Contains Nonbinding Recommendations 

Draft-Not for Implementation

Guidance for Industry 

Questions and Answers Regarding

Mandatory Food Recalls

Draft Guidance 

This guidance is being distributed for comment purposes only.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to 

ensure that the agency considers your comment on this draft guidance before it begins work 

on the final version of the guidance, submit either electronic or written comments on the draft 

guidance within 60 days of publication in the Federal Register of the notice announcing the 

availability of the draft guidance. Submit electronic comments to 

http://www.regulations.gov. Submit written comments to the Division of Dockets 

Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 

Rockville, MD 20852. All comments should be identified with the docket number listed in 

the notice of availability that publishes in the Federal Register. 

For questions regarding this draft document contact the ORA Office of Enforcement and 

Import Operations (OEIO) at 301-796-8209. 

U.S. Department of Health and Human Services

Food and Drug Administration 

Office of Regulatory Affairs

Center for Food Safety and Applied Nutrition

Center for Veterinary Medicine

May 2015 
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Table of Contents 

I. Introduction

II. Background

III. Questions and Answers 
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Guidance for Industry1

Questions and Answers Regarding

Mandatory Food Recalls

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) 

current thinking on this topic. It does not create or confer any rights for or on any person and 

does not operate to bind FDA or the public. You can use an alternative approach if the approach 

satisfies the requirements of the applicable statutes and regulations. If you want to discuss an 

alternative approach, contact the FDA staff responsible for implementing this guidance. If you 

cannot identify the appropriate FDA staff, call the telephone number listed on the title page of 

this guidance. 

I. INTRODUCTION

The purpose of this document is to provide guidance to industry on the implementation of the 

mandatory food recall provisions of Section 423 of the Federal Food, Drug, and Cosmetic Act 

(the FD&C Act), which was added by Section 206 of the FDA Food Safety Modernization Act 

of 2011 (FSMA). The guidance in this document is in the form of Questions and Answers and 

provides answers to common questions that might arise about these mandatory recall provisions 

and FDA’s current thinking regarding their implementation. 

FDA's guidance documents, including this guidance, do not establish legally enforceable 

responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should 

be viewed only as recommendations, unless specific regulatory or statutory requirements are 

cited. The use of the word should in Agency guidances means that something is suggested or 

recommended, but not required. 

II. BACKGROUND

FDA’s mandatory food recall authority went into effect when FSMA was enacted on January 4, 

2011. Section 423 of the FD&C Act, as added by Section 206 of FSMA, gives FDA the 

authority to order a responsible party to recall an article of food where FDA determines that there 

is a reasonable probability that the article of food (other than infant formula) is adulterated under 

section 402 of the FD&C Act [21 U.S.C. § 342] or misbranded under section 403(w) of the 

FD&C Act [21 U.S.C. § 343(w)] and that the use of or exposure to such article will cause serious 

adverse health consequences or death to humans or animals (SAHCODHA). 

 

1 This guidance has been prepared by the Office of Enforcement and Import Operations in the Office of Regulatory 

Affairs in cooperation with the Center for Food Safety and Applied Nutrition and the Center for Veterinary 

Medicine at the U.S. Food and Drug Administration. 
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III. QUESTIONS AND ANSWERS

This list of Questions and Answers is intended to provide answers to common questions about 

the mandatory recall provisions in section 423 of the FD&C Act and FDA’s current thinking 

regarding their implementation. 

1. Why is mandatory food recall authority important? 

Before FSMA was enacted, FDA relied on responsible parties to voluntarily recall 

violative food products (except infant formula recalls which are described under section 

412 of the FD&C Act). FDA continues to rely on responsible parties to voluntarily recall 

violative food products; however, FSMA’s mandatory recall authority allows FDA to

mandate a recall when a responsible party chooses not to conduct a voluntary recall when 

the criteria under section 423 of the FD&C Act are met. FDA can use its mandatory 

recall authority when FDA determines that there is a reasonable probability that an article 

of food is adulterated under section 402 of the FD&C Act and/or misbranded under 

section 403(w) of the FD&C Act and where there is a reasonable probability that the use 

of or exposure to such food would cause SAHCODHA. 

