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U.S. Department of Health and Human Services

Food

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Sending Food through International Mail - Selected Excerpts from the Prior Notice Interim Final Rule, Guidance Documents, and Fact Sheets

 

See also:

Final Rule, published on November 7, 2008, effective May 6, 2009

Final Rule: Information Required in Prior Notice of Imported Food published May 30, 2013


 

 

Overview
Home-Made Foods
Gifts of Food
CPG and Enforcement Discretion
Commercial Shipments
Non-Commercial Shipments
Samples
Additional Selected Excerpts
Abbreviated Information on Requirements


 

OVERVIEW

Food imported or offered import into the United States for human or animals is subject to prior notice requirements regardless of the mode of transportation. However, the Prior Notice Interim Final Rule treats imported food arriving by international mail somewhat differently than other modes of transportation. The Interim Final Rule defines International mail to mean foreign national mail services. International mail does not include express carriers, express consignment operators, or other private delivery services. See Interim Final Rule §1.276(b)(7).

The timeframe requirements for food arriving by international mail are different, too. If food is arriving by international mail, the prior notice may be submitted more than 5 calendar days before the anticipated date of arrival; however, the prior notice must be submitted before the food is sent to the U.S. In addition, the Prior Notice Confirmation Number must accompany the article of food and must appear on the Customs Declaration that accompanies the package.

When the prior notice submission has been validated, the transmitter will receive a message showing that the prior notice has been received by the Food and Drug Administration (FDA) for review and accepted as facially complete. This message will include a unique Prior Notice Confirmation Number as well as the date and time of the submission and confirmation. The message will confirm that the prior notice is facially complete and has been received by the FDA for review. The Prior Notice Confirmation Number that appears in this message must appear on the Customs Declaration that accompanies the package. The transmitter can print a hard copy of the prior notice submission which also can be used as confirmation for prior notice submission, if necessary. See Interim Final Rule §1.279, and Interim Final Rule 68 FR 58975 Pages 58999-59000.

 

HOME-MADE FOODS arriving by International Mail

Home-made food is not subject to prior notice requirements if food that was made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for non-business reasons) to an individual in the United States; see Interim Final Rule § 1.277.

 

GIFTS of FOOD no longer in its natural state arriving by International Mail

If the food is sent by an individual as a personal gift (i.e., for non-business reasons) to an individual in the United States, the name and address of the firm that appears on the label under 21 CFR 101.5 may be submitted instead of the name, address, and registration number of the manufacturer. See Interim Final Rule § 1.281.

 

Compliance Policy Guide and Enforcement Discretion

In the preamble to the interim final rule, FDA stated that it planned to provide guidance to its staff regarding the agency's enforcement policies. Accordingly, a Compliance Policy Guide (CPG) was issued which establishes policies regarding the enforcement of the prior notice requirements, including the requirement to provide a required registration number. This guidance document represents the FDA's and Customs and Border Protection's (CBP) current thinking regarding enforcement of prior notice requirements. It does not create or confer any rights for or on any person and does not operate to bind FDA, CBP, or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

The CPG discusses several situations which impact food shipments arriving by international mail for which we can exercise enforcement discretion:

 

COMMERCIAL SHIPMENTS arriving by International Mail

Commercial shipments of food arriving in the United States by international mail are subject to prior notice requirements. Since December 2003, the agencies have been exercising enforcement discretion for a period of time before full enforcement. For minor or inadvertent prior notice violations, the action FDA and CBP staff typically should consider taking is education and communication. However, if the violation reflects a history of repeated conduct of a similar nature by a person who had been notified of such violations, then the action FDA and CBP staff typically should consider taking is assessment of CBP Civil Monetary Penalties. See Compliance Policy Guide, Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

 

NON-COMMERCIAL SHIPMENTS arriving by International Mail

Non-commercial shipments of food arriving in the United States by international mail are generally subject to prior notice requirements. However, since June 2004, the agencies have been exercising enforcement discretion. FDA and CBP should typically consider not taking any regulatory action when an article of food is imported or offered for import for non-commercial purposes with a non-commercial shipper. Generally, a non-commercial purpose is when the food is purchased or otherwise acquired by an individual for non-business purposes and the shipper is an individual (e.g., the individual delivers the food to a post office or common carrier for delivery to self, family member, or friend for non-business purposes, i.e., not for sale, resale, barter, business use, or commercial use.) Examples of foods imported or offered for import that may be covered by this non-commercial category are:

  • food in household goods, including military, civilian, governmental agency, and diplomatic transfers;
  • food purchased by a traveler and mailed or shipped to the traveler's U.S. address by the traveler;
  • gifts purchased at a commercial establishment and shipped by the purchaser, not the commercial establishment.

