LightEyez Limited
FDA issued a warning letter to LightEyez Limited (UK), the maker of MSM Eye Repair Drops and related ophthalmic products, after laboratory testing revealed gross microbial contamination (including Pseudomonas spp. and Mycobacterium spp.) in a batch of their eye drops. The products were also found to be unapproved new drugs under section 505(a) of the FD&C Act, with website claims asserting the drops could repair eyes, reduce glaucoma/cataracts, permanently change eye color by destroying melanin, and treat floaters and bloodshot eyes. FDA demanded a voluntary recall of all sterile products, full contamination investigations, and a written response within 15 working days, and warned that continued violations could result in refusal of admission of LightEyez products into the United States.
Flagged claims (11)
LightEyez products work by inhibiting the production of Melanin, other pigmentation and Tyrosinase . . . our products go beyond this giving you lasting, permanent changes.
Eye Repair
MSM assists in alleviating a wide range of problems: SOFTENS EYE TISSUES AND MEMBRANES Allowing absorption of Eye Lightning and Colour Changing Ingredients and for other particles to pass out[,] EQUALISES PRESSURE Supporting Cellular Synchronization[,] REPAIRS DAMAGE TO TISSUES & BLOOD VESSELS Supporting overall Cellular Health
What can I use MSM for:[,] To lessen Eye Floaters[,] To alleviate dry/irritated or itchy eyes[,] To help with bloodshot eyes or broken capillaries[,] To assist with vision problems[,] To stop eye allergies and to lessen symptoms[,] May also alleviate or reduce effects of Glaucoma or Cataracts
Color changing & Eye Lightening . . . If used as directed, our eye-drops will naturally lighten eyes and change eye color within three to fifteen months . . . They work by breaking down and flushing out melanin and other pigmentation, as well as inhibiting the production and action of Tyrosinase
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.
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
Is it permanent? Yes the change is 100% permanent. Melanin pigment in the eye is what scientists call a 'Terminal Cell'; this means that once the cell is gone, it will not be reproduced in the eye any longer. Thus, when the drop breaks down the Melanin, it is not replaced by the body . . . Bringing forth your new, natural eye color. Forever. Without Surgery . . .
our eye-drops will naturally lighten the color and appearance of your eyes within three months . . . able to inhibit tyrosinase, thus preventing future formation of melanin.
An innovative MSM based eye drop that repairs the eyes . . . or use to assist in medical treatment of floaters, tired eyes, bloodshot eyes, eye irritation and grittiness, damage eye membranes, and other eye conditions
Speeds up Eye Color Change[,] Repairs broken blood vessels[,] Removes Floaters[,] Overall Eye Health
Required actions (4)
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
A response to FDA's requests to issue a voluntary recall of all batches of MSM Eye Repair Drops and all other LightEyez sterile drug products remaining within expiry.
Complete investigations into this failure and extended to all sterile batches with potential microbial contamination or out-of-specification (OOS) microbiological result (whether or not later invalidated). The investigations should detail your findings regarding the root causes of the contamination.
Failure to address any violations may also result in the FDA refusing admission of articles manufactured by LightEyez into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most pharmacy / compounding sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker