The Food and Drug Administration is placing restrictions on fat-reducing injections that are administered in spas across the United States. According to an FDA statement last week, the drugs have not yet been cleared by federal scientists, and therefore, are going against the law.
Lipodissolve injections provide overweight individuals with an alternative to liposuction. However, the products have not been proven safe and effective as many spas claim.
The FDA issued formal warning letters to 12 spas that offer these lipodissolve injections. In the warnings, the spas were cited for making “false and misleading” claims that were “not supported by substantial evidence or substantial clinical experience.” The facilities were instructed to contact the FDA within 15 business days to report what steps they are taking to correct the issue.
Cases of permanent scarring and skin deformations have been reported following the use of these injections.
Dr. Jennifer Walden, a plastic surgeon at Lenox Hill Hospital, claimed that although the chemicals in the injections occur naturally in the human body, they still may not be safe.
“They are used in the metabolic process of our bodies to break down fat, but they were never intended to be extracted, mixed with other ingredients and reinjected to break down fat,” Walden said.
Doctors who are using the drugs cosmetically have been asked to submit an approval application to be reviewed by the FDA.