Regulators are tightening the leash on manufacturers of healthcare products after hundreds of deaths from contaminated cough syrups were reported overseas.
An investigation conducted by Reuters found that as many as 300 children have died worldwide from cough syrups made in India and Indonesia containing high levels of diethylene glycol (DEG) and ethylene glycol (EG).
These toxic substances are byproducts of making propylene glycol, the viscous liquid used in cough syrups. Their consumption can lead to acute renal failure and death.
The U.S. Food and Drug Administration (FDA) announced in August that the safeguards in place should have prevented these contaminated products from entering the market.
“Although we have no indication that any products described in the 2022 and 2023 WHO alerts have come into the U.S. drug supply chain, we are investigating the potential impact on FDA-regulated drug products,” the statement read.
Nonetheless, the regulating body has intensified scrutiny on healthcare product manufacturers in light of the alarming events.
This year, the FDA has admonished 28 domestic and international companies for allegedly failing to adequately test raw materials for EG and DEG. For instance, some reportedly relied only on their suppliers’ certificates of analysis attesting to the purity of ingredients.
Each entity was told to shape up their testing practices for high-risk ingredients or they’d be barred from exporting or importing products and applying to license any new drugs.
The FDA warnings about raw materials testing for EG and DEG sent in 2023 outnumber those sent over the previous five years combined.
The testing practices themselves have also been challenged, according to Peter Lindsay, a D.C.-based lawyer specializing in FDA regulation and compliance.
Hastings explained to Reuters that the FDA is “upping the bar a little bit” by making manufacturers go beyond sampling raw materials to include checking individual containers of ingredients.
It is worth noting that the FDA did not establish explicit rules for testing high-risk ingredients until this May. Moreover, as Greg Landry, a pharmacology and toxicology expert at Massachusetts College of Pharmacy & Health Sciences, told Reuters, it is difficult for them to monitor the quality of each and every consumer product.
Nonetheless, the FDA’s crackdown on healthcare products comes as food safety recalls have ballooned.
As covered in The Dallas Express, recalls issued this month have included 122 tons of Banquet frozen chicken meals for possible plastic contamination and 58,000 pounds of ground beef product from American Foods Group for potential E. coli contamination.
Sedgwick Claims Management Services published a report in March revealing a staggering 700% increase in the number of food units recalled by the FDA in 2022 compared to 2021.
While DEG poisonings haven’t been seen in the U.S. since the 1930s, children killed by contaminated cough syrups in countries like Indonesia, Gambia, and Uzbekistan — deaths for which no party has been held accountable — serve as a sober reminder of the potential consequences of tainted products.