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Legal and Regulatory updates for the food and supplement industry

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House Passes Bill to Ease Menu Labeling Rules

Posted on February 8, 2018
  • Over the past several years, FDA has been in the process of implementing menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act by the Affordable Care Act. 

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Continue Reading House Passes Bill to Ease Menu Labeling Rules

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

Panera Petitions FDA to Define “Egg”

Posted on January 26, 2018
  • The term “egg” is not specifically defined by FDA.  In fact, 21. C.F.R. 160.100 provides that “no regulation shall be promulgated” to define “the food commonly known as eggs.” The

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Continue Reading Panera Petitions FDA to Define “Egg”

FDA Issues Draft Guidance on HARPC for Animal Food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

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Continue Reading FDA Issues Draft Guidance on HARPC for Animal Food

DuPont Challenges FDA’s Proposal to Revoke Soy-Heart Health Claim

Posted on January 23, 2018
  • As reported on this blog in October 2017, the U.S. Food and Drug Administration (FDA) proposed a rule to revoke a regulation authorizing the use of a health claim on

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Continue Reading DuPont Challenges FDA’s Proposal to Revoke Soy-Heart Health Claim

Gottlieb Announces Plans to Strengthen Recall Process and FDA Publishes Draft Guidance to Clarify Its Approach to Product Recalls

Posted on January 19, 2018
  • As previously covered on this blog, a recent report by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concluded that FDA’s current

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Continue Reading Gottlieb Announces Plans to Strengthen Recall Process and FDA Publishes Draft Guidance to Clarify Its Approach to Product Recalls

FDA to Begin Process of Modernizing Certain Standards of Identity

Posted on January 18, 2018
  • On January 11, 2018, the U.S. Food and Drug Administration released its Strategic Policy Roadmap for 2018.
  • As part of its Strategic Policy Roadmap, FDA has signaled its intent

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Continue Reading FDA to Begin Process of Modernizing Certain Standards of Identity

FDA Denies Qualified Health Claim Linking Vitamin D Intake and Reduced Risk of MS

Posted on January 16, 2018
  • Since 1990, the U.S. Food and Drug Administration (FDA) has evaluated health claims on packaged foods to ensure that they are adequately substantiated. A health claim characterizes the relationship between

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Continue Reading FDA Denies Qualified Health Claim Linking Vitamin D Intake and Reduced Risk of MS

CDC expands use of Whole Genome Sequencing in Foodborne Illness

Posted on January 12, 2018
  • Whole genome sequencing (WGS) provides insight into the genetic fingerprint of a pathogen by sequencing the chemical building blocks that make up its DNA and is increasingly being employed in

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Continue Reading CDC expands use of Whole Genome Sequencing in Foodborne Illness

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