If you have ever needed to determine whether pulling an FDA-regulated product from retail shelves is a “market withdrawal” or a “recall” you know that the line between these two terms at times is murky at best. So, it is no surprise that there has been some buzz recently about FDA’s October 23, 2013, update to the Agency’s Regulatory Procedures Manual (“RPM”), when FDA stated that “Section 7-5-1, 2(b) ‘Notes,’ was revised to clarify the term ‘market withdrawal.’”
As readers of our blog know, the RPM is a document that FDA uses as a guide when determining when and how to conduct domestic and foreign regulatory and enforcement actions. RPM Chapter 7 deals with recall procedures. FDA’s statements suggest that the RPM update “clarif[ies] the term ‘market withdrawal,’” but does it?
Let’s start, first, with FDA’s definition of a market withdrawal in its regulations. 21 C.F.R. § 7.3(j) defines “market withdrawal” as:
a firm’s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the Food and Drug Administration or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.
A market withdrawal is not a recall, as the definition of “recall” itself points out. See 21 C.F.R. § 7.3(g) (“Recall does not include a market withdrawal or stock recovery.”). Before turning to the RPM, it makes sense to reflect on what a recall is.
Recall means a firm’s removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.
Id. To recap: market withdrawals are removals or corrections of products with minor FDCA violations distributed in interstate commerce for which FDA wouldn’t initiate legal action; recalls involve more substantial violations of the FDCA for which FDA would consider initiating legal action. The problem, for regulators and the regulated alike, is determining what constitutes a minor violation and what does not. So it is not surprising that industry, including this blog, was excited to apparently gain additional clarity, however small, regarding this important issue based on FDA’s statement that it had clarified the definition of a market withdrawal.
For at least the last five years or so, RPM Section 7-5-1, 2(b) “Notes,” has used an example of products that had been tampered with, but not by the manufacturer or distributor, to elucidate a distinction between “market withdrawal” and “recall.” This version of the RPM stated that, when requested by the relevant FDA offices, companies should:
submit a Recall Recommendation for a product removal as a result of actual or alleged tampering with individual unit(s) where there is no evidence of manufacturer or distributor responsibility. The district should recommend the action be classified as a market withdrawal as, although the situation may present a health hazard, there is no one identified as responsible for the violation. This will allow documentation and monitoring of specific corrective actions meeting the market withdrawal definition but considered significant to the agency.
FDA, Regulatory Procedures Manual ch. 7, § 5-1, 2(b) (2007). FDA says it has now “clarified” the term “market withdrawal.” Let’s look at the supposed clarification: the new RPM keeps the same language except for the last sentence (in bold), which now reads: “This will allow documentation and monitoring of the market withdrawal.”
What’s the difference? FDA tightened up its language to make more clear what has been the case for at least the last twelve years – removal of a product that is the subject of actual or alleged tampering where the manufacturer or distributor is not responsible is a market withdrawal. Rather than beat around the bush, FDA removed the fussy lingo from the prior RPM and decided to simply state that these situations are market withdrawals, not recalls. However, the Agency still wants to monitor them, so industry is expected to submit a Recall Recommendation to FDA.
This is not new, and has been the Agency’s position since at least 2001 (as far back as we researched). FDA, Regulatory Procedures Manual ch. 7 (2001) (Responsibilities and Procedures – District Office (Monitoring District)) (“When requested by OE/DCMO or the Center, submit a Recall Recommendation for a product removal as a result of actual or alleged tampering with individual unit(s) where there is no evidence of manufacturer or distributor responsibility. The District’s evaluation should state that the action is considered a market withdrawal.”).
So, in the end, what’s all the fuss about? Unfortunately, not much. For better or worse, Chapter 7 does not make major changes to the definition of “market withdrawal,” and certainly does not change the definition of “recall” or alter the distinction between a market withdrawal and a recall. So, we are all still left wondering when, exactly, a market withdrawal becomes a recall. We’d like to paraphrase Justice Stewart and say we know it when we see it, but that assumes there are no close calls. In the meantime, FDA will continue to assert that it is final arbiter of these decisions, and we will keep looking for more tea leaves to help you make the right call.