A small independent brief on how health products, clinic tools, and patient rules are actually policed — not how they are advertised.
Latest update: 22 October 2026.
On the desk
BlephEx, LLC: Unresolved FDA warning letter
Letter dated June 3, 2026 · CMS 725861 · Center for Devices and Radiological Health
The Food and Drug Administration told BlephEx, LLC of Brentwood, Tennessee, to stop marketing three eyelid devices for uses the agency says fall outside the class I exemptions the firm has relied on. The public letter also describes quality-system failures, including more than 177 complaints that FDA says were never properly reviewed, and a 2019 finding that the agency calls a repeat.
The products named are a powered eyelid-cleaning sponge, a battery-powered electrolysis unit, and heated expression forceps. FDA asked the firm to cease the commercial distribution at issue. A claim that the device is the fix, the cure, or a way to treat is not permissible. A 2024 trial at the University of Freiburg found the powered eyelid-cleaning device was not shown to produce results statistically different from a sham procedure.
The firm appears to be in chronic non-compliance with that warning letter. It continues to market itself, and it continues to appear on talk shows advertising the cure or the fix for dry eye.
Anyone can report. The BlephEx letter is what it looks like when the firm’s own file was empty.
Method
These notes start from public records: FDA letters, board minutes, court dockets, Justice Department announcements, and a firm’s own published materials. They stay inside those sources. A warning letter is an administrative notice. It is not a court judgment. The reader decides what it means. Corrections are posted on the same page as the error.
Posted here
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