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." 
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. 
Resources and articles
- U.S. Food and Drug Administration, Orlistat OTC (marketed as alli) Information", accessed June 2007.
- Deborah Kotz, "Battling the Bulge? A New Weight-Loss Drug Gains Approval," U.S. News & World Report, February 8, 2007.
- Prescription Access Litigation, "Prescription Access Litigation gives latest Bitter Pill Award to GlaxoSmithKline: Drugmaker gets the ‘With Allies Like This, Who Needs Enemas?’ Award for Irresponsibly Selling a Formerly Prescription-Only Weight Loss Drug Over-the-Counter", Media Release, June 7, 2007.
- John Mack, "Alli Newspeak: Oily Spotting is "Treatment Effect"", PharmaMarketing Blog, June 12, 2007.
- Julian Kesner, "Don't swallow the hype: It's approved by the FDA, but that does not make Alli a magic obesity cure," NYDailyNews.com, June 13, 2007.
- Adam Voiland, "FDA Committee Recommends Against Diet Drug; Another Arrives in Stores," U.S. News & World Report, June 13, 2007.
- Marrecca Fiore, "Group: Diet Drug Alli Linked to Colon Cancer," Fox News, June 14, 2007.
- Barbara Feder Ostrov and Saqib Rahim, "Smaller waistline vs. side effects - diet drug debuts," San Jose Mercury News, June 15, 2007.
- Prescription Access Litigation, "Alli’s side effects — er, 'treatment effects'" Prescription Access Litigation blog, June 12, 2007.
- Raina Kelley, "The Word Is 'Leakage'. Accidents may happen with a new OTC diet drug," Newsweek (MSNBC), June 25, 2007 issue.
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- "Alli: Starter Pack Label, February 2007.