FDA cracks down on lax testing after cough syrup deaths

Cough syrup being poured.
Cough syrup being poured. Photo credit Getty Images

The United States Food and Drug Administration is cracking down on lax testing practices by dozens of healthcare product manufacturers, according to a report.

The report comes from a Reuters review of regulatory alerts and found that the move from the FDA comes as hundreds of deaths have been reported overseas from contaminated cough syrups.

So far, 28 companies this year have been reprimanded by the FDA over their failure to prove they sufficiently tested the ingredients used in their over-the-counter drugs and consumer products, according to the report.

The drugs and consumer products were supposed to be tested for the toxins ethylene glycol and diethylene glycol, according to the report.

The manufacturers to face reprimands from the FDA were both U.S.-based and exporters from South Korea, Switzerland, Canada, India, and Egypt.

So far, there have been more drug makers failing to test raw materials for the toxins in 2023 than in the last five years combined, Reuters reported.

Cough syrups made in India and Indonesia were recently linked to the deaths of more than 300 kids around the world, NPR reported last month.

The medicines have since been tested and found to have high levels of the toxins, which can lead to acute kidney injury and death when consumed.

The FDA shared with Reuters that the U.S. supply chain has not been contaminated with either of the toxins. It also said that the number of warning letters issued by the agency “is not a comprehensive marker of our oversight.”

Featured Image Photo Credit: Getty Images