FDA Update

Baby Formula Recall Debacle Causes Shakeup at FDA

FDA Food Safety Chief Resigns after Formula Recall

Due to controversy regarding the massive recall and shortage of baby formula, Frank Yiannas, deputy commissioner of the FDA’s Office of Food Policy and Response will step down from his position as of February 24^th.

Mr. Yiannas, who is the top US food safety official noted that he felt a decentralized structure of the foods program affected his ability to operate as a team and therefore protect the public from this crisis.  The division has been accused of a lagging response to questions about safety at an Abbott Laboratories infant-formula manufacturing site that was linked to contamination and the illnesses and deaths of infants. There has been no definitive evidence linking its products to these incidents says representatives at Abbott.

The agency had been called upon to restructure the food program and appoint a leader who could resolve internal turmoil and conflict caused by “duplicative” and “competing roles and responsibilities.”  This was a result of an outside review organized by the nonprofit Reagan-Udall Foundation.  Commissioner Robert Califf has not acted on this in over a month after receiving the review.

Critics have said that the program’s leadership limited its ability to respond to a crisis. Susan Mayne leads the Center for Food Safety and Applied Nutrition and reports directly to Califf. Yiannas also reports directly to the FDA commissioner, and does not have direct oversight over CFSAN.

An agency spokesperson said in a statement that the FDA remains committed to providing an update on steps to strengthen the foods program. Additional updates on the organizational structure, including how Yiannas’ responsibilities will be handled, will be shared by the end of February, the spokesperson said.

Questions

For more information on the FDA baby formula crisis please email us at: info@mdiconsultants.com and ref: FDA baby formula crisis.