NEW YORK, NY – A surge in global deaths linked to contaminated cough syrups has prompted the U.S. Food and Drug Administration (FDA) to tighten scrutiny on healthcare product manufacturers. A Reuters analysis revealed that the FDA has issued reprimands to at least 28 companies this year for inadequate testing of ingredients susceptible to contamination by harmful toxins ethylene glycol (EG) and diethylene glycol (DEG).
The reprimanded companies include U.S. firms as well as exporters from India, South Korea, Switzerland, Canada, and Egypt. FDA’s enforcement actions this year surpass those of the previous five years combined in relation to testing for EG and DEG.
The FDA clarified that there is no evidence to suggest that products contaminated with DEG and EG have entered the U.S. supply chain. Peter Lindsay, an FDA regulation expert, stated that the agency is now mandating more rigorous testing procedures to identify contaminated ingredients.
Global incidents involving cough syrups from India and Indonesia have resulted in more than 300 deaths, mostly among children. Investigations have discovered high levels of DEG and EG, which can cause acute kidney injury and death. Regulatory bodies worldwide have intensified their scrutiny as a result, leading to criminal probes and lawsuits.
In the United States, inadequate regulation led to over 100 deaths from DEG poisoning in the 1930s. Despite enhancements in FDA’s oversight, regulations specifically targeting high-risk ingredients like propylene glycol (PG) and sorbitol solution for EG and DEG testing were only established in May.
Manufacturers receiving warning letters are given a chance to correct quality control deficiencies or face penalties, including potential bans on exports or imports. Many of these manufacturers produce products aimed at children, including diarrhea and pink eye medications, toothpaste, and sunscreen.
Florida-based Lex, a manufacturer of children’s cough and cold medicines, was cited for lax testing procedures dating back to 2004. The company claims to have addressed the FDA’s concerns.
Import alerts have been issued against 14 foreign manufacturers, prohibiting their products from entering the U.S. without further inspection. Companies failing to respond to FDA inquiries are also placed on import alert lists.
Despite the complexities of overseeing every consumer product, experts like Greg Landry commend the FDA’s swift action when contamination risks are identified. The FDA has also warned U.S. manufacturers of potential seizures and injunctions for failing to conduct requisite contamination checks.
Based on an original report by Reuters.