Lipo-dissolve targeted for regulation
Phosphatidylcholine-based products for injectable fat removal have not been approved by the FDA. The FDA has stated that "Lipo-Dissolve is not FDA approved for any use. In fact, there are no FDA-approved drugs with an indication to dissolve fat." The lack of FDA approval has led to action at the state level where regulations have been established or legislation is being considered to restrict or ban the use of lipodissolve until it has been studied and approved by the FDA.
In September 2007, the Kansas Board of Healing Arts, which regulates medical actions at the state level, endorsed a ban against physicians administering lipodissolve except as a part of an FDA-approved clinical trial. The ban was temporarily enjoined based on an appeal by a lipodissolve business and was re-opened in December 2007. In December, the Board passed temporary regulations restricting the availability of lipodissolve to physicians subject to an institutional review board and Kansas state regulators. Read more...
In Nevada, the state's Legislative Committee on Health Care has formed a subcommittee to review the use of laser treatments and cosmetic injections including lipodissolve and decide what, if any, oversight should be established to ensure safety. Lynette Daniels, chief of licensing for the state's Board of Medical Examiners states, “The board is very concerned about the medical spa industry, including the use of lipodisoslve and botox.” Read more...
Legislation to prohibit the administration of substances aimed at dissolving fat, including phosphtidylcholine-based injections, was introduced at a Nebraska hearing in January 2008. The bill says that substances could not be administered to dissolve fat except as a part of an FDA-approved trial. Read more...
In October 2007, The Oregon Medical Board adopted a Statement of Philosophy on mesotherapy and injection lipolysis. The Board stated that the formulations of PCDC lack standardization in terms of good manufacturing practices and sterility. Furthermore, reports on the safety and efficacy of injection lipolysis have been anecdotal. They recommend that the use of PCDC be permitted in the context of a clinical trial operating under an FDA-approved IND. "Lipodissolve™ and Lipostabil™ are not approved by the FDA. It is illegal to import or use them"... (Read More)
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