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  7. Public Notification: Body Shape Weight Loss System contains hidden drug ingredients
  1. Medication Health Fraud

Public Notification: Body Shape Weight Loss System contains hidden drug ingredients

[10-2-2024] FDA continues to advise consumers not to purchase or use Body Shape Weight Loss System, a product promoted and sold for weight loss. This product was identified during an examination of international mail shipments.

FDA laboratory analysis confirmed that Body Shape Weight Loss System contains sibutramine and phenolphthalein not listed on the product label.

Body Shape Weight Loss System 1

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

Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it may increase the risk of cancer.

[11-24-2020] The Food and Drug Administration is advising consumers not to purchase or use Body Shape Weight Loss System, a product promoted for weight loss. This product was identified during an examination of imported goods.

Body Shape Weight Loss System

FDA laboratory analysis confirmed that Body Shape Weight Loss System 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 heart rate in some people and may present a significant risk for people with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.

Health care professionals and patients should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Note: This notification is to inform the public of products marketed as dietary supplements or conventional foods with hidden drug ingredients and chemicals. These products are typically promoted for sexual enhancement, weight loss, or 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.

For more information:

Public Notification: Body Shape Weight Loss System contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Body Shape Weight Loss System, a product promoted for weight loss. This product was identified during an examination of imported goods.

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