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The Daily Intake

Legal and Regulatory updates for the food and supplement industry

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FDA Explains What to Expect As Compliance Date Nears for PC Animal Food Rule

Posted on August 15, 2018

On August 14, 2018, FDA released a constituent update regarding the upcoming compliance dates for the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

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Continue Reading FDA Explains What to Expect As Compliance Date Nears for PC Animal Food Rule

FDA Issues First Warning Letter for Alleged HARPC Violations

Posted on August 1, 2018

On July 26, 2018, FDA posted its first Warning Letter citing Kerry, Inc. for alleged violations of the Hazard Analysis and Risk-Based Preventive Controls (HARPC) and Current Good Manufacturing Practice

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Continue Reading FDA Issues First Warning Letter for Alleged HARPC Violations

FDA Issues First Draft Guidance Document on Intentional Adulteration

Posted on June 21, 2018

As promised in March 2018, FDA has issued the first of three guidance documents concerning its Final Rules on Mitigation Strategies to Protect Food Against Intentional Adulteration under the Food

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Continue Reading FDA Issues First Draft Guidance Document on Intentional Adulteration

FDA Issues Food Facility Registration Small Entity Compliance Guide

Posted on May 30, 2018

FDA has released a Small Entity Compliance Guide (SECG) to help food facilities comply with the registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 415

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FDA Encourages Importer Preparation for Next VQIP Application Cycle

Posted on May 29, 2018

As previously discussed on this blog, the Food Safety Modernization Act (FSMA) established a voluntary, fee-based program for the review and importation of foods from importers who achieve and

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Continue Reading FDA Encourages Importer Preparation for Next VQIP Application Cycle

FDA Releases Small Entity Compliance Guide Reiterating January 2018 Guide on Extension of Certain Compliance Dates for Four FSMA Rules

Posted on May 14, 2018

As previously covered on this blog, on August 24, 2016, FDA published a final rule that extended and clarified the compliance dates for certain provisions in four of the

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Continue Reading FDA Releases Small Entity Compliance Guide Reiterating January 2018 Guide on Extension of Certain Compliance Dates for Four FSMA Rules

FDA Releases Intentional Adulteration Training Course

Posted on May 10, 2018

In partnership with the Food Safety Preventive Controls Alliance (FSPCA), FDA has developed a free 30-minute “Food Defense Awareness for the Intentional Adulteration (IA) Rule” online training

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FDA Issues First Ever Mandatory Recall Order for Kratom Products

Posted on April 4, 2018

On April 2, 2018, FDA issued a mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for

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FDA Issues First Warning Letter Based on “Serious Violations” of Part 117 CGMP Regulations

Posted on March 30, 2018

On March 16, 2018, FDA issued a warning letter to Bhavani Fruits and Vegetables LLC in Maspeth, New York for “serious violations” of Current Good Manufacturing Practice (CGMP) requirements under

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Continue Reading FDA Issues First Warning Letter Based on “Serious Violations” of Part 117 CGMP Regulations

FDA Commissioner Scott Gottlieb Comments on Intentional Adulteration

Posted on March 29, 2018

In the March 28, 2018 FDA Voice blog Dr. Gottlieb provided background and insight on the Intentional Adulteration rule.
The FDA Food Safety Modernization Act (FSMA) charges FDA with addressing

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Continue Reading FDA Commissioner Scott Gottlieb Comments on Intentional Adulteration

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