2. What foods are subject to FDA’s mandatory food recall authority?

The articles of food that are subject to FDA’s mandatory recall authority are all articles of 

food (other than infant formula) that are manufactured, processed, packed, or held at a 

food facility that is required to register under section 415(a) of the FD&C Act. Infant 

formula is not covered under section 423 because it has its own recall requirements under 

section 412 of the FD&C Act. 

The term “food” refers to (1) articles used for food or drink for man or other animals, (2) 

chewing gum, and (3) articles used for components of any such article (section 201(f) of 

the FD&C Act [21 U.S.C. § 321(f)]). 

The term “food” includes dietary supplements, which are deemed to be food under the 

FD&C Act (section 201(ff) of the FD&C Act [21 U.S.C. § 321(ff)]). The term “dietary 

supplement” refers, with certain exceptions, to a product that is labeled as a dietary 

supplement, is intended for ingestion, is intended to supplement the diet, and contains at 

least one dietary ingredient. Dietary ingredient(s) in these products include: vitamins, 

minerals, herbs or other botanicals, amino acids, and substances for use by man to 

supplement the diet by increasing total dietary intake. Dietary ingredients can also be 

extracts, metabolites, constituents, concentrates, or a combination of any of the abovementioned dietary ingredients. 

3. What is a responsible party under section 423 of the FD&C Act?
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The responsible party with respect to an article of food under section 423 of the FD&C 

Act, is defined under section 417 of the FD&C Act. Section 417(a)(1) defines the term 

“responsible party” as a person who submits the registration under section 415(a) of the 

FD&C Act [21 U.S.C. 350d(a)] for a food facility that is required to register under 

section 415(a), at which such article of food is manufactured, processed, packed, or held. 

“Person” is defined in section 201(e) of the FD&C Act [21 U.S.C. 321(e)] as including 

individuals, partnerships, corporations and associations. As such, the owner, operator, or 

agent in charge of a facility who is responsible for submitting the registration is also

responsible for implementing and assuring the recall is performed, if so ordered under 

section 423 of the FD&C Act. 

4. When do the mandatory recall provisions go into effect? 

FDA’s mandatory recall authority under section 423 of the FD&C Act, added by section 

206 of FSMA, became effective when President Obama signed FSMA into law on 

January 4, 2011. 

5. What are the criteria for a mandatory recall? 

A couple of conditions must exist before FDA can use its mandatory recall authority

under section 423 of the FD&C Act. 

First, FDA has to make the determination that there is a reasonable probability that the 

article of food (other than infant formula) is adulterated under section 402 of the FD&C 

Act or misbranded under section 403(w) of the FD&C Act. 

Second, FDA has to make a determination that there is a reasonable probability that the 

use of or exposure to such food will cause SAHCODHA. 

6. What is the process FDA must follow for a mandatory recall? 

Once FDA has determined that the criteria for a mandatory recall have been met, FDA

must first provide the responsible party (as defined in section 417(a)(1) of the FD&C 

Act) with an opportunity to voluntarily cease distribution and recall the article of food. 

FDA will provide the opportunity to voluntarily cease distribution and recall to the 

responsible party in written form using an expeditious method. If the responsible party 

refuses or does not voluntarily cease distribution and recall the article of food within the 

time and manner prescribed by FDA, if so prescribed, FDA may order the responsible 

party to cease distributing the article of food, order the responsible party to give notice to 

certain other persons to cease distributing the article of food, and give the responsible 

party an opportunity for an informal hearing. After these steps are completed, FDA may 

order a recall under section 423(d) of the FD&C Act if it is determined that the removal 

of the article from commerce is necessary. Only the FDA Commissioner has the 

authority to order a recall under section 423(d). Recall orders under Section 423(d) may, 

if necessary, be vacated by the Commissioner.
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7. When is a food considered adulterated under Section 402 of the FD&C Act? 

