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 -

Food & Beverage Litigation Update | October 2017

OIG Report Suggests Improvements to FSMA Enforcement - A report from the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services has concluded that the Food and Drug Administration (FDA)...more

“Challenges Remain” for FDA’s Inspections of Food Facilities, According to Inspector General Report

by Kelley Drye & Warren LLP on

While FDA is on track to meet the initial inspection timeframes specified under the Food Safety Modernization Act (FSMA), questions remain about the effectiveness of those inspections and the capacity for FDA to meet future...more

Food, Dietary Supplement & Cosmetics Update | Vol. IV, Issue 6

by Jones Day on

TOP NEWS - FDA Proposes New Compliance Dates for the Water Provisions of the Produce Safety Final Rule - On September 13, 2017, the Food and Drug Administration issued a proposed rule to extend, for covered produce...more

Food & Beverage Litigation Update | September 2017 #3

FDA Announces Final FSMA Produce Safety Rule - The U.S. Food and Drug Administration (FDA) has announced that the produce safety rule of the Food Safety and Modernization Act of 2010 (FSMA) is now final, establishing...more

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

by Bergeson & Campbell, P.C. on

TSCA/FIFRA/TRI - EPA Adopts 2017 NAICS Codes For TRI: On August 16, 2017, the U.S. Environmental Protection Agency (EPA) announced that it is updating the list of North American Industry Classification System (NAICS) codes...more

A Client's Guide to FDA Inspections

A Food and Drug Administration (FDA) inspector has just knocked on your door and announced that he or she will now inspect your facility. What happens before, during and after this inspection, and what should your firm do to...more

Food and Beverage News and Trends - September 2017

by DLA Piper on

Report on consumer and retailer hurdles regarding electronic disclosure of GMO ingredients. - Consumers and small retailers face “key technological challenges” regarding electronic disclosure of GMO ingredients in foods,...more

FDA Delays Start of New Animal Food Inspections

by Barley Snyder on

The Food and Drug Administration recently announced it will delay the date for certain routine regulatory inspections of large animal food facilities until next year....more

Food Safety Plan Builder is Very Helpful, but Not the End of Your Plan

by Barley Snyder on

The Food and Drug Administration has new software to guide you through the creation of a food safety plan. But just because you follow it, doesn’t mean you’re automatically compliant with all federal regulations....more

FDA Clarifies Relationship Between Juice HACCP and the Preventive Controls Rules, Announces FSMA Enforcement Delays

by Faegre Baker Daniels on

August has been an active month for the Food and Drug Administration (FDA), as the agency released guidance affecting juice processors and importers, announced enforcement delays for Food Safety Modernization Act (FSMA)...more

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

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