[Federal Register Volume 91, Number 127 (Monday, July 6, 2026)]
[Notices]
[Pages 41049-41050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-13608]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. HHS-OASH-2026-0232]
Temporary Placement of 7-Hydroxymitragynine Above a Specified
Threshold in Schedule I; Request for Information
AGENCY: Office of the Assistant Secretary for Health, Department of
Health and Human Services.
ACTION: Notice; request for information; establishment of a public
docket.
-----------------------------------------------------------------------
SUMMARY: The Office of the Assistant Secretary for Health (OASH or we)
is opening a public docket to solicit input and comments on a proposed
threshold for 7-hydroxymitragynine (7-OH) scheduling under the
Controlled Substances Act. Public comments submitted to this docket
will be provided by the Secretary for Health and Human Services for
consideration by the Attorney General.
DATES: Submit either electronic or written comments, data, or
information by July 31, 2026.
ADDRESSES: Request for Information (RFI) Docket: You may examine the
RFI docket at regulations.gov under HHS-OASH-2026-0232. The docket
contains this RFI and all comments received to date. To submit a
response, click the ``Comment'' button inside Docket: HHS-OASH-2026-
0232 and follow all instructions.
[[Page 41050]]
FOR FURTHER INFORMATION CONTACT: Ruben Hernandez Segarra,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal Register, the Drug
Enforcement Administration (DEA) has published a document entitled
``Schedules of Controlled Substance: Temporary Placement of 7-
Hydroxymitragynine Above a Specified Threshold in Schedule I.'' In that
document, the DEA noted their intent to issue a temporary scheduling
order (in the form of a temporary amendment) to add 7-
hydroxymitragynine above a specified threshold, including its isomers,
esters, ethers, salts, and salts of isomers, esters, and ethers
whenever the existence of such isomers, esters, ethers, and salts is
possible, to schedule I under the Controlled Substances Act (CSA). The
DEA's specified threshold for 7-hydroxymitragynine is as follows:
(A) Any botanical material of the plant Mitragyna speciosa, also
known as kratom, and contains more than 0.050 percentage of 7-
hydroxymitragynine on a dry weight basis, or
(B) Any alternative article or material to that described in (A),
that is:
i. Resulting from synthetic methods and containing 7-
hydroxymitragynine present in amounts greater than 0.050 percentage
weight/weight, weight/volume, or volume/volume or greater than 1.00
milligram of 7-hydroxymitragynine in the article, or
ii. Material derived from Mitragyna speciosa and further processed
to manufacture alternative dosage forms such as extracts, concentrates,
processed edibles, or pressed pills, and which may have materials that
have been exposed to chemical, thermal, or other methods leading to
chemical transformations that result in 7-hydroxymitragynine present in
amounts greater than 0.050 percentage weight/weight, weight/volume, or
volume/volume, or greater than 1.00 milligram of 7-hydroxymitragynine
in the article.
II. Topics for Public Input
This notice is seeking input on the 7-OH threshold identified and
justified above. In particular, comments are sought on the following
topics:
1. Whether any additional data exist that further support this or
an alternative threshold level, and specifically, what concentration or
quantity of 7-OH in a product constitutes an imminent hazard to public
safety \1\ and
---------------------------------------------------------------------------
\1\ The Controlled Substances Act (CSA) provides the Attorney
General with the authority to temporarily place a substance in
schedule I of the CSA for two years without regard to the
requirements of 21 U.S.C. 811(b), if he finds that such action is
necessary to avoid an imminent hazard to public safety (21 U.S.C.
811(h)(1)). When issuing an order under 21 U.S.C. 811(h)(1), the
Attorney General shall be required to consider, with respect to the
finding of an imminent hazard to the public safety, only those
factors set forth in 21 U.S.C. 811(c)(4), (5), and (6), including
actual abuse, diversion from legitimate channels, and clandestine
importation, manufacture, or distribution (21 U.S.C. 811(h)(3)).
---------------------------------------------------------------------------
2. Whether data exist supporting alternative measurement
expressions for purposes of specifying the threshold level that is
necessary to avoid an imminent hazard to public safety.
Note that OASH is not soliciting comment on any permanent
scheduling decision, the general safety or utility of kratom-derived
products, or other policy questions outside the scope of the threshold
determination for temporary scheduling. Public comments submitted to
this docket will be provided by the Secretary for Health and Human
Services for consideration by the Attorney General.
Brian Christine,
Assistant Secretary for Health, Department of Health and Human
Services.
[FR Doc. 2026-13608 Filed 7-1-26; 4:15 pm]
BILLING CODE 4164-01-P