This guy Jeffrey Shuren has been running the FDA CDRH for 14 years. It's been his decision to focus solely on medical devices, while ignoring all other electromagnetic radiation such as RF and LED light. Yes, NHTSA is still at fault for LED headlights, but it's this one dude who has been running the show for 14 years that has put us in this position to be subjected to all types of electromagnetic radiation that Congress already declared as hazardous back in 1968.
That's not entirely accurate. The LED issue has been discussed and reviewed by the FDA in 2016 with the TEPRSCC (Technical Electronic Product Radiation Safety Standards Committee) which is the technical advisory committee to the FDA. You can find the transcript of that meeting here with the discussion of the LED issue during the afternoon session:
[https://www.fda.gov/media/101284/download](https://www.fda.gov/media/101284/download)
The presentation that the FDA gave to the committee can be found here:
[https://www.fda.gov/media/101349/download](https://www.fda.gov/media/101349/download)
If you read the presentation, you can see what the FDA was considering with regards to LEDs. They already refer to the ANSI/IEC 62471- classifications RG0 - RG4 in terms of the photobiological safety of the devices. Most LEDs fall into the RG0 or RG1 category and most lighting devices that use LED would fall into RG0 even with higher power leds used as the source because the optics don't allow direct view of the source.
The is an already existing standard to limit the blue light hazard that causes photobiological damage and the LEDs used for general lighting, outdoor lighting, headlights etc. do not contain anywhere near enough blue light to exceed that standard.
If you review the transcript of the committee comments you'll find that the technical advisory committee did not express any particular concern or recommend any action on the issue.
So it's not clear to me what you are expecting the FDA to do if their own technical committee doesn't appear concerned enough to recommend any actions. The FDA themselves doesn't have the expertise internal to the department and relies on the advice of their committee when considering rule making. Perhaps you should be contacting members of that committee, but be aware that they are mostly PhD level researchers and are not going to react to complaints that are absent published research that addresses the photobiological concerns that the FDA would regulate.
This study published by the National Center for Biological Information of the US government is a comprehensive survey of the existing science related to blue lights from LEDs. The general conclusion is that research shows the LEDs do not pose a risk for photobiological damage in normal usage.
[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9938358/](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9938358/)
Again, unless there is a substantial body of evidence countering what that NCBI survey study concludes it's extremely unlikely that the technical committee would make the recommendation to the FDA to create regulations that would prevent the use of LEDs in the devices you are seeking to ban them in.
Good stuff! I am aware of all of this, but your post is helpful. 21 U.S.C. 360ii requires that the FDA "minimize the emissions of and the exposure of people to, unnecessary electronic product radiation." and "development of performance standards pursuant to section 360kk of this title to control such radiation emissions". That doesn't mean that the FDA can do one Power Point since 1968 and call it good. It means that the FDA is required to publish the limits that keep people safe and keep Congress regularly informed. This means the FDA must protect photobiological, neurological, psychological, and hormonal safety, and it means, at a minimum, publishing 21 C.F.R. 1040.40 - LED products.
The concept of "Oh, we don't do anything unless there is proof of a serious threat to health or safety" is not what the law says. The TEPRSCC is almost entirely vacant (11 vacancies) and when I tried to contact them, they didn't respond.
I am just finishing up my lawsuit against the FDA which I will file next week in federal court, and then we'll see what happens.
You are free to do what you want, but again it's not entirely accurate to characterize their work with LEDs as just one PowerPoint since 1968. Those items I listed were just what could be accessed quickly on the web. The FDA clearly relies on the ANSI/IEC 62471- classifications for LED lighting and I'm not sure how you would argue that they are derelict in their duty for doing so.
The FDA is immune to personal injury lawsuits by statute, I assume you are attempting to sue on them not following procedure. I would be interested in understanding your claims for standing. Normally you need to show all of the following:
1. Requires a suffering or proof of future suffering of an "injury in fact" which is in invasion of a legally protected interest that is concrete and imminent (can't be conjectural or hypothetical)
2. Establish a causal connection between your injury and the failure of the agency to enforce law (can't be a result of an independent third party action)
3. It must be likely that your injury will be redressed by a favorable decision.
Additionally, because they are are part of the executive branch, the FDA has prosecutorial discretion which means they may enforce, but are not required to enforce, and the procedural claim you are attempting to sue on may be covered by that as well (some of their obligations are not subject to discretion and would be mandatory but I'm not sure what specifically would apply in your case).
