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FDA Regulations and Compliance

President Bush signed into law June 12, 2002, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act or "The Act"). This new legislation provided the Food and Drug Administration (FDA) new authority for protecting the nation's food supply against terrorist acts and other public health threats. The proposed regulation as published in the Federal Register has four main provisions, which apply to domestic and imported products to the United States; Registration, Prior Notice, Administrative Detention and Record Keeping. Non-Compliance can result in civil and criminal penalties imposed by the federal government. Read our FDA frequently asked questions below.

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Food and Drug Frequently Asked Questions

Who must submit prior notice?
Purchaser or importer (or agent) who resides or maintains a place of business in the United States.

When must I submit prior notice?
See Federal Register pending Rules and Regulations.

What information must I include in the prior notice?
See Federal Register pending Rules and Regulations.

How should I submit prior notice?
FDA and Customs and Border Protection (CBP) announced May 27, 2003, that they are working together to integrate and streamline the submission of the FDA's prior notice requirements of the Bioterrorism Act by modifying the Customs Automated Commercial System (ACS). FDA and CBP are developing a system that will be less burdensome on the trade while at the same time fulfilling the mandates of the Bioterrorism Act.

Will I receive immediate acknowledgement of my submission?
Yes, FDA plans that an acknowledgement will be issued with the time and date.

May I amend or update the prior notice?
Yes, under the proposed rule, the FDA will accept amendments once, under specified, limited circumstances, for information regarding product specificity or quantity that did not exist at the time you submitted the original prior notice.

What are the consequences of submitting no or inadequate prior notice?
The product will be refused admission into the United States.

Who submits the information?
Importers/Customs Brokers, in most instances, should be able to submit the required Prior Notice information to the FDA via ACS.

Who must register warehouses and/or facilities?
Domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the United States.

By what date must facilities be registered with FDA?
Facilities must be registered with the FDA by Dec. 12, 2003.

Who must keep records?

  1. Domestic manufacturers, processors, packers, transporters, distributors, receivers, holders and importers of food intended for consumption in the United States.
  2. Foreign facilities that manufacture/process, pack or hold food for human or animal consumption in the United States.
  3. Records are required regardless of whether the food enters interstate commerce.

When does the record keeping period begin?
At the time the activity begins.

What is the record retention period?

You must maintain records for

  • perishable foods not intended for processing into nonperishable foods for one hour from the time created.
  • animal food, including pet food, for one year from the date created.
  • all other foods for two years from the date created.

Is electronic record-keeping acceptable?

When will record-keeping regulations begin?
With the exception of "small businesses," 6 months after the publication date of the final rule in the Federal Register.

What is the fine for non-compliance?

  • first conviction: 1 year in prison, $1,000 fine or both,
  • subsequent convictions: 3 years in prison, $10,000 fine or both
  • intent to defraud or mislead: 3 years in prison, $10,000 fine or both.

Who receives a copy of the detention order?
The owner, operator or agent in charge of the place where the article of food is.

When does a detention order terminate?
The FDA will issue a detention termination notice releasing the article of food to any person who received the detention order. If the FDA fails to issue a detention termination notice, and the 30-day detention period expires, the detention order is deemed to be terminated.