The shipper and the carrier are different entities, and the carrier is likely to be a commercial entity even when the shipper is an individual. Thus, the food for non-commercial purposes may arrive by international mail or any other mode of transportation, but must be shipped by one individual to another individual (self, family member, or friend) to be considered for non-commercial purposes. For example, when an individual purchases food at Store A and sends that food to an individual by mail, the individual is the shipper and the carrier is the mail service. However, if Store A ships the food, Store A is the shipper. Since Store A is not an individual, this last example is not covered by the criteria because the food was not imported or offered for import with a non-commercial shipper. (While a "person" sometimes can be an individual, partnership, corporation, or association, see 21 U.S.C. 321(e), by "individual" we mean a human being, not a partnership, corporation, or association.) see Compliance Policy Guide, Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

 

SAMPLES arriving by International Mail

Certain samples of food are generally subject to prior notice requirements.

Food samples not considered articles of food: If the samples are items that are in such early stages of research and development that they cannot yet be considered food for the purposes of prior notice, then they would not be subject to prior notice requirements (Q&A, Section C., Question 1.3). In addition, if the sample is in a form that is not an article of food, such as a slurry of lettuce for pesticide analysis or a sterile sample container filled with juice for heavy metal analysis, then prior notice would not apply (Q&A, Section C., Question 17.2). See Interim Final Rule 68 FR 58975 Page 58993. See Guidance for Industry, Prior Notice of Imported Food Questions and Answers (Edition 2).

Food samples for quality assurance, research or analysis: If food is imported or offered for import for quality assurance, research or analysis purposes only, not for human or animal consumption and not for resale and if the prior notice submission does not include the registration number assigned to the manufacturing facility that is associated with the article of food, FDA and CBP should typically consider not taking any regulatory action.

Samples of food are considered to be for quality assurance, research or analysis purposes when they are imported in small quantities (i.e., quantities consistent with the quality assurance, research, or analysis purposes) and the entire sample is used up by the analysis or is destroyed after analysis or a reasonable retention period after analysis. The analysis may include sensory analysis or evaluations such as those organoleptic analyses for testing the quality of tea or for testing for histamines. Evidence that an article of food is imported for quality assurance, research, or analysis purposes only might include, among other evidence, that the food and shipment documents are marked accordingly. The enforcement discretion does not apply to samples intended for test marketing, such as tasting at trade shows or product promotional tasting events. See Compliance Policy Guide, Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

 

Additional Selected Excerpts from the Prior Notice Interim Final Rule, Guidance Documents, and Fact Sheets

Who is authorized to submit prior notice? A prior notice for an article of food may be submitted by any person with knowledge of the required information. This person is the submitter. The submitter also may use another person to transmit the required information on his/her behalf. The person who transmits the information is the transmitter. The submitter and transmitter may be the same person. See Interim Final Rule § 1.278.

What is the definition of "shipper"? The interim final rule defines "shipper" as "the owner or exporter of the article of food who consigns and ships the article from a foreign country or the person who sends an article of food by international mail to the United States." See Interim Final Rule § 1.276(b)(12).


 

Abbreviated Information on Requirements for Submission of Prior Notice for Foods Arriving by International Mail

Refer to Prior Notice of Imported Foods particularly, Sending Food Gifts Through International Mail and Prior Notice for Food Articles sent by International Mail Step-by-Step Web System Instructions for additional information. For enforcement policies, refer to the Compliance Policy Guide (CPG).

Abbreviated Information

ArticlePrior Notice RequiredGenerally Enforced
Home-made foods: Food made by an individual in his/her personal residence and sent by that individual as a personal gift (i.e., for non-business reasons) to an individual in the United States.NoNot applicable
Non-Commercial Shipments: Food imported or offered for import for non-commercial purposes with a non-commercial shipper. A non-commercial purpose is when the food is purchased or otherwise acquired by an individual for non-business purposes and the shipper is an individual (e.g., the individual delivers the food to a post office or common carrier for delivery to self, family member, or friend for non-business purposes, i.e., not for sale, resale, barter, business use, or commercial use.) This includes food purchased by a traveler and mailed or shipped to the traveler's U.S. address by the traveler; gifts purchased at a commercial establishment and shipped by the purchaser, not the commercial establishment.YesNo, refer to CPG
Gifts of Food that is no longer in its natural state: Generally, the prior notice should include the identity of the manufacturing facility and the registration number of the manufacturing facility (§ 1.281(a)(6)). Here, the manufactured food is sent by an individual as a personal gift (i.e., for non-business reasons) to an individual in the U.S.YesYes, however, the name and address of the firm listed on the label may be provided in lieu of the registration number (§ 1.281a)(6))
Samples of Food 1: The samples are items that are in such early stages of research and development that they cannot yet be considered food, or the sample is in a form that is not an article of food, such as a slurry of lettuce for pesticide analysis or a sterile sample container filled with juice for heavy metal analysis.NoNot applicable
Samples of Food 2: Food imported or offered for import for quality assurance, research or analysis purposes only, not for human or animal consumption and not for resale.YesYes, except for the registration number of the manufacturing facility; refer to CPG