TRP Company, Inc
FDA issued a warning letter to TRP Company, Inc. (Reno, NV), owned by Thomas Pominville, regarding twelve ophthalmic homeopathic drug products sold at thereliefproducts.com, including 'Dryness Relief,' 'Pink Eye Relief,' 'Allergy Eyes Relief,' and others. The products were deemed unapproved new drugs under FD&C Act section 505(a) because they are not generally recognized as safe and effective for their labeled uses and lack FDA-approved applications. FDA also cited adulteration violations stemming from CGMP failures at the contract manufacturer. The letter warns that failure to correct violations may result in seizure, injunction, and import detention.
Flagged claims (21)
Temporarily relieves extreme dryness, lack of tears, achy eyes, eyestrain, and redness
Temporarily [sic] relief from symptoms such as shapes and squiggly lines in vision, floaters, dark-dots and dust particles in your vision
[F]ormulated to naturally address common pink eye symptoms . . . gently soothe all types of eye irritation including burning, grittiness, and overnight crusting of the eye
Temporarily relieves redness, burning, and itching
[F]ormulated to temporarily alleviate red eye symptoms . . . soothe red, irritated, and watering eyes
[P]rovide temporary relief of . . . dry, irritated eyes
[F]ormulated to temporarily alleviate blepharitis symptoms . . . temporarily alleviate swollen, red lids, crusting lids, oily & sticky lids
[F]ormulated to naturally address common stye symptoms . . . provide soothing relief from symptoms such as inflammation, bumps on the eyelid, swollen lids, itching, burning, watering, and discomfort
[F]ormulated to temporarily alleviate blurred vision
Temporarily relieves red, swollen bumps on the eye lid[,] alleviates swelling, burning, and watering
[P]rovides temporary relief for symptoms such as excessive watering and itchy eyes, dry, red eyes, burning as well as acute and chronic allergies
Temporarily relieves eye fatigue and blurry vision
[F]ormulated to temporarily alleviate eye strain symptoms . . . temporarily alleviate dry eyes, eye strain with headache, ocular fatigue, blurry vision
[F]ormulated to temporarily alleviate eye floaters and corneal opacities
[F]ormulated to temporarily alleviate acute, chronic, and seasonal eye allergy symptoms
Temporarily relieves redness, burning, crusting, and grittiness
Temporarily relieves acute, chronic, and seasonal eye allergies, redness, burning, itchiness, and excessive watering
Temporarily relieves cloudy and blurry vision[,] Supports corneal and macular eye health
Temporarily relieves blurry vision, dry, red eyes, tired eyes, cloudy vision . . . and poor night vision
[T]emporarily alleviates . . . symptoms including eye floaters, blurry or cloudy vision, and ocular fatigue
[F]ormulated to temporarily alleviate eye twitching and spasms . . . provide temporary relief for symptoms such as twitching eyelids, spasms, quivering, irritation, sensitivity, eye strain, and tired eyes
Required actions (3)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
In addition, please note that unapproved new drugs are subject to refusal of admission into the United States, and such products may be subject to detention without physical examination.
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