Connie D. looked like she'd always been comfortable in her size four skin as she strutted the runway in her custom black dress, made for her by Project Runway's Laura Bennett, at last week's Millions Event. To date Connie has lost a total of 60 lbs. and looks and feels great. But, she knows the road does not end here. "When I made this decision, it wasn't for a short time; it's for a lifetime."

Nearly 50 successful alli users gathered in the Big Apple to share their stories as a part of the one-year alli anniversary. Connie and 13 other alli users are telling their success stories in a short book titled, "We Lost It."  The book is available on allimillions.com. Most of the real-life stories, including Connie's, are also on myalli.com. 

And over the next few weeks, we will introduce you to a few alli users here on the blog.

alli has sold over 2 million starter packages to date (and adding tens of thousands every week). That's a lot of people learning how to eat better (fewer calories in) and get more active (more calories burned).

As Margaret Meade said, "Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it's the only thing that ever has." 

I'm following anecdotally (I can't read everything) what the hundreds of thousands of people who started using alli in June have to say about this new and unique combination of a fat blocker and food education program. To date, over 100,000 messages have been left on the official alli message board. Over 5 million unique visitors have visited the product Web site, myalli.com.

In addition, tens of thousands of users are talking to each other about alli in blogs and online discussion groups they've formed themselves. One of the biggest is alli allies on Weight Watchers. See our new blogrolls in the right-hand column for more links to online communities.

Can these two million alli users change the way Americans define meaningful weight loss and how best to go about it? Can a committed group of Americans combat weight loss myths? Is it a revolution yet??

P.S. The screen grab above is from our public service Web site questioneverything.com (short for "question everything about weight loss"), which started the ball rolling before alli launched by providing food education and provocative discussions about weight loss myths.

If you have a question about the alli program, let me know.

N.B. See this new GSK study reporting on product satisfaction from controlled clinical trials.

I know "safety" is a key concern for people before they put anything into their body, whether it's food or a pill. That's why I find it interesting when I'm asked how alli can possibly be the only FDA-approved weight loss aid.

I get asked questions like "there are so many products available in the weight loss section of stores and/or online - how can only one be FDA-approved?" The answer is that getting FDA approval for a new over-the-counter drug is a rigorous process where studies of safety and effectiveness are carefully scrutinized. Let me give you a little background.

To gain FDA approval, OTC medicines need to prove safety and effectiveness before they can be sold. When we applied for over-the-counter status for orlistat, under the name alli, we relied on the scientific knowledge gained from over 100 clinical trials, 30,000 people who had participated in clinical trials, and 28 million prescriptions written for it around the world.

By contrast, guess how many clinical trials the maker of a supplement or herbal weight loss pill needs to submit to the FDA before it's sold "over-the-counter"? None.  They may have them, but they aren't required to share them.

Most people incorrectly believe that dietary and weight loss supplements are FDA approved

Millions of Americans are using dietary and weight loss supplements. In fact, according to our study conducted in 2005, one-third of respondents who have tried to lose weight report having used dietary supplements. And half the survey respondents mistakenly believed these supplements are reviewed and approved by the FDA for their safety and efficacy.

That surprising misconception was reported in a large survey conducted by the University of Connecticut (and funded by GSK). A key finding (download PDF of study abstract):

• Over 50% of those surveyed mistakenly believe the FDA approves weight loss supplements for safety and almost 50% believe the FDA reviews them for effectiveness.

It's my hunch that this kind of confusion about weight loss supplements is fueling Americans' use of unproven and potentially unsafe options that aren't approved by the FDA.

How do we change misconceptions about herbal weight loss supplements?

• How do we correct the misconceptions that people hold about the differences between weight loss supplements and weight loss medicines? 

I'd really like to hear your thoughts.

P.S.

To be "over-the-counter" means you don't need a prescription to buy something from a grocery store or pharmacy.  Vitamins, paper towels, weight loss supplements - they're all sold "over-the-counter." But to be an OTC (also stands for over-the-counter, are we confused yet?) medicine, a product needs FDA approval and proof of safety and effectiveness before it can be purchased by consumers "off-the-shelf."