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New Draft Guidance on Remote Regulatory Assessments

Posted on July 27, 2022

On July 22, the FDA published a draft guidance on conducting Remote Regulatory Assessments. Remote Regulatory Assessments (RRAs) were originally developed during the COVID-19 health emergency and are a set

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FDA Evaluation of Agency Activities

Posted on July 21, 2022

On July 19, 2022, FDA Commissioner Robert Califf published a statement regarding FDA’s evaluation of agency activities. In his statement, Califf acknowledged that the agency has recently confronted challenges that

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Bill Introduced to Establish Single Food Safety Agency

Posted on July 20, 2022

On July 13, Chair of the House Appropriations Committee Rosa DeLauro (D-CT-03) and Senator Dick Durbin (D-IL) introduced the Food Safety Administration Act, which is legislation that would establish

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FDA Approves Six Accreditation Bodies Under LAAF

Posted on July 14, 2022

On July 12, 2022, FDA announced its recognition of six accreditation bodies under the Laboratory Accreditation for Analyses of Foods (LAAF) program. Accredited bodies under LAAF may, in turn, accredit

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FDA Warns 4 Companies for Selling Tainted Honey-Based Products

Posted on July 13, 2022

On July 12, the FDA announced that it issued warning letters to four companies for illegally selling honey-based products that could pose a significant health risk to consumers due to

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FDA Finalizes Guidance for Animal Food Facilities

Posted on July 7, 2022

On July 6, 2022, FDA announced it had finalized its Guidance for Industry (GFI) #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. The guidance aims to

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FDA Webinar on Genome-Edited Animals for Food Use

Posted on June 30, 2022

On June 27, 2022, FDA’s Center for Veterinary Medicine (CVM) announced that it had published a pre-recorded animal biotechnology case study webinar. The webinar addresses the agency’s risk-based review

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Georgia Court Finds Dietary Supplement Labeling Claim within FDA’s Jurisdiction

Posted on June 29, 2022

On June 24, the Court of Appeals of Georgia held that Plaintiff Shawn Smith’s deceptive product labeling case raised questions best left to the FDA.
By way of background, in

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JANAAC Recognized as an Accreditation Body Under FDA’s Accredited Third Party Certification Program

Posted on June 27, 2022

The Food Safety Modernization Act (FSMA) established the Accredited Third-Party Certification Program, also referred to as the Third-Party Program (TPP). The voluntary TPP allows accreditation bodies (ABs) to apply for

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FDA Publishes Guidance on Oversight of Food Covered by SRAs

Posted on June 22, 2022

On June 21, the FDA published a final guidance for FDA staff entitled “FDA Oversight of Food Covered by Systems Recognition Agreements” (SRAs). The guidance covers FDA’s regulatory

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