FDA Sends Strong Lipodissolve Warning to Med Spas

The Food and Drug Administration announced April 7 that it sent warning letters to six medical spas and a Brazilian company asking them to cease and desist from making false and misleading claims about injectable lipodissolve products.

The companies cited by the FDA have made claims that their injectables are superior to other fat-dissolving or -removing procedures, and the injections can treat conditions such as gynecomastia and surgical deformities, said Kathleen Anderson, deputy director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research, in a briefing with reporters. The claims are illegal without clinical evidence or explicit FDA approval for the injectables, which generally contain phosphatidylcholine (PPC) and/or deoxycholate, and a variety of vitamins, minerals, and herbal extracts.

The letters were sent by overnight mail on April 5 to six American spas: Monarch Medspa, King of Prussia, Penn.; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Md.; Innovative Directions in Health, Edina, Minn.; Pure Med Spa, Boca Raton, Fla.; and All About You Med Spa, Madison, Ind.

The Brazilian company cited by the FDA sells lipodissolve products through its two Web sites www.zipmed.net and www.mesoone.com. The agency has issued an import alert for the Web sites, which should prevent the importation and distribution of the products.

Ms. Anderson said the companies were singled out because they had made what were considered to be the most egregious claims among the sites the FDA has monitored.

The agency is hoping to warn consumers that if they purchase these services, they are receiving therapies that are not approved by the FDA, she said. In addition, the drug components—PPC and deoxycholate—are not specifically approved as injectables or for fat dissolution. They are approved for inhalation as a lung surfactant in acute respiratory distress syndrome, said Ms. Anderson.

A complete list of concerns about lipodissolve, also known as mesotherapy or injectable lipolysis, can be found on an updated page for consumers on the FDA Web site. Among the safety concerns are permanent scarring, skin deformation, and painful knots under the skin. The agency has received five reports of such adverse events, Ms. Anderson said.

The FDA also said that clinicians who are using lipodissolve products should submit an application for approval so the agency can evaluate safety and efficacy. The Aesthetic Surgery Education and Research Foundation is conducting a small, placebo-controlled study using sham injections, compared with injections of PPC and sodium deoxycholate. The FDA has approved the study.

But most professional societies, including the Physicians Coalition for Injectable Safety, the American Society for Aesthetic Plastic Surgery (ASAPS), and the American Society for Dermatologic Surgery, have warned against fat-dissolving injections until there is further proof of efficacy and safety.

The FDA, for its part, said it would be monitoring further use of lipodissolve, whether by unlicensed practitioners or physicians. “If there are clinics and medical practices that are going to be making false and misleading claims, then we will go after them as well,” said Sudha Shukla, Pharm. D., of the FDA’s Division of New Drugs and Labeling Compliance, during the briefing.

It is not clear how many lipodissolve procedures are done each year. The ASAPS reported that 18,000 were done in 2008, but that an insufficient number of clinicians responded to its annual survey in 2009 to give a reliable number.

The companies cited by the FDA have 15 days to respond to the agency’s warning. If sufficient steps are not taken, then the agency has the power to issue an injunction or seize products, said Ms. Anderson.

The Food and Drug Administration announced April 7 that it sent warning letters to six medical spas and a Brazilian company asking them to cease and desist from making false and misleading claims about injectable lipodissolve products.

The companies cited by the FDA have made claims that their injectables are superior to other fat-dissolving or -removing procedures, and the injections can treat conditions such as gynecomastia and surgical deformities, said Kathleen Anderson, deputy director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research, in a briefing with reporters. The claims are illegal without clinical evidence or explicit FDA approval for the injectables, which generally contain phosphatidylcholine (PPC) and/or deoxycholate, and a variety of vitamins, minerals, and herbal extracts.

The letters were sent by overnight mail on April 5 to six American spas: Monarch Medspa, King of Prussia, Penn.; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Md.; Innovative Directions in Health, Edina, Minn.; Pure Med Spa, Boca Raton, Fla.; and All About You Med Spa, Madison, Ind.

The Brazilian company cited by the FDA sells lipodissolve products through its two Web sites www.zipmed.net and www.mesoone.com. The agency has issued an import alert for the Web sites, which should prevent the importation and distribution of the products.

Ms. Anderson said the companies were singled out because they had made what were considered to be the most egregious claims among the sites the FDA has monitored.

The agency is hoping to warn consumers that if they purchase these services, they are receiving therapies that are not approved by the FDA, she said. In addition, the drug components—PPC and deoxycholate—are not specifically approved as injectables or for fat dissolution. They are approved for inhalation as a lung surfactant in acute respiratory distress syndrome, said Ms. Anderson.

