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WARNING LETTER

July 9, 2025

RE: 712417

Dear Mr. Guinness:

This letter is to advise you that on April 14, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet address https://myrevitalize.com/ where your Revitalize Energizing Eye Drops drug product is available for purchase in the United States without a prescription. We also reviewed your social media site on Facebook https://www.facebook.com/RevitalizeEnergy which direct consumers to your website to purchase your product.

Based on our review, your Revitalize Energizing Eye Drops drug product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), 331(d). In addition, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under sections 301 (d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.

Unapproved New Drug and Misbranded Drug Violations

Your Revitalize Energizing Eye Drops is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body.

Examples of claims from the product labeling, your website, and your social media site posts that provide evidence intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:

“Drug Facts . . . Uses ▪Temporarily relieves burning and irritation due to dryness of the eye. ▪ Relieves redness of the eye due to minor eye irritations.” [from the Drug Facts panel on product carton labeling]

“Camphor…To Cool & Refresh” [from your product carton labeling]

“Revitalize is the first eye drop designed to fight screen fatigue. Our patented formula relieves eye strain, boosts focus, and refreshes tired eyes in seconds.” [from your website, https://myrevitalize.com/pages/our-formulation-1]

“Instant Energy & Screen Fatigue Relief…Refresh tired eyes with our energizing eye drops…” [from your website https://myrevitalize.com/]

“Our energizing formula is built for people who live on screens. Every ingredient is selected with purpose and designed to relieve eye muscle fatigue, boost focus, and refresh tired vision…. Caffeine & Taurine: To Energize…Menthol & Camphor: To Cool and Refresh” [from your website https://myrevitalize.com/]

“Revitalize also includes a proprietary blend of stimulants designed to alleviate the effects of screen fatigue.” [from your website https://myrevitalize.com/]

“After applying Revitalize, users will feel a deep cooling sensation to stimulate the tear duct and help with the absorption of the remaining ingredients. From there users will feel their eyes refreshed and stimulated. That is our inactive ingredients interacting with the focus adjustment mechanism of the eye.” [from your website https://myrevitalize.com/]

Article posted on your Facebook page that includes the caption “Why did we formulate Revitalize to include caffeine? Aside from its energetic benefits, its antioxidant benefits protects from cataracts caused by UV-B rays.” [from your Facebook page at https://www.facebook.com/share/p/16sSvSaQaD/ (posted to the Revitalize Energy Facebook page on May 31, 2023)]

Video posted on your Facebook page with the caption “When staring at something for too long, your phone, laptop, the road, etc., reset the focus of your eyes with Revitalize!” where a user explains the benefits of caffeine for the eyes in Revitalize Energizing Eye Drops. [From your Facebook page at https://www.facebook.com/reel/1370836136981074 (posted to the Revitalize Energy Facebook page on June 2, 2023)]

Unapproved New Drug Violations

Based on the above evidence of intended use, your Revitalize Energizing Eye Drops is intended for use as an ophthalmic demulcent (lubricant) drug product. As described below, this drug product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).

A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. Your Revitalize Energizing Eye Drops is not generally are not generally recognized as safe and effective (GRASE) for its above referenced uses¹ and, therefore, is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). There is no FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, in effect for your Revitalize Energizing Eye Drops drug product.

Your drug product is marketed as an ophthalmic demulcent and vasoconstrictor drug product and is subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which generally governs nonprescription drugs marketed without an approved application. Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as “over-the-counter (OTC) monograph drugs”— may be legally marketed if they meet applicable requirements. With respect to nonprescription ophthalmic drug products, such as your Revitalize Energizing Eye Drops, in order to be GRASE and not a new drug, the product must, among other things, conform to the conditions in the applicable OTC monograph, here OTC monograph M018: Ophthalmic Drug Products for Over-the-Counter Human Use (hereinafter M018).² However, your Revitalize Energizing Eye Drops drug product does not conform to the conditions specified in M018 for the reasons described below, and thus cannot be legally marketed under section 505G.

Your Revitalize Energizing Eye Drops is a demulcent product formulated with several active ingredients that are not permitted for OTC ophthalmic demulcent or vasoconstrictor drug products under M018.12 and M018.18 respectively. Specifically, according to your product’s labeling, your Revitalize Energizing Eye Drops product is formulated with active ingredients menthol, camphor, caffeine, and taurine.

However, menthol, camphor, caffeine, and taurine are not active ingredients permitted for ophthalmic demulcent drug products under M018.12. We note that, although you identify these ingredients as inactive ingredients on the product label, statements on your website show that they are active ingredients because they are intended to furnish pharmacological activity for the treatment of a disease or condition.³ Examples of these statements include, “Our energizing formula is built for people who live on screens. Every ingredient is selected with purpose and designed to relieve eye muscle fatigue, boost focus, and refresh tired vision…. Caffeine & Taurine: To Energize…Menthol & Camphor: To Cool and Refresh” and “Why did we formulate Revitalize to include caffeine? Aside from its energetic benefits, its antioxidant benefits protects from cataracts caused by UV-B rays.” Additionally, the following are also posted to your Facebook page: a video dated June 2, 2023 where a user explains the benefits of caffeine for the eyes; and a direct link to an article posted on June 15, 2023 with the caption “Benefits of taurine for you? Why did we add it to Revitalize? Check out research on longevity effects of taurine.” Thus, these ingredients are active ingredients and, because they are not active ingredients permitted under M018.12 or M018.18, your Revitalize Energizing Eye Drops product does not conform with the conditions for lawful marketing of an OTC ophthalmic demulcent or vasoconstrictor drug product as set forth in M018.

In addition, your Revitalize Energizing Eye Drops drug product labeling includes intended uses that are not permitted in M018. Specifically, claims such as “protects from cataracts caused by UV-B rays,” “instant energy,” and “energizing eye” go beyond the allowed general intended uses for an OTC demulcent or vasoconstrictor ophthalmic drug product and do not conform to M018.60 or M018.75.

Thus, your Revitalize Energizing Eye Drops drug product does not comply with the applicable conditions specified in M018 and has not otherwise been found GRASE.4 Accordingly, this product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which this product would be legally marketed without an approved application. Because there is no approved application in effect for this product, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).

Misbranded Drug Violations

Revitalize Energizing Eye Drops is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the “FDA” logo is displayed on your product label and website as “FDA COMPLIANT” (“Passed All Required FDA testing”), “MADE IN A FDA REGISTERED FACILITY” (“Trusted Manufacturing”), and “FDA GRAS APPROVED” (“Formulated within FDA Guidance”). Such claims create the impression that your drug is approved or legally marketable (see 21 CFR 207.77(b)). As previously noted, your Revitalize Energizing Eye Drop is not the subject of an FDA-approved application, therefore, claims that suggest your product has been FDA-reviewed or FDA-approved are false or misleading.

Additionally, your Revitalize Energizing Eye Drops is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because this product is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.

The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

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. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov. Please include your firm name and the unique identifier “712417” in the subject line of the email.

Sincerely,
/S/

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

__________________________

1 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that your above-referenced topical ophthalmic drug products are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling.

2 M018 reflects the conditions as set forth in the relevant final orders established and in effect under section 505G; see Order OTC000023, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf.

3 See21 CFR 201.66(b)(2), which defines an active ingredient as “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.”

4 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that Revitalize Energizing Eye Drops product is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling, nor has FDA determined this drug product to be GRASE pursuant to an order issued under section 505G(b).