FDA REGISTRATION

FDA Registration Services | www.m.itbhdg.com | www.itbhdg.com

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):

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.

OUR SERVICES

FDA REGISTRATION


FOOD COMPANIES

☻ Foods for humans

☻ Baby foods

Powdered Infant Formula, Required Nutrients, Notification of New Formula, Ready-to-feed Liquid Formula, Exempt Infant Formula  | www.m.itbhdg.com | www.itbhdg.com

* Powdered Infant Formula

* Required Nutrients

* Notification of New Formula

* Ready-to-feed Liquid Formula

FDA Registration of your pet food company : cat, dog, bird, fish | www.m.itbhdg.com | www.itbhdg.com

Pets Foods for Cat | Dog | Bird | Fish


SUPPLEMENTS COMPANIES

Expand the market of your dietary supplements | www.m.itbhdg.com | www.itbhdg.com

DS CGMP Rule

Botanical Dietary Supplements

Vitamin, Mineral Dietary Supplements

Health Claims


FOOD CANNING ESTABLISHMENTS

FDA Registration of your Food Canning Company | www.m.itbhdg.com | www.itbhdg.com

FCE Registration

SID Filing


COSMETICS COMPANIES

FDA Cosmetics | Perfumes, Lipsticks, Fingernail 
Polishes, Eye and Facial Makeup, Shampoos, Hair Colors, Deodorants, Skin Moisturizers

Perfumes | Lipsticks

Fingernail Polishes | Eye and Facial Makeup

Shampoos | Hair Colors | Deodorants

Skin Moisturizers

Establishment registration

U.S. Agent Service

Sunscreens are listed as Over-the-Counter (OTC) DRUGS, not cosmetics in the United States


MEDICAL DEVICES COMPANIES

Premarket Notification 510(k), Premarket Approval (PMA), Medical Devices Listing

Premarket Notification 510(k)

Premarket Approval (PMA)

Medical Devices Listing

Establishment Registration


DRUGS COMPANIES

Abbreviated New Drug Application (ANDA): Generics, Applications for Over-the-Counter (OTC) Drugs | www.m.itbhdg.com | www.itbhdg.com

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA): Generics

Therapeutic Biologics Applications (BLA)

Applications for Over-the-Counter (OTC) Drugs

Drugs Listing

Establishment Registration


MORE FDA SERVICES


☛ Initial Importer Service

U.S. Agent Service

☛ FSVP Importer Service

☛ Importer of Record Service

Prior Notice


FOREIGN LANGUAGES


DEUTSCH | GERMAN

FDA Registrierung

NEDERLANDS | DUTCH

FDA Registratie

ESPAÑOL | SPANISH

Registro FDA

FRANÇAIS | FRENCH

Enregistrement FDA


COMMODITIES TRADE: FOOD IMPORT-EXPORT

Organic cacao, cocoa, coffee products at the best prices and free shipping

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.

Cacao, Cocoa

Organic cacao, cocoa, coffee products at the best prices and free shipping

* Cocoa beans

* Cocoa nibs

* Cocoa liquor

* Cocoa powder

* Cocoa butter

Specialty, Gourmet Coffee

Organic cacao, cocoa, coffee products at the best prices and free shipping


Our representatives are standing by for any question. We speak English, Dutch and French for your convenience.

MORE INFORMATION? Contact us today.

www.fda.itbhdg.com | www.m.itbhdg.com | www.itbhdg.com

EXTENDED OFFICE HOURS : 3:00 AM – 6:00 PM Eastern Standard Time – EST, Monday – Sunday | Multilingual and International Team to handle your requests within hours, not days.

LIVE CHAT available on all websites.

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T : +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577
Skype: itbholdings