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Legal and Regulatory updates for the food and supplement industry

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FDA Issues Draft Guidance on “Small Business” under FSMA Preventive Controls Regulations

Posted on March 20, 2018
  • As previously reported on this blog, FDA published final rules to implement the Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food under the FDA

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Continue Reading FDA Issues Draft Guidance on “Small Business” under FSMA Preventive Controls Regulations

GAO Report: FDA Can Do More to Achieve Food Safety & Nutrition Goals

Posted on March 7, 2018
  • The Food Safety Modernization Act (FSMA), enacted in January 2011, shifted the FDA’s focus from responding to illnesses to preventing food contamination.  A new report by the U.S. Government

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Continue Reading GAO Report: FDA Can Do More to Achieve Food Safety & Nutrition Goals

FDA Recognizes First Accreditation Body Under Accredited Third-Party Certification Program

Posted on February 2, 2018
  • As previously covered on this blog, in November 2015, the U.S. Food and Drug Administration (FDA) finalized The Food Safety Modernization Act (FSMA) rule on Accredited Third-Party Certification that

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Continue Reading FDA Recognizes First Accreditation Body Under Accredited Third-Party Certification Program

FSMA Update: More Clarification on FSVP from FDA

Posted on January 30, 2018
  • As previously reported on this blog (see here, here and here), the U.S. Food and Drug Administration (FDA) has issued guidance documents, fact sheets, and a Q&A document

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Continue Reading FSMA Update: More Clarification on FSVP from FDA

FDA Issues Draft Guidance on HARPC for Animal Food

Posted on January 24, 2018
  • As previously reported on this blog, FDA published final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions for human and animal food under the FDA

…
Continue Reading FDA Issues Draft Guidance on HARPC for Animal Food

FSMA Update: FDA Issues Guidance on Enforcement Discretion Related to FSMA Provisions

Posted on January 5, 2018
  • Today, the FDA published guidance outlining key areas where it intends to exercise enforcement discretion in four of the rules that implement aspects of the Food Safety Modernization Act (FSMA).

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Continue Reading FSMA Update: FDA Issues Guidance on Enforcement Discretion Related to FSMA Provisions

FDA Publishes Draft Guidance Concerning “Refusal of Inspection”

Posted on December 11, 2017
  • Section 807(b) of the Federal Food, Drug, and Cosmetic Act, added by section 306 of the Food Safety Modernization Act (FSMA) authorizes the U.S. Food and Drug Administration (FDA) to

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Continue Reading FDA Publishes Draft Guidance Concerning “Refusal of Inspection”

FSMA For Cotton Ginners?

Posted on November 28, 2017
  • Are cotton farmers and ginners subject to FDA’s Food Safety Modernization Act (FSMA)?  If you are a cotton ginner that is not a farm the answer is currently yes.

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Continue Reading FSMA For Cotton Ginners?

FDA Issues Guidance to Allow “Co-Manufacturers” Additional Time to Implement Certain Supply-Chain Program Requirements

Posted on November 3, 2017
  • As our readership is well aware, three of the rules created to implement the FDA Food Safety Modernization Act (FSMA) – Preventive Controls for Human Foods, Preventive Controls for Animal

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Continue Reading FDA Issues Guidance to Allow “Co-Manufacturers” Additional Time to Implement Certain Supply-Chain Program Requirements

FSMA Update: FDA Launches Web Page with Compliance Dates

Posted on October 24, 2017
  • The U.S. Food and Drug Administration (FDA) introduced a new web page that consolidates the compliance dates for the Agency’s Food Safety Modernization Act (FSMA) rules. The rules that include

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Continue Reading FSMA Update: FDA Launches Web Page with Compliance Dates

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