FDA WARNING_LETTER - TRP Company, Inc - September 11, 2023

The FDA issued a Warning Letter to Thomas Pominville of TRP Company, Inc. on September 11, 2023, regarding the sale of unapproved new drugs. This letter reiterates previous communications from September 2022 and February 2023.

The FDA's July 2023 review of TRP's website (https://www.thereliefproducts.com/) found that products including "Dryness Relief," "Pink Eye Relief," "Allergy Eyes Relief," "Red Eye Relief," "Eye Strain Relief," "Eye Lid Relief," "Aging Eye Relief," "Blur Relief," "Floaters Relief," "Twitching Relief," "Stye Relief," and "Dryness Relief PF" are offered for sale in the United States. These ophthalmic products are considered drugs under section 201(g)(1) of the FD&C Act due to their intended use claims, such as "Temporarily relieves extreme dryness" or "Temporarily alleviates blurred vision."

The FDA determined these products are "new drugs" under section 201(p) because they are not generally recognized as safe and effective (GRASE) for their stated uses. Since no FDA-approved applications exist for these products, their introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act. The letter emphasizes public health concerns due