TRP Company, Inc Warning Letter Details

Summary

TRP Company, Inc was warned that twelve ophthalmic eye relief products—including "Dryness Relief," "Pink Eye Relief," "Allergy Eyes Relief," "Red Eye Relief," and others—were unapproved new drugs in violation of section 505(a) of the FD&C Act. FDA's July 2023 website review found that these products continued to be offered for sale in the United States despite a prior September 2022 warning and February 2023 correspondence advising the company of their illegal status. The violations were of particular concern because ophthalmic products administered directly to the eyes pose greater risk of harm due to the route of administration bypassing natural body defenses.