Counterfeit Botulinum Toxin and Cosmetic Iatrogenic Botulism: Emerging Threats that Require Regulatory Reform

Background: There has been a concerning increase in reported cases of cosmetic iatrogenic botulism (CIB) linked to botulinum neurotoxin type A (BoNTA) injections performed by unlicensed or untrained individuals or involving counterfeit BoNTA products administered in non-healthcare settings. Methods: A search was conducted across PubMed, Google Scholar, and Cochrane databases from their inception to identify reports in English regarding CIB linked to procedures carried out by unlicensed or untrained individuals or involving counterfeit BoNTA products. Reviews, letters, and commentaries were excluded. Additionally, online searches were performed to locate reports from Federal and State Boards and Medical Societies. Results: Ten reports of such occurrences were identified, six in the United States and four globally, involving a total of 303 participants. Four of these reports included health advisories issued by the Centers for Disease Control and Prevention (CDC) and State Boards. All but two reports specified the patient’s gender, with a predominance of female patients. Symptoms of botulism typically began within three days of procedure–the most common initial symptoms were blurred vision and ptosis. Approximately half of the patients required hospitalization. When administered, botulism antitoxin proved immediately effective, leading to shorter hospital stays and no fatalities. Discussion: The regulatory gaps that may contribute to unsafe practices in this area are highlighted. There is an urgent need for unified national regulations in the United States, along with global standards, to clearly define who is authorized to perform these procedures and under what conditions they can do so. Furthermore, it is essential to enhance enforcement measures and increase public awareness to protect patients and uphold the highest safety standards.