Going Off Label? Questions & Answers
What is “On Label”?
Although Cold lasers can be used on animals without limitation, the FDA has cleared cold lasers for use on humans for the purpose of pain reduction, inflammation reduction and increased blood flow. These are the only “on label” uses for cold lasers on humans. No one can legally make another claim about the products or the services that they provide using that product. There are people on the web claiming to cure lots of “off label” conditions with a laser but as soon as the FDA gets more free time, I would expect them to shut down these businesses. ColdLasers.Com does not claim that the laser can help any other conditions than the 3 FDA cleared uses.
Why are there not more conditions on label?
The first company that tries to get clearance an application like Fibromyalgia cleared can spend million of dollars to get their product cleared. They could even be rejected and lose all their investment. If the get the approval ,it is not a patent so their competitors can immediately jump on their clearance and get the same approval for a lot less. This is similar to what would happen if they allowed generic drugs to be released right after the first developer gets to market. Then you have to consider that laser sales are relatively small. When you add up all the numbers, the first company could easily get financially crushed by attempting to get clearance for a specific condition. It just doesn’t make sense for companies to take that kind of financial risk.
Does the laser help healing?
Studies have shown that laser therapy helps release ATP that is a trigger for healing in the body. This has been proven in studies but the FDA has not cleared any laser products for increased healing. Cold Laser can be sold for the treatment of joint Pain but no manufacturer or sales organization can claim that a laser will make the condition better.
Why the FDA requirements are good?
For any health care, it is important to make sure that people have a realistic expectation and the FDA makes sure this happens. If a person with Crohns disease buys a laser (thinking it is a silver bullet) and uses it while eating a whole wheat sandwich, the results are going to be bad. The laser will not have significant impact because their problem is bigger than a laser can fix. Users must take a holistic approach and make sure they are doing everything possible to correct their problem. The FDA limitation makes sure that groups are not giving people hope false by claiming a laser will fix problems that are outside the scope of laser therapy.
What are some “Off Label” Conditions?
The following is a list of common “off label” conditions treated with cold lasers. According the FDA, lasers can be used to treat the pain associated with these conditions but not the conditions themselves. It is up to the practitioner or user to determine if they think the therapy will do more than help with pain, inflammation and blood flow for these conditions.
- Scar Tissue
- Bone Repair
- Carpal Tunnel
- Colds & Flu
- Emotional Trauma
- Gut Issues
- Heart Issues
- Immune System Disorders
- Joints Problems
- Kidney Problems
- Liver Problems
- Lymphatic Drainage
- Neurological Problems
- Pancreas Problems
- Parkinson’s Disease
- Para /Sympathetic Trauma
- Rash / Skin Issues
- Surgery Recover
- Tissue Oxidation
- Yeast issues
Can a laser be used for “Off Label” Conditions?
Once a buyer has the laser in their possession, they can use if for any purpose they want. They just cannot advertise for any service other FDA cleared applications. Practitioners can experiment with the product and home owners can buy a wide variety of books to help them use the product for other uses.
Can you help me find a solution?
If you are a person with a chronic condition who is not getting what they need from their MD, we recommend that you visit several functional medicine practitioners. These health care providers use a whole body approach to medicine that includes spinal adjustment (chiropractor), acupuncture, herbal remedies, physical therapy, vibration therapy, cold laser therapy and many other great options. Their solutions are not limited to prescription drugs and surgery. Unfortunately, these practices seem to require a gift that not everyone has and there has to be strong bond between the practitioner and patient so we recommend trying multiple options until you find the one that works for you. If you can find one that uses cold lasers and you are getting good results, then we can help you find the best equipment and there is no risk in your investment.
If you are practitioner looking to expand your services, cold lasers are a great way to blow the doors off your patients. If you want the reputation as the person to go to get results, a cold laser can be the best investment for your practice. Call us and we can help find the best value cold laser system for your practice.