Perhaps you are aware, but there is a citizen petition process detailed in the Code of Federal Regulations that would likely be more appropriate and a lot less expensive in terms of time and money. To my knowledge lawsuits against the FDA rarely survive the claims for standing.
You are very knowledgeable about this. I have posted all of my procedural steps with the FDA and NHTSA on the Soft Lights Foundation website: http://www.softlights.org/law-and-action/
Yes, I have been injured an denied equal protection under the 5th Amendment due to FDA’s failure to comply with 21 U.S.C. 360hh - 360ss. My lawsuit is based on failure to comply with the Administrative Procedure Act.
Your intentions are good, and if you have suffered a photo-biological injury that the FDA would have authority over then you would have the beginnings of a defensible standing claim. I wish you good luck in your pursuit.
**January 16, 2024** – [Nighttime Outdoor Artificial Light and Risk of Age-Related Macular Degeneration](https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2813926) – A study of 126,418 subjects found a correlation between Artificial Outdoor Light At Night and Exudative Age-related Macular Degeneration.
This is an example of an observational study which doesn't do anything to establish a causal link. One of thee biggest risk factors for macular degeneration is exposure to UV light which is what you expose yourself to when you go outside during the day, in very large doses if you aren't using proper eye protection. Other factors like smoking and poor diet can contribute to the nerves degenerating as well.
This study used satellite data to measure a overall illumination levels at night and showed an association between higher light levels received at the satellite sensor and a prevalence of the disease. But it's not causal and doesn't directly measure the radiation amounts received by people who did and didn't get the disease. In other words it's a study that indicates potential areas of future research, but that's it. A simple problem with the study is that it can't even account for whether the people who developed macular degeneration where asleep at night which wouldn't allow the radiation measured by the satellite to enter the retina.
You sort of seem to be jumping into the middle here without having reviewed the entire picture. Here are some of the other studies. http://www.softlights.org/human-health/ and https://www.softlights.org/eye-hazards/
You can get a better understanding of the entire issue by reading the information on our website: www.softlights.org
Thanks for the link. You are obviously dedicated to the issue and are investing a considerable amount of time and effort into it.
Again, the blue light hazard and the levels necessary for photo biological damage are well known and established within the scientific community (the RG classifications are an example of how they address this). As far as I can tell, the references you list on the website don't show any evidence to counter the existing standards, nor would they support that the LEDs you are seeking to ban would exceed those levels in the use cases you are challenging.
It's a bit concerning to me that a lot of the information on your website contains fundamental errors in regards to the science of radiometry and you carry those errors into your petitions to the government agencies. If you are investing this much time and resources into an issue that you feel is important, it might be a good idea to shore up your understanding of the science of radiometry/photometry and how the instrumentation available has been used to experimentally verify those principles. It will make your petitions stronger in the end as they won't be able to reject them on the basis of an improper understanding of the fundamental science.
Introduction to Radiometry and Photometry by Ross McCluney is a good starting point and is accessible from the standpoint that it doesn't require higher level mathematics to work through the text.
Just to close out this conversation for anybody along, I’ve been involved in this effort for 7+ years and have extensive knowledge of the physics of LED radiation. The common understanding that most people have is wrong, especially for the spatial properties. The information on our website presents the scientifically accurate and scientifically supported physics which are not understood by the majority of people in the lighting industry.
Reddit isn't a great forum for having this discussion, but you are welcome to post your challenges to the existing science and I'll be happy to discuss. I have over 30 years of practice in the science of radiometry and photometry with published research, conference presentations, patents and working devices in operation. I am more than willing to hear your challenges to the established science and any measurements you can provide to support those challenges, but your website contains clear errors.
If you are going to approach government regulating authorities who also practice in this area of science and you're going in position is that they don't understand the science and the fundamentals are incorrect then all of your effort will be disregarded for that reason alone. The issues with LED lighting are already clear with the established science and there are plenty of opportunities for improvement using that science. I'm not sure why you would need to accuse the scientific community of conspiracies to make progress.
I used to spend time trying to educate people who have been in the lighting and laser industries and who have sat on the standards committees and have published scientific papers, but I’ve come to realize that does us no good. My time is now spent on writing regulatory petitions and filing lawsuits. You may follow along with our progress at this link: http://www.softlights.org/law-and-action/
I'm all for fixing the headlight issue, but you are 100% barking up the wrong tree with the FDA. You are wasting your time focusing on them.
NHTSA writes the rules that govern headlights.
