Tag Archives: FDA

FDA Launches Accredited Third-Party Certification Website

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 established a program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and food produced by such … Continue Reading

FDA: No Plans to Reopen Nutrition Facts Label Rule

In May 2016, FDA issued final rules to implement changes to the nutrition labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products was initially slated for July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales).  As covered on this blog last … Continue Reading

FDA to Extend Compliance Dates for Nutrition Facts Label Changes

As previously covered on this blog, in May 2016, FDA issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products that are initially introduced into interstate commerce is currently slated for July 26, 2018 (or July 26, 2019 for manufacturers … Continue Reading

Consumer Groups Sue FDA for Delaying Menu Labeling Rule

As previously covered on this blog, on May 4, 2017, FDA published an interim final rule that delays the compliance date for menu labeling requirements from May 5, 2017, until May 8, 2018 and invites comments for 60 days on the implementation of the menu labeling requirements. Yesterday, the Center for Science in the Public … Continue Reading

FDA Slated to Extend Compliance Dates for Agricultural Water Standards

Agricultural water can be a major conduit of pathogens that can contaminate produce. FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes agricultural water standards.  In particular, the Produce Safety Rule sets microbial quality standards for agricultural water, including irrigation water that comes into contact with produce.  In March 2017, the … Continue Reading

Kraft Motion to Dismiss ‘All Natural’ Lawsuit

Kraft seeks to end ‘all-natural’ sour cream labeling suit (subscription to Law360 required) Kraft Heinz Foods Co. (Kraft) asked the court (the U.S. District Court for the Eastern District of New York) to dismiss a putative class action over claims the “All Natural” label on its Breakstone’s sour cream is misleading because the sour cream … Continue Reading

More Than 99.5% of ‘Gluten-Free’ Products Tested by FDA in Compliance

As previously reported on this blog, in August 2013, the U.S. Food and Drug Administration (FDA) issued a final rule on “gluten-free” food labeling. After the final compliance date of August 5, 2014, FDA measured the gluten level of more than 250 different products labeled “gluten-free.” More than 99.5% of the food products labeled “gluten-free” … Continue Reading

Questions (and Answers) on FSVP

As previously covered on this blog, the general compliance date for the foreign supplier verification program (FSVP), under the Food Safety Modernization Act (FSMA), is May 30, 2017 (for a summary of which importers are covered by the general compliance date, see here). The U.S. Food and Drug Administration recently issued additional guidance for importers on … Continue Reading

USA Rice Questions Whether Riced Vegetables Can Use Rice In Their Name

USA Rice, in a recent blog post indicated that it is considering asking FDA and other regulatory agencies to “look into” the use of “rice” or “riced” in the name of vegetables that have gone through a ricer.  USA Rice President and CEO Betsy Ward states “Vegetables that have gone through a ricer are still … Continue Reading

CFS and Others Sue FDA Over GRAS Rule

FDA has premarket review authority over food additives; however, substances that are generally recognized as safe (GRAS) are not legally considered “food additives” as that term is defined under the Federal Food, Drug and Cosmetic Act, and therefore are not subject to the premarket clearance requirements that apply to other substances used in or in … Continue Reading

State Regulators Chime in on Plant-based Milk Labeling Debate

Under a standard of identity “milk” is defined as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more health cows” (21 C.F.R. Section 131.110).  For years, the dairy industry has called on the FDA to crack down on the use of dairy-related terms such as “milk” for plant-based … Continue Reading

FDA Issues New Guidance on FSMA’s FSVP Rule

As previously covered on this blog, the general compliance date for the foreign supplier verification program (FSVP), under the Food Safety Modernization Act (FSMA), is May 30, 2017. The U.S. Food and Drug Administration recently issued updated fact sheets, and new guidance on how to identify the importer under the FSVP Rule. The May 30th … Continue Reading

FDA Withdraws Draft Guidance on the Use of Certain Fruit Juice and Vegetable Juice as Color Additives

As previously covered on this blog, in December 2016, FDA announced the publication of Draft Guidance on “Fruit Juice and Vegetable Juice as Color Additives in Food” to assist manufacturers in determining whether a color additive derived from a particular plant material meets the specifications for fruit juice under § 73.250 or vegetable juice under § 73.260.  The … Continue Reading

FDA Increasingly Using Whole Genome Sequencing to Achieve Food Safety Goals

As background, whole genome sequencing (WGS) essentially provides insight into the genetic fingerprint of a pathogen by sequencing the chemical building blocks that make up its DNA.  Since 2012, FDA has regularly turned to WGS to better understand foodborne pathogens, including identifying the nature and source of microbes that contaminate food and cause outbreaks of … Continue Reading

“Healthy” Update: Industry, Others Weigh In on ‘Healthy’ Claims

As previously reported on this blog, FDA received a Citizen Petition from KIND in December 2015 requesting that the Agency revisit the definition of “healthy” — which has not changed since 1994 — to take into account present-day scientific understanding about the health benefits of many nutrient-dense foods, and in September 2016, FDA issued a request … Continue Reading

FDA Formally Extends Menu Labeling Compliance Date to 2018

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

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

Campylobacter and Salmonella Top CDC’s 2016 List of Causes of Foodborne Illnesses

The Foodborne Diseases Active Surveillance Network (FoodNet) has been tracking trends for infections transmitted commonly through food since 1996, collecting data on approximately 15 percent of the U.S. population.  FoodNet is a collaboration of the Centers for Disease Control and Prevention (CDC), 10 state health departments, USDA’s Food Safety and Inspection Service (FSIS) and the … Continue Reading

U.S. FDA Recognizes Australia as Having a Comparable Food Safety System

Today, the U.S. Food and Drug Administration (FDA) announced that the Agency has signed an arrangement with the Australian Department of Agriculture and Water Resources recognizing each other’s food safety systems as comparable to one another. This follows FDA’s decision to recognize New Zealand and Canada as comparable foreign food safety systems in 2012 and 2016, … Continue Reading

FDA Considering Requests to Maintain or Extend Scheduled Implementation of Nutrition Facts Label Changes

As previously covered on this blog, in May 2016, FDA issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products that are initially introduced into interstate commerce is currently slated for July 26, 2018 (or July 26, 2019 for manufacturers … Continue Reading

FDA Launches “Organ Chip” Project to Support Food and Dietary Supplement Safety Research

“Organs-on-Chips” technology has been the focus of a public-private collaboration between FDA, the federal Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH).  “Organs-on-Chips” essentially involves creating miniature-sized human organ systems on micro-engineered chips about the size of an AA battery.  This technology has revolutionized the manner in which scientists can study the … Continue Reading

Potential New Head of FDA Open to Delaying Nutrition Facts Label Changes

As previously covered on this blog, in May 2016, FDA issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products that are initially introduced into interstate commerce is currently slated for July 26, 2018 (or July 26, 2019 for manufacturers … Continue Reading
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