📌 Key Takeaways
- Japan’s Ministry of Health, Labour and Welfare (MHLW) issued a formal appropriate-use notice on June 16, 2026,
targeting off-label cosmetic and weight-loss use of GLP-1 receptor agonists
including Mounjaro, Ozempic, and Wegovy.
Notice reference: Iyaku-an-hatsu 0616 No. 16 - Health Minister Kenichiro Ueno directly requested countermeasures from
Eli Lilly Japan (Mounjaro) and Novo Nordisk Pharma Japan (Ozempic / Wegovy) - The notice officially acknowledges that some clinics and pharmacies are prescribing GLP-1 drugs for cosmetic and weight-loss purposes
outside approved indications—and warns of unconfirmed safety risks - Advertising GLP-1 drugs for cosmetic or weight-loss purposes is now explicitly prohibited.
Adverse event reports must now include “off-label use (cosmetic purpose)” as the reason for use - The notice explicitly states that supply must not be disrupted
“for patients who truly need these medications”—
formally acknowledging that cosmetic misuse is threatening access for diabetic patients
On June 16, 2026, Japan’s Ministry of Health, Labour and Welfare (MHLW) issued a formal appropriate-use notice
targeting the off-label cosmetic and weight-loss use of GLP-1 receptor agonists.
The notice covers Mounjaro (tirzepatide), Ozempic (semaglutide), and Wegovy (semaglutide),
and was issued under reference numbers Iyaku-an-hatsu 0616 No. 16 and Isei-so-hatsu 0616 No. 1.
Health Minister Kenichiro Ueno confirmed at a post-cabinet press conference the same day
that he had personally requested action from Eli Lilly Japan and Novo Nordisk Pharma Japan.
“If used outside their intended purpose,” he stated,
“there is a risk of unexpected health harm.”
⚠️ Critical Note:
If an adverse event occurs from off-label use,
the patient may not be eligible for Japan’s Adverse Drug Reaction Relief Fund.
INDEX
Why Did MHLW Act Now? The Regulatory Background
Mounjaro (tirzepatide) was originally approved in Japan as a treatment for type 2 diabetes.
In February 2024, its indication was expanded to include severe obesity
(BMI ≥27 with two or more comorbidities, or BMI ≥35).
Despite these strict criteria, prescriptions through aesthetic clinics and online medical services
surged for patients seeking weight loss for cosmetic rather than medical reasons.
NERO has previously reported on this trend,
including the growing disruption to legitimate supply chains.
📅 GLP-1 Regulatory Timeline in Japan
Mounjaro (tirzepatide) receives expanded approval for obesity in Japan.
Strict eligibility criteria established: BMI thresholds, comorbidity requirements,
and prior diet/exercise therapy.
Resale of Mounjaro surges on social media and secondhand marketplaces.
Osaka Prefectural Police refer a case for prosecution;
Tokyo Metropolitan Government issues direct warnings on X (formerly Twitter).
The U.S. FDA proposes removing semaglutide and tirzepatide
from the 503B compounding list,
with a public comment deadline of June 29, 2026.
MHLW issues formal appropriate-use notice (Iyaku-an-hatsu 0616 No. 16 et al.).
Health Minister Ueno directly requests action from Eli Lilly Japan and Novo Nordisk Pharma Japan.
Public alerts issued on X clarifying that Mounjaro is approved only for type 2 diabetes.
The Four Restrictions: What the Notice Explicitly Prohibits
❌ Restriction 1: Off-Label Use for Cosmetic or Weight-Loss Purposes
The notice states explicitly that
“safety and efficacy have not been confirmed when used outside approved indications.”
Mounjaro’s approved indications are limited to type 2 diabetes
and severe obesity meeting strict BMI and comorbidity criteria.
Prescribing for “diet” or “cosmetic” purposes constitutes off-label use,
even when performed by a licensed physician.
❌ Restriction 2: Advertising Off-Label GLP-1 Use
The notice states that advertising unapproved or off-label drugs in self-pay medical services
is “prohibited in principle.”
While clinic websites may be partially exempt,
any advertisement that emphasizes efficacy without adequate scientific evidence
to drive patients toward treatment is classified as “exaggerated advertising” and prohibited.
Phrases such as “Lose weight with Mounjaro” or “Slim down with GLP-1”
may violate this standard.
⚠️ Requirement: Mandatory Risk Disclosure to Patients Before Use
The notice mandates that prescribers must explain risks to patients before initiating GLP-1 therapy.
This includes serious adverse events such as hypoglycemia and acute pancreatitis,
as well as commonly occurring gastrointestinal symptoms:
nausea, vomiting, diarrhea, constipation, and abdominal pain.