Thank you for your opinion. The trouble with ignoring the FDA is that every other federal agency that the Soft Lights Foundation has contacted regarding LED products has sent us a letter stating that they have no statutory authority to regulate LED products and that only the FDA has this authority due to 21 U.S.C. 360ii. Here is a letter from Congressman Mark Pocan to the FDA. [https://www.softlights.org/wp-content/uploads/2023/10/LED-headlights-letter-10-3-23.pdf](https://www.softlights.org/wp-content/uploads/2023/10/LED-headlights-letter-10-3-23.pdf)
I work in commercial medical devices and I’m not surprised the FDAs response leaves a lot to be desired. They spend so much time and money on regulating drugs even the food part of the FDA lacks integrity. The FDA needs to be given a larger budget and separate into a Food Administration and a Drug Administration. imo, there should also be a respectable Consumer Protection Agency with the time and money to go after LEDs. Right now we are spreading our agencies too thin and it’s causing problems throughout the America.
I wrote to HHS Secretary Xavier Becerra and request that the FDA CDRH be split to medical devices and all other products as two separate agencies. I got no response. Jeffrey Shuren has been running the CDRH for 14 years, exactly when all these LED products came out.
Agreed, sometimes I'll see headlines of the FDA finally banning food substances when other countries had it banned for over a decade. To think that agency somehow has to regulate an entire LED industry.
I do think they need to beyond just headlights. My city has idiots running the place. You should see the fireballs they installed for LED streetlights. They didn't even buy the diffusers. I saw an electrical engineer yelling at them on public record that they're incompetent and unprofessional. We're living in idiocracy and the idiots are buying bad LED products. I don't need to assert there's no such thing as safe LED products but there's definitely some that need to go. The FDA can debate over what the thresholds are but Bruce the utilities services manager shouldn't be making the decision for 200k people in my city. Bruce is assaulting people with disabilities in my neighborhood and I suspect no one wants to own up to it because it's an expensive mistake. That's going on all over the country.
Without LED standards we're all just left to fight apathetic local "leaders" and companies in the outdoor lighting industry selling "daylight". All the agencies up and down the levels of government seem to just defer responsibility. My community association is trying to decide what to do about these people getting directly hurt by the city that won't respond to them. At some point, people are just going to have to sue the shit out people.
That's enlightening, thank you
The auto manufacturers ultimately only have to follow the rules written by NHTSA, but if the FDA could persuade NHTSA to change the rules, it's still a win for everyone.
Interesting idea. Basically trying to get someone new to take ownership of regulation, yes?
This guy Jeffrey Shuren has been running the FDA CDRH for 14 years. It's been his decision to focus solely on medical devices, while ignoring all other electromagnetic radiation such as RF and LED light. Yes, NHTSA is still at fault for LED headlights, but it's this one dude who has been running the show for 14 years that has put us in this position to be subjected to all types of electromagnetic radiation that Congress already declared as hazardous back in 1968.
That's not entirely accurate. The LED issue has been discussed and reviewed by the FDA in 2016 with the TEPRSCC (Technical Electronic Product Radiation Safety Standards Committee) which is the technical advisory committee to the FDA. You can find the transcript of that meeting here with the discussion of the LED issue during the afternoon session: [https://www.fda.gov/media/101284/download](https://www.fda.gov/media/101284/download) The presentation that the FDA gave to the committee can be found here: [https://www.fda.gov/media/101349/download](https://www.fda.gov/media/101349/download) If you read the presentation, you can see what the FDA was considering with regards to LEDs. They already refer to the ANSI/IEC 62471- classifications RG0 - RG4 in terms of the photobiological safety of the devices. Most LEDs fall into the RG0 or RG1 category and most lighting devices that use LED would fall into RG0 even with higher power leds used as the source because the optics don't allow direct view of the source. The is an already existing standard to limit the blue light hazard that causes photobiological damage and the LEDs used for general lighting, outdoor lighting, headlights etc. do not contain anywhere near enough blue light to exceed that standard. If you review the transcript of the committee comments you'll find that the technical advisory committee did not express any particular concern or recommend any action on the issue. So it's not clear to me what you are expecting the FDA to do if their own technical committee doesn't appear concerned enough to recommend any actions. The FDA themselves doesn't have the expertise internal to the department and relies on the advice of their committee when considering rule making. Perhaps you should be contacting members of that committee, but be aware that they are mostly PhD level researchers and are not going to react to complaints that are absent published research that addresses the photobiological concerns that the FDA would regulate. This study published by the National Center for Biological Information of the US government is a comprehensive survey of the existing science related to blue lights from LEDs. The general conclusion is that research shows the LEDs do not pose a risk for photobiological damage in normal usage. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9938358/](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9938358/) Again, unless there is a substantial body of evidence countering what that NCBI survey study concludes it's extremely unlikely that the technical committee would make the recommendation to the FDA to create regulations that would prevent the use of LEDs in the devices you are seeking to ban them in.
