Contains Nonbinding Recommendations 

Guidance for FDA Staff 

Compliance Policy Guide 

Sec. 100.250 Food Facility Registration – 

Human and Animal Food 

Additional copies are available from:
 

Office of Policy and Risk Management
 

Office of Regulatory Affairs
 

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Food and Drug Administration 

12420 Parklawn Drive
 

Rockville, MD 20857
 

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http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm 

You may submit either electronic or written comments regarding this guidance at any time. 

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. 

U.S. Department of Health and Human Services
 

Food and Drug Administration
 

Center for Food Safety and Applied Nutrition
 

Center for Veterinary Medicine
 

Office of Regulatory Affairs
 

June 2014 

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Contains Nonbinding Recommendations 

Table of Contents 

I. Introduction 

II. Background 

III. Policy 

IV. Regulatory Action Guidance 

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Contains Nonbinding Recommendations 

Guidance for FDA Staff
 

Compliance Policy Guide
 

Sec. 100.250 Food Facility Registration –
 

Human and Animal Food
 

This guidance represents 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 for FDA staff on food facility registration 

under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350d), 

including the requirement that certain human and animal food facilities register with FDA, the 

requirement that registered facilities biennially renew their registrations with FDA, and FDA’s 

authority to suspend a food facility’s registration. 

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. 

The term food, when used in this document, has the meaning specified in 21 CFR 1.227(b)(4) 

and refers to both food for humans and food for animals. 

II. Background: 

Food Facility Registration 

Section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 

2002 (the Bioterrorism Act) (Pub. L. 107-188) amended the FD&C Act by adding section 415, 

which established requirements for food facilities to register with FDA. Under section 415 of the 

FD&C Act (21 U.S.C. 350d), the owner, operator, or agent in charge of a domestic or foreign 

facility that manufactures, processes, packs, or holds food for human or animal consumption in 

the United States is required to register the facility with FDA, unless an exception applies (see 21 

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CFR 1.226 and 1.227). The term “facility” is described in section 415(c)(1) of the FD&C Act 

and defined by regulation in 21 CFR 1.227(b)(2). Facilities that do not have to register are listed 

in 21 CFR 1.226. Certain other establishments are not required to register because they do not 

manufacture, process, pack, or hold “food,” as defined in 21 CFR 1.227(b)(4). This definition 

for “food” excludes food contact substances (including packaging materials), as defined in 

section 409(h)(6) of the FD&C Act (21 U.S.C. 348(h)(6)), and pesticides as defined in 7 U.S.C. 

136(u). Thus, facilities that manufacture, process, pack, or hold only food contact substances or 

only pesticides are not required to register with FDA under section 415 of the FD&C Act. 

A domestic facility means any facility located in any State or Territory of the United States, the 

District of Columbia, or the Commonwealth of Puerto Rico that manufactures, processes, packs, 

or holds food for consumption in the United States (21 CFR 1.227(b)(2)(i)). A domestic food 

facility that is required to register must register whether or not food from that facility enters 

interstate commerce (21 CFR 1.225(b)). A foreign facility means a facility other than a domestic 

facility that manufactures, processes, packs, or holds food for consumption in the United States 

(21 CFR 1.227(b)(2)(ii)). Only facilities - domestic and foreign - that manufacture, process, 

pack or hold food for consumption in the United States are required to register with FDA under 

section 415 of the FD&C Act. 

Under section 415(a)(2) of the FD&C Act, the registrant for a facility must notify FDA in a 

timely manner of changes to the facility’s registration information. The failure to register a food 

facility in accordance with section 415 is a prohibited act under section 301(dd) of the FD&C 

Act (21 U.S.C. 331(dd)). 

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 4, 

2011, amended section 415 of the FD&C Act in relevant part to require registrants for food 

facilities to submit additional registration information to FDA, including the email address of the 

contact person for a domestic facility, the email address of the U.S. agent for a foreign facility, 

and an assurance that FDA will be permitted to inspect the facility at the times and in the manner 

permitted by the FD&C Act. FSMA also amended section 415 of the FD&C Act to require food 

facilities to renew registrations with FDA biennially, and to provide FDA with the authority to 

suspend the registration of a food facility in certain circumstances, as discussed further below. 

