Shenzhen Hengkaifeng Commerce and Trade Co., Ltd Warning Letter Details

Summary

Shenzhen Hengkaifeng Commerce and Trade Co., Ltd failed to properly register and list its Sensitivity Toothpaste drug product with FDA's electronic Drug Registration and Listing System (eDRLS), violating section 510(j) of the Federal Food, Drug, and Cosmetic Act. The company's drug listing submission contained inaccurate active ingredient information, listing hydrated silica instead of the actual ingredients potassium nitrate 5% and sodium fluoride 0.1%, and misidentified the dosage form and route of administration as liquid oral rather than foam for dental use. These discrepancies between the listing and product labeling rendered the drug misbranded under section 502(o) of the FD&C Act, making its introduction into interstate commerce prohibited.