What industry needs to comply with US FDA?

Food, Beverages, and Dietary Supplements: Every owner, operator or person in charge of a facility that manufactures, processes, packs or holds food or beverages for human or animal consumption in the United States must register that facility with the US FDA and list the products. Foreign manufacturers must also appoint a U.S. Agent.

Medical Devices: Any company (both domestic and foreign), including initial distributors (importers), involved in putting medical devices in the USA commercial marketplace must register their establishments with the FDA and must list their devices and manufacturers. In addition to registration, foreign establishments must also appoint a U.S. Agent.

Drugs: Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, re-packers or re-labelers are also required to list all of their commercially marketed drug products. Foreign establishments must also appoint a U.S. Agent.

What kind of food facilities requires FDA registration?

The Bioterrorism Act requires US FDA registration for food facilities, that manufacture, process, pack, or hold food for human or animal consumption in the U.S. Owner, operator, or agent in charge of domestic food facility is required to register the facility with the US FDA.

Is US Agent necessary?

US Agent appointment is mandatory by US FDA for food, drug, or medical device facility. The US FDA may communicate with companies through the US Agent. The US Agent must reside or maintain a place of business in the U.S. and must be physically present in the U.S.

What are US Agent’s responsibilities?

US Agent’s main responsibilities:

  • Intermediary for communications between US FDA and facilities. It acts as emergent contact window for FDA.

  • Representative for the company and assists the FDA to schedule inspections of the facilities. 

  • To receive documents and information from the FDA on for the company.

  • To submit registration for your facility with the FDA.

How to sell food products in the US?

  • Facility Registration & appoint a US Agent.

  • Proper Labeling.

  • GMP manufacturing.

  • Prior notice before shipment.

Does dietary supplement establishment require FDA registration?

YES, it is mandatory by U.S. FDA registration.

Does FDA registration number denote US FDA approval? Does food facility will get certificate of registration from U.S. FDA?

No, U.S. FDA will assign a registration number to each registered facility. FDA registration number does not denote FDA approval. Also, U.S. FDA does not issue a certificate of registration nor does U.S. FDA recognize one. Willow Glen Consultancy issues certificate for the facility to show the registration is verified as effective.

What happens if I do not register with US FDA?

If you are a foreign facility, your shipments won’t be allowed into the United States. Your product will likely be held at the port of entry, and you are responsible for expenses incurred, including arranging and paying for all storage, transportation, and posting of bond. You may also commit a prohibited act. The federal government may take legal actions.

If you are a domestic facility and do not register, you may commit a prohibited act. The federal government may bring both civil and criminal charges against you.

What’s the benefit to appoint an independent US Agent?

Independent US Agent has no conflict of interest and will keep your information confidential. The federal government may send confidential information to you through your appointed U.S. Agent. The federal government may also ask questions about your products or facility related questions through your U.S. Agent. These confidential information and trade secret, should stay secret from your competitor, broker, and custom agent.

 

Where can I search the FDA food registration information?

It is confidential. The list of registered facilities and documents, including information provided in those documents, are not subject to public disclosure under the Freedom of Information Act.

Does U.S. FDA inspect food facility before registration?

No, U.S. FDA does not inspect food facility before assigning registration number. FDA may inspect the facility after registration when needed.

Does U.S. FDA review and approve food labels?   

Food product labels are not required for U.S. FDA registration. U.S FDA does not review or approve food labels. However, it is important to make sure your product label comply with the guidance to prevent any detention or call back.

 
 

April 11, 2017

Questions and Answers Regarding Food Facility Registration

Frequently asked questions.

September 13, 2016

What You Need To Know About Registration of Food Facilities Small Entity Compliance Guide

  • Food included & excluded in the regulation.

  • Facilities that do not have to register.

  • Suspension of registration.

  • Registration regulation at-a-glance.

September 06, 2016

FDA Regulation of Salt and Sodium

  • Regulatory Status of salt/sodium.

  • Nutrition labeling and claims for salt and sodium.

  • Current activities at FDA regarding salt and sodium.

December 09, 2015

Questions and Answers Regarding Food Facility Registration

FDA FAQ for Food Facility Registration (Sixth Edition). 

November 2014.

November 25, 2015

FDA Food Labeling Guide

Covers:

  • General food labeling requirement.

  • Name of food.

  • Net quantity of contents statements.

  • Ingredient lists.

  • Nutrition labeling.

  • Claims.

September 23, 2015

Compliance Policy Guide: Food Facility Registration – Human and Animal Food

Guidance for FDA Staff:

  • Biennial Registration Renewal.

  • Suspension of Registration.

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Willow Glen Consultancy LLC

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