Natural Ophthalmics, Inc.
FDA issued a warning letter to Natural Ophthalmics, Inc. (Lafayette, CO) on September 11, 2023, after reviewing the company's website and finding six homeopathic ophthalmic products — including 'Cataract Eye Drops with Cineraria' and 'Women's Tear Stimulation Dry Eye Drops' — marketed with disease-treatment claims that render them unapproved new drugs under section 505(a) of the FD&C Act. The products are not generally recognized as safe and effective for their intended uses and lack any FDA-approved application. FDA warned that failure to correct violations may result in seizure or injunction, and required a written response within fifteen working days.
Flagged claims (8)
Finally – Unique eye drops which stimulate the production of all three tear film layers while supporting the health of the cornea, conjunctiva and eyelid. Both formulas share five powerful broad spectrum ingredients which relieve symptoms caused from inflammation due to aqueous deficiency, including severe dryness such as with Sjogren's Syndrome. Additionally, women experience more dry eye symptoms due to hormonal fluctuations so we added the two most commonly prescribed ingredients for these symptoms.
These homeopathic drops trigger the transfer of oxygen and nutrients from the blood to the aqueous to nourish and detoxify the living tissue of the crystalline lens. Cineraria maritima has been used homeopathically for over 100 years to safely and effectively treat cataract.
Both the Thin and Tick drops work similarly. . .. In addition, they contain Calendula, which is indicated for corneal health and vitality.
These drops contain powerful ingredients to stimulate tear film production, counter-act irritation, halt allergies and reduce foreign body sensation . . . The clarifying 'Thin Drop' is preservative free and used as often as needed to alleviate dry, red, itchy, irritated eyes and is also OK with all contacts. The 'Thick Drop' reduces mechanical irritation.
Unique eye drops which stimulate the production of all three tear film layers while supporting the health of the cornea, conjunctiva and eyelid.
'I have an 84 year old male patient who has been using your Cineraria eye drops for cataract. His vision has improved from 20/200 down to 20/60.'
'Your drops are like miracle drugs for dry eye. I have had dry eyes ever since I moved to Phoenix in 1995. They have gotten progressively worse as I've gotten older and I am now 48. I would wake up in the middle of the night and find that my eyes would sting and burn. After using the Natural Ophthalmics drops for the past 6 months I have found that I no longer have the severe feeling that I would get in the middle of the night. Your drop has tremendously helped with reducing the severity of my dry condition.'
Allergy Eye Drops stop allergy symptoms such as itching, burning, watering, edema and general ocular sensitivity.
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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