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Burger King Has Its Way: Vegan Whopper Class Action Suit Dismissed

In an order issued on July 20, Judge Raag Singhal of the US District Court for the Southern District of Florida dismissed a class action lawsuit that claimed Burger King Corporation’s advertising deceived customers by making...more

Recipe for Reopening Restaurants and Retail Food Establishments

As restaurants and other retail food establishments begin to reopen around the country, trade associations and the US Food and Drug Administration (FDA) have both issued guidance for retail food establishments that provide...more

Federal Food Regulation Changes Under COVID-19

As the public health emergency caused by the coronavirus (COVID-19) continuously evolves, the US Department of Agriculture Food Safety Inspection Service (FSIS) and the Food and Drug Administration (FDA) are actively...more

FSIS, FDA Provide Flexibility with Temporary Guidance

The US Department of Agriculture Food Safety Inspection Service (FSIS) and US Food and Drug Administration (FDA) have released policy statements and temporary guidance providing flexibility on certain regulatory requirements...more

FSIS Stresses Continuity and Cooperation

The designation of the food industry as critical infrastructure in the context of the coronavirus (COVID-19) pandemic has led to necessary and sensible efforts to realign the federal regulatory landscape to facilitate this...more

FSIS Advises on Animal-Raising Label Claims but Issues Still Exist

The USDA’s Food Safety and Inspection Service (FSIS) updated two labeling guidelines involving animal raising claims in December. Labeling Guideline on Documentation Needed to Substantiate Animal Raising Claims...more

Life Sciences International Review - Q2 2019

EU – REGULATORY - Brexit, Notified Bodies, and Medical Devices - The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more

What’s in My Meal Kit? USDA Releases Guideline for Meal Kits Containing Meat or Poultry

The US Department of Agriculture (USDA) issued a Notice of Availability and Request for Public Comment on a new guideline addressing multi-component food kits that contain meat or poultry items (Meal Kit Guideline). The Meal...more

FDA Supports Changing Date Label Phrasing on Foods—but Consumer Confusion Is Likely to Continue

FDA released a consumer update stating that it supports industry’s effort to toss expiration dating terms on foods, such as “use before,” “sell by,” and “expires on,” for the more neutral date phrase “best if used by.”...more

FDA Finalizes Program for Medical Device Reporting in Summary Form for Certain Manufacturers

The US Food and Drug Administration (FDA) issued an order in the Federal Register on August 17 announcing a new “Voluntary Malfunction Summary Reporting Program.” FDA issued this order to implement certain provisions of the...more

US House Votes to Repeal Medical Device Excise Tax

While the US House of Representatives recently voted to repeal the medical device excise tax imposed by a 2010 amendment to the Affordable Care Act, there is no sign that the Senate will vote on this issue any time soon. ...more

USDA Releases Long-Awaited Bioengineered Labeling Disclosure Rule

The US Department of Agriculture, through its Agricultural Marketing Service, released its highly anticipated rule proposing a nationwide labeling requirement for foods containing bioengineered ingredients, also known as...more

No Such Thing as Simple Food Labeling: Changes Ahead in 2018

Significant statutory and regulatory changes are on the horizon this year in the world of food labeling as regulators and lawmakers introduce rules that can potentially impact the food industry and its compliance obligations....more

FDA Delays eMDR System Adverse Event Codes Update

The electronic medical device reporting system adverse event code update was originally planned for deployment in April, but was delayed until July 5, 2018, to give industry more time to comply....more

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