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 and diethylene glycol , 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.
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. 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.
The letters sent to the 28 U.S. and foreign manufacturers threaten to block either exports or imports of their products and new drug applications from those firms if they do not improve testing practices. Lex co-owner Charlene Paz said the company has addressed the shortcomings identified by the FDA and is conducting all required tests for impurities whenever they get ingredients susceptible to EG and DEG contamination.