FSMA › The United States Food and Drug Administration

The Food Safety Modernization Act is a United States federal statute enacted in 2011 to ensure the safety of the U.S. food supply and prevent food contamination. The main features of the FSMA include expanding the FDA's inspection of food processing facilities and imported food products, requiring all food processors, manufactures and handlers to register with HHS and maintain food safety records, and shifting the government's focus away from responding to food contamination and towards preventing food contamination.

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News & Analysis as of May 19, 2013

Comment Period Extended For Proposed FSMA Rules

by Steve Kluting | Varnum LLP on 4/26/2013

Yesterday, the Michigan Department of Agriculture and Rural Development hosted officials from the Food & Drug Administration at a "Listening Session" on the newly proposed rules under the Food Safety Modernization Act (FSMA),...more

FDA Uses New Recall Power For First Time

by Steve Kluting | Varnum LLP on 3/26/2013

More than two years ago, the Food Safety Modernization Act authorized, for the first time, the FDA to force a company to conduct a food recall. Prior to that, all food recalls (with the exceptions of baby formula) were...more

FDA Food Safety Rulemaking Tour Heads to the Northwest

by Michael Gelardi | Davis Wright Tremaine LLP on 3/19/2013

The federal Food and Drug Administration (FDA) will hold a public meeting on FDA’s proposed food safety rules in Portland, OR on March 27-28. The rules implement portions of the recent Food Safety Modernization Act by...more

FDA Flexes Its FSMA Muscles, Initiates Mandatory Recall

by Jacqueline Berman, Robert Hibbert, Stephen Mahinka, Anthony "Tony" Pavel, Zachary Rothstein, Kathleen Sanzo | Morgan Lewis on 3/13/2013

Recall notification suggests the agency is ready and willing to use its new, enhanced enforcement authority. On February 13, the U.S. Food and Drug Administration (FDA) began its first enforcement action under the...more

Levick Weekly - March 1, 2013: The Libor Scandal; Prosecutors Have A New Plan

by Gene Grabowski, Richard S. Levick | LEVICK on 3/4/2013

In This Issue: - The Food Safety Modernization Act - The LIBOR Scandal - Prosecutors Have a New Plan - Food Safety Compliance - A Hogan Lovells Roundtable - Lessons from the Oldest CEO Succession Plan on...more

Food Litigation Newsletter - February 2013

by Perkins Coie on 2/27/2013

In This Issue: - Court Rules that Yogurt Dispute Belongs Before the FDA - Conclusory Allegations that Advertising is “False and Misleading” Fail Minimum Pleading Standards - 5-Hour Energy Authorized To Sue...more

FDA Proposes New Rules Regarding Growing, Harvesting, Packing And Holding Domestic And Foreign Produce

by Jason Reiser | Pepper Hamilton LLP on 2/14/2013

On January 5, 2013, the U.S. Food and Drug Administration (FDA), as part of a continuing overhaul of the United States’ food safety laws under the Food Safety Modernization Act (FSMA), published proposed rules regarding the...more

Is Your Food Safe to Eat?

by Thorsnes Bartolotta McGuire LLP on 2/7/2013

According to the U.S. Food and Drug Administration (FDA), one in six people suffer a food-borne illness in the United States each year. Sweeping new rules proposed by the FDA in January are intended to reduce the amount of...more

FDA Issues Two Proposed Rules That Will Significantly Change Regulatory Requirements For Food Safety

by Seth Mailhot, Peter Reichertz, Robert Uram | Sheppard Mullin Richter & Hampton LLP on 2/5/2013

The FDA Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011, proposes the most sweeping reform of U.S. food safety laws in more than 70 years. As part of the changes...more

FDA Shifts Focus to Prevention with Publication of Proposed Food Safety Rules

by Todd A. Harrison, John Moore, Matthew R. Rabinowitz, Erin Seder, Ralph S. Tyler | Venable LLP on 1/16/2013

On January 4th, the U.S. Food and Drug Administration (FDA) published two long-awaited proposed food safety rules aimed at preventing foodborne illness. The proposed rules implement the 2011 Food Safety Modernization Act...more

