Cosmetic Injectable Labeling and Use

Consumers are often confused with the terms “investigational” and “off-label” when they deal with cosmetic injectables. This is due to the fact that these terms are often used interchangeably, somehow implying that they mean the same. However, they are not.

In order to solve the dilemma, the Physicians Coalition for Injectable Safety offers some guidelines and definitions in order for consumers to understand these terms properly.

Coalition leader Roger Daily, MD of Portland, Oregon explained that a label containing a specific consumer safety information is required by the Food and Drug Administration after a drug or medical devices has been approved. "There are very specific labeling requirements including things such as brand name, drug content, the indications for a drug or device, dosing, adverse reactions, warnings and even data obtained from clinical studies," Daily added.

Daily further explained that “off-label” refers to the legal practice of prescribing a drug for a purpose other than its stated indication. For instance, most dermal fillers are specifically approved for use in the nasolabial folds. If dermal fillers are used for other forms of tissue enhancement, then these are under the “off-label” realm since these treatments were not part of the clinical data submitted for approval.

On the other hand, the term “investigational” means that either a drug or a device is being studied in a particular application as part of the process necessary to submit for approval to the FDA. An example of this is the use of Botox for the treatment of headaches. There is no approval similar or specific to this kind of treatment, therefore this is an investigational use – one that is being studied by physician-investigators.

A complete listing of FDA-approved cosmetic injectables with off-labe uses, and a listing of investigational cosmetic injectables and uses are available at InjectableSafety.org.