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FDA Launches New Web Portal

WASHINGTON — In another step toward regulatory transparency, the U.S. Food and Drug Administration has established a new Web portal that will offer visitors a single Internet location to find information regarding FDA enforcement activities, including court actions, inspection information and compliance-related issues. The new portal will include a searchable database that contains each inspected facility's

WASHINGTON — In another step toward regulatory transparency, the U.S. Food and Drug Administration has established a new Web portal that will offer visitors a single Internet location to find information regarding FDA enforcement activities, including court actions, inspection information and compliance-related issues.

The new portal will include a searchable database that contains each inspected facility's name and address, the type of product made by the facility, inspection dates and final inspection classifications. The portal also links to a summary of the most common “Inspectional Observations of objectionable conditions or practices” cited during FDA inspections, and enforcement-related data at data.gov.

“These efforts aim to increase public understanding of the public health impact of FDA's enforcement efforts, help inform industry's compliance efforts, increase company accountability to consumers and business partners, minimize public confusion about which products are being recalled, and help consumers make more-informed decisions about the products they buy,” Tamara Ward, FDA press officer, told SN.

According to an agency release, improved access to information about FDA's enforcement and compliance activities will benefit the public, as well as food suppliers and retailers, by:

  • Providing more information about company practices that may jeopardize public health, as well as about companies that have had satisfactory FDA inspections.

  • Offering information about recall and enforcement activities that will help consumers make decisions about products.

  • Making it easier to access information about inspection results, which can be expected to create a greater incentive to bring practices into compliance with the law.

  • Reducing consumer confusion by clarifying information about food products that are not subject to a particular recall.

In addition, the new site provides information and links dealing with regulatory compliance and enforcement actions, procedures for identifying violations, procedures for notification of violations, and general enforcement information.

This move is part of public disclosure, the second phase of the agency's Transparency Initiative launched in summer 2009 “in response to the Obama administration's commitment to openness in government,” according to the FDA.

In the first phase, the FDA planned to give the public general information about the FDA and what the agency does. Planned actions for the initiative include better communication regarding agency policies and procedures, a more transparent review process, improved transparency in communications with importers, and guidance and regulations that work toward transparency.

By the end of 2011, FDA plans to begin disclosing additional information regarding the agency's evaluation of filers, expand its disclosure of Untitled Letters and “in appropriate situations” during food recalls, support the food industry's efforts to inform consumers about products that are not subject to the recall.

The new portal is located at www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/ucm254426.htm