Product recalls are critical events for firms that produce food and medical products. The lives and health of patients and consumers can be at stake. Companies risk enforcement action by the Food and Drug Administration (FDA), tort liability and damages to their reputations. Although the decision to initiate a recall is often voluntary, FDA oversees recalls and uses both formal compliance tools and public communications to ensure that recalls are properly completed. This client guide describes FDA recalls, including companies' responsibilities and FDA's authority.
Q. When does a recall occur?
A. A recall occurs when a firm removes or corrects a marketed product that violates Food and Drug Administration (FDA)-administered laws and regulations and would be subject to FDA legal action.1 Recalls are intended to protect the public from products that are harmful, deceptive or defective.
In FY 2016, FDA oversaw 2,847 recall events involving 8,305 recorded recalled products.2
Q. Does every violation of the Federal Food, Drug, and Cosmetic Act lead to a recall?
A. No. Depending on the seriousness of the violation, risk to public health and other factors, FDA may use compliance and enforcement tools, rather than seek a recall, to ensure that a firm corrects the violation. As we explained in A Client's Guide to FDA Inspections, these measures include judicial actions, warning letters, administrative detention, suspension of registration and import bans. These tools may affect a manufacturer's current inventory, how it would manufacture product in the future and product approvals, but they do not reach product that a manufacturer has already placed into the stream of commerce or that has been sold to a consumer or patient.
Q. Are there situations other than recalls where a firm may remove FDA-regulated products from the market?
A. Yes. One situation is a market withdrawal, which occurs when a firm chooses to remove or correct a distributed product from the marketplace that does not violate FDA-administered laws and regulations or involves a minor violation that would not warrant legal action by FDA. For example, a manufacturer may withdraw a product from the market because of an incorrect address on its label, a relatively minor violation.3
There are two nonrecall situations specific to medical devices. One situation is a device enhancement, in which a firm makes a change to improve a device that is not made to remedy a violation of FDA law or regulations.4 The other situation is routine servicing, when a firm engages in regularly scheduled maintenance of a device.5
Q. How is a recall initiated?
A. There are four ways that a recall is initiated: 1. A firm may voluntarily initiate a recall through its own decision-making process, such as via an internal audit, safety or quality control programs, employee reporting or consumer feedback. 2. FDA may also recommend, through an informal discussion, that a firm initiate a voluntary recall based on information available to the agency, such as consumer complaints or results from an inspection, an outbreak investigation or laboratory tests.6
3. In urgent situations, FDA's Associate Commissioner for Regulatory Affairs may formally request voluntary recall action by a firm, providing the firm with a letter explaining the violation and associated health hazards, the need for an immediate recall and recommendations for a recall strategy.7
Footnotes
1 21 C.F.R. § 7.3(g).
2 FDA, FDA Enforcement Statistics Summary Fiscal Year 2016 (2017), https://www.fda.gov/downloads/ICECI/EnforcementActions/UCM540606.pdf.
3 FDA, Distinguishing Medical Device Recalls from Medical Device Enhancements, 5 (2014), https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm418469.pdf.
4 Id at 4.
5 Id at 5.
6 FDA, Regulatory Procedures Manual, §7-5-1 (2017).
7 Id. at §7-5-2.
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