FDA – FAQs

U.S. FOOD AND DRUG ADMINISTRATION (USFDA)

  1. What is the role of the U.S. Food and Drug Administration?
  2. What is the Role and Responsibility of the Importer?
  3. Role of the U.S. Customs Broker:
  4. What is the Bio-Terrorism Act of 2002?
  5. What is a Facility?
  6. What is a Domestic Facility?
  7. What is a Foreign Facility?
  8. What is Meant by Processing?
  9. What is Involved with a Food Facility Registration?
  10. What Import Documents ARE REQUIRED by the FDA?
  11. What information is required to fill out a U.S. Customs Invoice?
  12. What Are the Consequences of Non-Compliance?
  13. What is a FDA Review / Exam / Sample?
  14. What are the steps in Practicing Reasonable Care?
  15. Industry Links:

What is the role of the U.S. Food and Drug Administration?

  • Ensuring that the food we eat is safe, wholesome and sanitary
  • Ensuring that the cosmetics we use won’t harm us
  • Ensuring that medications, medical devices and radiation-emitting devices are safe and effective

 

To learn more attend a U.S. Customs Compliance Seminar.

 

What is the Role and Responsibility of the Importer?

  • Ultimately responsible for payment of duties & taxes to U. S. Customs and Border Protection
  • Importer must fully inform and update the customs broker of:
    • Product use
    • List of products with descriptions
    • Industry Sector
    • Countries of Origin on purchased goods
    • Manufacturing / value added process
  •  Inform foreign suppliers of all required information and documentation
  • Ensure Harmonized Tariff System classification is correct
  • Request an Exporter’s Statement of Origin for applicable goods
  • Require carrier to inform the customs broker of port of entry
  • Retain records for five years
  • Have entry documents adjusted by broker promptly when changes to value, origin or tariff classification are known

To learn more attend a U.S. Customs Compliance Seminar.

 

Role of the U.S. Customs Broker:

A U.S. Customs broker works with and on behalf of the importer client, to facilitate clearance of personal and commercial goods into the United States. Customs brokers are highly regulated by Customs & Border Protection, in addition to other agencies. Some of the requirements include:

  • Transacting Customs business requires licensure by CBP
  • U. S. Citizen
  • Good moral character
  • Pass formidable written exam
    • Evidence knowledge of Customs related laws and procedures, in order to render valuable service to Importers


Duties & responsibilities include:

  • Maintaining records in approved manner
  • Confidentiality of records – nondisclosure
  • Responsible supervision of staff
  • Fiduciary due diligence
  • Correct advice to clients


Communication & coordination with other government agencies (OGA’s)

  • Food & Drug Administration (FDA)
  • Consumer Protection Safety Commission (CPSC)
  • Alcohol, Tobacco and Firearms (ATF)
  • United States Department of Agriculture (USDA or Ag)
  • Environmental Protection Agency (EPA)

 

To learn more attend a U.S. Customs Compliance Seminar.

 

What is the Bio-Terrorism Act of 2002?

Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (BTA)

World Health Organization defined food security as the implication that all people at all times have access to safe, sufficient and nutritious food to maintain a healthy and active life

  • 9/11 created a need for increasing focus on safety of food supply chain
  • Bioterrorism: Use of biologic agents or toxins targeted at civilian populations to coerce political or social objectives
  • World food supply is globalized – little isolation from farm to processing to table
  • Prevention as the first line of defense
  • Increases the number of inspections
  • Requires improvements to the information management systems of the FDA
  • Requires that any foreign facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered
  • Requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food
  • Allows the FDA access to all records relating to such articles

 

What is a Facility?

A facility includes any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs or holds food. Such term does not include farms, restaurants, other food establishments, non-profit food establishments in which food is prepared for or served directly to the consumer, or fishing vessels (except such vessels engaged in processing as defined in section 123.3(k) of title 21, Code of Federal Regulations)

 

What is a Domestic Facility?

Domestic Facility is a facility located in any of the States or Territories of the United States.

 

What is a Foreign Facility?

A Foreign Facility is a facility that manufactures, processes, packs, or holds food, but only if food from such facility is exported to the United States without further processing or packaging outside the United States.

 

What is Meant by Processing?

With respect to fish or fishery products, processing refers to the handling, storing, preparing, heading, eviscerating, shucking, freezing, changing into different market forms, manufacturing, preserving, packing, labeling, dockside unloading, or holding of fish or fishery products.


What is Involved with a Food Facility Registration?

The Bioterrorism Act (BTA) requires all foreign facilities that manufacture, process, pack, or hold food for human or animal consumption for or in the United States to register

Food requiring facility registration includes:

  • Dietary supplements and dietary ingredients
  • Infant formula
  • 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 components of food
  • Canned and frozen foods
  • Bakery goods, snack foods, candy and chewing gum
  • Live food animals
  • Animal feed and pet food

 

Foreign facilities must designate a U.S. Agent, who lives or maintains a place of business in the U.S. and is physically present in the U.S. for purposes of registration

 

What Import Documents ARE REQUIRED by the FDA?

  • Valid U.S. Customs Power of Attorney
  • U.S. Customs Bond
  • NAFTA Certificate (if applicable)
  • Invoice (Proforma, Customs, or Commercial)
  • e-Manifest

 

What information is required to fill out a U.S. Customs Invoice?

  • Port of entry
  • Names & addresses of the buyer, seller and ultimate consignee
  • IRS or Social Security number of the buyer and consignee
  • Adequate and legible description of the merchandise
  • Quantities in weights and measures
  • Purchase price or value of each item
  • Charges
  • Rebates
  • Goods and services furnished
  • Complete name and address of the food manufacturer
  • Registration numbers of the manufacturer / processor and storage operators
  • If the food product is not in its natural state, a copy of the label is helpful
  • How the food product is packed – plastic bags, bottles, cans, etc.
  • How the food product is processed – dried, irradiated, pasteurized, etc.
  • Temperature of food shipment – ambient, frozen or chilled
  • Depending on the product, there may be additional elements necessary
  • Country of Origin and Country of Production

 

What Are the Consequences of Non-Compliance?

Inaccurately describing merchandise to avoid BTA requirements can lead to:

  • Delayed releases
  • Increased examinations
  • Substantial monetary penalties
  • Seizure and forfeiture
  • Criminal prosecution
  • Permanent revocation of the right to import FDA regulated goods
  • Civil monetary penalties to anyone who had knowledge, or aided

 

What is a FDA Review / Exam / Sample?

  • Customs Brokers review for FDA disposition frequently throughout the day
  • If review or exam / sample status – immediate notification
  • When exam / sample determination is made during regular FDA hours, it will generally be conducted immediately at the port
  • If the shipment crosses outside regular hours, arrangements will need to be made between the Importer of Record and the carrier for disposition


What are the steps in Practicing Reasonable Care?

  • Conducting business in a manner that reflects full intent to obey the law
  • Knowing the rules and procedures required for a particular transaction or article
  • Having the necessary rules and publications on hand
  • Seeking out and obtaining necessary training
  • Working with experts to assist you
  • Having written procedures for various activities
  • Attending classes, lectures and seminars
  • Be able to prove that you have exercised reasonable care – document actions

 

Industry Links:

 

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