Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER)

United States

WARNING LETTER

August 25, 2025

RE: 710151

Dear Privacy Compliance Officer:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.gr33n.com/ in June 2025. The FDA has observed that your websites offer “Jimerito Honey Eye Drops” for sale in the United States. We have also reviewed your social media account at https://www.instagram.com/trygr33n/ where you direct consumers to your https://www.gr33n.com/ website to purchase your product. Based on our review, this product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (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 “Jimerito Honey Eye Drops” product is 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.

Based on a review of your websites, your “Jimerito Honey Eye Drops” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is 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 from your websites that provide evidence of the intended use of this product as a drug include, but may not be limited to, the following:

On your “Jimerito Honey Eye Drops” product page https://www.gr33n.com/products/jimeritohoney-eye-drops?variant=44243932217534:

“Experiencing Declining Eye Health? Jimerito offers relief you can trust. Gr33n’s Jimerito Honey Eye Drops combat the effects of declining eye health with instant hydration and long-term support, keeping your eyes clear, refreshed, and protected.”
Customer review: “Healthy Eyes, Happy Life ‘I was starting to struggle with early signs of cataracts, like blurry vision and eye discomfort. Since using Gr33n Jimerito drops, my eyes feel clearer and healthier, and my vision is more comfortable every day.’”
Customer review: “My sight has improved! “I truly recommend this product if you have floaters and sight problems. I’ve being using it for a week and most of my floaters are gone and my sight is improved! I love it!”
“Fight Off Eye Fatigue Instantly”
“Improve & Sharpen Your Vision By providing essential hydration and lubrication, it can help your eyes focus more clearly.”
“Help Protect Against Glaucoma & Cataracts Supports healthy blood flow and reduces eye pressure to help prevent serious vision issues.”
“Clinically Proven to Improve Your Eye Health”
“74% of People have reported clearer vision and sharper focus after regular use.”
May 29, 2025, customer review: “I purchased the [J]imerito honey for my grandfather he has glaucoma and cataracts . . . he said that it is working for him.”

On a post on your Instagram social media account at https://www.instagram.com/trygr33n/:

February 26, 2025 video post: “Seeing floaters, struggling with blurry vision, or dealing with dry, irritated eyes? Jimerito Honey Eye Drops, powered by pure stingless bee honey, naturally hydrate, soothe, and protect your eyes—supporting clearer vision, cataract prevention, and overall eye health. Experience the power of nature!”
March 10, 2025 video post: “[W]hen your vision was struggling for much you had to stop driving at night, and your phone gave you headaches…but then you found Jimerito Honey, and now everything just feels clearer.” “Struggling with eye strain, tired eyes, or trouble seeing clearly at night? [J]imerito honey is made with pure stingless bee honey, packed with natural nutrients to support eye health and clarity. experience the difference today!”

Your “Jimerito Honey Eye Drops” is not generally recognized as safe and effective (GRASE) for its above referenced uses and, therefore, this product 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 this product. Accordingly, the introduction or delivery for introduction into interstate commerce of this product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

The violations cited in this letter are 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 “710151” 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