FDA releases 2017 enforcement statistics and recall draft guidance

On January 17, 2018, the U.S. Food and Drug Administration (“FDA”) released its 2017 enforcement statistics. Overall, the statistics showed that there were no food importation debarment enforcement actions in the past year. Notably, there were 15,318 warning letters issued, 9,199 products recalled, and 2,945 recall events. There were 12 injunctions, 5 drug product debarments, and 3 seizures. Warning Letters The 15,318 warning letters issued in 2017 were a slight increase from 2016 when 14,590 letters were issued. Although the total number of warning letters in 2017 was a significant increase since 2012, when 4,882 warning letters were issued by FDA. Out of the total warning letters in 2017, the majority of the warning letters were issued by the Center for Tobacco Products (“CTP”), which issued 14,875 letters. This is a very high number considering the CTP’s regulations are fairly recent. Although, this number seems to be on trend as 14,032 letters…

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