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Alli is an over-the-counter (OTC) weight-loss drug marketed by GlaxoSmithKline. (Alli - pronounced 'al-eye' - is a reduced strength version of Xenical (generic name orlistat), a prescription-only drug manufactured by Roche).

U.S. FDA Approval

The U.S. Food and Drug Administration approved Alli on February 7, 2007, for OTC marketing "in conjunction with a weight loss program that includes a reduced calorie diet, a low fat diet, and an exercise program. It is approved for use in adults 18 years and older. A multivitamin should be taken every day when alli is used as part of a weight loss program." [1]

The FDA approved label for the product includes the warning that:

orlistat works by preventing the absorption of some of the fat you eat. The fat passes out of your body, so you may have bowel changes. You may get:
  • gas with oily spotting
  • loose stools
  • more frequent stools that may be hard to control
eating a low-fat diet lowers the chance of having these bowel changes. [2]

Contact details

Video: GSK video on "treatment effects"

Resources and articles

SourceWatch articles


  1. U.S. Food and Drug Administration, Orlistat OTC (marketed as alli) Information", February 12, 2007.
  2. "Alli: Starter Pack Label, February 2007.

External links

USFDA links

External articles

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