Posts tagged FDA.
Posted in Legal Bites
FDA Issues New Sodium Guidelines

On October 13, 2021, the U.S. Food and Drug Administration (“FDA”) released new voluntary guidance aimed at reducing average daily sodium intake by 12 percent over the next 2.5 years. The guidance sets voluntary target mean sodium concentrations and upper bound sodium concentrations for 163 food categories, including prepared foods, cheeses, sauces, frozen meals and baby food.

The FDA stated that the guidance “is intended to provide measurable voluntary short-term (2.5-year) goals for sodium content in commercially processed, packaged and prepared foods to reduce ...

Posted in Legal Bites
House Appropriations Committee Directs FDA F&B Priorities

On June 30, 2021, the House Committee on Appropriations (the “Committee”) issued a report accompanying a bill making appropriations for the U.S. Department of Agriculture, Food and Drug Administration (“FDA”), and related agencies for fiscal year 2022.

The report includes the Committee’s review and direction as to the FDA’s work. While most of this guidance was focused on drug-related regulation, the Committee offered some specific directives on food and beverage regulation that may guide the FDA’s future work. The topics of interest in the report related to the ...

Posted in Legal Bites
FDA Foods Program Releases Guidance Topics

On June 29, 2021, the U.S. Food and Drug Administration’s (“FDA”) Center for Food Safety and Applied Nutrition and Office of Food Policy and Response released a list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during the next 12 months. 

The FDA anticipates publishing guidance for many of these documents by June 2022. The FDA stated that the agency “is taking this action to provide stakeholders increased transparency and additional insights into the foods program priorities. Guidance documents represent the FDA’s current ...

Posted in Legal Bites
FDA Announces $134M Budget Increase for FY 2022

On June 7, 2021, the FDA released its Fiscal Year 2022 budget request, outlining key investments for food safety. The request details how the FDA plans to use funds in FY 2022 to support food safety and nutrition. The budget provides increases to core food safety programs and outlines emerging issues of concern for the agency.

The agency’s FY 2022 Budget provides $1.6 billion in budget authority for food safety, an increase of $134 million from the previous year.

The agency’s press release states: “[o]f the increase of $134 million for food safety activities, $45 million is for ...

Posted in Legal Bites
FDA Announces Intended Consumer Research on "Healthy" Claims

On May 6, 2021, the FDA issued a procedural notice on the preliminary quantitative consumer research it plans to conduct on symbols that could be used in the future to convey the nutrient content claim “healthy.”

This research is part of the FDA’s Nutrition Innovation Strategy, which seeks to reduce the burden of nutrition-related chronic diseases and to modernize claims. By using a symbol for a nutrient claim, the goal would be for consumers to have a quick signal about what benefits a food or beverage they choose might have.

As part of its efforts to promote public health, FDA ...

Posted in Legal Bites
FDA Announces Actions on Leafy Green Safety

On April 6, 2021, the U.S. Food and Drug Administration (“FDA”) announced agency actions to advance the safety of leafy greens.

First, the FDA announced that it was releasing a report of its investigation on the Fall 2020 outbreak of E. coli linked to the consumption of leafy greens. The report found that the outbreak, which caused 40 reported domestic illnesses, was linked via whole-genome sequencing (WGS) and geography to outbreaks traced back to the California growing region associated with the consumption of leafy greens in 2019 and 2018. The FDA investigated the outbreak ...

Posted in Legal Bites
FDA/USDA: No Transmission of COVID-19 Through Food/Food Packaging

On February 18, 2021, Acting FDA Commissioner Janet Woodcock and Acting USDA Secretary Kevin Shea issued a joint COVID-19 update statement that current epidemiologic and scientific information available to the FDA and USDA indicates no transmission of COVID-19 through food or food packaging.

The press release states: “Our confidence in the safety of the U.S. food supply remains steadfast. Consumers should be reassured that we continue to believe, based on our understanding of currently available reliable scientific information, and supported by overwhelming ...

Posted in Legal Bites
FDA Clarifies Food Traceability Rule and Extends Comment Period

On January 12, 2021, the Food and Drug Administration (“FDA”) announced two updates to stakeholders regarding the agency’s Food Traceability Proposed Rule. 

The Proposed Rule was initially announced on September 12, 2020, and it establishes additional traceability recordkeeping requirements for companies that manufacture, process, pack or store foods that the FDA has included on its Food Traceability List.

First, the FDA announced clarifying edits to the Food Traceability List. All of the specific edits are described in a memo: “Food Traceability List for ...

Posted in Legal Bites
FDA Announces 2024 Compliance Date for 2021-2022 Food Labeling Regulations

On January 4, 2021, the Food and Drug Administration announced that it would set January 1, 2024 as the uniform compliance date for final food labeling regulations that are issued in calendar years 2021 and 2022.

In its Federal Register publication of the rule, the FDA stated: “Use of a uniform compliance date provides for an orderly and economical industry adjustment to new labeling requirements by allowing sufficient lead time to plan for the use of existing label inventories and the development of new labeling materials.”

If any food labeling regulation involves special ...

Posted in Legal Bites
FDA, EPA and USDA Renew Inter-Agency Food Waste Reduction Initiative

On December 17, 2020, three U.S. agencies: The U.S. Environmental Protection Agency (“EPA”), U.S. Food and Drug Administration (“FDA”) and U.S. Department of Agriculture (“USDA”) announced the renewal of the Formal Agreement Among EPA, FDA and USDA Relative to Cooperation and Coordination on Food Loss and Waste. The renewed agreement has a three-year term.

The Winning on Reducing Food Waste Federal Interagency Strategy prioritizes action areas to reduce food loss and waste. As related activities and projects are completed through 2020, the EPA, USDA and FDA will ...

Posted in Legal Bites
Will The FDA Enforce Its New Nutrition Labeling Rule? 

On September 18, 2020, the U.S. Food and Drug Administration announced additional flexibility for manufacturers to comply with the agency’s updated Nutrition and Supplement Facts labeling requirements. Those requirements go into effect on January 1, 2021. 

The Nutrition and Supplement Facts labeling requirement marks a significant change in requirements for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. The final rule updates the list of nutrients that are ...

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