FDA WARNING_LETTER - My Holistic Honey c/o Shenzhen Qanhai Wanb Express Supply Chain Co., LTD - September 02, 2025
Discuss this record with AI
The FDA issued a warning letter to Bingbing Feng regarding the product "Holistic Honey EYE DROP" sold on the website https://myholistichoney.com/. The inspection, conducted in July 2025, revealed that the product is marketed as an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The product is intended for ophthalmic use, which poses significant public health risks due to the potential bypass of the body"s natural defenses. The product claims to promote healthier eyes and reduce long-term vision problems, classifying it as a drug under section 201(g)(1) of the FD&C Act.
The FDA noted that "Holistic Honey EYE DROP" is not generally recognized as safe and effective (GRASE) for its intended uses, and no FDA-approved application is in effect for this product. Consequently, its introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act.
The FDA requires Bingbing Feng to investigate and rectify these violations, ensuring compliance with federal law. The company must respond within fifteen working days, detailing corrective actions taken and preventive measures for future compliance. Failure to address these issues may result in legal actions, including product seizure or injunction. The response should be directed to the FDA"s Office of Unapproved Drugs and Labeling Compliance, including the unique identifier "712052" in correspondence.
- Inspection Date
- September 2, 2025
- Product Type
- Drugs
ID · e7eea525-8866-4145-b94d-5ede9c1ef7fc
Full citation text and observation details available on the Dashboard.