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FDA Warns About Lipodissolve Product Claims:

FDA is alerting consumers that...

Phosphatidylcholine-based Injections Are not FDA Approved for Any Use

In the United States, prescription drugs are required to undergo rigorous laboratory, animal, and human clinical testing before they can be put on the market, and then undergo ongoing post-marketing tracking. The FDA reviews results of these studies to verify the identity, potency, purity, and stability of the ingredients, as well, to verify that the drug is safe and effective for its intended use. PCDC has not undergone the necessary testing required for FDA-approval.

Phospatidylcholine-based products (Also known as Lipostabil®, Lipodissolve, Lipo-zap, Flab-Jab, Mesotherapy, Lipotherapy, Injection Lipolysis) for injectable fat removal have not been approved by FDA. The FDA has stated that Lipostabil® is a "new drug because there is not substantial evidence that the product is generally recognized as safe and effective for its intended use. Since the product is a new drug it may not be marketed in the United States without an approved new drug application..." The FDA has further stated, "Consumers need to know that this is a buyer-beware situation. These are unapproved drugs for unapproved uses and we can't guarantee consumers' safety" and the FDA is investigating and evaluating the practice of using Lipodissolve.

There has not been a new drug application for phosphatidylcholine-based products for injectable fat removal and no well-controlled studies of safety and efficacy. Most representations of safety and effectiveness that are readily available are based on testimonials from an individual or a select few patients. While there are some small, published studies, none of these would meet the safety and effectiveness standards necessary for this product to be approved by FDA.

Finally, there is no standardized formula for these treatments. There are no published reports demonstrating scientific testing to ensure that the various components are safe or stable when combined into a mixture. Additionally, the origin of components used in these fat reduction mixtures is neither clear nor easily ascertainable.

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