FDA warns firms against selling unapproved eye products.
The U.S. Food and Drug Administration (FDA) has taken action against eight companies for manufacturing or selling unapproved eye products, which the agency states is a violation of federal law.
The FDA issued warning letters to these companies regarding their eye products, which are being illegally marketed to treat various conditions such as conjunctivitis, cataracts, and glaucoma. The agency expressed concern about the potential harm these unapproved products can cause, as drugs applied to the eyes bypass the body’s natural defenses.
“Some of these eye products are labeled to contain silver, which may be characterized as silver sulfate, silver sulphate, or argentum. Long-term use of drugs containing silver can cause some areas of the skin and other body tissues, including in the eye, to permanently turn gray or blue-gray, which is called ‘argyria,'” the FDA warned.
Furthermore, the FDA emphasized that unapproved drugs claiming to cure or prevent serious conditions may lead individuals to forgo or delay safe and effective medical treatments that have undergone the FDA review process.
The FDA sent warning letters to Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan AG/Similasan USA, TRP Company, and Walgreens Boots Alliance. These companies are manufacturing or selling eye products that have safety concerns.
Affected Products
- Boiron’s Optique 1 Eye Drops
- CVS Health Pink Eye Relief Drops
- DR Vitamin’s Vision Clarity Eye Drops, Life Extension Brite Eyes III, Can-C Eye Drops, and Longevity Science Visual Ocuity
- Natural Ophthalmics’ Women’s Tear Stimulation Dry Eye Drops, Allergy Desensitization Eye Drops, Ortho-K Thin (Daytime) Eye Drops, Ortho-K Thick (Night) Eye Drops, Tear Stimulation Forté Dry Eye Drops, and Cataract Eye Drops with Cineraria
- OcluMed Eye Drops
- Similasan’s Dry Eye Relief, Complete Eye Relief, Allergy Eye Relief, Kids Allergy Eye Relief, Red Eye Relief, Pink Eye Relief, Kids Pink Eye Relief, Aging Eye Relief, Computer Eye Relief, Stye Eye Relief, Pink Eye Nighttime Gel, and Dry Eye Nighttime Gel
- TRP Company’s 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, and Stye Relief
- Walgreens’ Allergy Eye Drops, Stye Eye Drops, and Pink Eye Drops
Some of the warning letters also mentioned quality issues related to the sterility of the products.
In late August, the FDA issued a recall of eyedrop products manufactured by Dr. Berne’s Whole Health Products due to concerns about contamination.
The voluntary recall applies to all lots of Dr. Berne’s MSM DROPS 5%, 15% Solution, Dr. Berne’s Organic Castor Oil Eye Drops, and Dr. Berne’s MSM MIST 15% Solution, according to an FDA recall notice.
An analysis conducted by the FDA revealed that a lot of MSM DROPS 5% Solution failed sterility tests, with both bacterial and fungal contamination found in the product.
These recalled products are used as lubricating eyedrops and were sold through Dr. Berne’s online store.
A few days prior to the recall, the FDA issued a warning advising consumers not to purchase or use two eyedrop products: Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops.
These products contain methylsulfonylmethane (MSM) as an active ingredient. The FDA states that these items are unapproved drugs and are illegally marketed in the United States. There are no eye drops due to bacterial and fungal contamination, posing life-threatening infection risk.”>legally marketed ophthalmic drugs that contain MSM as an active ingredient.
Amniotic Fluid Eyedrop Warning
In April, the FDA issued a public safety notification regarding the sale of amniotic fluid eyedrops for the treatment of eye diseases. These products had not undergone the necessary premarket review and approval, raising concerns about their safety and effectiveness.
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