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.
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 were issued by CTP in 2016. Notably, there was a marked decreased in the warning letters issued by FDA’s Center for Devices and Radiological Health (“CDRH”), which sent 42 warnings in 2017 and that was close to half of the 85 warning letters that CDRH sent in 2016.
Some trends observed with the FDA warning letters include the Center for Drug Evaluation and Research (“CDER”) issuing warnings for data integrity deviations and problems related to the relationship and duties divided between sponsors and contract manufacturing organizations. Another trend with FDA warning letters has been for firms failing to test for product contamination. For example, one firm faced a warning letter for failing to test if diethylene glycol (“DEG”) or ethylene glycol (“EG”) was present in its products, when such ingredients had led to lethal poisoning incidents globally. The CTP warning letters largely involved sales to minors violations.
The FDA recalled 9,199 products in 2017, which was a slight increase from the prior year when 8,305 products were recalled. Out of the total 9,199 FDA recalls in 2017, Center for Food Safety and Applied Nutrition (“CFSAN”) had the most total product recalls with 3,609 products. Food recalls also increased from almost 700 recall events in 2016 to almost 800 recall events in 2017.
The most recall events came from the CDRH, which had 1,068 recall events across Class I, II, and III devices. Specifically, the most recall events initiated by CDRH were for Class II devices, which had 977 total recall events.
Relatedly, FDA issued draft guidance on January 18, 2017 regarding recalls. The draft guidance aims to improve the recall process and ensure that consumers are better protected by industry providing more timely and comprehensive information on recalled products. Specifically, FDA answered the question as to when a firm should issue public warnings and stated that public warnings should be issued when there is an urgent situation where a product being recalled presents a serious hazard to health and where it would be difficult to use other means to prevent the use of a recalled product. For example, a public warning may likely be needed when a recalled product has already been widely distributed. Additionally, the agency clarified who can issue a public warning; FDA may prepare and issue public warnings on its own in certain circumstances, such as when the public needs an immediate warning concerning a product and the firm has not issued a public warning or the warning is deficient. FDA typically will work with the recalling firm to get accurate facts for its public warning.
Moreover, the agency explained that public warnings should not contain certain information such as information that takes away from the true purpose or substance of the warning. Additionally, FDA stated that warnings that are brief and succinct are better at informing consumers. Also, firms should not use the warning to promote the qualities of the product being recalled or other products sold by the firm. Phrases that can be interpreted as minimizing the hazard, such as “an abundance of caution,” should not be used, especially when illnesses and injuries have actually resulted from the product.
FDA will accept public comments on the draft guidance until March 20, 2018. The Health Law Pulse will continue to monitor the draft guidance and FDA enforcement actions in 2018.