On this page:
- What weight loss products have been cited?
- Why did FDA act against these products?
- What health risks are associated with these products?
- Which undeclared active pharmaceutical ingredients were found?
- Where are these products sold?
- Is FDA taking further action?
- What should consumers do?
On March 20, 2009, the Food and Drug Administration (FDA) further expanded its nationwide alert about tainted weight loss products containing undeclared, active pharmaceutical ingredients. The alert now lists more than 70 weight loss products that may be harmful.
FDA initially alerted consumers against using certain tainted weight loss products on Dec. 22, 2008. The agency expanded that alert on Jan. 8, 2009. The alert issued on March 20, 2009, identifies three additional weight loss products (Herbal Xenicol, Slimbionic, and Xsvelten) and four new undeclared active pharmaceutical ingredients (fenproporex, fluoxetine, furosemide, and cetilistat).
What weight loss products have been cited?
For the latest list of tainted weight loss products, visit Contaminated Weight Loss Products.
Why did FDA act against these products?
These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, prescription drugs in amounts that greatly exceed maximum recommended dosages.
Some of the products claim to be "natural" or to contain only "herbal" ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. These products have not been approved by FDA, are illegal, and may be potentially harmful to unsuspecting consumers.
What health risks are associated with these products?
The risks posed by these products can be very serious and include high blood pressure, seizures, rapid heartbeat, palpitations, heart attack, and stroke.
Which undeclared active pharmaceutical ingredients were found?
- Sibutramine, a prescription-only appetite suppressant that is also a controlled substance. It was found in many of these products at high levels that can increase the incidence and severity of the listed health risks.
- Fenproporex, a controlled substance that is not approved for marketing in the United States. It can cause arrhythmia (a disorder of your heart rate or rhythm) and possible sudden death.
- Fluoxetine, a prescription-only antidepressant.
- Bumetanide and furosemide, potent diuretics (drugs that increase the production of urine) available by prescription only.
- Cetilistat, an experimental obesity drug not approved for marketing in the United States.
- Phenytoin, a prescription-only anti-seizure medication.
- Phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States.
Where are these products sold?
These weight-loss products, some of which are marketed as dietary supplements, are promoted and sold on various Web sites and in some retail stores and beauty salons.
Is FDA taking further action?
FDA has inspected a number of companies associated with the sale of these illegal products and is currently seeking product recalls. Based on FDA's inspections and the companies' inadequate responses to recall requests, the agency may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges.
What should consumers do?
- If you use any of these weight loss products, stop taking them and consult your health care professional immediately.
- Seek guidance from a health care professional before purchasing weight loss products.
- Report serious adverse reactions or product quality problems to FDA's MedWatch Adverse Event Reporting program at MedWatch.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Updated: March 27, 2009