FDA WARNING_LETTER - Shenzhen Hengkaifeng Commerce and Trade Co., Ltd - May 27, 2025

The FDA issued a Warning Letter to Wansheng Baihuo on May 6, 2025, regarding drug listing violations for their product, Sensitivity Toothpastes (NDC 84117-013). The firm failed to fulfill listing obligations under section 510(j) of the FD&C Act, a prohibited act under section 301(p). This also renders the product misbranded under section 502(o), with introduction into interstate commerce prohibited by section 301(a).

Specific violations include discrepancies between the listing submission and product labeling. The listing states the active ingredient as hydrated silica, while the label lists potassium nitrate 5% and sodium fluoride 0.1%. Additionally, the listing specifies the dosage form as liquid and route of administration as oral, but the label indicates a foam for dental administration.

The FDA emphasizes that accurate drug listing information is crucial for patient safety, inspections, supply chain security, and post-market surveillance. The firm had previously received a deficiency letter on September 11, 2024, and a data removal notification on October 26, 2024, due to these continued deficiencies, resulting in the product's data removal from the National Drug Code Directory. Another email on January 31, 2025, highlighted additional deficiencies.

Wansheng Baihuo must respond in writing within 15