The U.S. FDA is cracking down on lax testing practices by dozens of makers of healthcare products following hundreds of deaths overseas from contaminated cough syrups, a Reuters review of regulatory alerts found.
The Food and Drug Administration has reprimanded at least 28 companies this year, saying they failed to prove sufficient testing of ingredients used in over-the-counter drugs and consumer products for the toxins ethylene glycol (EG) and diethylene glycol (DEG), according to a Reuters analysis of agency import alerts and warning letters to manufacturers.
The manufacturers include U.S.-based companies and exporters from India, South Korea, Switzerland, Canada and Egypt.
The FDA has flagged more manufacturers for failing to test raw materials susceptible to EG and DEG contamination in 2023 than in the previous five years combined, the Reuters analysis found.
The FDA told Reuters it has no indication products contaminated with DEG and EG have entered the U.S. supply chain, and that the number of warning letters issued in a given period “is not a comprehensive marker of our oversight.”
Peter Lindsay, a lawyer at Paul Hastings in Washington, D.C. who specializes in FDA regulation and compliance, said to better spot contamination the agency was now requiring manufacturers to check individual containers of ingredients rather than just sampling raw materials.
“They’re upping the bar a little bit and trying to get industry to understand and recognize some of the risks in these areas,” he said.
Cough syrups made in India and Indonesia have been linked to deaths of more than 300 children globally. The medicines were found to contain high levels of DEG and EG, leading to acute kidney injury and death.
The poisonings have sparked criminal probes, lawsuits and a surge in regulatory scrutiny worldwide. Reuters reported earlier this month that some Indian drugmakers involved could not prove they had purchased pharmaceutical grade ingredients or tested their medicines for the toxins.
In the United States, more than 100 people, most of them children, died in the 1930s from DEG poisoning, prompting laws that greatly enhanced the FDA’s regulatory power over drugs.
Yet the agency did not establish explicit rules to test high-risk ingredients like propylene glycol (PG) and sorbitol solution for EG and DEG until May 2023.
Previous guidance from 2007 recommended certain tests be performed on glycerin, another common ingredient in over-the-counter drugs and consumer goods, to prevent distribution of DEG-contaminated products. It now requires the same scrutiny of PG and other high-risk components for DEG and EG.