evaluate formulation-dependent differences in systemic exposure when proposing that limit?
• To the authors and Foundation: Would the framework permit or advantage products using any claimed formulation?
• To the authors and UF: Were university conflict-of-interest officials consulted about the policy publication or potential commercial interests?

Request-for-comment status

No requests for comment were sent to the researchers, university, or journal during preparation of this report. No reply or refusal is implied. Documented responses and corrections are invited, particularly submission declarations, editorial assessments, licensing records, and applicable management plans.

Read the primary record

• Frontiers: Defining kratom—evidence-based policy guidelines for a rapidly evolving marketOctober 22, 2026 · Authorship, §1.1 product categories, §3.3 serving limits, complete conflict statement, funding, and publication history. Permanent DOI.
• US20260151446A1: Improved oral bioavailability formulation for Mitragyna speciosa (kratom)Inventors, assignee listing, government support, Claims 6 and 11, Examples 4–6, Tables 5 and 7.
• WO2024092269A1: International patent-family publicationPriority and PCT filing history, institutional listings, specification, and claims.
• Frontiers: Policies and publication ethicsContemporaneous general disclosure policies: July 1, 2026 archive and October 1, 2026 archive. These establish the broad standard, not a case-specific editorial determination or the authors’ private declarations.
• UF Research Foundation: Revenue distributionInstitutional inventor revenue-sharing mechanism. See also UF Innovate’s Innovator’s Guide; neither establishes payments for this application.
• 42 CFR Part 50, Subpart F: Objectivity in PHS-funded research§50.603 financial-interest definition and exclusions; §§50.604–50.605 institutional review, management, and reporting duties.
• UF Policy 1-003: Conflicts of Commitment and Conflicts of InterestCurrent institutional definitions, exclusions, review, and management procedures; individual applicability requires underlying records.