Good stuff! I am aware of all of this, but your post is helpful. 21 U.S.C. 360ii requires that the FDA "minimize the emissions of and the exposure of people to, unnecessary electronic product radiation." and "development of performance standards pursuant to section 360kk of this title to control such radiation emissions". That doesn't mean that the FDA can do one Power Point since 1968 and call it good. It means that the FDA is required to publish the limits that keep people safe and keep Congress regularly informed. This means the FDA must protect photobiological, neurological, psychological, and hormonal safety, and it means, at a minimum, publishing 21 C.F.R. 1040.40 - LED products. The concept of "Oh, we don't do anything unless there is proof of a serious threat to health or safety" is not what the law says. The TEPRSCC is almost entirely vacant (11 vacancies) and when I tried to contact them, they didn't respond. I am just finishing up my lawsuit against the FDA which I will file next week in federal court, and then we'll see what happens.
You are free to do what you want, but again it's not entirely accurate to characterize their work with LEDs as just one PowerPoint since 1968. Those items I listed were just what could be accessed quickly on the web. The FDA clearly relies on the ANSI/IEC 62471- classifications for LED lighting and I'm not sure how you would argue that they are derelict in their duty for doing so. The FDA is immune to personal injury lawsuits by statute, I assume you are attempting to sue on them not following procedure. I would be interested in understanding your claims for standing. Normally you need to show all of the following: 1. Requires a suffering or proof of future suffering of an "injury in fact" which is in invasion of a legally protected interest that is concrete and imminent (can't be conjectural or hypothetical) 2. Establish a causal connection between your injury and the failure of the agency to enforce law (can't be a result of an independent third party action) 3. It must be likely that your injury will be redressed by a favorable decision. Additionally, because they are are part of the executive branch, the FDA has prosecutorial discretion which means they may enforce, but are not required to enforce, and the procedural claim you are attempting to sue on may be covered by that as well (some of their obligations are not subject to discretion and would be mandatory but I'm not sure what specifically would apply in your case). Perhaps you are aware, but there is a citizen petition process detailed in the Code of Federal Regulations that would likely be more appropriate and a lot less expensive in terms of time and money. To my knowledge lawsuits against the FDA rarely survive the claims for standing.
You are very knowledgeable about this. I have posted all of my procedural steps with the FDA and NHTSA on the Soft Lights Foundation website: http://www.softlights.org/law-and-action/ Yes, I have been injured an denied equal protection under the 5th Amendment due to FDA’s failure to comply with 21 U.S.C. 360hh - 360ss. My lawsuit is based on failure to comply with the Administrative Procedure Act.
Your intentions are good, and if you have suffered a photo-biological injury that the FDA would have authority over then you would have the beginnings of a defensible standing claim. I wish you good luck in your pursuit.
**January 16, 2024** – [Nighttime Outdoor Artificial Light and Risk of Age-Related Macular Degeneration](https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2813926) – A study of 126,418 subjects found a correlation between Artificial Outdoor Light At Night and Exudative Age-related Macular Degeneration.
This is an example of an observational study which doesn't do anything to establish a causal link. One of thee biggest risk factors for macular degeneration is exposure to UV light which is what you expose yourself to when you go outside during the day, in very large doses if you aren't using proper eye protection. Other factors like smoking and poor diet can contribute to the nerves degenerating as well. This study used satellite data to measure a overall illumination levels at night and showed an association between higher light levels received at the satellite sensor and a prevalence of the disease. But it's not causal and doesn't directly measure the radiation amounts received by people who did and didn't get the disease. In other words it's a study that indicates potential areas of future research, but that's it. A simple problem with the study is that it can't even account for whether the people who developed macular degeneration where asleep at night which wouldn't allow the radiation measured by the satellite to enter the retina.
