LightEyez Limited - 665450 - 02/15/2024 (2024)

Warning Letter 320-24-23

February 15, 2024

Dear Dr. Carmichael:

The U.S. Food and Drug Administration (FDA) has obtained samples and conducted testing of “LightEyez.com MSM Eye Drops v2.0 – Eye Repair” (MSM Eye Repair Drops) ophthalmic drug product. This over-the-counter (OTC) drug product is labeled as and confirmed by your Chief Executive Officer (CEO), as being owned and marketed by your firm, LightEyez Limited (LightEyez).

The results of FDA laboratory testing of a batch of MSM Eye Repair Drops demonstrates that this drug product is adulterated within the meaning of section 501(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), 21 U.S.C. 351(a)(1), in that it consists in whole or in part of any filthy, putrid, or decomposed substance. Introducing or delivering this product for introduction into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

The FDA has reviewed the August 25, 2023, correspondence from you and your manufacturer, (b)(4), submitted in response to our meeting held with LightEyez on August 24, 2023, regarding the batch of MSM Eye Repair Drops product tested by FDA. Our review of the correspondence along with the test results led to our determination that your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211 (21 CFR Parts 210 and 211); therefore, your drug product is also adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).

Further, this letter is to advise you that the FDA reviewed the product labeling for your “MSM Eye Repair Drops” product and your website at the Internet address https://www.lighteyez.com/ in August and September 2023. The FDA has observed that in addition to your “MSM Eye Repair Drops” product, your website also offers other variations of MSM eye drop products including, but not limited to, “MSM Eye Support Eye Drop,” “Antioxidant Eye Drop (with MSM),” and “Limbal Ring Preserver;” 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” (herein referred to as “your MSM, color changing, and eye lightening eye drop products”) for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Your MSM, color changing, and eye lightening eye drop products are especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.

Adulteration Violations

FDA laboratory testing of MSM Eye Repair Drops, batch “P15D7 April 11th 2023” obtained directly from your LightEyez website found gross microbial contamination. Microbiological testing of ten composite samples (i.e., two individual samples per composite) were analyzed. All ten composite samples found gross microbial growth. These test results demonstrate that this ophthalmic drug product is adulterated under section 501(a)(1) of the FD&C Act, in that it consists in whole or in part of a filthy, putrid, or decomposed substance.

Examples of microbial contaminants found in your product include Pseudomonas spp., Mycobacterium spp., Mycolicibacterium spp., and Methylorubrum spp. The presence of microorganisms in conjunction with the route of administration poses a high risk to patients. Using contaminated eye drops could result in a range of ocular infections, from minor to serious vision-threatening infections which could progress in some cases to a life-threatening infection.

On August 22, 2023, FDA issued a drug safety alert warning consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops, including your MSM Eye Repair Drops, due to bacterial contamination, as noted on the following FDA website:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-methylsulfonylmethane-msm-eye-drops-due

On August 24, 2023, the FDA held a teleconference with your legal representative located in the United Kingdom (U.K.) regarding your MSM Eye Repair Drops. During the call, your representative stated that your firm supplies your U.S. manufacturer (b)(4) with drug components to conduct further manufacturing of your ophthalmic drug product. Your firm agreed to voluntarily recall your sterile drug products in U.S. distribution and that your U.S. manufacturer (b)(4) would process the voluntary recall of your ophthalmic drug products.

On August 25, 2023, your U.S. manufacturer (b)(4), located in Sarasota, Florida, responded to FDA and confirmed drug components used in your MSM Eye Repair Drops were imported from LightEyez (U.K.). The drug components imported included methylsulfonylmethane (MSM) used as an active ingredient in your ophthalmic drug product. (b)(4) also indicated that a malfunctioning water system resulted in the use of unfiltered municipal water in your ophthalmic drug product.

Since the last communication received August 28, 2023, you and your manufacturer, (b)(4), have ceased communication with FDA and have yet to initiate a recall through FDA. We do note that, by at least September 12, 2023, your firm posted a “service alert” on your firm’s website at https://www.lighteyez.com/neweyecolorsupport.html to recall MSM Eye Repair Drops, but only regarding batch “P15D7 April 11th 2023.”

