Civil penalties for not registering a food company with FDA being considered

More than half of surveyed food manufacturers do not know they must register contact information with FDA, according to a recent food safety report by the Office of the Inspector General (OAG). As of December 2003, FDA began requiring food facilities—both foreign and domestic—that manufacture, process, pack, or hold food for consumption in the United States to register with FDA.

In July 2009, FDA reported that they had received 382,866 registrations, of which 226,373 are foreign facilities and 156,493 are domestic facilities.

But a recent OAG survey report found that:

  • Five percent of selected facilities failed to register with FDA
  • Two percent of selected facilities failed to cancel their registration with FDA
  • Forty-eight percent of selected facilities either failed to provide accurate information when they first registered or failed to provide accurate information after a change in the facilities' information, as required.
  • Fifty-two percent of the managers reported that they were not aware of FDA's registry requirements.

Registering basic information may seem like a small matter, but the OAG is taking the matter seriously. The agency would like FDA to consider seeking statutory authority to impose civil penalties through administrative proceedings against facilities that do not comply with the registry requirements. The OAG believes civil penalties could be an effective method to encourage companies to comply.

According to the OAG report, “FDA agreed in principle with our second recommendation to consider seeking statutory authority to impose civil penalties through administrative proceedings. FDA noted that proposed legislation would allow FDA to deem a facility's food misbranded if that facility is not properly registered, and allow FDA to cancel a registration.” The OAG is suggesting daily fines as an intermediate step before taking more severe actions such as seizures.

Other OAG recommendations include making optional fields within the registry mandatory and working more closely with the food industry to reach compliance. “FDA should focus its education and outreach activities on informing facilities about the requirement to update their information within 60 days of a change in the facility's information, and FDA should consider using industry Web sites and trade publications, in addition to its Web site and listserv, to highlight this requirement,” said the OAG report.

FDA requires each domestic facility to provide:

  1. Facility name, full address, telephone number, and all trade names the facility uses;
  2. Name, address, and phone number of the parent company (if applicable);
  3. Name, address, and phone number for the owner, operator, or agent in charge of the facility;
  4. Emergency contact phone number.

To register or update your company information, click here.

For the full OAG report, click here.

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