
Dear Supporters,
We have a concrete statement directly from the FDA that they acknowledge and assert their authority to regulate the visible optical radiation from LEDs. Therefore, where are the regulations? I have a simple task request for each of you. Please call the office of your Congressperson (House or Senate or both) in Washington, D.C. and ask the staff member for an email address to ask a question. Then, send this question:
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Dear [Congressperson],
The FDA has confirmed that they have the authority and imperative to regulate LED visible radiation by issuing CSMS# 17-000330 - LIGHT-EMITTING DIODE (LED) REPORTING TO FDA on June 6, 2017, which states, "FDA has regulatory authority over radiation-emitting electronic products, which are defined in 21 CFR 1000.3 as any electrically-powered product that can emit any form of radiation on the electromagnetic spectrum. As such, reporting to FDA upon importation of radiation-emitting electronic products is required. LED products emit visible optical radiation, which qualifies them to be radiation-emitting electronic products and gives FDA regulatory authority.”
https://content.govdelivery.com/.../USD.../bulletins/1a00f8a
Thus, since the FDA acknowledges and asserts that they have regulatory authority over the visible optical radiation emitted by LEDs, where are the regulations and why won't the FDA approve petition FDA-2022-P-1151? I am requesting assistance from your office with getting an answer to this question.
Sincerely,
[Your Name]
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Please forward any response to me. Thank you!
Mark Baker
President
Soft Lights Foundation
mbaker@softlights.org