Light Therapy: False Claims and Liability

Those of us operating in the tanning industry know to avoid advertising to the public with statements like, “Our tanning beds will give you Vitamin D” because it opens us up to lawsuits from attorneys general and the FTC. What about when it comes to light therapy? What are our limits when advertising or talking to salon guests about the services? The lines may not be as clear as we need them to be, or we just have not been properly educated – yet.

If you are not a licensed practitioner, you are not able to cure, treat, diagnose or prevent any medical or psychological disorder, disease or condition. Salon operators cannot imply that their services are similar to anything a practicing chiropractor, nurse practitioner, physician, etc. would provide to a patient, nor should you ever refer to salon guests as “patients.”

Salon operators are unable to evaluate, detect, identify or assess any disease or condition. We are not allowed to say we can heal, make any claims or promises, prescribe, recommend treatments or suggest our services will repair a guest’s condition. No certification, therapist course or even board certification will allow one to make or advertise these claims unless you are a licensed medical practicing professional. It is important to emphasize when advertising and speaking to salon guests that they understand we are not medical providers and we cannot treat underlying health conditions or diseases; rather our services can support overall health and wellness.

Don’t set yourself up for a dark situation with the FDA or FTC by overreaching into the role of a medical professional you are not licensed to be.”

The FDA oversees the manufacturing and labeling of medical devices, and compliance with regulations is the manufacturer’s responsibility. Once a device has been registered and approved, the user of the device is supposed to follow the directions per use. Practitioners, therapists, salons, doctors, etc. aren’t regulated by the FDA in this regard until they become a device manufacturer or marketer. One becomes a manufacturer or marketer by making a claim about a device that is not covered by its registration.

If a device you offer in your facility is a Class II device and has 510(k) report, you should only advertise and speak to what is listed in the device registration for the 510(k). For example, if something has been registered that it “uses light-based energy delivered to and or through the skin to effect change in the tissue that results in the reduction of wrinkles,” you can advertise that this device will reduce crow’s feet, smooth lines and reduce wrinkles. You can search the 510(k) database for your devices or ask the manufacturer for the report. Beyond this, the FTC oversees trade activities for misleading claims and advertisements. We must always be cautious of how we are communicating with salon customers and advertising the services we offer.

In 2019, the FDA created a new device category called “Low Risk General Wellness” products, which refers to devices that promote healthy lifestyles – including LED-light therapy systems. You can search online FDA Guidance Document 1300013 to download a copy to keep on hand in your facility; this document provides crucial information on this new category and whether devices qualify as one, and how to go about advertising them to the public.

When a salon guest comes to you with questions or concerns, never take a diagnostic approach. For example, if a customer complains of chronic wrist pain, you should never say it is “probably carpal tunnel.” In the same instance, you should also never offer prescription-based suggestions – such as telling a guest that three 20-minute sessions per week under your light device will stop their pain, unless you have a device that is FDA-cleared specifically for the treatment of carpal tunnel symptoms. A research-based response would be best, such as: “A few of our guests have mentioned that light therapy has helped ease symptoms”; “There are some studies mentioning benefits of light therapy and reduction of pain”, or “You should do some research, and then consider trying the red-light treatments we offer.”

When speaking on the benefits of red light, it is generally fine to state that benefits include reduction of pain, increase of circulation, and stimulation of cellular repair and regeneration. Just make sure to never make false claims! Stick to talking about what the device you offer was registered for; don’t set yourself up to walk into a dark situation with the FDA or FTC by overreaching into the role of a medical professional you are not licensed to be.