📋 New Requirement: Adverse Event Reports Must Specify “Cosmetic Purpose”
When an adverse event occurs from off-label use,
healthcare providers are legally required to file an adverse drug reaction report
under Article 68-10(2) of Japan’s Pharmaceuticals and Medical Devices Act.
The new notice requires that the “reason for use” field in such reports
explicitly state “off-label use (cosmetic purpose).”
This creates a formal government tracking system
for adverse events arising from cosmetic GLP-1 use.
“Supply Must Not Be Disrupted for Patients Who Truly Need It”
One of the most significant phrases in the June 16 notice is the directive
that supply must not be disrupted “for patients who truly need these medications.”
This language represents the MHLW’s first official acknowledgment
that off-label cosmetic demand is creating real shortages
for patients with type 2 diabetes and severe obesity
who depend on these drugs for medical treatment.
The structural problem is clear:
when GLP-1 drugs are diverted to cosmetic use,
diabetic patients who rely on them as a medical necessity
lose access to treatment.
Japan’s health ministry has now formally placed this on the record.
AND two or more obesity-related health conditions;
OR BMI ≥35 kg/m² (only after diet and exercise therapy proves insufficient)
now formally classified as off-label by this notice
advertising language implying off-label cosmetic use is prohibited
NERO has covered this issue from multiple angles—
Mounjaro resales on social media, FDA compounding restrictions,
counterfeit GLP-1 products in the UK.
Today, Japan’s health ministry made its formal move.
The most consequential element of this notice is the requirement to document
“off-label use (cosmetic purpose)” in adverse event reports.
This is not merely a warning.
It is the construction of a formal government surveillance system
for cosmetic GLP-1 use—
and once adverse event data accumulates,
it will become the evidentiary basis for further regulatory tightening.
“Everyone’s doing it” is no longer a defense.
Japan’s health ministry took its first formal step today.
Summary
- MHLW issued a formal appropriate-use notice on June 16, 2026
(Iyaku-an-hatsu 0616 No. 16; Isei-so-hatsu 0616 No. 1),
with Health Minister Ueno directly requesting action from Eli Lilly Japan and Novo Nordisk Pharma Japan - The notice officially recognizes that GLP-1 drugs are being prescribed for cosmetic purposes
outside approved indications,
and warns that off-label use carries unconfirmed safety risks and potential health harm - Advertising GLP-1 drugs for cosmetic weight loss is prohibited in principle.
A new rule requires adverse event reports to specify “off-label use (cosmetic purpose),”
establishing a formal government tracking mechanism - The notice’s directive to protect supply “for patients who truly need it”
marks the first official acknowledgment that cosmetic misuse
is threatening treatment access for diabetic patients in Japan
Frequently Asked Questions
it does not immediately create criminal liability for existing prescriptions.
However, NERO recommends discussing with your prescribing physician
whether to continue, and confirming the risk monitoring plan in place.
If an adverse event occurs under off-label use,
you may not be eligible for Japan’s Adverse Drug Reaction Relief Fund.
Off-label prescribing by physicians is not immediately illegal,
but clinics are now required to comply with informed consent obligations,
adverse event reporting requirements, and advertising restrictions.
Further regulatory tightening remains possible as adverse event data accumulates.
(1) Type 2 diabetes, when diet and exercise therapy alone are insufficient;
(2) Obesity with BMI ≥27 kg/m² plus hypertension, dyslipidemia, or type 2 diabetes
and two or more obesity-related conditions,
OR BMI ≥35 kg/m² after diet and exercise therapy proves insufficient.
Wanting to lose weight for cosmetic reasons alone does not meet these criteria.
Sources
Ministry of Health, Labour and Welfare (MHLW), Japan. “Appropriate Use of GLP-1 Receptor Agonists and GIP/GLP-1 Receptor Agonists.” Notice Iyaku-an-hatsu 0616 No. 16; Isei-so-hatsu 0616 No. 1; Isei-san-jo-ki-hatsu 0616 No. 1. June 16, 2026. /
Post-Cabinet Press Conference, Health Minister Kenichiro Ueno, June 16, 2026. /
AnswersNews. “MHLW Requests Appropriate Use of GLP-1 Receptor Agonists; Manufacturers Asked to Respond.” June 16, 2026. /
MIXS Online. “MHLW Requests Countermeasures from Eli Lilly Japan and Novo Nordisk, Makers of Mounjaro and Ozempic.” June 17, 2026. /
MHLW. Mounjaro (Tirzepatide) Electronic Package Insert, revised February 2024. /
MHLW. Wegovy (Semaglutide) Optimal Use Promotion Guidelines, 2024.
