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Healthy Choices: The Power and Perils of Health and Wellness Claims in Advertising

Even before COVID-19 had turned each of us into an amateur epidemiologist, companies in nearly every industry had begun to recognize the magnetic appeal of health and wellness claims in consumer advertising. Marketers of...more

FDA Announces Increased Inspections and Enforcement Actions, Additional Guidance to Reduce Toxic Elements in Food for Babies and...

On March 5, 2021, FDA issued a public statement announcing regulatory actions to reduce toxic elements — with a particular focus on arsenic, lead, cadmium and mercury — in food for babies and young children. FDA cited the...more

California Ramps Up Chemical Bans, Disclosure Obligations for Personal Care and Beauty Products

Governor Gavin Newsom further expanded California’s regulation of chemicals in personal care products by signing AB 2762 and SB 312 on September 30, 2020. Commencing on January 1, 2025, AB 2762 prohibits manufacturing or...more

FDA Finalizes Requirements for ‘Gluten-Free’ Labeling of Fermented or Hydrolyzed Foods

On August 12, 2020, the Food and Drug Administration (FDA) issued a final rule, “Gluten-Free Labeling of Fermented or Hydrolyzed Foods,” to establish compliance requirements for fermented and hydrolyzed foods, as well as...more

OSHA and CDC Release Interim COVID-19 Guidance for Seafood Processing Industry Workers

On June 25, 2020, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) and the Centers for Disease Control and Prevention (CDC), in consultation with the U.S. Food and Drug Administration (FDA),...more

Citizen’s Petition Filed for FDA Pathway to Legally Market Supplements With CBD

On June 17, 2020, The Council for Responsible Nutrition (CRN) filed a Citizen’s Petition with the Food and Drug Administration (FDA) requesting that the FDA establish a regulatory pathway to legally market dietary supplements...more

FDA Amends Imported Non-NIOSH Approved Respirator EUA

In a June 6 Letter of Authorization (LoA), the U.S. Food and Drug Administration (FDA) reissued its March 28 LoA to revise emergency use authorization (EUA) eligibility criteria for imported, non-National Institute for...more

FDA Revises Enforcement Policy for Face Masks and Respirators

On May 26, 2020, the United States Food and Drug Administration (FDA) revised its Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, which supersedes the...more

FDA Revises EUA Criteria for Respirators Manufactured in China (Updated)

In a June 6 Letter of Authorization (LoA) regarding the emergency use authorization (EUA) for non-National Institute for Occupational Safety and Health (NIOSH)-approved disposable filtering facepiece respirators manufactured...more

[Virtual Event] 4th Advanced Summit on Food Law – Regulation, Compliance and Litigation - July 15th - 16th, 8:00 am - 5:05 pm CDT

Network and brainstorm with top regulatory and compliance executives and legal counsel. ACI’s Food Law conference is a unique, interactive forum where key legal, regulatory and compliance stakeholders for the food industry...more

FDA Issues EUA to Increase Availability of Non-Surgical Gowns and Other Apparel

On May 22, 2020, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) in response to concerns relating to insufficient supply and availability of non-surgical gowns and other apparel for use by...more

FDA Grants EUA for General Purpose Face Masks and Continues to Address PPE Shortage

On April 18, 2020, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for face masks in its continuing effort to address shortages of the personal protective equipment (PPE). This most recent...more

FDA Revises Guidance on Using Ethanol in Hand Sanitizer Products During the COVID-19 Pandemic

On April 15, 2020, the Food and Drug Administration (FDA) updated its three hand sanitizer guidance documents to address the use of fuel- and technical-grade ethanol as an active pharmaceutical ingredient (API) in hand...more

China’s Latest Measures for Medical Equipment Exports

In recent weeks, the Chinese government has faced criticism from governments around the world about the quality of medical equipment manufactured in China. In response, the Chinese government has adopted measures to...more

Another Step in Expanding Personal Protective Equipment: FDA Extends EUA to Face Shields

The Food and Drug Administration (FDA) issued on April 9, 2020 its first emergency use authorization (EUA) for face shields to address the significant shortage of personal protective equipment (PPE) during the COVID-19...more

FDA Opens Door to Respirators From Chinese Manufacturers, Revises Respirator Enforcement Policy

On April 3, 2020, the Food and Drug Administration (FDA) issued a new emergency use authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China. This EUA supplements the...more

Limited Foreign Supplier Verification Inspections Continue Through Remote Document Review During COVID-19

On April 3, 2020, the Food and Drug Administration (FDA) issued a Constituent Update notifying the public that for Foreign Supplier Verification Program (FSVP) inspections, FDA requests importers electronically send records...more

FDA Eases Menu Labeling Requirements for Chain Restaurants and Retail Food Establishments During the COVID-19 Pandemic

On April 1, 2020, the Food and Drug Administration (FDA) issued a Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public...more

FDA Helps the Food Supply Chain by Easing Labeling Requirements During the COVID-19 Pandemic

On March 26, 2020, the Food and Drug Administration (FDA) issued Guidance for Industry: Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency to provide restaurants...more

FDA Fact Sheet: Dos and Don’ts of Safely Distributing Human Food for Use as Animal Food

Production of animal food, like human food, is an essential function Americans depend on daily, reinforced by the Department of Homeland Security in its Guidance on the Essential Critical Infrastructure Workforce: Ensuring...more

FDA Continues to Respond to Food Industry COVID-19 Concerns

The Food and Drug Administration (FDA) updated its Frequently Asked Questions (FAQ) on March 23 to include additional recommendations for the food industry during the COVID-19 pandemic. FDA addressed four particular...more

FDA Responds to COVID-19 Concerns: Our Food Supply Is Safe

On March 18, the U.S. Food and Drug Administration (FDA) hosted a call with Frank Yiannas, Deputy Commissioner, Office of Food Policy and Response, Michael Rogers, Assistant Commissioner for Human and Animal Food Operations,...more

Food Importers: Act Before May 31 to Take Advantage of FDA’s Food Importation ‘Express Lane’

The Food and Drug Administration’s (FDA) “express lane” for food importers, the Voluntary Qualified Importer Program (VQIP), is now accepting applications for the period between October 1, 2020 and September 30, 2021,...more

How Will FDA Assembling the Botanical Safety Consortium Affect Your Company’s Botanical Ingredients?

Earlier this year, former Commissioner Gottlieb identified new efforts by the Food and Drug Administration (FDA) to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight. To further this...more

FDA Touts Results of New Prosecutorial Enforcement Muscle Worldwide

The Food and Drug Administration (FDA) is increasing and strengthening its ability to enforce criminal sanctions against conduct related to illegal FDA-regulated products across the globe, according to an October...more

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