FDA Proposes Significant Changes to Food Safety Regulations to Secure Nation's Food Supply

by Womble Carlyle Sandridge & Rice, PLLC on 1/15/2013

Food companies and farmers should be aware that they have approximately 4 months to provide their comments to the FDA regarding its proposed new food safety standards. On January 4, 2013, the FDA proposed two new regulations...more

FDA Releases New Food Safety Rules

by Alejandro Bras, Michael Steel | Morrison & Foerster LLP on 1/11/2013

The Food and Drug Administration (FDA) recently released drafts of two long-awaited food safety rules as part of the agency’s ongoing implementation of the 2011 Food Safety Modernization Act (FSMA). The first proposed rule...more

FDA Releases Two More Rules Implementing the Food Safety and Modernization Act

by Fuerst Ittleman David & Joseph, PL on 1/11/2013

As we previously reported, President Obama signed the Food Safety and Modernization Act (“FSMA“) in January 2011 to help ensure the safety and security of foods in the United States. On January 7, 2013, the U.S. Food and...more

Capital Thinking Update - January 7, 2013

by Amy Davenport, Tanya DeRivi, Eugenia Edwards, Jared Fleisher, Matthew Kulkin, Jessica Monahan, Amy Budner Smith, Scott Thompson, Joseph Urso, Sarah Vilms, Dana Weeks, Pam Welsh | Patton Boggs LLP on 1/11/2013

In This Issue: - General Legislative - Fiscal Cliff - Agriculture & Food - Budget, Appropriations - Cybersecurity - Education - Energy - Environment - Financial Services - Health Care - Financial...more

FDA Releases Major New Food Safety Proposals

by Jonathan Havens, Robert Hibbert, Anthony "Tony" Pavel, Zachary Rothstein, Kathleen Sanzo, Gary Yingling | Morgan Lewis on 1/10/2013

Affected parties should familiarize themselves with proposed rules for safe food processing and handling and on-farm produce safety; comments to FDA are due by May 16....more

FDA Issues Proposed Rules And Explanatory Fact Sheets For FSMA

by Lawrence Reichman | Perkins Coie on 1/9/2013

On January 4, 2013, the Food and Drug Administration (FDA) issued two long-awaited proposed rules implementing important aspects of the 2011 Food Safety Modernization Act (FSMA). These rules are intended to help prevent...more

FDA Announces Publication of Two Proposed Rules Implementing the Food Safety Modernization Act

by Nathan Beaver, Michael Flanagan | Foley & Lardner LLP on 1/8/2013

On Friday, January 4, 2013, FDA announced the pre-publication of two long-awaited proposed rules implementing parts of the Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011....more

Companies Need to Review Their Insurance as FDA Announces First Rules Under FSMA

by Jonathan M. Cohen | Gilbert LLP on 1/7/2013

On January 4, 2013, the Food and Drug Administration (“FDA”) issued the first two rules that will put into effect the Food Safety Modernization Act (“FSMA”), a law passed by Congress in 2011 that is designed to prevent...more

FDA Exhibits Increased Authority under Food Safety and Modernization Act

by Fuerst Ittleman David & Joseph, PL on 1/3/2013

In early September of 2012, the U.S. Food and Drug Administration (“FDA“) and Centers for Disease Control and Prevention (“CDC“) announced an investigation into a multi-state outbreak of Salmonella Bredeney infections linked...more

FDA Suspends Sunland, Inc.; Major Peanut Butter Producer Hit with First Food Facility Suspension Under the Food Safety...

by Duane Morris LLP on 12/1/2012

On November 26, 2012, the U.S. Food and Drug Administration (FDA) announced the suspension of the registration of Sunland, Inc., a producer of nuts, and nut and seed spreads, pursuant to the FDA's authority under Section 102...more

FDA Warning Letters to Sprout Growers Highlight Complicated Legal Issues Associated with Warning Letters and Guidance Documents

by Fuerst Ittleman David & Joseph, PL on 10/1/2012

Since 1996, there have been at least 30 reported outbreaks of foodborne illness associated with different types of raw and lightly cooked sprouts caused mostly by Salmonella and E. coli. In 1999, in response to numerous...more

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