Even though the FDA has not yet approved the diet drug Alli (low-dose Xenical) for over-the-counter sale, GlaxoSmithKline has launched a weight-loss website that presumably will be a key part of its efforts to market the diet pill.

The website, QuestionEverything.com, says it "was developed and is maintained by GlaxoSmithKline Consumer Healthcare," the side of Glaxo that markets the company's products that are sold without a prescription. At present, Glaxo has no diet pill on the market.

The site, of course, does not mention Alli (pronounced Al-EYE) by name. That would set off alarm bells at the FDA, which has declared Alli "approvable" but has held up a final decision until certain unspecified conditions are met.

But in anticipation of FDA approval of Alli later this year, the QuestionEverything.com site -- which requires that visitors register in order to post comments or questions and take part in surveys -- is collecting thousands of email addresses for use in its orlistat marketing campaign.

"By submitting this form GlaxoSmithKline Consumer Healthcare has your permission to send you future communications on one or more of our brands," the website says. "Our desire is to deliver value to such as timely health information, valuable promotional offers, relevant product news or to request your feedback in consumer surveys."

Sanofi-Aventis, which is also hoping for FDA approval later this year of its highly anticipated prescription weight-loss drug Acomplia (rimonabant), to the best of our knowledge has not launched any similar prelaunch website.

Even without pitching Alli, Glaxo's website -- under the slogan "question everything you know about weight-loss" -- takes a number of direct shots at the diet pills currently being sold over the internet and in health-food stores.

"Your heart should race from being in love, not from your diet pill," is just one of the pieces of advice being offered about Alli's future competitors. "Some weight loss supplements claim to increase your metabolism, but what they're really increasing is your heart rate because they contain ingredients like caffeine. They stimulate your heart and don't produce substantial weight loss."

The New York Times reported on April 26th that Glaxo envisions Alli being sold at free-standing drugstore kiosks along with a colorful kit containing 250-page booklets with diet advice and meal plans, calorie counters and dining-out guides.

Consumers would also be able to sign up for a free online behavioral support program, along with e-mail newsletters and chat rooms where people can trade stories of their diet successes and lapses, the Times reported.

While Glaxo has a reputation for being very successful in transitioning prescription drugs to over-the-counter products, with the smoking cessation product Nicorette frequently cited as an example, Alli presents a new type of challenge.

Prescription Xenical has been far less than the blockbuster drug once envisioned largely because of side-effects that include diarrhea, flatulence and episodes of incontinence.

In a Glaxo study of patients taking Xenical at the over-the-counter dosage, about 3 percent quit because of the side effects.

"We have to go out of our way to make sure people understand how the product works," Glaxo marketing executive Steven L. Burton told the Times.