The Soft Lights Foundation, a non-profit organization that “advocates for the protection of people and the environment from the harms of Visible Light radiation emitted by products that use Light Emitting Diodes”, has lost its latest round of safety petitions that it filed with the Food and Drug Administration. The foundation filed four petitions over the past two years, which included supplements and public comments.
The petitions are aimed at establishing regulations on the amount of electromagnetic radiation emitted by LEDs. In a 19-page response, the FDA detailed why each claim is being rejected.
The first claim included the statement that LED lighting needs to be regulated to, “protect the physical and psychological health, safety, comfort, and civil rights of those who are negatively impacted by LED light.” The first claim also requested the LED lighting not be classified as energy efficient. In it’s lengthy response to the claim, the FDA concluded, “The FDA finds the evidence you provided insufficient to demonstrate a regulation restricting the chip-level peak luminance and peak radiance of LED lights is necessary to protect public health and safety from electronic product radiation.”
Claim 2 from the Soft Lights Foundation stated, “that LED strobing lights have negative effects on human health, including “nausea, panic attacks, seizures, reduced cognitive functioning, and possible eye injury”. The FDA responded by saying, “FDA has determined that the information provided in support of CP2 is insufficient to demonstrate a performance standard to control the emission of electronic product radiation from LED flashing lights with restrictions on spatial non-uniformity, chip-level peak luminance and peak radiance, dispersion characteristics, spectral power distribution, digital flicker, and pulse width modulation is necessary at this time for the protection of the public health and safety.”
The third claim is directed at LED headlights on vehicles. The Soft Lights Foundation claim asserted that LED headlights create a “blinding glare”. The FDA response was that the foundation did not meet the requirements for intervention. “You provided no scientific evidence of the effects of glare caused by LED electronic product radiation on human health,” is part of the decision by the FDA.
The final claim is related to health effects of LED street lighting. The FDA says it did “comprehensive” study from a third party organization, and found that to be inconclusive. “Based on this assessment, FDA has determined that insufficient evidence exists in the literature to demonstrate that a performance standard to control the emission of electronic product radiation by products that use LEDs is necessary at this time for the protection of the public health and safety.”
The Soft Lights Foundation issued a statement after losing the ruling, which in part said, “Without an intervention by Congress or the Courts, municipalities, businesses, manufacturers, and employers are each now forced to develop and publish their own policy for LED products to ensure the health, safety, and civil rights of the public and the protection of the environment, and a failure by an entity to establish the necessary health, safety, and civil rights policies in relation to the entity’s use or manufacture of unregulated and unsafe LED products makes the entity liable for tort or discrimination claims due to negligence or a failure to provide a duty of care.”
Tagged with FDA, LED, legislation, lightED