U.S. Health and Human Services honcho Mike Leavitt is baring his teeth at Chinese exporters that don't meet certification standards. Saying that regulators simply can't inspect all imported goods--some $2 trillion this year--companies that don't meet FDA standards won't be allowed to sell their products in the United States.
Leavitt's comments came during a trip to China to follow up on an agreement reached with Chinese regulators in December. Then, officials agreed to boost certification and regulation of exporters and to close some loopholes that have allowed Chinese companies to ship off unsafe food and drugs. Exporters are now required to register with the Chinese government, which will certify that they meet FDA standards.
Among the loopholes left to close: One that allowed chemical companies to produce drug ingredients without being inspected by drug regulators. That, of course, is one of the reasons why heparin tainted with oversulfated chondroitin made its way from Chinese suppliers to the U.S., where it was eventually recalled--but only after being linked to hundreds of severe allergic reactions, including up to 81 deaths.
- see the story in the Wall Street Journal