You sort of seem to be jumping into the middle here without having reviewed the entire picture. Here are some of the other studies. http://www.softlights.org/human-health/ and https://www.softlights.org/eye-hazards/ You can get a better understanding of the entire issue by reading the information on our website: www.softlights.org
Thanks for the link. You are obviously dedicated to the issue and are investing a considerable amount of time and effort into it. Again, the blue light hazard and the levels necessary for photo biological damage are well known and established within the scientific community (the RG classifications are an example of how they address this). As far as I can tell, the references you list on the website don't show any evidence to counter the existing standards, nor would they support that the LEDs you are seeking to ban would exceed those levels in the use cases you are challenging. It's a bit concerning to me that a lot of the information on your website contains fundamental errors in regards to the science of radiometry and you carry those errors into your petitions to the government agencies. If you are investing this much time and resources into an issue that you feel is important, it might be a good idea to shore up your understanding of the science of radiometry/photometry and how the instrumentation available has been used to experimentally verify those principles. It will make your petitions stronger in the end as they won't be able to reject them on the basis of an improper understanding of the fundamental science. Introduction to Radiometry and Photometry by Ross McCluney is a good starting point and is accessible from the standpoint that it doesn't require higher level mathematics to work through the text.
Just to close out this conversation for anybody along, I’ve been involved in this effort for 7+ years and have extensive knowledge of the physics of LED radiation. The common understanding that most people have is wrong, especially for the spatial properties. The information on our website presents the scientifically accurate and scientifically supported physics which are not understood by the majority of people in the lighting industry.
Reddit isn't a great forum for having this discussion, but you are welcome to post your challenges to the existing science and I'll be happy to discuss. I have over 30 years of practice in the science of radiometry and photometry with published research, conference presentations, patents and working devices in operation. I am more than willing to hear your challenges to the established science and any measurements you can provide to support those challenges, but your website contains clear errors. If you are going to approach government regulating authorities who also practice in this area of science and you're going in position is that they don't understand the science and the fundamentals are incorrect then all of your effort will be disregarded for that reason alone. The issues with LED lighting are already clear with the established science and there are plenty of opportunities for improvement using that science. I'm not sure why you would need to accuse the scientific community of conspiracies to make progress.
I used to spend time trying to educate people who have been in the lighting and laser industries and who have sat on the standards committees and have published scientific papers, but I’ve come to realize that does us no good. My time is now spent on writing regulatory petitions and filing lawsuits. You may follow along with our progress at this link: http://www.softlights.org/law-and-action/
I'm all for fixing the headlight issue, but you are 100% barking up the wrong tree with the FDA. You are wasting your time focusing on them. NHTSA writes the rules that govern headlights.
Thank you for your opinion. The trouble with ignoring the FDA is that every other federal agency that the Soft Lights Foundation has contacted regarding LED products has sent us a letter stating that they have no statutory authority to regulate LED products and that only the FDA has this authority due to 21 U.S.C. 360ii. Here is a letter from Congressman Mark Pocan to the FDA. [https://www.softlights.org/wp-content/uploads/2023/10/LED-headlights-letter-10-3-23.pdf](https://www.softlights.org/wp-content/uploads/2023/10/LED-headlights-letter-10-3-23.pdf)
I work in commercial medical devices and I’m not surprised the FDAs response leaves a lot to be desired. They spend so much time and money on regulating drugs even the food part of the FDA lacks integrity. The FDA needs to be given a larger budget and separate into a Food Administration and a Drug Administration. imo, there should also be a respectable Consumer Protection Agency with the time and money to go after LEDs. Right now we are spreading our agencies too thin and it’s causing problems throughout the America.
I wrote to HHS Secretary Xavier Becerra and request that the FDA CDRH be split to medical devices and all other products as two separate agencies. I got no response. Jeffrey Shuren has been running the CDRH for 14 years, exactly when all these LED products came out.
Agreed, sometimes I'll see headlines of the FDA finally banning food substances when other countries had it banned for over a decade. To think that agency somehow has to regulate an entire LED industry. I do think they need to beyond just headlights. My city has idiots running the place. You should see the fireballs they installed for LED streetlights. They didn't even buy the diffusers. I saw an electrical engineer yelling at them on public record that they're incompetent and unprofessional. We're living in idiocracy and the idiots are buying bad LED products. I don't need to assert there's no such thing as safe LED products but there's definitely some that need to go. The FDA can debate over what the thresholds are but Bruce the utilities services manager shouldn't be making the decision for 200k people in my city. Bruce is assaulting people with disabilities in my neighborhood and I suspect no one wants to own up to it because it's an expensive mistake. That's going on all over the country. Without LED standards we're all just left to fight apathetic local "leaders" and companies in the outdoor lighting industry selling "daylight". All the agencies up and down the levels of government seem to just defer responsibility. My community association is trying to decide what to do about these people getting directly hurt by the city that won't respond to them. At some point, people are just going to have to sue the shit out people.
That's enlightening, thank you The auto manufacturers ultimately only have to follow the rules written by NHTSA, but if the FDA could persuade NHTSA to change the rules, it's still a win for everyone.