| U.S. Food and Drug Administration |
FDA Consumer Alert P04-39, Apr 01, 2004
FDA Warns Distributors of Dietary Supplements
Promoted Online for Weight Loss
The Food and Drug Administration (FDA) has sent warning letters to 16 dietary
supplement distributors making false and misleading claims for weight loss
products promoted over the internet.
"Obesity in America is at epidemic proportions, and we will not tolerate
companies making false claims promising easy fixes," Health and Human Services
Secretary Tommy G. Thompson said. "There is no substitute for eating well and
remaining physically active."
Many of these products claim to block starch, carbohydrates and fat calories,
while allowing consumers to lose weight without any changes in lifestyle. For
example, some of the product labels have claimed:
- "Eat All You Want! Block the Starch and Lose Weight!";
- "Neutralize up to 66 percent of the starch consumed in a meal";
- "This advanced dietary-fat inhibitor helps block the absorption of fat
calories";
- "Take 3 capsules before bedtime. Watch the fat disappear!"; and
- "Guaranteed to block the breakdown of carbohydrates and simple sugars from
being converted into fat."
"These products give unfounded hope to people who are attempting to lose
weight. False and misleading claims have significant health consequences to
individuals that may be overweight because these products do not produce the
desired results," said Acting FDA Commissioner Lester M. Crawford, D.V.M., Ph.D.
"FDA will continue to enforce the law and pursue products that lure consumers
with unsubstantiated weight loss claims."
Although dietary supplement labeling may include claims about the
supplement's effect on the structure or function of the human body, the law
requires that "structure/function" claims must have substantiation and be
truthful and not misleading. After reviewing the claims of the various products,
FDA concluded that claims being made regarding these products are not supported
by reliable scientific evidence.
FDA is requesting a response from the firms in writing within 15 days of
receipt of the warning letters stating the action the firms will take to correct
the noted violations and to ensure that similar violations do not occur in the
future.
Today's announcement reflects FDA's continued commitment to two of its
highest priorities:
- To make available more and better information about foods and dietary
supplements to American consumers, so they can make informed choices about the
products they consume. In announcing this initiative in December 2002, FDA
reaffirmed its commitment to protect consumers from products bearing false or
misleading claims on conventional foods and dietary supplements.
- To combat the national epidemic of obesity. FDA's March 2004 Working Group
Report on Obesity recommends enforcement actions against weight loss products
having false or misleading claims.
Consumers that have purchased any of these products should contact the firms'
customer service department about their "return policy." Click here for a list of the distributors affected by this notice.
This advisory was prepared by the FDA Office of Public Affairs.