May 31, 2024
FDA Rejects LED Safety Petitions
Scientific data insufficient to support health risk claims, per FDA's review
The U.S. Food and Drug Administration (FDA) has formally denied several requests from the Soft Lights Foundation to establish regulations on electromagnetic radiation emitted by light-emitting diodes (LEDs). The detailed rejection letter, sent on May 24, 2024, to the foundation's president Mark Baker, addresses four petitions and multiple supplements filed between June 2022 and September 2023. This decision comes amidst broader efforts by Baker, who, in January, filed a lawsuit against the FDA seeking to legally compel the agency to enact the requested changes. The lawsuit, which is still in its early stages, underscores the ongoing tensions between the foundation's advocacy for stricter regulations and the FDA's current stance on LED safety.
Baker, President of the Soft Lights Foundation, expressed deep concern over the FDA's decision, highlighting the potential health risks associated with LED lighting. The FDA’s ruling, according to Baker, not only leaves millions of Americans unprotected but also prevents other federal agencies from implementing safety regulations for LED products. Baker pointed out that LED lights have been linked to serious health issues, including seizures, migraines, and eye injuries, affecting those who are particularly sensitive to LED radiation.
No Regulation of LED Electromagnetic Radiation
Petition Requests: The petitions requested the FDA to issue regulations under 21 CFR Part 1040 to control electromagnetic radiation from LEDs, addressing concerns about spatial non-uniformity, chip-level peak luminance and peak radiance, spectral power distribution, and square wave flicker.
FDA’s Denial: The FDA denied the requests, stating there is insufficient evidence to support the need for such regulations to protect public health and safety. The agency noted that while they acknowledge that LEDs emit non-uniform light, the scientific data provided did not establish a clear connection between the asserted health impacts and LED characteristics.
Insufficient Evidence for Adverse Health Effects
Petition Claims: The petitions asserted that LED light causes a variety of health issues, including seizures, migraines, and eye injuries.
FDA’s Response: The FDA emphasized that the evidence submitted, including personal stories and some scientific articles, was not robust enough. The FDA relies heavily on well-conducted research and scientific consensus, which were lacking in the submissions. They highlighted that personal stories, while compelling, do not provide the necessary generalizable data to justify regulatory action.
Specific Petition Denials and Justifications
Spatial Non-uniformity:
Denial: The FDA found no scientific data linking spatial non-uniformity of LED light to public health risks. Articles provided did not address health issues directly related to this characteristic.
Spectral Power Distribution:
Denial: Although aware of research on blue light’s impact on circadian rhythms, the FDA found current evidence insufficient to warrant a regulation limiting LED color temperature. Studies provided did not establish a causal link between blue light exposure from LEDs and long-term health issues.
Chip-Level Peak Luminance and Radiance:
Denial: The FDA found no substantial evidence that chip-level peak luminance and radiance of LEDs pose a health risk under typical exposure conditions. Existing standards already address potential hazards.
Square Wave/Digital Flicker:
Denial: The agency noted ongoing efforts by standards organizations to address flicker concerns and determined that existing mitigations are sufficient. Evidence provided did not demonstrate a significant public health risk from LED flicker.
Broader Legal and Regulatory Context
Legal Background: The FDA clarified its authority under the Radiation Control provisions of the FD&C Act, stating that it is only required to issue performance standards if it determines they are necessary for public health and safety. The agency found no such necessity for the requested LED regulations.
Scientific Literature Review: An independent review commissioned by the FDA concluded that the quality of evidence on LED health effects is low, often limited by methodological flaws and inconsistent results. This further supported the decision not to issue new regulations.
Baker expressed his disappointment in response to the FDA's decision to reject the petitions. "The FDA's refusal to regulate LED products leaves millions of Americans vulnerable to the health risks associated with LED lighting," said Baker. He emphasized that this decision means other federal agencies, such as NHTSA, DOE, and OSHA, are blocked from publishing regulations that could mitigate these risks.
Baker also raised concerns about the implications of this decision. "Without federal oversight, the responsibility for regulating LED products now falls to state and local governments," he noted. Baker warned that this shift could lead to inconsistent safety standards and increased liability for municipalities, businesses, and manufacturers. He called for intervention by Congress or the courts to ensure that comprehensive and consistent regulations are established to protect public health and safety.
The FDA’s 19-page letter highlights the agency's comprehensive evaluation of the petitions' requested actions. While the FDA reaffirmed its commitment to monitoring and addressing potential health impacts from radiation-emitting products, it concluded that the current evidence does not justify the proposed regulatory changes for LED lights. This decision suggests that regulatory efforts are stalled for now.
In January, Mark Baker filed a lawsuit against the FDA seeking to legally compel the agency to enact the requested changes. This legal matter is still in its early stages.
