NEW YORK: The US Food and Drug Administration (FDA) is intensifying its efforts to ensure rigorous testing practices among numerous healthcare product manufacturers following a series of hundreds of deaths overseas attributed to contaminated Indian cough syrups.
A Reuters investigation into regulatory alerts has revealed that the FDA has reprimanded at least 28 companies this year, asserting that they failed to provide sufficient evidence of testing for toxins such as ethylene glycol (EG) and diethylene glycol (DEG) in ingredients used in over-the-counter drugs and consumer products.
These companies encompass both US-based manufacturers and exporters from countries including India, South Korea, Switzerland, Canada, and Egypt. Notably, the FDA has taken more actions against manufacturers in 2023 regarding testing of raw materials susceptible to EG and DEG contamination than in the previous five years combined.
The FDA emphasized that there is no indication that products contaminated with DEG and EG have entered the US supply chain, and it clarified that the number of warning letters issued is not an all-encompassing indicator of its oversight.
To enhance contamination detection, the FDA is requiring manufacturers to inspect individual containers of ingredients rather than merely sampling raw materials. This represents an elevation of standards to better address potential risks in these areas.
The origins of this crackdown can be traced to the deaths of over 300 children worldwide, linked to cough syrups manufactured in India and Indonesia that were found to contain high levels of DEG and EG. These contaminants led to acute kidney injury and fatalities, sparking criminal investigations, lawsuits, and heightened regulatory scrutiny on a global scale.
US FDA Investigations into Toxic Cough Syrup
In the United States, DEG poisoning claimed more than 100 lives in the 1930s, predominantly affecting children. In response, legislation was enacted that significantly expanded the FDA’s regulatory authority over drugs. However, the FDA had not established explicit rules for testing high-risk ingredients like propylene glycol (PG) and sorbitol solution for DEG and EG until May 2023.
The FDA’s warning letters provide manufacturers with an opportunity to rectify quality control issues or face penalties. These letters also convey the threat of blocking exports or imports of their products and new drug applications if they do not enhance their testing practices.
Furthermore, several foreign manufacturers susceptible to DEG and EG contamination have been placed on import alert lists due to insufficient quality control. These include South Korea’s LCC, the maker of Oriox mouthwashes, and India-based toothpaste manufacturers Suhan Aerosol and Orchid Lifesciences. Fourteen of these companies were cited for not responding to record requests, with no further comment provided.
Additionally, 13 US manufacturers of consumer products, ranging from earwax removers to nasal sprays and hand soap, have faced warnings of potential seizures and injunctions by the FDA. These warnings were issued for failing to conduct required contamination checks and other shortcomings, with some companies relying on suppliers’ certificates of analysis for ingredient purity.
