On February 15, 2024, the FDA issued a Warning Letter to LightEyez Limited after testing by the agency found the company’s LightEyez.com MSM Eye Drops V2.0 — Eye Repair (MSM Eye Repair Drops) to have microbial contamination in samples of the drops. In addition, the FDA stated that the drops “consists in whole or in part of any filthy, putrid, or decomposed substance.”

The FDA found that the products were prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practices (CGMP). In addition, the FDA reviewed the company’s website and found statements about the company’s MSM Eye Repair Drop, MSM Eye Support Eye Drop, Antioxidant Eye Drop (with MSM), and Limbal Ring Preserver products, as well as color changing eye drop products (including Ultra X - The Ultimate Color Changing Drop, The Ultra Drop, and Advanced Extra Strength Color Changing Eye Drop (Kijoc Mushroom)), and eye lightening eye drop products (including Premium Manuka Eye Lightening Drop, The Original Eye Lightening Drop, and The ‘Just Raw Honey’ Eye Lightening Drop) to be unapproved new drugs because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.

For example, MSM Eye Drop products were promoted with statements such as, “MSM softens eye tissues; equalises the pressure of eyes, repairs damage to membranes and helps eye tissues to be able to more effectively absorb nutrients.” and “. . . To lessen Eye Floaters . . . To alleviate dry/irritated or itchy eyes . . . To help with the effects of eye allergies and to lessen symptoms.”

For more information and tests of related products, see ConsumerLab’s Review of Vision Supplements.

Also see the answer to the following questions: Which supplements are helpful for age-related macular degeneration (AMD)?

Can supplements, natural eye drops, or lifestyle modifications improve symptoms of dry eye?

Do any supplements help prevent or reduce eye floaters?

Which supplements are best for seasonal allergies?

Premium High Strength Eye Colour Changer (Jarrah + Manuka Honey) products were promoted with statements such as, “Potential Medical Uses[,] . . . combat the side effects of Glaucoma medication, that cause the Iris and Sclera to become darker[,] . . . This eyedrop can be used for overall Whitening of the eye[,] Using the medication Melanotan I & II to tan the skin, causes extra Melanin to be produced. An unpleasant side effect of this is the Melanin level in your eyes also increases. Our eyedrops can prevent this effect from occurring. Or lighten the eyes if it has already occurred.”

See ConsumerLab’s answer to What are the health benefits of manuka honey, and is it safe? for information about related products.

The FDA also stated in its letter that it considers most of these products to be “new drugs” because they are not recognized as safe and effective for their intended use.

The company must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address these violations.

For more information, use the link below.

Warning: LightEyez Limited

See related recalls and warnings:

Belmont Eyecare Warned for Colloidal Silver, MSM, and Castor Oil Eye Drop Claims

FDA Warns CVS, Walgreens, Similasan & Others for Eye Drop Violations

Dr. Berne’s Whole Health Products Warned for Contaminated Eye Drop Products, Drug Claims

Recalled Eye Drops Linked to Vision Loss and One Death