Further, FSMA amended section 801(l)(1) of the FD&C Act (21 U.S.C. 381(l)) to provide that if 

an article of food being imported or offered for import into the United States is from a foreign 

facility for which a registration has not been submitted to FDA, as required by section 415 of the 

FD&C Act, or is from a foreign facility for which a registration has been suspended under 

section 415, the article must be held at the port of entry for the article, and may not be delivered 

to the importer, owner, or consignee of the article, until the foreign facility is registered. Unlike 

the requirements related to a drug or device establishment, which provide that the failure of such 

an establishment to register with FDA, as required under section 510 of the FD&C Act (21 

U.S.C. 360), causes the drugs or devices manufactured, prepared, propagated, compounded, or 

processed in such an establishment to be misbranded under section 502(o) of the FD&C Act (21 

U.S.C. 352(o)), and therefore subject such misbranded drugs and devices to refusal of admission 

under section 801(a) of the FD&C Act, the failure of a food facility to register with FDA, or the 

suspension of a food facility’s registration, alone does not cause food manufactured, processed, 

packed, or held in such facility to be misbranded under the FD&C Act. 

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However, the failure of a food facility to register with FDA is a prohibited act under section 

301(dd) of the FD&C Act (21 USC 331(dd)). In addition, as discussed elsewhere in this CPG, 

under section 415(b)(4) of the FD&C Act, if the registration of a food facility is suspended, no 

person can import or export, offer to import or export, or otherwise introduce food from the 

facility into interstate or intrastate commerce in the United States. The introduction or delivery 

for introduction into interstate commerce of an article of food in violation of section 415 is a 

prohibited act under section 301(d) of the FD&C Act. In general, the commission of a prohibited 

act subjects persons to enforcement actions, which may include injunction or prosecution. 

FDA's guidance "What You Need to Know About Registration of Food Facilities" provides 

information on how to submit registration for a food facility through FDA’s electronic portal at 

www.access.fda.gov. It also provides information on how to submit paper registration. 

Biennial Registration Renewal 

Section 415(a)(3) of the FD&C Act, as amended by FSMA, requires food facilities required to 

register with FDA to renew such registrations biennially. Specifically, section 415(a)(3) requires 

that, during the period beginning on October 1 and ending on December 31 of each evennumbered year, a food facility that has submitted a registration to FDA must submit to FDA a 

renewal registration that contains the required information specified in section 415(a)(2). A 

registrant that has not had any changes to the previously submitted registration information may 

use an abbreviated registration renewal process provided by FDA. A food facility that fails to 

renew its registration with FDA, as required by section 415(a)(3), has failed to register in 

accordance with section 415 and thereby has committed a prohibited act under section 301(dd) of 

the FD&C Act. 

Suspension of Registration 

Section 415(b) of the FD&C Act, as amended by FSMA, provides that FDA may suspend the 

registration of a food facility in certain circumstances. Specifically, if FDA determines that food 

manufactured, processed, packed, received, or held by a registered facility has a reasonable 

probability of causing serious adverse health consequences or death to humans or animals, FDA 

may by order suspend the registration of a facility that: 

1.	 Created, caused, or was otherwise responsible for such reasonable probability; or 

2.	 Knew of, or had reason to know of, such reasonable probability; and packed, received, or 

held such food. 

Under section 415(b)(4) of the FD&C Act, as amended by FSMA, if the registration of a human 

or animal food facility is suspended, no person can import or export, or offer to import or export, 

food from the facility into the United States, or otherwise introduce food from the facility into 

interstate or intrastate commerce in the United States while the suspension order for the facility is 

in effect. Under section 301(d) of the FD&C Act (21 U.S.C. 331(d)), the introduction or 

delivery for introduction into interstate commerce of an article of food in violation of section 415 

is a prohibited act. Section 801(l) of the FD&C Act, as amended by FSMA, provides, in relevant 

part, that an article of food being imported or offered for import into the United States that is 

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from a foreign facility for which a registration has been suspended under section 415 must be 

held at the port of entry for the article of food, and may not be delivered to the importer, owner, 

or consignee of the article. 

