I'm very happy to report that there is a way to report our health issues with LED lights and/or screens to the U.S. Food and Drug Administration and I encourage everyone who can to please do so. They welcome your reports even if you’re not in the United States.

Since the replacement of fluorescent lights in February 2022 with very triggering LEDs with ~100% flicker in the NYC Public School where I had been working, I've been reaching out to every city, state, and federal agency I could think of to simply ask how I could report that these lights had so badly affected my health that I couldn't safely enter the school building anymore (and I am very concerned about the potential impact on any sensitive children among the million NYC public school children). Every agency, including initially the FDA, told me they wouldn't even accept a report because there aren't any regulations for LED lights yet. However, I learned in the process that in general, the FDA oversees light-producing devices (which they group with other radiation-producing devices, since visible light is a type of radiation).

A report that I sent in anyway to what I knew was the wrong place at the FDA by snail mail, eventually fortuitously made it to the right office. A representative contacted me and we've talked on the phone and been emailing for the past couple of weeks (I've leaned heavily on my scientific credentials and discussed the lack of good science around LED products and health). I truly believe they are open to helping if they receive evidence of a need.

The FDA Center for Devices and Radiological Health accepts reports of health issues involving any light-producing devices, regardless of whether those devices are subject to current regulations. They can make recommendations when there are health issues with products. While they currently don't have regulations that can help us (as we know), they will study it - to do so effectively they need our reports. My initial report sent through the wrong channel was the very first report they've received from any individual or manufacturer about health issues associated with LED products. For individuals, I assume this is because it isn't obvious that "FDA" and "radiation" are the right keywords and not even representatives in other divisions at the FDA or representatives at the EPA working with lighting products knew about this reporting avenue. So it's up to us to spread the word now, including to people with milder health issues than what many of us experience.

We are supposed to file an "Accidental Radiation Occurrences (AROs) form (Form 3649)." Please don't let the fact that this form was obviously not designed with us in mind put you off from filing. Manufacturers are required to use this system to immediately relay any reports of health issues with their products to the FDA (regardless of whether there are regulations) and the form implies a single isolated incident. Please fill in parts of the form relevant to you - note that LED products are the last item in the Product Information list - and attach any supporting information you'd like to attach when you submit the form. For example, you might include a narrative describing your situation/supplementing the form or any supporting information that you think could be helpful to researchers at the FDA. If you don’t have a US address, just write in your actual address even though the form was designed for US addresses. I asked how we should handle needing to report that all or most LED lights/screens are harmful to us and how to handle that we might not know manufacturer information for LED products in public places and they responded:

  • If the complaint/report is about a general issue with a wide variety of LED products, that could be one ARO, and only one single form needs to be completed/submitted.

  • If someone has problems with a known specific LED product, we would also like to know about it. So, a separate ARO report for a specific product would be appreciated.

I asked about privacy and was told "information of submitters will remain confidential and we won’t share them with anyone outside the agency."

I'm going to share as much as I can with the FDA about my experiences generally and with select products, including correspondence I've had directly reporting to manufacturers. I'm going to report my health issues with both LED lights and with screens, even though I don't completely understand exactly which hardware and software aspects create my issues with LED screens. I'm going to specifically highlight LEDs in schools and other areas that I think are key from a public health perspective. However, if all you are able to do is to send in a very brief, general report, that would also be helpful so the FDA can get a better sense of the scope of the issue.

I hope that if we can use and spread the word about this reporting system, enough momentum will build to support rigorous scientific research, public health studies, calls for manufacturers to actually share health reports with the FDA, and eventually appropriate regulations. In addition to all of us adults experiencing significant challenges, I'm even more concerned about trying to protect sensitive children who may be unaware of the cause of health or learning issues.

The Accidental Radiation Occurrence Report form is in section 6 of this webpage:

Radiation-Emitting Products Industry Assistance: Walk-through | FDA

or available directly through this link: https://www.fda.gov/media/79866/download

Reports may either be emailed to [RadHealthCustomerService@fda.hhs.gov](mailto:RadHealthCustomerService@fda.hhs.gov) or sent by mail using the address on the form.

Thank you so much for your help with this!

If anyone knows of comparable government agencies in other countries that actually accept reports of health issues from LED products, that would also be helpful to know.

Jenny

P.S. I'm going to add this info to FlickerSense.org within a couple days to create a dedicated webpage.

5 days later

Please help to spread the word to your contacts about how to report health problems with LED lights and/or LED screens to the US FDA. This is a link to a dedicated page on the topic:

https://www.flickersense.org/How-to-report-LED-health-problems

Right now they only have one report (from me), so they need much more data to take action. I think our reporting through this avenue is immensely important since they can't advocate for regulations or the funding of research if they don't have data. Although manufacturers should have been relaying our reports of health problems to the FDA, they have not.

Thanks for your help!

Is this for US citizens / residents only?

Thanks for your work. Fantastic initiative!

  • jen replied to this.

    AGI Great question! I would hope they’d accept reports from outside the US since we all use a lot of the same LED products, but I don’t know. I’ve reached out to my FDA contact for an answer.

    Well, on the form you need to specify your address and you only can specify a US address. I'm a US citizen, but except for a very short time in my childhood, I have always been an expat. I can vote when I specify the address of where I resided the last time, but am not sure if you are allowed to do that when you're filing an FDA report.

      AGI seeker_of_no_light

      Good news! The FDA welcomes reports of health problems with LED devices regardless of your country.

      The form is designed for US residents, but please just write in what you need to for your address if you’re not in the US. I’ve repeatedly gotten the impression that the FDA just wants our reports - and they don’t want the restrictive/limited nature of the form itself to limit what we need to say. They definitely welcome attachments that go beyond the form itself.

      (I’m also updating my initial post about this).

      10 days later

      I just got a confirmation letter from the FDA that they received my new report - yay! I had printed the form, filled in as much as I could by hand, said “please see attached” a lot and then attached a long report and additional documentation, including evidence that manufacturers have received my reports. I sent everything to the email address. So all of that was fine. I got an autoreply immediately after submitting then it took about 4 days for an official letter with a case number to come by email.

      If you can only send a short report of problems, that’s also helpful - they really need our data and numbers are important.

      …and maybe if you add a note here if you report, we can keep this thread active 🙂

      a month later

      Going to fill it today. This new "modern" technologies destroys our vision and companies do whatever they want just to sell their products.. It affects everyone on long term. If it's not affecting you today, it can tomorrow! This has to stop

      • jen likes this.
      25 days later

      Some hopeful news from the FDA!

      A group at SoftLights.org has petitioned the FDA to create regulations for LED lights for health and safety reasons:

      On June 13, 2022, the Soft Lights Foundation formally petitioned the FDA to regulate LED light products. Petition The FDA has assigned docket number 2022-P-1151 and is taking public comments now. On October 14, 2022, we submitted an additional document focused on the medical harms of LED visible radiation.

      November 7, 2022 – The FDA notified us that the petition raises questions requiring “further review”. Interim Response.

      http://www.softlights.org/law-and-action/

      I’m hopeful that the FDA has delayed giving a real response because they want to review this further. It could be that reports starting to come from us to the FDA are having an impact in general and in regards to the petition. I encourage everyone who hasn’t yet to please report their LED light and/or screen health issues to the FDA now using Accidental Radiation Occurrence form 3649. https://www.flickersense.org/How-to-report-LED-health-problems

      Also, the above petition is open for public comment - I think for the petition, issues with flicker could be emphasized more and issues with screen use need to be raised.

      SoftLights.org is the group that has already collected over 30,000 signatures on a change.org petition about LED headlights.

      • tsb likes this.
      dev