Get ready for more-publicized recall notices from FDA

Agency plans to issue 'not yet classified' recall notices


Current FDA practice regarding recalls of foods, medical and veterinary products is for the agency to publicize recall notifications after the it has studied the incident and determined the level of risk implicit in the product deficiency. Now, as related in an FDA Voice posting on Jan. 18, the agency is going to announce a recall “sooner,” even before a study has been conducted or the level of risk identified, in the form of a “not yet classified” notice.

“As part of a larger effort to increase transparency, empower consumers, and enhance public health, the FDA is working to alert the public sooner whenever a product has been recalled,” writes Douglas Stearn, Director, Office of Enforcement and Import Operations, Office of Regulatory Affairs at FDA. Current practice is to issue the notice after the instance has been classified into one of three levels of risk, a process that “can sometimes take weeks – or even months when FDA needs to conduct a complex evaluation. Such analysis can involve determining whether any diseases or injuries have already occurred, the likelihood that a hazard might occur, or whether vulnerable segments of the population, such as children, are more at risk.”

FDA will continue to publish a weekly Enforcement Report, and that is where the eventual risk classification information will be posted when it is available. (FDA has also recently begun a report specific to medical device recalls.) In the meantime, FDA says that its press releases and similar notifications “has proven effective in bringing exhaustive TV, radio, and newspaper coverage about recalls.”

What process is undertaken to distinguish a rumor or supposition from a legitimate not-yet-classified product deficiency isn’t clear. FDA has issued new draft guidance on recalls, “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C”  which contains this statement: “FDA’s policy is to evaluate the particular circumstances of each individual recall in determining whether a public warning is needed in accordance with 21 CFR §7.42(b)(2) as part of the recall strategy. FDA may issue a public warning or notification before formally classifying a recall under 21 CFR § 7.4.” FDA’s web page on product recalls generally notes that FDA inspections of manufacturing facilities, or notices form the Centers for Disease Control, are two of the more usual sources of information, along with voluntary notices coming from manufacturers or distributors themselves. FDA’s existing classification is:

Class I: highest, most immediate risk of injury or death
Class II: intermediate risk of injury or illness
Class III: lowest risk; products out of specification but not threatening to life or health.