Erik

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So far Erik has created 86 blog entries.

FDA Releases Multitude of FSMA Guidance Documents and Resources

FDA has released a multitude of FSMA resources, announcements and guidance documents in August and September including: Constituent Update: Produce Safety Rule Compliance Dates Delayed, September 12, 2017 Compliance Guide for Small Entities on the Produce Safety Rule, September 2017 Sixth Chapter of Guidance for the Human Food Preventive Controls Rule, August 30, 2017 Small [...]

By | 2017-10-19T10:18:54+00:00 October 19th, 2017|Food Safety Modernization Act, FSMA|0 Comments

FDA Announces New Compliance Dates for Nutrition Labeling and Serving Size Rules

Today, the U.S. Food and Drug Administration (FDA) published a proposed rule which extends the compliance dates for the new requirements for nutrition and supplement facts labels, serving sizes, and dual column labeling by approximately 1.5 years.  Under the proposed rule, the compliance date for manufacturers with $10 million or more in annual food sales [...]

By | 2017-10-03T10:56:11+00:00 October 3rd, 2017|Food and Drug Administration, Nutrition Labeling|0 Comments

FDA Proposes Delay of FSMA Produce Safety Water Standards

On Wednesday, September 13, FDA published a proposed rule in the Federal Register that extends the compliance dates for the agricultural water requirements in the Food Safety Modernization Act (FSMA) Produce Safety Rule for produce other than sprouts.  For sprouts the agricultural water compliance dates remain unchanged.  Note the proposed rule does not impact compliance [...]

By | 2017-10-19T10:16:24+00:00 September 18th, 2017|Food Safety Modernization Act, Produce Safety Rule|0 Comments

FDA Announces FSMA Fees for FY2018

On August 2, 2017, the U.S. Food and Drug Administration (FDA) published in the Federal Register the Domestic and Foreign Facility Reinspection, Recall and Importer Reinspection Fee Rates for Fiscal Year 2018.  The fees are $248 per hour if domestic travel is required and $285 per hour if foreign travel is required.  The fees are [...]

By | 2017-08-04T10:31:16+00:00 August 4th, 2017|Food Safety Modernization Act, FSMA, Reinspection Fees|0 Comments

FSIS Retail Exemption Limits Announced for 2017; Dollar Values Decreased

On June 1, 2017, the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture published a notice in the Federal Register addressing the dollar limitations on the amount of meat and meat food products, poultry, and poultry products that a retail store can sell to hotels, restaurants, and similar institutions without disqualifying [...]

FDA Extends Menu Labeling Compliance Date; More Flexibility in Compliance Requirements Expected

On May 1, 2017, the U.S. Food and Drug Administration (FDA) announced that it would be publishing in the Federal Register an interim final rule to extend the compliance date for the menu labeling regulation (21 CFR § 101.11) to May 7, 2018.  The interim final rule in prepublication format is available here. In addition [...]

By | 2017-05-02T17:14:32+00:00 May 2nd, 2017|FDA, Menu Labeling|0 Comments

FDA Waives Sanitary Food Transportation Act Requirements for Retailers

On April 6, 2017, the U.S. Food and Drug Administration (FDA) published in the Federal Register a notice that the agency was waving retail food establishments from requirements of the Sanitary Food Transportation Act (SFTA) regulations.  FDA issued a document dated March 2017 responding to comments on the retail waiver and other waivers.  The waivers [...]

FDA Publishes Draft Nutrition Labeling Guidance

On January 4, 2017, the U.S. Food and Drug Administration (FDA) issued Draft Guidance for Industry: Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals, which provides questions and answers on topics related to compliance with the FDA [...]

By | 2017-01-19T12:34:01+00:00 January 18th, 2017|FDA, Nutrition Labeling|0 Comments

FSMA Final Guidance on Model Third Party Accreditation Standards

On December 6, 2016, the U.S. Food and Drug Administration (FDA) released final guidance intended to assist industry and FDA staff by recommending standards for accrediting third-party certification bodies for the voluntary third-party certification program established under the FDA Food Safety Modernization Act (FSMA). The final guidance document fulfills section 808(b)(2) of the FD&C Act [...]

By | 2017-01-11T01:47:11+00:00 January 11th, 2017|Food Safety Modernization Act, Third Party Auditors|0 Comments

FDA Final Rule on FSMA Third-Party Auditor User Fees

On December 14, 2016, the U.S. Food and Drug Administration (FDA) published a final rule entitled Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications to Provide for the User Fee Program (the “Final Rule”).  The Final Rule is effective January 13, 2017, and provides for a user [...]