FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury
FDA updated labeling for OTC weight loss drug alli (orlistat) to include warnings about kidney stones and kidney injury. Med-spas that recommend or sell alli must update patient information and counseling protocols.
Aforeworn detected this change in the Med-Spa & Aesthetics Clinics space on July 6, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Medium urgency. Med-spas that recommend, sell, or administer alli (orlistat) to clients. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Within 30 days of label change (effective immediately upon approval).. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Med-Spa & Aesthetics Clinics continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
The OTC Drug Facts Label now includes warnings about risk of kidney stones and kidney injury.
Who it affects
Med-spas that recommend, sell, or administer alli (orlistat) to clients.
What you must do
Update patient counseling materials and protocols to include new kidney risk warnings; ensure staff are informed.
Deadline
Within 30 days of label change (effective immediately upon approval).
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