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AGDE Corporation U.S. Food Agent FAQ
Why choose AGDE Corporation as your U.S. Food Agent
- AGDE Corporation is conveniently located just 5 minutes from U.S. FDA offices in Rockville, Maryland.
- We meet or exceed all U.S. FDA requirements and have more than 30 years of relevant experience.
- Advanced technology and dedicated professionals.
- We protect your information.
- Fast and efficient service.
What foods are covered
- Food and food additives for man or animals
- 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 foods
- Live food animals
- Bakery goods
- snack food and candy
What facilities are covered
- Domestic facilities are required to register whether or not food from the facility enters interstate commerce.
- Foreign facilities that manufacture/process, pack, or hold food also 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.
- Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register the facility with the FDA.
What facilities are not covered
- Retail food establishments
- Restaurants
- Nonprofit establishments that prepare food for, or serve food directly to, consumers;
- Fishing vessels not engaged in processing as defined in 21 CFR 123.3 (k)|
- Facilities regulated exclusively throughout the entire facility by the U.S. Department of Agriculture.
When is the deadline
- “As the rule becomes effective, FDA and CBP expect a "good faith" effort at compliance. The policy guide issued today makes clear that during the next 8 months, the two agencies will primarily rely on educating the affected firms and individuals. During this period, the agencies will utilize communication and education initiatives, escalating imposition of civil monetary penalities, and ultimately refusal of shipments. This phase-in period will end on August 12, 2004. As always, both agencies will continue to ensure that imported products are safe for human or animal consumption. Regarding food mailed, brought or accompanied to the U.S. by individuals for non-personal use, FDA and CBP generally will continue their education efforts and will not refuse its admission before August 12, 2004 because of inadequate or lacking prior notice.” U.S. FDA Press Release dated 12/11/03. You should register and retain AGDE Coporation early to avoid the rush.
What if I do not register
- The Bioterrorism Act makes failure to register a prohibited act. The Federal government can bring a civil action in Federal court to enjoin persons who commit a prohibited act; or the Federal government can bring a criminal action in Federal court to prosecute persons who are responsible for the commission of a prohibited act.
- If a foreign facility fails to register and also attempts to import food into the U.S., the Bioterrorism Act requires that the food be held at the port of entry unless FDA or U.S. Customs directs otherwise.
- If the food must be moved, the private parties involved (i.e., the owner, purchaser, importer, or receiver of the food) must arrange for moving it and promptly notify FDA of its location.
- The private parties are responsible for any costs associated with moving or storage of the food.
Does registration take a lot of time
- The FDA estimates that it will take one or two hours of a manager's time to read and understand the regulations.
- Filling out a registration form would take a total of one hour -- 45 minutes of an administrative worker's time and 15 minutes of an owner, operator, or agent-in-charge's time to certify the registration before submitting the form to FDA.
What services will AGDE Corporation provide as your U.S. Registered Food Agent?
- We will maintain a place of business within the U.S. in the manner required by the FDA regulations.
- We will assist your company in properly filing the Food Facility Registration Form and we will assist you with updates.
- We will accept all calls, E-mail and written communication from FDA regarding your company. We will promptly and accurately convey that information to your company.
- We will assist you in your upcoming Prior Notice submissions and provide access to on line Prior Notice submission to the FDA
What information must you make available to us?
- Emergency contact information.
- All trade names the facility uses.
- A description of the food types handled at the facility.
- Physical address
- Phone number of the facility
- Same information for the parent company, if the facility is a subsidiary All trade names the facility uses
- Food product categories (~21 CFR 170.3)
- A statement certifying that the information submitted is true and accurate and submitter is authorized to register the facility Name and contact information of the person submitting the certification statement
- Name of foreign facility's U.S. agent and the agent's contact information
- The name, full address, phone number, fax number, and E-mail address of each facility.
Is it expensive to retain a U.S. Registered Food Agent?
- FDA estimates vary depending on the number of lines shipped per year. AGDE Corporation has lower annual fees than other agents along with fast and experienced service, please request our fee schedule for exact rates.
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