Dear Supporters,
One of our supporters has succeeded in working through his US Senator to write a letter to the FDA asking why they haven’t approved our petition to regulate LED products. The FDA’s response to the Senator is here:
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FDA provided an interim response to the citizen petition (FDA-2022-P-1151) on November 7, 2022, in accordance with the regulations at 21 CFR 10.30(e)(2)(iv). Our interim response informed the petitioner that FDA has been unable to reach a decision on the petition because it raises issues requiring further review and analysis by agency officials. Please be assured that we are working diligently and considering carefully the scientific and other information that was submitted in the citizen petition, as well as information submitted to the public docket by interested persons. After FDA has considered the available scientific data and other information, we intend to issue a response to the citizen petition.
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The Nov. 7, 2022 letter was the one the FDA sent to me, essentially admitting they don’t have performance standards for LED products, but not wanting to admit it, so they are using a delay tactic.
I am requesting your help now to take this effort to the next level. Please call your Congressperson and ask them to send a letter with the following: “Dear Jeff Shuren, Director, Center for Devices and Radiological Health, FDA: Congress mandated in 1968 that the FDA regulate electromagnetic radiation from electronic products, which includes Light Emitting Diode products. To date, the FDA has not published the necessary performance standards for LEDs which would include restrictions on peak luminance, dispersion characteristics, spectral power distribution, square wave flicker, and flashing characteristics. How does the FDA justify this failure and when can Congress expect publication of performance standards for products such as LED vehicle headlights, LED streetlights, LED General Service Lamps, LED strip lights in beverage coolers, and LED strobe lights on emergency vehicles?”
If you are successful working with your Congressperson and get a response from the FDA, please send it to me. Or, if you need assistance, please email me.
Sincerely,
Mark Baker, President, Soft Lights Foundation, mbaker@softlights.org