Tag Archives: GUIDANCE

FDA Publishes Q&A Guidance on Mandatory Food Recalls

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The Food Safety Modernization Act (FSMA) added Section 423 to the Federal Food, Drug and Cosmetic Act to give the U.S. Food and Drug Administration (FDA) the authority to order a responsible party to recall food if there is a reasonable probability that the food is adulterated or misbranded, and that use or exposure to … Continue Reading

FDA Issues Draft Guidance on Produce Safety Requirements under FSMA

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FDA has published two draft guidance documents to assist processors and farmers in complying with product safety requirements under the Food Safety Modernization Act (FSMA). The FSMA final rule on Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls (HARPC) for Human Food (the Preventive Controls Rule) was published on September 17, 2015 (80 … Continue Reading

FDA Releases Q&A for Preventive Controls for Animal Foods

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In light of the approaching September 17, 2018 compliance date for small animal food businesses (i.e., those with less than 500 full-time equivalent employees) to comply with Hazard Analysis and Risk-Based Preventive Controls (HARPC) rules, FDA has released a Q&A document concerning what to expect in the near term regarding FDA enforcement and inspections. The … Continue Reading

FDA Announces Upcoming Efforts to Combat Antimicrobial Resistance in Animals

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In a July 31, 2018 press release, FDA Commissioner Scott Gottlieb announced upcoming efforts by FDA to implement “good antimicrobial stewardship practices.”  FDA’s Center for Veterinary Medicine (CVM) has already taken steps to support judicious use in animals of antimicrobials important for treating human disease. FDA will soon publish a five-year blueprint to further address … Continue Reading

FDA to Issue a Guidance Document Limiting Use of Milk in Plant-Based Beverages

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In the 2018 POLITICO Pro Summit, FDA Commissioner Scott Gottlieb signaled that FDA will begin collecting comments regarding enforcement of standard of identity for “milk”.  As noted in our June 27 blog, FDA is holding a public meeting on July 26, 2018 to discuss its Nutrition Innovation Strategy, including standards of identity.  FDA indicated in … Continue Reading

Groups Petition FSIS to Change “Product of the USA” Policy

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The Organization for Competitive Markets (OCM) and American Grassfed Association (AGA) have petitioned the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) to change its standard for making a “Product of the USA” claim on meat and meat products. Currently, FSIS allows the statement “Product of USA” if either (1) the country to which the product is … Continue Reading

FDA Releases Guidance on Dietary Fiber

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Today, June 15, 2018, FDA published in the Federal Register a notice that it has issued “Guidance for Industry: The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels”.  This direct-to-final guidance provides additional clarity on which isolated and synthetic non-digestible carbohydrates (NDCs) will be recognized by … Continue Reading

USDA Issues Guidelines Regarding Livestock Slaughter and Processing Inspection Exemptions

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On May 24, the United States Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) issued a guideline: FSIS Guideline for Determining Whether a Livestock Slaughter or Processing Firm is Exempt from the Inspection Requirements of the Federal Meat Inspection Act.  Absent an exemption, all establishments where cattle, goat, swine, or sheep are slaughtered … Continue Reading

FDA Issues Food Facility Registration Small Entity Compliance Guide

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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 of the FD&C Act requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to … Continue Reading

FDA Commissioner Scott Gottlieb Comments on Intentional Adulteration

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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 the burden of foodborne illness by requiring that producers, importers and distributors of food take systematic steps to prevent contamination. Congress passed FSMA with a … Continue Reading

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

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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 Food Safety Modernization Act (FSMA) on September 17, 2015. Small businesses may be eligible for certain exemptions and have later compliance dates than larger businesses covered … Continue Reading

FSMA Update: More Clarification on FSVP from FDA

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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 on how to comply with the foreign supplier verification program (FSVP) final rule, under the Food Safety Modernization Act (FSMA). The FSVP regulation establishes requirements relating to: the … Continue Reading

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

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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 Food, and the Foreign Supplier Verification Programs – have requirements for a supply-chain program for certain raw materials and other ingredients. FDA has designed the … Continue Reading

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

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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 (Sept. 17, 2015) under the Food Safety Modernization Act (FSMA) became effective on November 16, 2015.  Covered large and small businesses are now required to be in compliance … Continue Reading

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

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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 vegetables grown for human consumption.  Our detailed summary of the rule is available here. On September 5, 2017, FDA announced the availability of a Small Entity Compliance Guide (SECG) … Continue Reading

FDA Commissioner Issues Statement Touting Menu Labeling Rule, Announces Additional Guidance is Forthcoming

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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. Under the new requirements, restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the same name and selling substantially similar … Continue Reading

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

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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 copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule. In short, the final rule establishes various food defense measures that registered facilities are … Continue Reading

USDA-FSIS Issues Updated Guidelines for Premarket Label Approval

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The labeling of meat and poultry products primarily falls under the jurisdiction of the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS). FSIS administers the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA). Both the FMIA and the PPIA require food manufacturers to obtain prior approval for labels of … Continue Reading

FDA Clarifies Sanitary Transportation Rule Waiver for Retail Food Establishments

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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).  Click here for a complete copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule, and click here for our summary of the rule and its … Continue Reading

FDA Will Exercise Enforcement Discretion for the Use and Labeling of “Ultrafiltered Milk” in Certain Cheeses and Cheese Products

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Mechanical filtration technologies available for milk processing include ultrafiltration.  Ultrafiltered milk (UF Milk) is milk that is mechanically filtered via semipermeable membranes to partially remove water, lactose, minerals, and water-soluble vitamins without altering the “casein to whey protein” ratio of the milk and resulting in a liquid product. FDA’s regulations specify the standards of identity … Continue Reading

FDA Issues Guidances on Exemptions from FSMA Rules

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As previously reported on this blog, the U.S. Food and Drug Administration issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions under the FDA Food Safety Modernization Act (FSMA) on September 10, 2015. Prior to issuing the FSMA regulations, FDA established: A Seafood Hazard Analysis and Critical Control Point (HACCP) … Continue Reading

FDA Formally Extends Menu Labeling Compliance Date to 2018

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As covered on this blog last week, on April 26, 2017, the FDA submitted an interim final rule (IFR) to the Office of Management and Budget (OMB) seeking an “Extension of Compliance Date” for FDA’s menu labeling requirements. The menu labeling provisions were added to the Federal Food, Drug, and Cosmetic Act by the Affordable Care Act.  … Continue Reading

FDA Delays Menu Labeling Rule

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As previously covered on this blog, over the past few 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.  Under the new requirements, restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the … Continue Reading
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