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Relatedly, the FDA issued draft guidance on January 18, 2017 regarding recalls. The draft guidance aims to improve the recall process and ensure that consumers are better protected by the industry providing more timely and comprehensive information on recalled products. Specifically, the 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- the 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. The 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, the 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.
The FDA will accept public comments on the draft guidance until March 20, 2018. The Health Law Pulse will continue to monitor the draft guidance and FDA enforcement actions in 2018.