FDA approval is required for all new drugs. The FDA has determined that Lipostabil®, a phosphatidylcholine-based injectable product being marketed for dissolving fat is a new drug and therefore requires regulatory approval for marketing. The FDA has issued a warning letter clearly stating that marketing the product without such approval violates FDA regulations. Finally, FDA determined that a claim that this product does not require FDA approval because it is "natural" is false and misleading.
PDF Link: FDA Warning Letter