It has now been nine months since the U.S. Food and Drug Administration put a hold on approval of diet pill alli, and observers are starting to wonder if the agency is having second thoughts about making the half-strength version of Xenical (orlistat) the first FDA-approved over-the-counter weight-loss drug.

GlaxoSmithKline, which originally hoped to be putting up displays of alli (pronounced Al-EYE) in the aisles of pharmacies way back last summer, now is saying nothing about when it hopes to get the diet pill on the market.

The hush that has fallen over the subject of alli nine months after GlaxoSmithKline's announcement that it had received an "approvable" letter for alli from the U.S. Food and Drug Administration is not an encouraging sign.

An "approvable" letter means issues still need to be resolved prior to FDA action, and Steven L. Burton, vice president of weight control products for Glaxo, declined at the time to elaborate on what was holding up FDA approval except to say the agency did not ask for additional human testing.

Burton said the company was entering discussions with the FDA to address its additional questions, and expressed optimism that alli could be in drugstores before the end of 2006.

But not only is alli not in drugstore, but there have been no recent professions of optimism from GlaxoSmithKline.

This is all the more puzzling in light of the fact that two FDA advisory committees heard arguments both for and against approving the over-the-counter version of Xenical a year ago, and voted 11-to-3 in favor of non-prescription sale of the drug.

Members of the FDA advisory panels concluded unanimously that the proposed over-the-counter version helped patients lose an extra 5 to 6 pounds during the six months they would take it. They also voted 12-to-3 that the drug appeared generally safe, although some members voiced concerns about repeated and long-term use.

Glaxo hoped to market alli as a prescription-quality alternative to unapproved diet supplements sold in health-food stores, drugstores and over the internet, and has said alli could cost consumers $12 to $25 a week.

Another proposed weight-loss medication, Sanofi's highly touted prescription drug Acomplia (rimonabant), also is stalled at the FDA for unspecified reasons, with no further FDA action expected until late April.