Restylane had previous FDA approval for its use to improve the look of facial folds. The FDA can approve a company’s “New Drug Application,” and can work with the manufacturer to write up the indications (usage/directions), but the FDA cannot regulate how the drug is prescribed.
Many cosmetic surgeons have been using Restylane off-label for a while. Off-label does not mean illegal. It simply means that a product is used for something other than what it was intended. Doctors and cosmetic surgeons have the right to use a product for something other than what it was FDA approved for. However, the manufacturer cannot promote the use of their drug for any reason other than what it currently has FDA approval for.
Restylane’s parent company, Medicis Pharmaceutical Corporation, is happy to have the FDA’s stamp of approval for lip augmentation. Medicis CEO and Chairman, Jonah Shacknai, stated that Restylane is, “the first and only hyaluronic acid dermal filler approved in the United States for lip augmentation.”