News & Analysis as of

The United States Food and Drug Administration Food Safety Modernization Act

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -

FDA Reorganizes ORA Staff, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

On May 15, 2017, the Food and Drug Administration's ("FDA" or "Agency") Office of Regulatory Affairs ("ORA") began implementing a "Program Alignment Initiative." The Initiative requires the ORA staff, who are charged with...more

FSMA: What Every Food Industry Executive Should Do & Why

by Strasburger & Price, LLP on

With six of the seven rules implemented under the 2011 Food Safety Modernization Act (FSMA) currently being enforced, what should you know and do? Here are some considerations for facilities that manufacture, pack, process,...more

Wrap-Up of Federal and State Chemical Regulatory Developments, June 2017

by Bergeson & Campbell, P.C. on

Join the Environmental Law Institute (ELI) and the George Washington University Milken Institute School of Public Health on June 27, 2017, for a day-long conference exploring the federal government’s implementation of the...more

FSVP compliance dates arrive, challenges to food industry increase

by Thompson Coburn LLP on

On May 30, 2017, the FDA’s Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals went into effect, placing new compliance requirements on food importers. As readers will recall, in 2011,...more

FDA Deadline Extension: Agricultural Water Standards Compliance

by Strasburger & Price, LLP on

Demonstrating that submitting comments to the FDA can pay dividends, the FDA announced on June 6, 2017 that it will extend the compliance dates for agricultural water standards contained within the Produce Safety Rule. The...more

Retailers and Other Food Importers Must Ensure Food They Import Meets U.S. Safety Standards

by Bryan Cave on

Requirements take effect today under the FDA’s new Food Safety Verification Program (FSVP), which makes retailers and other businesses that import food into the United States responsible for verifying that the food has been...more

United States and Australia: Comparable Food Safety Systems

by Jones Day on

On April 19, 2017, FDA announced that both the United States and Australia have recognized each other's food safety systems as comparable to each other. This is the third time that the FDA has given this recognition to a...more

Romaine Calm: FSVP is Approaching

Does FSVP Apply to You? Are you the importer, consignee, or agent for food imported into the United States? If so, the Foreign Supplier Verification Program for Importers of Food for Humans and Animals (FSVP), a key...more

FDA Commissioner Nominee Gottlieb Written Responses Signal Support for Food Safety and Science-Based Approach to Consumer...

by Kelley Drye & Warren LLP on

Dr. Scott Gottlieb, recently submitted written responses to questions posed by members of the Senate Health, Education, Labor and Pensions Committee as a follow up to his hearing on April 5. As a follow up to our April 13...more

Are You Exempt? FDA Announces Waivers for Certain Businesses Subject to the Sanitary Transportation Rule

by Dickinson Wright on

The FDA Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food is now final and on April 5, 2017, the FDA published three waivers for certain qualifying businesses. The Sanitary...more

Food, Dietary Supplement & Cosmetics Update | Vol. IV, Issue 3

by Jones Day on

FDA Amends Waivers to Sanitary Transportation Rule - On April 6, 2017, the Food and Drug Administration ("FDA") notified industry regarding the amendment of waivers available under the Sanitary Transportation of Human...more

Senate Hearing on FDA Commissioner Nominee Scott Gottlieb Provides Insights on the Future of Food Safety and Labeling

by Kelley Drye & Warren LLP on

Last Wednesday, April 5, the Senate Committee on Health, Education, Labor, & Pensions held a hearing on the nomination of Scott Gottlieb, MD, as Commissioner of the Food and Drug Administration. As part of the hearing,...more

FDA sanitary transport rule impacts railroads, other shippers

by Thompson Coburn LLP on

The Food and Drug Administration’s new Sanitary Transport of Human and Animal Food Rule takes effect on April 6, 2017, imposing new rigorous food safety regulations on food shippers – including railroads – and creating a...more

Have You Noticed the Increase in Food Recalls?

by Robins Kaplan LLP on

Almost every day, the FDA announces a new recall or safety alert for a potentially dangerous food. Earlier this month, Trader Joe’s recalled some SKUs of apple sauce due to complaints that they may contain small pieces of...more

Food industry sees one of first whistleblower suits under FSMA

by Thompson Coburn LLP on

As part of the massive overhaul of food safety regulations under the Food Safety Modernization Act, Life Sciences Decoded reported in August on new whistleblower protections for food industry employees. On Feb. 9, six months...more

Food contact goods and the FSVP: Deciphering the FDA’s stance

by Thompson Coburn LLP on

The last 18 months have seen a flurry of regulatory activity as the FDA has finalized and begun enforcing a number of new regulations based on the Food Safety Modernization Act (FSMA). Among these regulatory schemes is the...more

CFSAN Director Anticipates “Tweaks,” Not Rollbacks Despite Administration’s De-Regulation Emphasis

by Kelley Drye & Warren LLP on

Dr. Susan Mayne, Director of FDA’s Center for Food Safety and Applied Nutrition, spoke on Thursday to the DC section of the Institute of Food Technologists. Responding to questions from the audience, Dr. Mayne was asked to...more

2017 Food And Beverage Industry Outlook: Part 1

by McGuireWoods LLP on

As 2017 marks the commencement of a new presidential administration, the food and beverage industry is one of many sectors facing anticipated regulatory and legislative reforms. Specifically, the industry can expect to see...more

Controlling L. mono in RTE Foods: FDA Publishes Draft Guidance

by Davis Wright Tremaine LLP on

Quick Bite: The FDA is seeking comment until July 17, 2017, on draft guidance about recommended practices to control Listeria monocytogenes in food facilities. The Details: The Food and Drug Administration (“FDA”)...more

Wrap-Up of Federal and State Chemical Regulatory Developments, January 2017

by Bergeson & Campbell, P.C. on

TSCA/FIFRA/IRIS/NTP/TRI - EPA Promulgates Final TSCA Reporting And Recordkeeping Rule For Nanoscale Materials: After over a decade of effort, the U.S. Environmental Protection Agency (EPA) issued on January 12, 2017, a...more

What the FDA has in store for the food industry in 2017

by Thompson Coburn LLP on

As Life Sciences Decoded looks forward in 2017, it is clear that FDA-regulated industries have a great deal of change confronting them. Last year, 2016, was a landmark year for the FDA and food regulations, as the agency...more

Is the FSMA a plaintiff’s lawyer’s dream and the food industry’s nightmare?

by Thompson Coburn LLP on

The Food Safety Modernization Act (FSMA) became law in 2011, signaling a sea change in U.S. food safety regulation and making prevention the cornerstone of safety measures. To achieve its lofty goals, while providing time for...more

Wrap-Up of Federal and State Chemical Regulatory Developments, December 2016

by Bergeson & Campbell, P.C. on

TSCA/FIFRA/IRIS/NTP/TRI - EPA Proposes To Add Nonylphenol Ethoxylates To Section 313: On November 16, 2016, the U.S. Environmental Protection Agency (EPA) proposed to add nonylphenol ethoxylates (NPE) as a category for...more

FDA Continues FSMA Implementation, Finalizes Guidance on Voluntary Qualified Importer Program to Expedite Food Imports

by Kelley Drye & Warren LLP on

The Food & Drug Administration (FDA) released last week a final version of its guidance for industry on the Voluntary Qualified Importer Program (VQIP), which will provide a mechanism for eligible food importers to expedite...more

Product Contamination: Strong Underwriting is Key

by Zelle LLP on

In 2011, the Food Safety Modernization Act, regarded by many as a major reform of the food safety provisions of the Federal Food, Drug and Cosmetic Act, significantly expanded the powers of the U.S. Food and Drug...more

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