Is Alli FDA Approved?

DrugStatusIndex provides a clear, data-driven view of the regulatory status of medications, compounds, and related products. This page explains whether Alli is FDA approved and how it is commonly categorized.

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Overview

Alli is the over-the-counter brand name for orlistat 60 mg, a weight-loss medication used to help overweight adults reduce dietary fat absorption and support weight management.

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FDA Status Details

Alli is classified as FDA Approved. It was approved by the FDA for over-the-counter use for weight loss in overweight adults age 18 and older when used with a reduced-calorie, low-fat diet.

OTC Approval

Alli is the 60 mg over-the-counter version of orlistat, while Xenical is the 120 mg prescription version. Alli remains the only FDA-approved OTC weight-loss medication.

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Brand & Safety Considerations

Alli should be distinguished from supplements marketed for weight loss. It is an FDA-approved medication with specific labeling, dosage guidance, and known gastrointestinal side effects related to fat absorption.

Alli FDA Status

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FDA Approved

Alli is listed as FDA Approved as the only over-the-counter FDA-approved weight-loss medication in the United States. :contentReference[oaicite:0]{index=0}

Why People Search This

Users often search for Alli to understand whether it is truly FDA approved, how it compares to Xenical, and whether it is safer than non-prescription weight-loss supplements.

Disclaimer

This page is for informational purposes only and reflects publicly available regulatory data. It does not provide medical advice or treatment recommendations.

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