FDA-approved aesthetic treatments vs off-label options

You may have heard the terms "FDA-approved" and "off-label use" from friends who've had Botox or other fillers or from celebrities and influencers who post about their cosmetic treatments online. But what do these terms mean exactly?

FDA-approved means that the U.S. Federal Food and Drug Administration (FDA) has determined that a product is safe and effective for a specific use based on studies and testing. Off-label use means that a medication is being used in a different way than what was approved based on research and your doctor's expertise. These are legal and legitimate ways to use medicines, despite not having FDA approval.

The idea of receiving an off-label or unapproved treatment may sound unusual, but it's actually done often and not only in the aesthetic space.

"Off-label use of a product or device is common," said Kelly Killeen, MD. "Depending on the device or medication, 20 to 60 percent of use is off-label,".

Examples of off-label use in aesthetics

Botulinum toxin, better known as Botox, is one of the best examples of an FDA-approved product that's used off-label in several ways. Since its first FDA approval in 1989 for the treatment of eye conditions such as strabismus and blepharospasm, Botox has received additional FDA approvals for several medical and cosmetic uses, from treating excessive sweating and migraines to glabellar wrinkles ("angry 11s") and crow's feet. It's used off-label for medical and cosmetic uses, too.

"A simple example is using Botox in the masseters (jaw muscles)," said Michael Keyes, MD. "It's technically off-label, but it's one of the most effective ways to slim the lower face and help with jaw clenching. Same with fillers in areas like the temples or tear troughs. They're not 'on-label,' but they're widely used, predictable and supported by extensive experience and published data."

Other cosmetic uses of Botox include lip flips and traptox, also known as Barbie Botox.

Dr. Keyes also noted that other devices used off-label in plastic surgery include soft tissue mesh used as an "internal bra" and radiofrequency devices used on areas other than the face.

Are off-label treatments safe?

"Off-label use is something we deal with all the time in plastic surgery, and when it's done thoughtfully, it's completely appropriate," said Dr. Keyes. "The FDA regulates how a product is marketed, not every clinical situation we see in real life. As surgeons, we often find safe, well-studied applications that haven't gone through the long and expensive FDA process to be listed on the label."

Understanding the risks and choosing a qualified doctor are crucial to safely using medications and devices off-label.

"Aesthetic treatments are real medical procedures and can have serious, life-altering and life-threatening complications," said Dr. Killeen. "It's important as a patient you understand what is being recommended to you, whether it's off-label or on-label use, what the potential complications are and who is there for you if there are problems."

She reinforced that while non-physicians may administer off-label cosmetic treatments, depending on state laws, having a board-certified physician in a core specialty, such as plastic surgery or dermatology, running the facility is vital.

"This will assure that you, as a patient, have adequate backup if you need assistance, and you are more likely to be treated in an evidence-based way with evidence-based protocols," said Dr. Killeen. "Remember, this is the specialty these physicians trained in for many years and maintain certifications assuring expertise; they didn't do a weekend course and hang a shingle. They put the work in to keep you safe."

If your surgeon recommends an off-label treatment, remember that "off-label doesn't mean experimental or unsafe," said Dr. Keys. "It usually just means the surgeon is tailoring the treatment to the patient's anatomy and goals, using tools we know work."

To find a qualified plastic surgeon for any cosmetic or reconstructive procedure, consult a member of the American Society of Plastic Surgeons. All ASPS members are board certified by the American Board of Plastic Surgery, have completed an accredited plastic surgery training program, practice in accredited facilities and follow strict standards of safety and ethics. Find an ASPS member in your area.