DR Vitamins, LLC dba DR Vitamin Solutions
FDA issued a warning letter to DR Vitamins, LLC dba DR Vitamin Solutions (North Richland Hills, TX) on September 11, 2023, citing four ophthalmic eye drop products — 'Vision Clarity Eye Drops,' 'Life Extension Brite Eyes III,' 'Can-C Eye Drops,' and 'Longevity Science Visual Ocuity' — as unapproved new drugs under FD&C Act section 505(a) and misbranded drugs under section 502(o). The products were marketed with claims to treat or prevent cataracts, glaucoma, floaters, and dry eyes using N-Acetyl-Carnosine (NAC), an ingredient not permitted under OTC Monograph M018 for ophthalmic demulcents. FDA found no adequate clinical evidence supporting GRASE status and noted the drug listing for 'Vision Clarity Eye Drops' had been inactive since January 2020. The company was directed to respond within 15 working days with corrective steps, with failure to comply potentially resulting in seizure or injunction.
Flagged claims (13)
For those with cataracts, glaucoma and other eye ailments, it is recommended to take 1 drop 4 times a day at various intervals morning, noon, evening and before bed.
Over the past decade and a half, NAC eye drops have become an increasingly popular product for resisting and reversing cataracts in both pets and humans.
By providing compounds like N-Acetyl-Carnosine (NAC), these Can-C Eye Drops are made to serve as your ultimate eye shield. As such, they may help to protect the eyes from damage in the form of free radicals, UV rays, and thereby, even cataracts.
people have been able to avoid having cataract surgery because they've used these drops.
Topical NAC shows potential for the treatment and prevention of cataracts.
NAC uses natural ingredients and the body's main antioxidant glutathione to chip away at the damaged cells of the cataracts. The damaged cells are cleared away and healthy cells can be protected from further damage.
The Brite Eyes III formula also contains the antioxidant N-acetyl-carnosine . . . Some experts think that carnosine has potential to support antioxidant activity which resists the presence of cataracts on the lens of the eye.
N-Acetyl-Carnosine (NAC) drops can help. Especially with cataracts.
[C]ontain heavily researched lubricants to help combat dry eye and other irritations.
Say Goodbye To Dry Eyes and Eye Irritations With Vision Clarity Eye Drops!
clinically studied ingredients[:] cataracts[,] dry eyes[, and] floaters.
[E]xpertly crafted to aid in the relief of dry, itchy eyes and other afflictions which might cause discomfort and limited vision.
Carnosine, a cataracts worst nightmare.
Required actions (2)
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.
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