Section 402 of the FD&C Act includes many reasons a food may be adulterated 

including: 

• If the food bears or contains any poisonous or deleterious substance which 

may render it injurious to health; consists in whole or in part of any filthy, 

putrid, or decomposed substance, or is otherwise unfit for food; or has been 

prepared, packed, or held under insanitary conditions whereby it may be 

rendered injurious to health; 

• If the food is a dietary supplement or contains a dietary ingredient that 

presents a significant or unreasonable risk of illness or injury under the 

conditions of use recommended or suggested in labeling; is a new dietary 

ingredient for which there is inadequate information to provide reasonable 

assurance that such ingredient does not present a significant or unreasonable 

risk of illness or injury; or is a dietary supplement declared by the Secretary to

pose an imminent hazard to public health or safety. 

8. When is a food considered misbranded under 403(w) of the FD&C Act?

Section 403(w) refers to product labeling required to be present if a food, other than a 

raw agricultural commodity, bears or contains a major food allergen. Major food 

allergens are defined at section 201(qq) of the FD&C Act [21 U.S.C. 321(qq)] as milk, 

egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and any food 

ingredients that contain a protein derived from these foods (with limited exceptions noted 

under section 201(qq)(2)). Under section 403(w), a food, other than a raw agricultural 

commodity, is misbranded if it bears or contains a major food allergen and the label for 

the food does not identify the name of the food source from which the major food 

allergen is derived, either through a “Contains” statement or in the ingredient list, as 

specified under section 403(w). 

9. What evidence might FDA consider when deciding to move forward with a 

mandatory food recall under Section 423? 

FDA will evaluate all applicable evidence, when determining whether there is a 

reasonable probability the article of food (other than infant formula) is adulterated under 

section 402 of the FD&C Act or misbranded under section 403(w) of the FD&C Act and 

that the use of or exposure to such article will cause SAHCODHA. Evidence may 

include: 

• Observations made during inspections of the responsible party or other parties; 

• Results from sample analyses; 

• Epidemiological data; 

• Reportable Food Registry data; and 

• Consumer and trade complaints.

10. How will FDA publicize information about the mandatory recall? 
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In accordance with Section 423(g) of the FD&C Act, FDA will ensure that a press release 

is published regarding the recall, as well as alerts and public notices, as appropriate, to 

provide notification to affected consumers and retailers. The publication will include, at 

a minimum, the name of the article of food subject to recall, a description of the risks 

associated with the food, and to the extent practical, information about similar articles of 

food that are not affected by the recall.

11. When would user fees to cover food recall activities be assessed, to whom, and for 

what activities? What are the costs of the fees? Can civil money penalties be 

assessed for not complying with a recall order?

Section 743(a)(1)(B) of the FD&C Act authorizes the collection of fees from a 

responsible party for a domestic facility as defined under 415(b) and an importer who 

does not comply with a food recall order under section 423 or under section 412(f) of the 

FD&C Act (infant formula recalls). The fees would cover time spent by FDA conducting 

food recall activities, including technical assistance, follow-up effectiveness checks, and 

public notifications. Noncompliance may include the following: (1) Not initiating a 

recall as ordered by FDA; (2) not conducting the recall in the manner specified by FDA 

in the recall order; or (3) not providing FDA with requested information regarding the 

recall, as ordered by FDA.

FDA publishes a Federal Register notice of fees for non-compliance with a Recall Order 

no later than 60 days before the start of each fiscal year. 

FSMA amended Section 303(f)(2)(A) of the FD&C Act [21 U.S.C. 333(f)(2)(A)] to 

permit FDA to assess civil money penalties to any person who does not comply with a 

recall order under Section 423. 

For more information on the Food Safety Modernization Act, go to: 

http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm