My Holistic Honey c/o Shenzhen Qanhai Wanb Express Supply Chain Co., LTD

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your product label and your website at the Internet address https://myholistichoney.com/ in July 2025. The FDA has observed that your website offers “Holistic Honey EYE DROP” (also referred to on your website as “Jimerito Honey Eye Drops”) for sale in the United States. 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 “Holistic Honey EYE DROP” 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 product label and website, your “Holistic Honey EYE DROP” 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 that provide evidence of the intended use of this product as a drug include, but may not be limited to, the following:

From your product label:

“HOLISTIC HONEY EYE DROP OPTIMAL VISION”

“It can quickly releve [sic] eye dryness and fatigue and restore eye comfort.”

“Noticeable relief & soothing comfortMy optometrist recommended Holistic Honey for my chronic dry eye condition, and I'm so glad they did. I finally have relief without having to rely on prescription medications!”

“Naturally promotes healing, reduces inflammation, and soothes irritation.”

“Fight Off Eye Fatigue InstantlyProvides immediate comfort & moisture to tired, strained eyes, making them feel refreshed & alert.”

“Give Your Eyes a Natural BoostCrafted with natural ingredients to help your eyes feel their best. It addresses dryness, irritation, and discomfort.”

“Experience Newfound ClarityBy providing essential hydration and lubrication to your eyes.”

“Supports Overall Eye ComfortSupports healthy blood flow and helps maintain comfortable vision.”

“Modern Life Takes a Toll on Your Eyes. Holistic Honey Fights Back.Our eyes work hard in today's digital world, and many of us experience dryness, strain, and discomfort—issues that can contribute to more serious conditions like cataracts or glaucoma over time. Holistic Honey is crafted with the power of nature (honey!) to address these very issues.

Unlike traditional eye drops, Holistic Honey goes beyond just moisture. They provide a natural solution to promote healthier, more comfortable eyes and help reduce the risk of long-term vision problems.”

Your “Holistic Honey EYE DROP” 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 these products 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 product is 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 “712052” in the subject line of the email.