Light Therapy and FDA Regulations - Facts vs Marketing Hype

One of the reasons I started my company was due to the lack of information and quite frankly, deceptive marketing practices around red light therapy and red light therapy research. From personal experience, I knew red light therapy had the potential to change lives and I was passionate about sharing it with others, but why was there so little information about how to use light therapy and why were so many sellers making claims like "FDA Approved," "FDA Certified" and "Medical Grade" while others appear to be offering the exact same device for the half price? In this blog article we will discuss exactly what the FDA does regulate and as consumers, the red flags you need to watch for when considering a particular device, seller, or red light therapy research.

Red light therapy has gained popularity as a non-invasive treatment for a variety of health and wellness concerns, from skincare to hair regrowth to pain management. Red light therapy devices emit specific wavelengths of red or near-infrared light to stimulate various cellular functions and to promote healing. However, amidst the growing interest in this technology, there are also a growing number of sellers popping up in the market with misleading advertising practices. The good news is that the FDA is drafting guidelines for Photobiomodulation (PBM) devices which includes red light devices! To read the draft guidelines, click here. In the meantime, read on as we cover a few red flags to watch out for!

One common misconception among consumers is the idea of an "FDA Approved" or "FDA Certified" red light therapy device. In reality, the FDA does not approve or certify red light therapy devices in the same way it does drugs or medical procedures. Instead, these devices are subject to FDA regulations that classify them as medical devices and require manufacturers to meet certain standards for safety and effectiveness. So the first red flag with any seller you come across is seeing the claim "FDA Approved" or "FDA Certified."

Most red light therapy devices fall under Class II medical devices, which means that the manufacturer must submit a 510(k) premarket notification to the FDA before marketing the device. The 510(k) submission demonstrates that the device is substantially equivalent to another legally marketed device (predicate device) and meets the applicable regulatory requirements. It does not imply FDA endorsement or approval of the device's efficacy. This is another really important point! So when you see terms such as "Medical Grade" or "FDA Approved Class II Device" it may sound very official, but it means absolutely NOTHING! This is another red flag to watch for!

Class II devices cover a wide range of products and pose moderate risks to users. They include items such as:

1. LED light therapy devices (e.g., red light therapy devices)
2. Infusion pumps
3. Powered wheelchairs
4. Certain pregnancy test kits
5. Pulse oximeters
6. LED Laser hair removal devices
7. Medical ultrasound equipment

Despite the regulatory framework in place, the red light therapy market is inundated with misleading advertising claims that exaggerate the benefits of these devices. Many of these companies were selling holiday and grow lights a year ago and have no experience or understanding of light therapy and the extensive red light therapy research we've conducted. Some manufacturers are making unsupported assertions about the effectiveness of their products or are promoting them for uses that are not backed by science and my actually cause harm! Yikes! As a consumer, you should be cautious and do plenty of red light therapy research before purchasing a red light therapy device to ensure you are getting a safe and reputable product. 

To make an informed decision when choosing a red light therapy device, consumers should look for devices that have undergone 510(k) clearance, indicating that the manufacturer has complied with FDA regulations. However, it is also essential to consider factors such as the device's specifications, reputation of the manufacturer, and customer reviews to gauge its quality and reliability. We are big supporters of U.S. Brands because we know the safety standards in the U.S. are higher than in China where most red light therapy sellers source their devices.

In conclusion, while red light therapy devices offer promising benefits for various health and wellness applications, consumers must be aware of FDA regulations, misleading advertising practices, and the lack of oversight of these devices. By understanding the regulatory landscape and being discerning consumers, individuals can make educated choices when incorporating red light therapy into their health and wellness routines. We are obviously a bit biased, but we think you should consider Light Therapy Resource! We are a U.S. Brand and we sell not only high quality light therapy devices, but also the education and ongoing support you need to truly harness the full benefits of light therapy! Also, we have conducted hours and hours of red light therapy research to help you pick the right product that aligns with you wellness goals. All Light Therapy Resource customers gain lifetime access to our exclusive customer portal, featuring loads of free resources and more added regularly by our team of Certified Light Therapists! To check out our current offerings, click here!