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Legal and Regulatory updates for the food and supplement industry

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FDA Releases Guidance Documents Concerning Animal Food CGMPs and the FSMA “Solely Engaged” Exemptions

Posted on October 19, 2017
  • As previously covered on this blog, the Final Rule for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, 80 Fed. Reg. 56170

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Continue Reading FDA Releases Guidance Documents Concerning Animal Food CGMPs and the FSMA “Solely Engaged” Exemptions

OIG: “Challenges Remain in FDA’s Inspections of Domestic Food Facilities”

Posted on October 2, 2017
  • A recently released Office of the Inspector General (OIG) report has found that the U.S. Food and Drug Administration (FDA) is making steady progress on its implementation of the Food

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Continue Reading OIG: “Challenges Remain in FDA’s Inspections of Domestic Food Facilities”

FDA Releases Training Module for Carriers Subject to the Sanitary Transportation Rule

Posted on September 21, 2017
  • As previously covered on this blog, on April 6, 2016, FDA published a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA). 

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Continue Reading FDA Releases Training Module for Carriers Subject to the Sanitary Transportation Rule

FDA Publishes Proposed Rule Seeking to Extend Compliance Dates for Agricultural Water Standards

Posted on September 13, 2017
  • FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and

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Continue Reading FDA Publishes Proposed Rule Seeking to Extend Compliance Dates for Agricultural Water Standards

FDA Issues Compliance Guide for Small Businesses under FSMA Produce Safety Rule

Posted on September 7, 2017
  • FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and

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Continue Reading FDA Issues Compliance Guide for Small Businesses under FSMA Produce Safety Rule

FDA Releases Sixth Chapter of Draft Guidance for the Human HARPC Rule

Posted on August 30, 2017
  • As our readership is well aware, the Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food was published on September 17, 2015 (80 FR 55907), and

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Continue Reading FDA Releases Sixth Chapter of Draft Guidance for the Human HARPC Rule

FDA Releases Compliance Guide for Small Businesses under FSMA Intentional Adulteration Rule

Posted on August 25, 2017
  • On May 27, 2016, FDA published its final rule to implement the intentional adulteration (or “food defense”) provisions of the FDA Food Safety Modernization Act (FSMA).  Click here for a

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Continue Reading FDA Releases Compliance Guide for Small Businesses under FSMA Intentional Adulteration Rule

FDA Launches Food Safety Plan Builder to Facilitate FSMA Compliance

Posted on August 23, 2017
  • The Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food was published on September 17, 2015 (80 FR 55907), and compliance dates for some businesses began

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Continue Reading FDA Launches Food Safety Plan Builder to Facilitate FSMA Compliance

FDA Clarifies Sanitary Transportation Rule Waiver for Retail Food Establishments

Posted on August 16, 2017
  • As previously covered on this blog, on April 6, 2016, FDA published a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA). 

…
Continue Reading FDA Clarifies Sanitary Transportation Rule Waiver for Retail Food Establishments

FDA Delays Preventive Controls Inspections for Large Animal Food Facilities

Posted on August 14, 2017
  • The second major compliance dates are coming up for the Preventive Controls for Animal Food Rule under FDA’s Food Safety Modernization Act (FSMA). On September 18, 2017, larger animal

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Continue Reading FDA Delays Preventive Controls Inspections for Large Animal Food Facilities

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Keller and Heckman, founded in 1962, has a broad practice in the areas of regulatory law, public policy, and litigation, serving both domestic and international clients. Our firm is a pioneer in the use of interdisciplinary approaches to problem-solving. Since 1971, we have had an in-house scientific staff that works closely with the firm’s attorneys on matters of technical complexity. Many of our attorneys also have government experience and expertise in multiple areas of the law.

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