A complete list of concerns about lipodissolve, also known as mesotherapy or injectable lipolysis, can be found on an updated page for consumers on the FDA Web site. Among the safety concerns are permanent scarring, skin deformation, and painful knots under the skin. The agency has received five reports of such adverse events, Ms. Anderson said.

The FDA also said that clinicians who are using lipodissolve products should submit an application for approval so the agency can evaluate safety and efficacy. The Aesthetic Surgery Education and Research Foundation is conducting a small, placebo-controlled study using sham injections, compared with injections of PPC and sodium deoxycholate. The FDA has approved the study.

But most professional societies, including the Physicians Coalition for Injectable Safety, the American Society for Aesthetic Plastic Surgery (ASAPS), and the American Society for Dermatologic Surgery, have warned against fat-dissolving injections until there is further proof of efficacy and safety.

The FDA, for its part, said it would be monitoring further use of lipodissolve, whether by unlicensed practitioners or physicians. “If there are clinics and medical practices that are going to be making false and misleading claims, then we will go after them as well,” said Sudha Shukla, Pharm. D., of the FDA’s Division of New Drugs and Labeling Compliance, during the briefing.

It is not clear how many lipodissolve procedures are done each year. The ASAPS reported that 18,000 were done in 2008, but that an insufficient number of clinicians responded to its annual survey in 2009 to give a reliable number.

The companies cited by the FDA have 15 days to respond to the agency’s warning. If sufficient steps are not taken, then the agency has the power to issue an injunction or seize products, said Ms. Anderson.

The Food and Drug Administration announced April 7 that it sent warning letters to six medical spas and a Brazilian company asking them to cease and desist from making false and misleading claims about injectable lipodissolve products.

The companies cited by the FDA have made claims that their injectables are superior to other fat-dissolving or -removing procedures, and the injections can treat conditions such as gynecomastia and surgical deformities, said Kathleen Anderson, deputy director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research, in a briefing with reporters. The claims are illegal without clinical evidence or explicit FDA approval for the injectables, which generally contain phosphatidylcholine (PPC) and/or deoxycholate, and a variety of vitamins, minerals, and herbal extracts.

The letters were sent by overnight mail on April 5 to six American spas: Monarch Medspa, King of Prussia, Penn.; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Md.; Innovative Directions in Health, Edina, Minn.; Pure Med Spa, Boca Raton, Fla.; and All About You Med Spa, Madison, Ind.

The Brazilian company cited by the FDA sells lipodissolve products through its two Web sites www.zipmed.net and www.mesoone.com. The agency has issued an import alert for the Web sites, which should prevent the importation and distribution of the products.

Ms. Anderson said the companies were singled out because they had made what were considered to be the most egregious claims among the sites the FDA has monitored.

The agency is hoping to warn consumers that if they purchase these services, they are receiving therapies that are not approved by the FDA, she said. In addition, the drug components—PPC and deoxycholate—are not specifically approved as injectables or for fat dissolution. They are approved for inhalation as a lung surfactant in acute respiratory distress syndrome, said Ms. Anderson.

A complete list of concerns about lipodissolve, also known as mesotherapy or injectable lipolysis, can be found on an updated page for consumers on the FDA Web site. Among the safety concerns are permanent scarring, skin deformation, and painful knots under the skin. The agency has received five reports of such adverse events, Ms. Anderson said.

The FDA also said that clinicians who are using lipodissolve products should submit an application for approval so the agency can evaluate safety and efficacy. The Aesthetic Surgery Education and Research Foundation is conducting a small, placebo-controlled study using sham injections, compared with injections of PPC and sodium deoxycholate. The FDA has approved the study.

But most professional societies, including the Physicians Coalition for Injectable Safety, the American Society for Aesthetic Plastic Surgery (ASAPS), and the American Society for Dermatologic Surgery, have warned against fat-dissolving injections until there is further proof of efficacy and safety.

The FDA, for its part, said it would be monitoring further use of lipodissolve, whether by unlicensed practitioners or physicians. “If there are clinics and medical practices that are going to be making false and misleading claims, then we will go after them as well,” said Sudha Shukla, Pharm. D., of the FDA’s Division of New Drugs and Labeling Compliance, during the briefing.

It is not clear how many lipodissolve procedures are done each year. The ASAPS reported that 18,000 were done in 2008, but that an insufficient number of clinicians responded to its annual survey in 2009 to give a reliable number.

The companies cited by the FDA have 15 days to respond to the agency’s warning. If sufficient steps are not taken, then the agency has the power to issue an injunction or seize products, said Ms. Anderson.