Regulatory Enforcement
FDA has stated, "we are aware of the practice of using Lipo-Dissolve and are investigating and evaluating it. It is NOT FDA approved. In fact, there are no FDA-approved drugs with an approved indication to dissolve fat and FDA cannot assure the safety and efficacy of these types of drugs.Consumers need to know that this is a buyer-beware situation. These are unapproved drugs forunapproved uses and we can't guarantee consumers' safety."
Domestic Regulation
Current FDA Status
FDA has stated, "we are aware of the practice of using Lipo-Dissolve and are investigating and evaluating it. It is NOT FDA approved. In fact, there are no FDA-approved drugs with an approved indication to dissolve fat and FDA cannot assure the safety and efficacy of these types of drugs. 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."
FDA Action:
The FDA has issued a warning letter clearly stating that marketing the PCDC product (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.
State Regulatory Action:
The states of Kansas, Nevada, Nebraska, and Oregon have all issued statements recognizing that PCDC injections are unapproved. Kansas has banned the administration of PCDC except as a part of an FDA-sanctioned clinical trial.
International Regulation
Brazil Ban
ANVISA, the Brazilian equivalent of the FDA has issued a statement banning use of phosphatidylcholine-based products for injectable fat removal.
Canada Ban
Health Canada ordered Physicians to stop administering Phosphatidylcholine-based injections for fat removal as they are not approved in Canada for any use.
UK Regulation:
The Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom issued a consumer warning stating that the product, PCDC Lipostabil, is being unlawfully advertised for cosmetic fat removal as it has not been assessed in clinical trials for this purpose.
New Zealand Regulation:
New Zealand's drug regulatory authority, Medsafe, has called for the immediate discontinuation of all advertising of injection Lipodissolve, since distribution of this product has not been approved anywhere in the country.