MFDS Cancels Product Approvals of 3 Companies for 'Selling Botulinum Toxin Without Approval'

Jetema, Korea BMI, Korea BNC
Botulinum Product Approval Cancellation 'Strong Measures'

[Asia Economy Reporter Kim Young-won] The Ministry of Food and Drug Safety (MFDS) has decided to revoke the approval of three botulinum toxin products from Jetema, Korea BMI, and Korea BNC. With the MFDS taking a tough stance, the legal battle that began last month with manufacturing suspension orders is expected to intensify.

The MFDS announced on the 2nd that it will cancel the product approvals for Jetema's "Jetema Dertoxin Injection 100U," Korea BMI's "Hytoks Injection 100 Units," and Korea BNC's "Bienox Injection" as of the 16th, due to these three botulinum toxin products being sold domestically without obtaining national batch release approval. All three companies will also face a six-month suspension of all manufacturing operations for selling export-only drugs domestically.

Botulinum toxin products are biopharmaceuticals mainly used for cosmetic procedures such as glabellar wrinkle improvement. Biological products must obtain national batch release approval from the MFDS, which reviews manufacturing and quality control, before being sold domestically.

Previously, on the 1st of last month, the MFDS detected that the three companies sold botulinum toxin products domestically without national batch release approval and imposed a six-month manufacturing suspension.

The companies immediately opposed the MFDS's decision and filed lawsuits. Jetema and Korea BNC argued, "Since the products were never sold domestically, there was no need to obtain national batch release approval."

Jetema filed lawsuits last month, including claims for nullification and cancellation of the disposition, as well as requests for suspension of execution and provisional suspension of effect, and received a suspension of effect approval from the Seoul Administrative Court. Korea BNC filed a provisional disposition request with the Daegu District Court on the 2nd of last month and received approval for suspension of effect on the 4th of the same month. Recently, the suspension period was extended until the 16th of this month.

Previously, Medytox in 2020, and Hugel and PharmaResearch Bio last year also received MFDS product approval cancellations for export-only botulinum toxin products due to failure to obtain national batch release approval. They too filed lawsuits opposing the MFDS's decisions.