The United States remains a major importer of food products. American consumers spent 460 Billion dollars per year. So, why not expand your exports there?
If your facility manufactures, packs or holds any of the following foods products, it must be registered with the United States Food and Drug Administration (FDA):
- Dietary supplements and dietary ingredients
- Infant formula
- Beverages (including alcoholic beverages and bottled water)
- Fruits and vegetables
- Fish and seafood
- Dairy products and shell eggs
- Raw agricultural commodities for use as food or components of food
- Canned and frozen foods
- Bakery goods, snack food, and candy (including chewing gum)
- Live animals
- Food for animals.
In compliance with the Food Safety Modernization Act (FSMA), the FDA established the following regulations:
■ Foreign and domestic facilities that manufacture or process, pack, hold food are required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities are required to register.
■ Unless registration is completed, any food product shipped to the United States will be DENIED ENTRY.
■ Foreign Supplier Verification
Importers are now required to have a program to verify that the food products they are bringing into the U.S are safe.
The FDA will increase the number of inspections of foreign facilities and can deny entry to an import if a foreign facility refuses an FDA inspection. Prior Notice submissions will need to include, as an additional element, any country to which the food has been refused entry.
Under the law, there is no fee for the initial FDA inspection. However, the FDA has the authority to assess and collect fees for some types of costs, such as re-inspection-related costs when an initial inspection has identified certain food safety problems ($221 an hour if no foreign travel is required and $289 an hour if foreign travel is required).
■ Food Canning Establishment Registration (FCE) & Scheduled Process Identification (SID)
Because foods without adequate acidity may allow the growth of microorganisms that cause foodborne illness, the FDA requires companies producing low-acid canned foods (LACF) and acidified foods (AF) to obtain a Food Canning Establishment (FCE) registration before exporting or distributing their food products in the U.S.
Further, these companies must also file documentation for each process used in the production of low-acid canned and acidified foods, in order to obtain Scheduled Process Identification (SID) Numbers.
■ U.S. AGENT Requirement
Foreign Food Facilities must designate an Agent who resides or maintains a place of business in the United States. The U.S. Agent’s responsibility is to be the Foreign Food Facility’s contact in both emergencies and routine operations. A U.S. Agent may also register the Foreign Food Facilities on behalf of foreign companies.
■ Animal and Veterinary
Domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA.
Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This process is done in conjunction with the human drug registration process.
☻ Foods for humans
☻ Baby foods
* Powdered Infant Formula
* Required Nutrients
* Notification of New Formula
* Ready-to-feed Liquid Formula
☻ Pets Foods for Cat | Dog | Bird | Fish
DS CGMP Rule
Botanical Dietary Supplements
Vitamin, Mineral Dietary Supplements
Perfumes | Lipsticks
Fingernail Polishes | Eye and Facial Makeup
Shampoos | Hair Colors | Deodorants
Sunscreens are listed as Over-the-Counter (OTC) DRUGS, not cosmetics in the United States
Premarket Notification 510(k)
Premarket Approval (PMA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA): Generics
Therapeutic Biologics Applications (BLA)
Applications for Over-the-Counter (OTC) Drugs
MORE FDA SERVICES
☛ Initial Importer Service
☛ FSVP Importer Service
☛ Importer of Record Service
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We continue to scour the planet to bring you, the highest quality food products. Sellers and buyers of agricultural commodities are invited to contact us.
* Cocoa nibs
* Cocoa liquor
* Cocoa butter
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