The U.S. Food and Drug Administration (FDA) is intensifying its efforts to tighten testing standards for healthcare product manufacturers after several hundred deaths were reported overseas due to contaminated cough syrups. A Reuters review of regulatory alerts reveals that the FDA has reprimanded at least 28 companies in the current year for failing to adequately test ingredients used in over-the-counter drugs and consumer products for the presence of toxins like ethylene glycol (EG) and diethylene glycol (DEG).
These regulatory actions have targeted companies from various countries, including the United States, India, South Korea, Switzerland, Canada, and Egypt. Notably, the FDA has issued more warning letters for failing to test raw materials susceptible to EG and DEG contamination in 2023 than it did in the previous five years combined.
Despite these actions, the FDA maintains that there is no evidence to suggest that products contaminated with DEG and EG have entered the U.S. supply chain. The agency also clarifies that the number of warning letters issued doesn’t comprehensively reflect its oversight efforts.
To address the issue of contamination more effectively, the FDA is now requiring manufacturers to check individual containers of ingredients instead of merely sampling raw materials. This marks a heightened standard designed to improve safety.
The backdrop for these regulatory actions is a series of tragic incidents involving cough syrups produced in India and Indonesia, which have been linked to the deaths of over 300 children worldwide. These medicines were found to contain elevated levels of DEG and EG, resulting in acute kidney injury and fatalities. These incidents have triggered criminal investigations, legal proceedings, and increased regulatory scrutiny globally.
In the United States, a DEG poisoning incident in the 1930s, resulting in the deaths of over 100 people, especially children, led to significant legislation empowering the FDA to regulate drugs rigorously. However, explicit rules for testing high-risk ingredients, such as propylene glycol (PG) and sorbitol solution for EG and DEG, were only established in May 2023.
The FDA’s warning letters provide manufacturers with an opportunity to address quality control issues or face penalties. These letters can lead to the blocking of exports or imports and the suspension of new drug applications from companies that do not improve their testing practices.
Import alerts have been issued for half of the companies reprimanded by the FDA this year, preventing at-risk products from entering the United States without examination by customs officials. Some of these manufacturers marketed products aimed at children, including diarrhea and pink eye medicines, toothpaste, and sunscreen.
While these measures signal the FDA’s commitment to ensuring safety and quality in healthcare products, the complexity of policing every consumer product remains a challenge. Nevertheless, when the FDA identifies issues, its response is swift and robust, according to experts in the field.