FAQ

No. We do not charge extra for routine amendments or for conveying information to and from FDA as long as it is within the scope of FDA food facility registration purposes.

There is no charge for mail, phone, or fax. If you request FedEx, we will charge you at cost. Please review the Agreement.

Food-Agent.com will prepare and provide a letter, explaining why you need not register, and we will promptly refund a substantial portion of the fee (please request and review the contract for details).

A facility is any distinct place within or outside the US, where food (for human or animal consumption in the US) is made, processed, packed, or held.

A single building may include more than one facility, if different parts of the building are under different management.

FDA estimates that several hundred thousand facilities must submit registrations. It is every facility that must register (not every brand, company or commodity).

A foreign facility can be exempt if it does not handle food that will be consumed in the US.

A foreign facility can be exempt if it handles food that is further processed by another facility outside the US (in a manner more substantial than mere labeling).

Farms are exempt if no processed food leaves the farm, and if no food is delivered to the farm.

Retail stores, restaurants, homes, and nonprofit food facilities.

Facilities regulated by the US Department of Agriculture (such as chicken and beef plants).

Transport vehicles.

No.  It covers food companies all over the world – within and outside of the US.

Because you are selling into the US.

Almost all foods, broadly defined, including:
fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities, live cattle and hogs, infant formula, bakery goods, candy, and canned foods.

Alcohol beverages such as beer, wine and spirits.

Pet food.

Additives such as colors, preservatives and flavors.

Dietary supplements such as vitamins and minerals.

Now, the deadline is before you ship food into the United States, with a renewal every even-numbered calendar year (e.g., 2014, 2016, 2018, etc.). Also, you need to update your data within 60 days of any important change.

The penalties can be severe. They include fines and criminal sanctions. They include banning your foods from the US, and banning you and your company from shipping food into the US.

Additionally, goods can get held up or detained at the port, often causing companies significant delays and even product loss. Your US importer will probably not be able to import the food until there is a proper FDA food facility registration.

If the registration is not renewed with the FDA at the end of each even-numbered year (i.e., usually by December 31st), the FDA will consider the registration to be inactive and will close out the company’s registration. If a company exports food to the US with an inactive or cancelled registration, the shipment will not be released into the US and will be held or detained at the port of entry. To avoid delays, additional costs, and possible spoilage of goods, it is thus extremely important to make sure that registrations are renewed with FDA on time. At Food-Agent.com, we manage the biennial renewal process and will assist our clients in making sure registrations are up-to-date.

If your company is located outside the US, the Bioterrorism Act requires you to appoint a US based agent.

We act as a reliable liaison between you and FDA, seven days a week, as required by the regulations. We help keep your records up-to-date and accurate to avoid issues with FDA and the registration and when importing food products.

You could pay substantially more than necessary. Several other agents charge higher base fees, and then add extra fees for minor services (such as amendments and confirmations).

If you ask your importer to perform this regulatory function for you, your importer is likely to know about problems before you do.  It is not clear that your importer is in a binding, confidential relationship with you.  It is also not clear that your importer has any particular expertise in FDA compliance.

If FDA needs to reach you in an emergency, FDA is likely to contact your US agent.  If this critical information is not conveyed to you promptly and reliably, it could cost you far more than an agent fee.

We represent hundreds of international food companies and have done so for over a decade.

Food-Agent.com is part of an established, Washington, DC-based law firm with clients in many countries.

We meet or exceed all FDA requirements and have more than 15 years of relevant experience.

Our rates are substantially lower as compared to FDA estimates and other agents.

Our system blends the power of information technology and dedicated legal professionals.

We can work with you in many of the world’s languages.

We protect the integrity of your information, ensure FDA and you receive the right information in a timely manner, and make sure that others do not get this information.

We will tell you the truth, promptly.

We make it easy to comply.

No.  We have designed a system that, on average, should take no more than 30 minutes of your time.

By the way, FDA’s form calls for over 185 data elements and FDA says the filing could take up to 12 hours (without expert help).

We will maintain a place of business within the US 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, email and written communication from FDA regarding your company.

We will promptly and accurately convey the same to your company in the language of your choice.

We will assist you with FDA inspection documents and e-mails for your facility’s first inspection.

The name, full address, phone number, fax number, and email address of each facility.

The name and address of the parent company (if the facility is a subsidiary of the parent company).

Emergency contact information.

All trade names the facility uses.

A brief description of the types of food handled at the facility.

FDA estimates that agents will charge about $1,200 per year.  Some agents charge more.  Food-Agent.com’s fees are lower than FDA estimates and other agents.  Please review our fee schedule for exact rates.

No.  There is no obligation until you have received, reviewed and signed a contract.  We will not share your confidential information (or your email address) with any third party (other than FDA, under the specific terms set forth in the contract).

A facility is any distinct place within the US where food (for human or animal consumption in the US) is made, processed, packed, or held. US facilities must register with FDA by December 12, 2003.

A single building may include more than one facility, if different parts of the building are under different management.

FDA estimates that several hundred thousand facilities must submit registrations. It is every facility that must register (not every brand, company or commodity).

Farms are exempt if no processed food leaves the farm, and if no food is delivered to the farm.

Retail stores, restaurants, homes, and nonprofit food facilities.

Facilities regulated by the US Department of Agriculture (such as chicken and beef plants).

Almost all foods, broadly defined, including: fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities, live cattle and hogs, infant formula, bakery goods, candy, and canned foods.

Alcohol beverages such as beer, wine and spirits.

Pet food.

Additives such as colors, preservatives and flavors.

Dietary supplements such as vitamins and minerals.

Chicken and beef are usually exempt.

Packaging materials such as cans, corks, and bottles.

This requirement began on December 12, 2003.

The penalties can be severe.

They include fines and criminal sanctions.

No.  You do not need to appoint an agent, but you do need to register, and we can help you to more properly and easily comply with the requirements.

Food-Agent.com is part of an established, Washington, DC-based law firm with clients in many countries.

We have more than 15 years of relevant experience.

Our system blends the power of information technology and dedicated legal professionals.

We will protect the integrity of your information, ensure FDA and you receive the right information in a timely manner, and make sure that others do not get this information.

We will tell you the truth, promptly.

We make it easy to comply.

No.  We have designed a system that, on average, should take no more than 30 minutes of your time.

By the way, FDA’s form calls for over 185 data elements and FDA says the filing could take up to 12 hours (without expert help).

The name, full address, phone number, fax number, and email address of each facility.

The name and address of the parent company (if the facility is a subsidiary of the parent company).

Emergency contact information.

All trade names the facility uses.

A brief description of the types of food handled at the facility.

No.  There is no obligation until you have received, reviewed and signed a contract.  We will not share your confidential information (or your email address) with any third party (other than FDA, under the specific terms set forth in the contract).

Payment in US Dollars.

• Online. For easy, secure online payment, go to this page. We accept Visa, MasterCard, American Express, Discover, and most debit cards.
• Check. Payable to Lehrman Beverage Law, PLLC. 2911 Hunter Mill Road, Suite 303, Oakton, VA 22124.
• Wire. Instructions available upon request. Wire transfers may incur high bank fees.