- OVERVIEW of FDA REGULATIONS -
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The United States Food and Drug Administration (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. 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.
Imported food products are subject to FDA review when the food is offered for import at U.S. ports of entry. 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 01) that food facilities register with FDA and 02) the submission of prior notice of imported food.
- TABLE of CONTENTS -
FDA Registration of Food Facilities
Prior Notice oflmported Food Products
Foreign Supplier Verification Program (FSVP)
List of Food Safety Documents for FSVP
Additional Useful Information & Links
- FDA REGISTRATION of FOOD FACILITIES -
The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Section 415 of the FD&C Act, as amended by FSMA, also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to 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 food 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: 01) Created, caused, or was otherwise responsible for such reasonable probability; or 02) Knew of, or had reason to know of, such reasonable probability; and packed, received, or held such food.
Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA. To that end, kindly find several useful links below. The first will lead you to a general overview of the FDA's guidance concerning Registration of Food Facilities. The second contains a link-tree for Online Registration pages. The third is a step-by-step guide to Food Facility Registration.
01) Registration of Food Facilities
02) Online Registration of Food Facilities
03) Food Facility Registration User Guide: Step-by-Step Instructions
- FILING PRIOR NOTICE of IMPORTED FOOD -
Nearly 20% of all imports into the U.S. are food and food products. In 2002 Congress passed the Bioterrorism Act as a part of its ongoing effort to combat terrorism - in this instance, by reducing the ability for international terrorists to carry out terrorist attacks in the U.S. by contaminating imported foods. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Act) directs FDA, as the food regulatory agency of the Department of Health and Human Services, to take additional steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply or other food-related emergencies.
The Act requires that FDA receive prior notice (PN) before food is imported or offered for import into the United States. Advance notice of import shipments allows FDA, with the support of the U.S. Customs and Border Protection (CBP), to target import inspections more effectively and help protect the nation's food supply against terrorist acts and other public health emergencies. On October 9, 2003 the Department of Health and Human Services (HHS) issued two new FDA rules to enhance the security of the food supply, one of which was the Interim Final Rule (IFR) for Prior Notice of Imported Foods. Since December 12, 2003, prior notice must be provided for all food for humans and animals that is imported or offered for import into the United States (Title 21 Code of Federal Regulations (21 CFR), Part 1, Subpart I). Prior notice can be provided in one of two ways:
The U.S. Customs and Border Protection (CBP) is modifying the Automated Broker Interface of the Automated Commercial System (ABI/ ACS) to allow prior notice to be submitted to FDA through the existing interface between CBP and FDA.
The Prior Notice System Interface (PNSI) is available to individuals or companies who cannot, or choose not to, file through CBP. PNSI submissions are expected to include prior notice for shipments through international mail; In-Bond entries or admissions into FTZ by carriers or others who do not need to make a full CBP entry at the time of filing the prior notice; filers or brokers who need to file CBP entries at a time the ACS/OASIS interface is not available, and others who simply prefer to use an interactive system.
The number of days before arrival that a PN can be submitted is no more than 15 calendars days before arrival if using PNSI and no more than 30 calendar days before arrival if submitting via ABI/ACS. More detailed information regard-ing the amendments can be found via the Federal Register, Volume 73, Number 217.
On May 5, 2011, an additional amendment to the regulations was published as an interim final rule as required by the FDA FSMA. This interim final rule went into effect July 3, 2011. The amendment requires an additional element of information in a prior notice of imported food. This change requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry. The new information can help FDA make better informed decisions in managing the potential risks of food imported into the United States. See the Interim Final Rule: Information Required in Prior Notice of Imported Food for additional information. In May 2013, FDA issued a final rule that adopts the interim final rule. For Instructions on the Prior Notice System Interface, see Filing Prior Notice, which includes the following resources and more.
01) Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. MAY 2009.
02) What You Need to Know About Prior Notice of Imported Food
03) Step by Step Web System Instructions
04) Prior Notice of Imported Food Questions and Answers
NOTE: United Safety Agents does not directly offer FDA registration or prior notice filing services but does work closely with a number of exceedingly competent and knowledgeable Customs Brokerage firms. If you requires assistance with FDA registration and/or prior notice filing, United’s Customs Brokerage partners stand ready to assist.
- FOREIGN SUPPLIER VERIFICATION PROGRAM -
The Foreign Supplier Verification Program (FSVP) requires importers (or FSVP agents) covered by the rule to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not
adulterated and is not misbranded with respect to allergen labeling. For the purposes of FSVP, an importer is the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. FSVP Agent or representative of the foreign owner of consignee at the time of entry, as confirmed in a signed statement of consent.
01) FSMA Final Rule on Foreign Supplier Verification Programs
02) Frequently Asked Questions on FSMA
03) United Safety Agents’ FSVP Agency Program
NOTE: list of documents typically required for FSVP verification and Agency can be found here.
- USEFUL LINKS & ADDITIONALRESOURCES -
The following links provide insight into common topics. If you have a specific question, please feel free to reach out to United Safety Agents via phone or email. Alternatively, you may reserve a time that works best here.
01) U.S. Customs & Border Protection Webstie
02) CBP Importing Food for Commercial Use (Resale)
03) U.S. Food & Drug Administration Webstie
04) Industry News & Resources
05) Overview of FSVP Regulations
06) Frequently Asked Questions of FSVP Regulations
07) Deadlines for FSVP Compliance
08) Guidance Documents & Regulatory Information by Topic
09) Current Good Manufacturing Practices (CGMPs)
10) Hazard Analysis & Critical Control Points (HACCP)
- CONTACT UNITED SAFETY AGENTS-
If you have any questions or require additional information, please contact United Safety Agents LLC directly via Email: firstname.lastname@example.org, Phone: +1 (888) 551-7403, Fax: +1 (888) 557-2649, UnitedSafetyAgents.com, or by Mail: 715 W. Park Avenue, No. 222, Oakhurst, New Jersey 07755-9998, United States of America.
This document contain information which is privileged, confidential, and protected. Any disclosure, copying, distribution, or use of the contents of this message is prohibited. Document may contain Non-binding recommendations. United Safety Agents LLC provides FDA/FSVP compliance services to businesses and has no direct affiliation with the FDA.
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