III. Policy: 

Food Facility Registration 

FDA will enforce the registration requirements of section 415 of the FD&C Act and 

implementing regulations in 21 CFR part 1, subpart H as appropriate in each situation. The 

failure to register a food facility in accordance with section 415 is a prohibited act under section 

301(dd) of the FD&C Act. FDA may consider a facility to not be registered in accordance with 

section 415 if: 

1. The facility has not submitted a registration to FDA; 

2. The facility’s registration is incomplete; or 

3. The facility’s registration has expired because the facility failed to renew its registration. 

FDA’s prior notice for imported foods system is the agency’s primary tool for ensuring that 

foreign facilities that offer food for import into the United States are registered under section 415 

of the FD&C Act. (See 21 CFR 1.285 and CPG Sec. 110.310 Prior Notice of Imported Food 

Under the Public Health Security and Bioterrorism Preparedness Response Act of 2002). If FDA 

determines that a foreign food facility is not registered in accordance with section 415 and 21 

CFR part 1, subpart H, the food being imported or offered for import into the United States from 

the foreign facility is subject to being held at the port of entry (as defined in 19 CFR 101.1), in 

accordance with section 801(l) of the FD&C Act, unless U.S. Customs Border Protection (CBP) 

concurrence is obtained for the export of the food and the food is immediately exported from the 

port of arrival (as defined in 21 CFR 1.276(b)(11) (see 21 CFR 1.285(b)). Food held in this 

circumstance shall not be entered and shall not be delivered to the importer, owner, or ultimate 

consignee until the foreign facility is registered in accordance with section 415 and 21 CFR part 

1, subpart H, and the appropriate registration number is provided in prior notice as specified in 

21 CFR 1.285(i). FDA may allow the food held at the port of entry to be moved to a secure 

facility, as appropriate (21 CFR 1.285(c)(2)). However, FDA ordinarily will not allow the food 

to be transferred by any person from the port of entry into the U.S. or from the secure facility. 

Biennial Registration Renewal 

FDA will consider a registration for a food facility to be expired if the registration is not 

renewed, as required by section 415(a)(3) of the FD&C Act. Thus, if a food facility that 

previously submitted a registration to FDA does not submit a registration renewal to FDA during 

the period beginning on October 1 and ending on December 31 of each even-numbered year, 

FDA will consider the registration for the facility to be expired, and will notify the registrant for 

the facility that the facility’s registration has expired. FDA will consider a food facility with an 

expired registration to have failed to register in accordance with section 415. As previously 

stated in this document, the failure of a food facility to renew its registration with FDA, as 

required by section 415(a)(3), means that the facility has failed to register in accordance with 

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section 415 of the FD&C Act. Accordingly, the failure to register a food facility in accordance 

with section 415 is a prohibited act under section 301(dd) of the FD&C Act. 

Suspension of Registration 

Under section 415(b)(4) of the FD&C Act, if the registration of a food facility is suspended, no 

person can import or export, or offer to import or export, food from the facility into the United 

States, or otherwise introduce food from the facility into interstate or intrastate commerce in the 

United States while the suspension order for the facility is in effect. The introduction or delivery 

for introduction into interstate commerce of an article of food in violation of section 415 is a 

prohibited act under section 301(d) of the FD&C Act. 

If a domestic facility that is subject to a registration suspension order introduces food from such 

facility into intrastate or interstate commerce, FDA may pursue enforcement action, such as 

administrative detention, seizure, injunction, mandatory recall, prosecution, or a combination of 

such actions, as appropriate, provided that the applicable legal requirements are satisfied. 

If FDA determines that a food offered for entry into the United States is from a foreign food 

facility with a suspended registration, such article shall be held at the port of entry according to 

section 801(l) of the FD&C Act. 

IV. Regulatory Action Guidance: 

Food Facility Registration 

The owner, operator, or agent in charge of a domestic facility, as defined in 21 CFR 

1.227(b)(2)(i), must register the facility with FDA, unless exempted, as provided in 21 CFR 

1.226, whether or not food from the facility enters interstate commerce. FDA anticipates that it, 

or a State agency acting on behalf of FDA, may discover a domestic facility's failure to be 

registered during a routine inspection of the facility. During an inspection, the investigator 

should determine whether a facility is registered and whether information in the registration is 

accurate and current. If the investigator identifies a registration violation, the investigator should 

advise the facility’s management of the requirement to register or the requirement to update 

mandatory elements of the registration. The investigator should also provide the management 

with FDA’s guidance, “What You Need to Know About Registration of Food Facilities.” The 

investigator should document in the establishment inspection report the information obtained 

regarding the facility’s registration. The investigator also should document information provided 

to the management of the unregistered facility regarding the registration requirements of section 

415 of the FD&C Act. 

