Image: U.S. Food and Drug Administration — public domain (U.S. Government work)
What the regulator says
The United States Food and Drug Administration (FDA) is advising consumers not to purchase or use LUZE Fit Intensity. FDA laboratory analysis confirmed that the product contains sibutramine, a controlled substance not listed on the product label. The FDA notes that it is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients, and urges consumers to exercise caution before purchasing such products.
The product
LUZE Fit Intensity is a product promoted and sold for weight loss. It is typically represented as being all natural and is potentially marketed as a dietary supplement or conventional food.
The substance or defect
FDA laboratory analysis confirmed the presence of sibutramine, a controlled substance that was removed from the market due to safety concerns. Sibutramine is known to significantly raise blood pressure and/or heart rate in some people, posing serious risks for those with a history of heart disease, heart failure, irregular heartbeat, or stroke. The product may also interact in life-threatening ways with other medications.
Where it was sold
LUZE Fit Intensity has been promoted and sold for weight loss on various websites, including https://shop.app, and possibly in some retail stores.
What to do
Consumers should not purchase or use LUZE Fit Intensity. Healthcare professionals and consumers who experience adverse events or side effects related to this product should report them to the FDA’s MedWatch Safety Information and Adverse Event Reporting Programme by completing the online voluntary reporting form at https://www.accessdata.fda.gov/scripts/medwatch/ or by downloading and submitting the form via fax to 1-800-FDA-0178.
Source
This alert is based on a notice issued by the United States Food and Drug Administration (FDA) on 15 September 2026. The original notice is available at https://www.fda.gov/drugs/medication-health-fraud-notifications/luze-fit-intensity-may-be-harmful-due-hidden-ingredient.
Sheni Labs publishes one alert a day from official regulator notices. This item reports the notice; it is not a Sheni Labs verdict. Corrections: info@accreditation.ge. Republished on GMJ News.
