"For something to be safe and effective, it has to be studied in the population it's intended for, and only then can you say it's safe and effective. Frankly, those are terms used by the Food and Drug Administration once something comes to market," Dr. Senay says. "Not true in this case because it hasn't been studied in the population that it's intended for. There's no way they can say that."
Since the pills are marketed as a supplement, not a drug, they are not subject to FDA trials.
The pill contains the herbal diuretics, Uva Ursi and Juniper Berry. Doctors are saying the unregulated use of diuretics by children can be dangerous.
"Kids who take diuretics can put themselves at risk for kidney problems and metabolism problems. Since we don't know, it's difficult to say whether or not these are safe for kids. Some of the diuretics are not indicated for kids under 12. Again, no way to know, without knowing it's safe, I can't imagine who would give it to a kid," says Dr. Senay.
Psychiatrists are worried as well about the message this pill sends to kids. "The notion of giving kids pills to lose weight reinforces our destructive focus on thinness as the ultimate beauty," says Dr. Elena Lister, a child psychiatrist in Manhattan. "And that's harmful."
But Kaye says her pill gives fat children "hope and motivation" and helps their metabolism. Kaye is a self-published diet guru and medical journalist who bills herself as America's Favorite Nutritionist. She sells the Skinny Pills on her Web site at $39.99 for a 30-day supply - although only pre-ordering is available, none of the kids' supplement has been shipped yet.
The pills come with a set of flash cards based on Kaye's "AM/PM" food plan - one that suggests eating foods high in fiber in the morning and protein-heavy, or "fat-burning foods," at night.
Kaye first attracted national attention, when she told TV and radio audiences to forget about exercise and eat themselves skinny with a food plan based on international research. In 36 months, Kaye has created a near-cult of followers who swear by her program and include health practitioners who actually prescribe her Skinny AM-PM System of fat-blocking fiber-rich foods, fat-burning protein-rich foods and Skinny Pills to patients. Kaye appears regularly as the nutritionist on Good Day Dallas and is the host of her own radio talk show.
"I think it sets a dangerous precedent - that pills are a solution to all our problems," says Dr. Kerry Sulkowicz, who heads the Public Information Committee of the American Psychoanalytic Association. "Clearly there are risks, psychologically and physically, to obesity at any age, but obesity is not a simply physical matter. You're just putting a Band-Aid on a deeper problem."
"You have to use your common sense. The supplements are not regulated in the sense that prescription drugs are by the Food and Drug Administration, you are always taking a risk when you buy the things," says Dr. Senay.
According to the Center for Disease Control, there are now over 5 million obese kids in America, and 15 percent of children between the ages of 6 and 19 (double the number 20 years ago) are suffering an alarming rise in breathing disorders, gallbladder disease, adult onset diabetes with its very real risks of blindness, kidney failure, stroke, heart attack and pre-mature death, breathing disorders, gallbladder disease.