One person has died and several have suffered heart problems after consuming the weight loss products, warned the FDA.
“Sibutramine is known to increase blood pressure and/or pulse rate in some patients and may present a serious risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke,” according to a FDA statement. “Sibutramine may also interact in life-threatening ways with other medications a consumer may be taking.”
Reflecting these safety concerns, the ingredient was withdrawn from the US market in December 2010.
Sold exclusively on the internet under the brand names Fruta Planta and Reduce Weight Fruta Planta, the US distributor is PRock Marketing LLC, of Kissimmee, Florida, which has recalled the products.
The FDA advises people who are using the products to stop immediately.
Negative side effects
Consumers who have experienced any negative side effects are advised to 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 (www.fda.gov/MedWatch/report.htm ).
Fruta Planta, supplied in 30 capsule boxes, claims to be a 100% Chinese Weight Loss Solution. According to the Fruita Planta label: “Fruta Planta reduces your appetite and helps to curve cravings while boosting your metabolism. This product has no known side effects. Lose up to 25 pounds in the first month. No diet, no exercise required.”
Meanwhile, a statement on the FrutaPlanta’s website (www.frutaplanta.com ) confirmed that product orders were no longer being accepted.
Safety or efficacy
It also highlights a FDA MedWatch Alert statement: "Fruta Planta has not been approved by the FDA. Thus, we do not have information to support the safety or efficacy of this product."
But the company questioned whether its products had been tested and found to contain sibutramine.
The notice adds: “Since 1998, Fruta Planta has provided consumers a healthy and safe way to lose unwanted pounds. We urge all of our clients to always consult their health care provider before taking any weight loss supplement.”
No one from Fruta Planta was available to speak to NutraIngredientsUSA.com.
Immediately before publication, NutraIngredientsUSA.com found a range of websites still promoting the recalled products.