On September 15, 2023, FDA conducted an on-site investigation at (b)(4) listed address. However, neither (b)(4) nor LightEyez were found at the location. Based on FDA’s investigation and the cessation of communications with FDA by your firm and (b)(4), we are unable to inspect the manufacturing operations of either LightEyez or (b)(4).

Your firm failed to have adequate quality oversight responsibility over your manufacturer’s activities (e.g., further processing, use of water suitable for intended use) as required by 21 CFR 211.22(a).

In response to this letter, provide:

• The updated address for the headquarters of LightEyez.
• The name and address of all LightEyez facilities that manufacture drug products distributed to the U.S. market. This also includes the name and address of all contract organizations you have or are currently using to manufacture drug products for the U.S. market.
• A complete list of all drug products owned by LightEyez and offered for sale or distributed to the U.S. market.
• 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.

Unapproved New Drugs

Based on our review of your labeling and website, your MSM, color changing, and eye lightening eye drop products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.

Examples of claims observed on your website that provide evidence of the intended use of your MSM, color changing, and eye lightening eye drop products as drugs include, but may not be limited to, the following:

On the “MSM Eye Repair Drops” product label:
• “Eye Repair”

On the “MSM Eye Repair Drops” product page https://www.lighteyez.com/store/p3/MSM_Eye_Repair_Drops%E2%80%8B.html:
• “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”
• “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”

On the product page for your eye lightening eye drops “Premium High Strength Eye Colour Changer (Jarrah + Manuka Honey),”¹

https://www.lighteyez.com/store/p27/Premium_High_Strength_Eye_Colour_Changer%2C_%28Jarrah___Manuka_Honey%29.html:
• “About[,] . . . 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.”
• “How does it Work?[,] The Eye Drop works by inhibiting the production of Melanin. . . active ingredients interact to create a protective Melanin blocker over the iris. Once it is absorbed through the ocular surface, the protective film begins to block and reduce the concentration of melanin in the back of your iris from reaching the front of the iris (stroma).”
• “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.”

Your MSM, color changing, and eye lightening eye drop products are not generally recognized as safe and effective (GRASE) for their above-referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Suitable Container Closures

Based on our review of your firm’s website at https://www.lighteyez.com/neweyecolorsupport.html, we have concerns regarding whether your container closure system will provide adequate protection against foreseeable external factors. Your website provides consumers with instructions on how to clear blockages of your container closure dropper tip intended for your ophthalmic drug products. Your recommendations instruct consumers to insert a foreign object into the dropper tip nozzle and/or remove the dropper tip to clear a blockage, which risks contamination of your ophthalmic drug products with foreign particulate matter and/or microorganisms.

Additionally, your website indicates that your container closure system is subject to leaking. You acknowledge that “this is especially if it is an international shipment. Since transportation via air causes pressure to build up in containers.” A container closure system should provide the dosage form with adequate protection from factors that can cause a degradation in the quality of that dosage form over its shelf life. A drug product can also suffer an unacceptable loss in quality if it is contaminated by filth.

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your product(s). You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.

Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.

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, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. 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. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3027822577 and ATTN: Bill Fowler.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research

CC:
LightEyez Limited
Steve McDonald
Legal Representative
legal@lighteyez.com

(b)(4)

______________________

1 The same claims appear on the websites for “Premium High Strength Eye Colour Changer Jarrah Honey Drops,” “Premium Manuka Eye Lightening Drop,” “The Original Eye Lightening Drop,” “The Sensitive Eye Lightening Drop,” and “The ‘Just Raw Honey’ Eye Lightening Drop” (with respective product links
https://www.lighteyez.com/store/p22/Premium_High_Strength_Eye_Colour_Changer_Jarrah_Honey_Drops.html, https://www.lighteyez.com/store/p5/Premium_Manuka_Eye_Lightening_Drop.html,
https://www.lighteyez.com/store/p1/The_Original_Eye_Lightening_Drop.html,
https://www.lighteyez.com/store/p6/Color_changing_Eye_Drop_for_Sensitive_Eyes.html,
https://www.lighteyez.com/store/p15/The_%27Just_Raw_Honey%27_Eye_Lightening_Drop.html)