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FDA Registration Services

Who Must Register with the FDA Pursuant to the Bioterrorism Act (BTA) of 2002?

Food Facilities, which include all domestic and foreign facilities that manufacture, process, pack, or hold food or beverages, for importation or distribution in the United States.

When do I Need a U.S. Agent?

Companies located outside the United States must designate a U.S. Agent for FDA communications.

What are the U.S. Agents Responsibilities?

The U.S. Agent is responsible for being readily available to respond to FDA communications. FDA will communicate with the designated U.S. Agent, to schedule inspections and require an immediate response. The U.S. Agent is a person or entity located within, or that maintains an office, in the United States and acts as your domestic representative in all communications with the FDA. Under Section 107 of the FSMA, all foreign food facilities must designate a U.S. Agent upon registration and re-registration. FSMA now includes new responsibility for the U.S. Agent, as the U.S. Agent is financially liable for the payment of re-inspection and user fees assessed against the registered facility.

What are the Costs Involved?

Diaz Trade Consulting charges an annual fee of $595 USD per facility which includes FDA registration, Biennial Registration, U.S. Agent services, as well as a certificate of registration.

Do you Provide Certificates of Registration?

Yes, Diaz Trade Consulting issues certificates of registration to provide confirmation to your industry that you are fulfilling U.S. FDA registration requirements, which assist in avoiding costly delays.

What is the Food Safety Modernization Act (FSMA)?

The FDA’s Food Safety Modernization Act (FSMA), is the most sweeping reform of our food safety laws in more than 70 years and was signed into law by President Obama on January 4, 2011. FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

Companies in the food and beverage industry must comply with the requirements set-forth in the U.S. Federal Food, Drug and Cosmetic Act (FDCA), originally enacted in 1938, subsequently amended by the Bioterrorism Act of 2002 (BTA) and the Food Safety Modernization Act (FSMA).

The new FSMA places several new restrictions on all companies involved in any way with the food supply into the United States whether the company is located in the United States or anywhere else in the world. The FSMA provides the FDA with greater authority to prevent food safety concerns, and increases the agency’s enforcement powers. FSMA now provides FDA with the power suspend food facility registrations for non-compliance.

What are some Highlights of FDA’s New Powers Under FSMA?

Food Facility Biennial Registration Requirement

Increased Liability for U.S. Agents

Collection of Fees by FDA: Section 107 of the FSMA authorizes FDA to assess and collect fees related to food recall activities, as well as certain re-inspections for domestic and foreign food facilities, and importers. FDA charges an hourly re-inspection rate depending on whether or not foreign travel is required.

Mandatory Recalls: Section 206 of the FSMA provides FDA with authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to by FDA.

Expanded Administrative Detention: Section 207 of the FSMA provides FDA with a new, more flexible standard for administratively detaining products that are potentially in violation of FDA’s laws or regulations.

Mandated Inspection Frequency: Section 306 of the FSMA mandates the FDA significantly increase the frequency of food facility inspections -- all "high-risk" domestic facilities must be inspected within five years of enactment and no less than every three years thereafter. A minimum of 600 foreign facilities must be inspected within one year of enactment and those inspections are to double every year thereafter for the next five years.

Authority to deny entry: Section 304 of the FSMA states that the FDA can refuse entry into the U.S. of food being imported from a foreign facility if FDA is denied access to the facility by the registrant or the government of the country where the facility is located.

What is a Biennial Registration?

Section 102 of the FSMA requires all food facilities to renew their FDA registrations biennially (every two years, which started in 2012). The FSMA further authorizes the FDA to cancel the registration numbers for those food facilities that do not re-register in this period, forcing those facilities to re-register and obtain a new registration number. Food imports from foreign facilities that fail to re-register will be detained or refused.

What Types of Enforcement Action Does FDA Take?

Examples of enforcement actions by the FDA may include Notices of FDA Action detaining goods upon entry causing time delays, being placed on the FDA’s Import Alert ("red light") list, warning letters, FDA’s inspections, and liquidated damages claims issued by U.S. Customs and Border Protection ("CBP") for an underlying FDA violation.

What Other Services Does Diaz Trade Consulting Offer?

Diaz Trade Consulting is led by Jennifer Diaz, a Board Certified International Trade Attorney, considered an expert in International law by the Florida Bar and provides the following services:

  • Timely and properly registering domestic and foreign facilities with the FDA to obtain an FDA Registration Number.
  • Appointment of Diaz Trade Consulting as the United States agent for the facility or facilities. NOTE: All non-U.S. companies must appoint a United States agent when registering with the FDA.
  • FDA registration, U.S. agent, and a full range of training and compliance services tailored to both domestic and foreign companies. Assistance includes pre-compliance (assisting to successfully bring your product to market in the U.S., including customized training) as well as assistance in successfully navigating FDA enforcement actions.
  • Advise on records required to be maintained as ordered by the FDA.
  • Advise on label review to assure your product complies with FDA requirements.
  • We are available to promptly communicate with officials from CBP as well as the FDA. We can assist with questions or problems that may arise in connection with any FDA regulated shipments to the United States which have been examined, delayed, detained, or refused entry into the United States. Examples include assistance in:
      • Adequately responding to Notices of FDA Action received by FDA when goods are detained causing time delays,
      • Petitioning FDA to request removal from FDA’s Import Alert ("red light") list,
      • Responding to a Warning Letter received by FDA,
      • Preparing for an FDA inspection,
      • Responding to a liquidated damages claim issued by U.S. Customs and Border Protection ("CBP") for an underlying FDA violation.
  • Customized training programs.
  • Provide access to a FREE blog to provide you with timely updates about new FDA and Customs policies and issues that impact your business.