FDA: Sit and Slim II Contains Hidden Drug Ingredients

FDA warns consumers not to purchase or use Sit and Slim II product advertised for weight loss

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Sit and Slim II, a product promoted and sold for weight loss on various websites and possibly in some retail stores.

FDA laboratory analysis confirmed that Sit and Slim II contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. These products may also interact, in life-threatening ways, with other medications a consumer may be taking.

Laboratory analysis also confirmed that Sit and Slim contains phenolphthalein. Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories. 


Review Date: 
October 10, 2014
Last Updated:
October 15, 2014