- FDA’s Import Program
- Prior Notice
- Additional Resources
- Clearance/review legend
- Purpose of this Overview
FDA is responsible for enforcing the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws which are designed to protect consumers' health, safety, and pocketbook. These laws apply equally to domestic and imported products.
With the exception of most meat and poultry, all food and cosmetics as defined in the FD&C Act, are subject to examination by FDA when imported or offered for import into the United States. Most meat and poultry products are regulated by the U.S. Department of Agriculture .
All color additives used in foods and cosmetics in the United States must be approved by FDA; many cannot be used unless certified in FDA's own laboratories.
Food imported into the United States must meet the same laws and regulations as food produced in the United States. It must be safe and contain no prohibited ingredients, and all labeling and packaging must be informative and truthful, with the labeling information in English (or Spanish in Puerto Rico).
Imported food products are subject to FDA review when the food is offered for import at U.S. ports of entry. FDA does not certify, license, or otherwise approve individual food importers, products, labels, or shipments prior to importation. Importers can import food into the United States as long as the facilities that produce, pack, store, or otherwise handle the products are registered with FDA and meet other FDA requirements, such as sanitation.
During the entry process, firms must provide to FDA information related to the specific products and the manufacturers of the products. Based on the entry information provided and other information FDA has, FDA will decide whether the product meets U.S. requirements and can be released into U.S. commerce.
In the wake of various acts of terrorism, FDA exercises heightened vigilance in assessing food defense risk and maintaining the safety of the nation’s food supply. Under provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which amended the FD&C Act, FDA established regulations requiring (1) that food facilities register with FDA and (2) the submission of prior notice of imported food.
Most facilities that manufacture, process, pack, or hold food must register with FDA biennially (every two years). This includes most foreign manufacturers and importers. There are few exceptions from the registration requirements; for example, farms and restaurants do not have to register. There is no fee to register with FDA.
Under the prior notice requirements, FDA must receive notice before food is imported or offered for import into the United States. The purpose of prior notice is to enable FDA to target inspections or examinations of the imported food at U.S. ports of entry more effectively, and to determine whether there is any credible information that the imported food shipment presents a threat or serious risk to public health. Food imported or offered for import into the United States without adequate prior notice may be refused admission into the United States. Under the Food Safety and Modernization Act (FSMA) of 2010, if the imported food was refused entry in another country, the prior notice must also identify the other country (or countries) where the food was refused entry.
The prior notice requirement applies to all foods, unless excluded, for humans or animals, including:
Dietary supplements and dietary ingredients;
Beverages (including alcoholic beverages and bottled water);
Fruits and vegetables;
Fish and Seafood;
Dairy products and eggs;
Raw agricultural commodities for use as food or as components of food;
Animal feed (including pet food);
Food and feed additives; and,
Live food animals.
Exclusions from the prior notice requirements include:
Food carried by or accompanying an individual arriving in the United States for his or her personal use (i.e., for consumption by themselves, family, or friends, and not for sale or other distribution);
Food that is imported then exported without leaving the port of arrival until export;
Meat food products, poultry products, and egg products that are subject to the exclusive jurisdiction of the U.S. Department of Agriculture;
Food made by an individual in his or her personal residence and sent by that individual as a personal gift to an individual in the United States; and
Food shipped as baggage or cargo constituting the diplomatic bag (e.g., from one nation’s government office to its embassy in the United States).
Generally, FDA’s prior notice regulations apply to all food for humans and other animals imported or offered for import into the United States, for use, storage, or distribution in the United States, including food for gifts. FDA’s website contains information about FDA’s prior notice policy regarding sending gifts to your friends and family and regarding importing gift packs.
For more information about filing prior notice, please visit FDA’s Prior Notice of Imported Foods Web site. If you need assistance filing prior notice, you may contact the Division of Food Defense Targeting (formerly the Prior Notice Center) at 1-866-521-2297 (571-468-1488 outside the United States; fax 571-468-1936) or through e-mail at email@example.com. For technical assistance (such as password help) with the FDA Prior Notice System Interface (PNSI) or the Food Facility Registration Module, contact the FDA Industry Systems Help Desk at 1-800-216-7331 (301-575-0156 outside the United States; fax 301-436-2804) or firstname.lastname@example.org.
Cosmetic products imported into the United States must meet the same laws and regulations as those produced in the United States. They must be safe for their intended uses and cannot contain prohibited ingredients. All labeling and packaging must be informative and truthful, with the labeling information in English (or Spanish in Puerto Rico). Certain cosmetic products must be labeled with warning statements.
FDA encourages cosmetic firms to register their establishments and file Cosmetic Product Ingredient Statements with FDA's Voluntary Cosmetic Registration Program (VCRP). However, firms importing products considered to be cosmetics in the United States are not required to register with FDA. The VCRP can only accept Cosmetic Product Ingredient Statements for cosmetics that are already on the market in the United States. A registration number is not required for importing cosmetics into the United States.
For import questions not related to prior notice, contact the Division of Import Operations at FDAImportsInquiry@fda.hhs.gov, or 301-796-0356 (fax 301-827-4086).
- Import Program Overview
- Federal Food, Drug, and Cosmetics Act (FD&C Act)
- USDA Food Safety and Inspection Service (FSIS)
- Color Additives
- Labeling of Food Articles Distributed Solely in Puerto Rico
- Importing Food Products into the United States
- Bioterrorism Act of 2002
- Food Facility Registration
- Registration of Food Facilities
- How to Start a Food Business:
- Import Program
- Prior Notice
- FDA Food Safety Modernization Act (FSMA)
- Prior Notice of Imported Food
- Sending Food through International Mail
- Importing Gift Packs and Prior Notice
- Help Desk
- Ingredients Prohibited & Restricted by FDA Regulations
- Foreign Food Facility Inspection Program:
- Cosmetic Imports
- Cosmetic Labeling
- Voluntary Cosmetic Registration Program (VCRP)
This overview provides information in response to questions that have been asked of the CFSAN Information Center through phone calls, emails, and letters about food (i.e., human food) business requirements. The overview provides concise information and directs readers to additional relevant information and publicly available resources. The Information Center consulted subject matter experts within FDA or other agency resources, as appropriate, to develop this information.
The information provided on this webpage is an informal communication that is not intended to be guidance. FDA's good guidance practices, its policies and procedures for developing, issuing, and using guidance documents, are set forth in 21 CFR 10.115.
CFSAN's intent in posting this information is to provide an overview of the subject matter, with links to more detailed information such as federal laws, regulations, guidance documents, and other federal agency websites. Additional information about state and local laws, regulations, requirements, and guidance may be available from state and local agencies and resources.