Ad Law Access https://www.kelleydrye.com/viewpoints/blogs/ad-law-access Updates on advertising law and privacy law trends, issues, and developments Tue, 03 Dec 2024 10:20:34 -0500 60 hourly 1 FDA Releases Guidance on Implementation of FSMA Fee Provisions https://www.kelleydrye.com/viewpoints/blogs/ad-law-access/fda-releases-guidance-on-implementation-of-fsma-fee-provisions https://www.kelleydrye.com/viewpoints/blogs/ad-law-access/fda-releases-guidance-on-implementation-of-fsma-fee-provisions Tue, 11 Oct 2011 18:28:40 -0400 The Food and Drug Administration (“FDA”) has released a question and answer guide to its implementation of the fee provisions of the Food Safety Modernization Act of 2011. The purpose of the fee provisions is to allow the FDA to recover reinspection, recall noncompliance, and importer program related costs from domestic and foreign facilities and importers.

Persons responsible for facilities subject to the fees should review the guidance and note that although the FDA began assessing fees for reinspection of domestic and foreign facilities and for failure to comply with a recall order on October 1, 2011, the fees for import reinspection will not be assessed until the FDA has resolved the issues raised in comments on the fee schedule released in the August 1, 2011 Federal Register.

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New Food Safety Law Sets the Stage for Industry Participation in Numerous Rulemakings https://www.kelleydrye.com/viewpoints/blogs/ad-law-access/new-food-safety-law-sets-the-stage-for-industry-participation-in-numerous-rulemakings https://www.kelleydrye.com/viewpoints/blogs/ad-law-access/new-food-safety-law-sets-the-stage-for-industry-participation-in-numerous-rulemakings Fri, 04 Feb 2011 11:22:22 -0500 The Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, requires the Food and Drug Administration (FDA) to undertake sweeping regulatory action to strengthen the safety of the nation’s food supply. Many of the items on FDA’s “to do” list require significant and swift action. Over the next two years, FDA must engage in a number of rulemakings and issue several guidance documents to implement the FSMA.

FDA must take certain actions in 2011, including:

  • Issue guidelines regarding new dietary ingredients in dietary supplements
  • Promulgate facility registration suspension guidelines

Several of FDA’s action items must be completed by January 4, 2012, including:

  • Issue notice of proposed rulemaking regarding safe fruit and vegetable harvest and processing
  • Designate high-risk foods requiring additional recordkeeping
  • Promulgate rules establishing the foreign supplier verification program for importers
  • Develop and publish a list of acceptable customer notification methods that grocery stores may use to post recall information

Other action items affecting a large portion of the food industry have a July 4, 2012 deadline:

  • Promulgate regulations establishing science-based minimum standards for hazard analyses and preventive controls
  • Promulgate rules regarding the sanitary transportation of food

Industry stakeholders should determine how the new law affects them and prepare to participate in the notice and comment process. For a copy of the Kelley Drye client advisory regarding the FSMA, please click here. For a timeline of all FDA actions required under the FSMA, please click here.

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