Expect more scrutiny, recall focus in 2013

ExpertRECALL year-end report features insights of former regulatory officials and top attorneys.

U.S. manufacturers and retailers can expect greater scrutiny from Congress and federal regulators in 2013 following historic and high-profile recall events over the past year, according to the Stericycle ExpertRECALL™ 2012 Year-End Report.

"2012 was a watershed year for recalls, from the meningitis outbreak and extensive nut butter recalls to the publicly criticized delays in the implementation of the Food Safety Modernization Act (FSMA) and efforts to implement the final regulations of the Consumer Product Safety Improvement Act," said Mike Rozembajgier , Vice President of Recalls for Stericycle ExpertRECALL. "Manufacturers, retailers and others in the supply chain need to consider those events when planning for 2013."

Rozembajgier said the following 2012 events offered important lessons and have spurred greater public scrutiny and possible federal action in 2013:

  • The potential for increased regulatory oversight in response to the compounding pharmacy issues in Massachusetts and elsewhere show how essential it is to have proper quality control measures in place.
  • The Bumbo baby seat recall teaches the high importance of effective recall communication and remedy.
  • The Sunland peanut butter recall – involving a nationally distributed organic product – serves as a wake-up call for quickly identifying a recall's scope to protect consumers around the country.
  • The U.S. Food and Drug Administration's (FDA) first time using its mandatory power granted by FSMA to suspend Sunland's registration indicates stricter federal oversight is underway, with less negotiating room for companies.

The year-end report includes opinions from legal and regulatory experts with experience in FDA- and Consumer Product Safety Commission (CPSC)-related matters. These experts share insight into FDA trends from the FSMA to the striking increase in recalls. Also discussed are noteworthy CPSC events, including recall trends and the development of the product safety database. The report can be downloaded at http://info.expertrecall.com/lessons-learned-preparing-for-2013.

"Recalls that fall under the FDA's authority have been rising in recent quarters, while CPSC recalls continue to trend downward and more products are withheld at our nation's ports. But regardless of the trends, product recalls are the most often observed, and potentially most damaging, public safety-related events for a company," Rozembajgier said. "That's why we've worked with other recall experts to create a year-end report to gain perspective around recall data – its current state and future outlook."

Expert attorneys featured in this report include:

  • David M. Fox: A partner at Hogan Lovells U.S. LLP who served as Assistant Chief Counsel for the FDA for six years prior to his Hogan Lovells career where he specializes in pharmaceutical issues.
  • Stephen D. Terman : Principal attorney at OFW Law PC explains trends in medical devices based on his extensive experience with medical device law and regulatory issues.
  • Leslie T. Krasny: A partner at Keller and Heckman LLP shares information regarding food safety this year with her extensive experience in food and dietary law.
  • David Schmeltzer: Former Director of Compliance for the CPSC for 20 years discusses major product recalls and the controversial CPSC database.


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