The Failure to Regulate LEDs

In the USA, the Food and Drug Administration has the legal mandate from Congress to regulate the visible radiation emitted by Light Emitting Diode products. Yet, the FDA has never published the required performance standards that would ensure the comfort, health, and safety of the public. The switch to LEDs is fundamentally based on the misinformation that LEDs save energy and the false claim that LED visible radiation is safe.

Below is a timeline showing how we got to this point.

Timeline

1946 – Congress passes the Administrative Procedure Act.

1961 – Texas Instruments invents infrared LED.

1962 – Nick Holonyak Jr. invents red LED.

1966 – Congress passes the Motor Vehicle Safety Act.

1967Green LED invented.

1967 – NHTSA creates the Federal Motor Vehicle Safety Standards Section 108 for headlights.

1968 – Congress passes the Radiation Control for Health and Safety Act, directing the Food and Drug Administration to regulate electromagnetic radiation from electronic products, which includes the visible radiation from LEDs.

1993Shuji Nakamura invents high-brightness blue LED.

1996Nichia Corporation releases phosphor-coated white partial-conversion LEDs using blue light.

2001LEDs are being classified the same as Lasers.

2005Discussion of whether LEDs are safe.

2007Lutron History of Energy Efficiency. An energy efficiency claim requires that the new technology provide the same quality of service as the previous technology. A dimmer switch that introduces flicker is not energy efficiency.

2008 – US Department of Energy states that LED light is directional.

2009 – Underwriters Laboratories presentation states that there are no LED safety standards.

2010 – The Federal Trade Commission sues Lights of America for misrepresenting light output.

2012 LEDs are no longer being classified as lasers.

2013 – Philips claims their LED emits 200 lumens/watt and that this is “energy efficient”.

2013 Phase out of Incandescent Light Bulbs.

2014 A brief history of LED lighting.

2016 – The American Medical Association releases a major report stating that blue wavelength light is toxic to human health.

2017 Research shows that LED radiation poses “great risk” of eye damage.

2018 History of White LEDs.

2019 – The first mathematical proof that LEDs emit spatially anisotropic radiation in a Lambertian shape.

2021 – Vishay publishes Eye Safety Risk of Infrared LEDs.

2021 – Cree Lighting admits that the lighting industry has been using the wrong metrics for LED lighting.

2022 – US Department of Energy signs a Memorandum of Understanding with the Illuminating Engineering Society to develop “needed” metrics, test methods, and standards for Solid State Lighting. In other words, metrics and standards for LEDs don’t exist yet.

2023 – Light pollution now increasing at a rate of 10% per year due to the switch to LED lighting.

2024 – Mark Baker sues the Food and Drug Administration for failing to regulate LED products.

The LED Regulation Story

In 2001, the standard Safety of Laser Products IEC 60825-1 stated, “Throughout this part 1 light emitting diodes (LED) are included whenever the word “laser” is used.” Thus, at the turn of the millennium, LEDs were treated with the same duty of care as lasers.

In April 2005, Andrew Dennington, Optical Design Manager for Carclo Technical Plastics said at a conference, “The latest generation of LEDs is not safe, and someone will have their eyes damaged by a high-power LED product.” In the 2012 Electronics Weekly article Ensuring Safety in LED Lighting, the author discusses the blue light hazard, high luminance dangers, and interruption of circadian rhythms. Thus, we know that in the LED industry has been well aware that LEDs are very powerful and already capable of causing harm. Did the LED industry and government officials create and publish standards to ensure our protection from this powerful electromagnetic radiation? The answer, sadly, is no.

The 2012 Electronics Weekly article stated, “At one time, LED products were included in the laser safety standard IEC 60825. This is no longer the case.” What happened between 2001, when LEDs were regulated as lasers, and 2012, to cause LEDs to no longer be classified as lasers and how are LEDs classified today?

