Recent FDA Recall Highlights & Developments
- The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the use, content and circumstances for issuance of public warning and public notifications for recalls.
- FDA finalized Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff, providing answers to common questions regarding the agency's mandatory food recall authority.
- The agency gained the authority to issue a mandatory recall order for controlled substances under circumstances involving a reasonable probability of serious adverse health consequences or death.
- FDA increased recall information dissemination via social media, announcing a multi-state Salmonella outbreak on Twitter and Facebook.
- The agency issued its first mandatory food order of a food product under the agency's recall authority, which required the removal of Salmonella-contaminated kratom products from the market.
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.
When does a recall occur?
A recall occurs when a firm removes or corrects a marketed product that violates 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 fiscal year (FY) 2017, FDA oversaw 2,945 recall events involving 9,199 recorded recalled products.2
Does every violation of the Federal Food, Drug and Cosmetic Act lead to a recall?
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.
Are there situations other than recalls where a firm may remove FDAregulated products from the market?
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
1 21 C.F.R. § 7.3(g).
2 FDA, FDA Enforcement Statistics Summary Fiscal Year 2017 (2017), https://www.fda.gov/downloads/ICECI/EnforcementActions/UCM592790.pdf.
3 FDA, Distinguishing Medical Device Recalls from Medical Device Enhancements; Guidance for Industry and Food and Drug Administration Staff, 5 (2014), https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm418469.pdf.
4 Id at 4.
5 Id at 5.
To view the full article, please click here
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.