The Districts have direct reference authority to issue an Untitled Letter to a domestic food 

facility and the Centers (CFSAN or CVM, as appropriate) may issue an Untitled Letter to a 

foreign or domestic food facility when the facility is required to register under section 415 of the 

FD&C Act, the facility has not registered, and the following conditions apply: 

•	 The facility manufactures, processes, packs, or holds food for human or animal 

consumption in the U.S. and the facility is not exempt from the registration requirement; 

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•	 The establishment file documents that facility management has been advised orally or in 

writing that the owner, operator, or agent in charge must register the facility with FDA; 

and 

•	 The office issuing the Untitled Letter has verified that the facility is not registered. 

CFSAN or CVM, as appropriate, should advise the Division of Food Defense Targeting (DFDT), 

formerly known as the Prior Notice Center, when a foreign facility has not registered with FDA 

in accordance with section 415 for future shipment targeting. Articles of food from the foreign 

facility for which a registration has not been submitted to FDA in accordance with section 415 

are subject to being held at the port of entry pursuant to section 801(l) of the FD&C Act. 

Biennial Registration Renewal 

CFSAN, Office of Compliance, or CVM, Office Of Surveillance and Compliance, or a District 

Office, as appropriate, may notify a facility that has not submitted a registration renewal to FDA, 

as required by section 415(a)(3) of the FD&C Act, of the requirement for biennial registration 

renewal. The process for notifying a food facility that has not submitted a registration renewal to 

FDA of the renewal requirement should be coordinated by the appropriate District Office and 

Center. 

Suspension of Registration 

The District or appropriate Center may recommend suspension of registration for a human or 

animal food facility based on evidence that food manufactured, processed, packed, received, or 

held by the facility has a reasonable probability of causing serious adverse health consequences 

or death to humans or animals and the facility: 

1.	 Created, caused, or was otherwise responsible for such reasonable probability; or 

2.	 Knew of, or had reason to know of, such reasonable probability; and packed, received, or 

held such food. (See section 415(b) of the FD&C Act). 

Suspension of a food facility’s registration may be considered whenever the criteria for 

suspension in section 415(b) of the FD&C Act are met. Examples of circumstances in which the 

District or Center should give priority consideration to recommending suspension of a food 

facility’s registration include, but are not limited to, the following: 

1.	 Inspectional or other evidence (e.g., evidence of Class 1 recall situation or evidence of 

food associated with foodborne illnesses) indicates that the firm has significant violations 

of the FD&C Act and has not permanently corrected the source of the problem. 

2.	 The firm is subject to a prehearing order to cease distribution and give notice under 

FDA’s mandatory recall authority, section 423(b) of the FD&C Act (21 U.S.C. 350l(b)). 

3.	 The firm is subject to an emergency permit order under 21 CFR part 108 or the District or 

Center is considering a recommendation to issue an emergency permit order to the firm. 

4.	 The firm is a foreign facility and food from the firm is subject to an Import Alert that 

provides for detention without physical examination because the food may cause serious 

adverse health consequences or death to humans or animals. 

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Under section 415(b)(4) of the FD&C Act, if the registration of a food facility is suspended, no 

person can import or export, or offer to import or export, food from the facility into the United 

States, or otherwise introduce food from the facility into interstate or intrastate commerce in the 

United States while the suspension order for the facility is in effect. The introduction or delivery 

for introduction into interstate commerce of any article of food in violation of section 415 is a 

prohibited act under section 301(d) of the FD&C Act. While a registration suspension order is in 

effect for a domestic facility, the District in which the facility is located should take appropriate 

actions to ensure that food from the facility is not introduced into interstate or intrastate 

commerce in the United States. 

CFSAN or CVM, as appropriate, should advise the DFDT when a registration suspension order 

is issued to a foreign facility for future shipment targeting. While the registration suspension 

order is in effect, articles of food from the foreign facility are subject to being held at the port of 

entry pursuant to section 801(l) of the FD&C Act.* 

*Material between asterisks is new or revised.” 

Issued: 12/2003 

Revised: 11/2004, 8/2006, 6/2014 

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