In the 2005 article LEDs are safe – Fact or Fiction?, we learn that IEC 60825-1, published by the International Electrotechnical Commission (IEC), and commonly known as the Laser Safety Standard, covered LEDs and treated them as lasers. At the request of industry, the IEC then removed LEDs from IEC 60825-1 and created IEC EN62471 Photobiological Safety of Lamps and Lamp Systems, thus loosening the restrictions on LED visible radiation and providing no IEC standards for neurological safety for LEDs. The USA never adopted either standard IEC 60825-1 or IEC EN62471 and has never published any comfort, health, or safety regulations for LED visible radiation.

Lasers are obviously not illumination devices, so the regulation of laser devices is in provided IEC 60825-1. But flat surface LEDs are obviously not illumination devices either. LEDs emit a directed energy beam, which is slightly less focused than a laser and not monochromatic, but clear LEDs emit a beam of light that can be a hazard for the eye. In addition, as has been now well documented, there is often digital flicker associated with LED light, often an excessive amount of hazardous blue wavelength light, and luminance has reached at least 100,000,000 candela per square meter. Surely, LED products should be tightly regulated, right? Well, not according to the LED industry. Instead, the industry decided that LEDs could be used as an illumination device and convinced the standards bodies to include LEDs in IEC 62471, the standard for standard lamps. This callous decision to discard health and safety in favor of industry wishes is one of the key reasons why hazardous LED products are now everywhere with little or no regulation.

In the article titled Digital Billboard Recommendations and Comparisons to Conventional Billboards, Dr. Ian Lewin writes that the maximum comfortable density of light for humans is 300 candela per square meter (nits). The maximum tolerable density of light is 50,000 nits. LED chip makers are now exceeding 100,000,000 nits. Yet, the maximum luminance from LED products is not regulated anywhere!

In the USA, Congress recognized that the electromagnetic radiation from electronic products can make people sick. Thus, Congress passed the Radiation Control for Health and Safety Act in 1968 which directed the US Food and Drug Administration to regulate this radiation. The FDA’s regulations are codified in Title 21 of the Code of Federal Regulations, Subchapter J, Radiological Health. Part 1040 is titled Performance Standards for Light Emitting Products and includes the performance standard regulations for lasers. What is missing from part 1040 are the regulations for Light Emitting Diode products. The failure of the FDA to regulate LED products and publish regulations and restrictions on luminance, spatial distribution, spectral power distribution, square wave flicker, pulse width modulation, and flash characteristics is another key reason why LED products are now everywhere without protections to keep us safe.

The Soft Lights Foundation petitioned the FDA on June 12, 2022, to comply with the 1968 Radiation Control for Health and Safety Act. The docket number is FDA-2022-P-1151. The FDA has failed to act on this petition. After the FDA failed to act on this petition, Soft Lights Foundation President Mark Baker filed a lawsuit in federal court against the FDA to compel the FDA to comply with 21 U.S.C. 360hh – 360ss and publish performance standards for LED products.

Here is the list of electronic products that emit electromagnetic radiation where the FDA has published performance standards to ensure protection of the public in section 21 of the Code of Federal Regulations.

1020.10 – Television Receivers
1020.20 – Cold-Cathode Gas Discharge Tubes
1020.30 – Diagnostic x-ray systems and their major components
1020.31 – Radiologic equipment
1020.32 – Fluoroscopic equipment
1020.33 – Computed tomography (CT) equipment
1020.34 – Cabinet x-ray systems
1030.10 – Microwave ovens
1040.10 – Laser products
1040.11 – Specific laser products
1040.20 – Sunlamp products and ultraviolet lamps intended for use in sunlamp products
1040.30 – High-intensity mercury vapor discharge lamps

Where are the regulations for cellphone towers, cell phones, wifi routers, smart meters, LED light bulbs, LED vehicle headlights, LED streetlights, LED flashing lights, etc?

The Energy Efficiency Myth

LED products were pushed by the LED industry and the US Department of Energy as being more energy efficient than incandescent light bulbs.

LED lights use their energy much more efficiently than other types of bulbs[f] – Fraudulent. LEDs produce a different type of visible radiation than incandescent and other types of bulbs. The result is a low-quality light with an intense peak of radiation in the center and non-uniform spread. To be energy efficient, the device must do the same job, which in this case is to provide uniform illumination the same way an incandescent bulb does.[f] Since LEDs cannot perform the same job as incandescent, LEDs cannot be claimed to be energy efficient.

LED luminaires employ a number of small point sources of light.– Fraudulent. The Illuminating Engineering Society makes this claim in their document IES RP-8-18, Recommended Practice for Design and Maintenance of Roadway and Parking Facility Lighting. LEDs are mathematical Lambertian sources, not mathematical point sources. Because LEDs emit from a flat surface, the shape of the radiation is not a uniform sphere from a central point. Rather, the radiation forms a Lambertian volume that has a non-uniform energy profile.[f] The IES RP-8-18 cannot be used for LED radiation devices.

With respect to the blue light hazard, LED lamps are no different from conventional technologies, such as incandescent and fluorescent lights.[f] Signify makes this fraudulent claim in a white paper. LEDs have an entirely different spectral power distribution than incandescent. LEDs labeled as 4000K and 5000K, which Signify promotes, have a peak of energy at 450 nanometers, which is the exact wavelength that can damage the eye.

“LED bulbs also allow for an overall improved quality of light, as they create a more focused glow than fluorescent and incandescent lights”[f] This fraudulent concept is promoted by many lighting industry companies and organizations. Humans need uniform illumination to be able properly understand the object they are looking at. LEDs, however, emit a focused beam of visible radiation that is non-uniform, so no matter what angle or steradian is being illuminated, the center will have an intense peak radiance, while the edges will have hardly any radiance at all. This is a low-quality, toxic, hazardous, and discriminatory spatial radiation profile.

LED sources (lamps or systems) and luminaires that fall into Risk Group 0 or 1 as defined by IEC can be used by consumers.“[f] Notice how carefully crafted this wording is. Signify is not saying that LEDs are safe for Risk Group 3 (those with epilepsy, autism, PTSD, migraines, etc.), only that LEDs that are classified as Risk Group 0 or Risk Group 1 can be used by consumers. Since LEDs cause eye damage and psychological damage for those in Risk Group 2 and 3, the statement made by Signify is purposely deceptive.


The Cartel

The L.E.D. Quandry – July 14, 2016

Phoebus Cartel 2.0 Gets DOE to Roll Back Lightbulb Efficiency Standards – February 5, 2021 – This author gets it wrong about LEDs.

The industry and government officials have ignored the spatial, temporal, and spectral properties of LED radiation, insisting on using the simple formulas that worked well for spatially isotropic radiation. However, ignoring these radiation properties and using simple formulas yields invalid results. LED radiation is directed energy and can cause significant harm to biological systems. The spatial, temporal and spectral properties must be accurately accounted for.

One of the key concepts from the LEDs are safe – Fact or Fiction? article is that “in some circumstances the most hazardous viewing position may be some distance from the source. John O’Hagan cites the example of traffic-light LED arrays. When viewed close up, the radiation from only one LED is imaged in the eye, whereas from further away the radiation from all of the LEDs is imaged.” Take, for example, an octagonal stop sign with a flashing LED at each of the eight vertices. Up close, the radiation from only one of the LEDs will hit the eye. But if a person stands further away, the intensity of all eight LEDs will hit the eye at the same time, which can lead to thermal or chemical damage. The USA has no regulations for this situation. This article discusses the dangers of LED radiation.

Photons are discrete quantum of electromagnetic radiation with zero mass. These photons carry energy which can be described spatially, temporally, and spectrally. Photons can be classified by their energies, such as x-rays, microwaves and human visible light. When the radiation emitter is spatially isotropic, certain assumptions can be made about how the energy is distributed throughout space and simple formulas can be used. When the radiation emitter is spatially anisotropic, such as from LEDs, every point in space must be individually accounted for because the point may contain a different energy.