Fruta Planta weight loss products have been marketed as a "100% Chinese Weight Loss Solution," promising to reduce appetite, curb cravings, and boost metabolism, with claims of losing up to 25 pounds in the first month without known side effects. However, these claims are misleading and dangerous. The Food and Drug Administration (FDA) has issued warnings against Fruta Planta, citing the presence of sibutramine, a controlled substance that poses serious health risks.
The Danger of Sibutramine
Sibutramine was once approved by the FDA as a prescription-only weight loss supplement. However, it was withdrawn from the US market in October 2010 due to safety concerns. Clinical trials revealed that sibutramine increases the risk of serious heart events, such as heart attacks and strokes, by 16%, while offering only a small difference in weight loss compared to a placebo.
The FDA warns that 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. Furthermore, sibutramine may interact in life-threatening ways with other medications a consumer may be taking.
FDA Warnings and Recalls
The FDA has been actively warning consumers against Fruta Planta and similar products. FDA laboratory analysis confirmed that Fruta Planta purchased from eBay.com contains sibutramine. In one instance, the FDA attempted to contact aialoj0, a seller on eBay, to discuss how the company could protect consumers from these dangerous products.
PRock Marketing LLC, of Kissimmee, Florida, the US distributor of Fruta Planta, has recalled all lots of Fruta Planta and Reduce Weight Fruta Planta after FDA testing determined that the product contains sibutramine. This recall was announced on December 31. The FDA has received multiple reports of adverse events associated with the use of Fruta Planta and Reduce Weight Fruta Planta, including several cardiac events and one death.
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Identifying Fruta Planta Products
Fruta Planta and Reduce Weight Fruta Planta are marketed as the same product and are available in 30-capsule boxes. Godi International also marketed Fruta Planta in 30-capsule boxes, Reduce Weight Fruta Planta in 30-capsule boxes with a gold sticker.
What to Do If You Have Used Fruta Planta
The FDA advises consumers to stop using Fruta Planta immediately. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. PRock Marketing's recall notice recommends that consumers throw the product away in a sealed container where children and animals cannot gain access to it or return it to the company.
The FDA invites health care professionals and patients to report adverse events or side effects to FDA's MedWatch Safety Information and Adverse Event Reporting Program.
The Risk of Untested Supplements
The Fruta Planta case highlights the risk of using dietary supplements that have not been approved by the FDA. Unlike drugs, dietary supplements do not require FDA approval, though manufacturers and distributors are responsible for selling a safe product. The FDA has alerted consumers to at least 300 tainted products marketed as dietary supplements in recent years and received numerous injury complaints related to them.
These products are often promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” However, FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients.
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