Jonathan Havens on Food and Drug Administration (FDA)

Trump Administration Proposes Consolidating Federal Food Safety Responsibilites Into Single Agency at USDA, Renaming FDA the...

On June 21, 2018, the Trump administration proposed consolidation of the federal food safety functions of the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture's (USDA) Food Safety and Inspection...more

6/26/2018 / Food and Drug Administration (FDA) , Food Safety , Trump Administration , USDA

FDA and USDA Collaborate to Streamline Produce Safety Requirements for Farmers

On June 5, 2018, the U.S. Food and Drug Administration (FDA or the Agency) and the U.S. Department of Agriculture (USDA) announced the alignment of USDA's Harmonized Good Agricultural Practices Audit Program (USDA H-GAP) with...more

6/14/2018 / Agricultural Sector , Farms , Food and Drug Administration (FDA) , Food Safety , FSMA , USDA

Navigating Five Key Legal and Regulatory Hurdles to Get and Keep Your Product on the Market

Food and beverage, drug, medical device, cosmetics, and consumer products companies must navigate a maze of legal and regulatory challenges in order to get and keep their products on the market — from concept, to development,...more

5/23/2018 / Consumer Product Safety Commission (CPSC) , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Popular , Trade Secrets , Utility Patents

Food Regulatory Update: FDA Moving Forward With Nutrition Facts and Menu Labeling Rules, Plans to Redefine “Healthy” and Encourage...

In remarks at the National Food Policy Conference (NFPC) in Washington, D.C. on March 29, 2018, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., detailed the Agency’s wide-ranging plans...more

4/3/2018 / Food and Drug Administration (FDA) , Food Labeling , Menu-Labeling , Nutrition Facts Labels

FDA to Evaluate Minimally or Non-Addictive Cigarette Product Standard, Also Plans to Look at Flavors and Premium Cigars

Earlier today, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., announced FDA’s issuance of an advance notice of proposed rulemaking (ANPRM) to explore a product standard to lower...more

3/15/2018 / Advanced Notice of Proposed Rulemaking (ANPRM) , Food and Drug Administration (FDA) , Tobacco , Tobacco Regulations

FDA Update: Agency Seeks to Strengthen Public Warning and Notification of Recalls, Exercises FSMA Enforcement

Within the past few weeks, the U.S. Food and Drug Administration (FDA or the Agency) has, among other things: Issued a Draft Guidance to strengthen public warning and notification of recalls of foods, drugs, medical...more

1/22/2018 / Draft Guidance , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , FSMA

FDA Takes Further Actions to Encourage Digital Health Innovation, Issuing CDS, Medical Software, and SaMD Guidance Documents

Today, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Dr. Scott Gottlieb announced that the Agency is issuing three new, significant policy documents to advance FDA’s approach to the development and...more

12/8/2017 / Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Software

Menu Labeling Update: FDA Issues New Guidance, Plans to Implement Rule in May 2018

Yesterday, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, "Menu Labeling: Supplemental Guidance for Industry" (Draft Guidance). In the Draft Guidance, FDA addresses comments it received...more

11/9/2017 / Draft Guidance , Food and Drug Administration (FDA) , Food Labeling , Grocery Stores , Menu-Labeling , Nutrition Facts Labels , Restaurant Industry

FDA Warns Companies Marketing Unsubstantiated Marijuana-Derived Products That Claim to Treat or Cure Cancer

Earlier this week, the U.S. Food and Drug Administration (FDA or the Agency) issued Warning Letters to four companies – Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers...more

11/3/2017 / Food and Drug Administration (FDA) , Marijuana , Marketing , Medical Marijuana , Warning Letters

Medical Device Update: FDA Releases Device Change Final Guidances and Breakthrough Devices Draft Guidance, Qualifies First Device...

Yesterday, the U.S. Food and Drug Administration (FDA or the Agency) took a number of steps to “advance medical device innovation and help patients gain faster access to beneficial technologies,” as characterized by FDA...more

10/26/2017 / 510(k) RTA , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Modification

FDA Agrees to Enforce Menu Labeling Rule in May 2018, Delays New Nutrition Facts Label Compliance Deadline Until January 2020

As discussed previously, earlier this year, the U.S. Food and Drug Administration (FDA or the Agency) delayed its Menu Labeling Rule (the Rule) until May 7, 2018. FDA’s announcement in May came just one day before the Rule...more

10/3/2017 / Food and Drug Administration (FDA) , Menu-Labeling , Nutrition Facts Labels , Restaurant Industry , Retail Market

FDA Commissioner Touts Seamless Clinical Trails, Use of Modeling and Simulation As Ways to Lower Drug Costs

In remarks at the Regulatory Affairs Professionals Society’s (RAPS) 2017 Regulatory Convergence Conference yesterday, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., spent considerable...more

9/13/2017 / Food and Drug Administration (FDA) , Investigational New Drug Application (IND) , Pharmaceutical Industry , Prescription Drugs

New York City Agrees To Delay Menu Labeling Until FDA Compliance Date

Late last week, groups representing restaurants, grocery stores, and convenience stores reached an agreement with New York City (the City) to ensure that the City will not enforce its analog of the U.S. Food and Drug...more

8/29/2017 / Food and Drug Administration (FDA) , Food Labeling , Menu-Labeling , Restaurant Industry

Menu Labeling Litigation Update: FDA Files Motion to Dismiss Suit Challenging Agency’s Rule Delay, Urges Southern District to...

This week, there were developments in two menu labeling lawsuits about which we reported previously: a lawsuit challenging the U.S. Food and Drug Administration’s (FDA or the Agency) delay of its menu labeling rule, and a...more

8/16/2017 / Delays , Food and Drug Administration (FDA) , Food Labeling , Menu-Labeling , Nutrition Facts Labels , Restaurant Industry , Retail Market

FDA Announces Major Tobacco Regulatory Policy Shift; Will Address Lowering Nicotine to Non-Addictive Levels, Delay Marketing...

On July 28, 2017, the U.S. Food and Drug Administration (FDA or the Agency) announced a new, comprehensive plan for tobacco and nicotine regulation that will place nicotine, and the issue of addiction, at the center of the...more

8/1/2017 / Advanced Notice of Proposed Rulemaking (ANPRM) , Food and Drug Administration (FDA) , Tobacco , Tobacco Regulations

House Passes FDA Reauthorization Act; Would Reauthorize Key User Fee Programs and Lengthen Medical Device Malfunction Reporting...

Last week, the U.S. House of Representatives (the House) passed by voice vote the FDA Reauthorization Act of 2017 (FDARA or the Act). Introduced on May 16, 2017 by House Energy and Commerce Committee Chairman Greg Walden...more

7/24/2017 / FDA Reauthorization Act , Food and Drug Administration (FDA) , GDUFA , Medical Device User Fee Program (MDUFA IV) , Medical Devices , PDUFA , Proposed Legislation , User Fees

Restaurants, Grocery Stores, and Convenience Stores Sue to Block New York City's Menu Labeling Rule

The U.S. Food and Drug Administration’s (FDA or the Agency) decision a couple of months ago to delay its Menu Labeling Rule until May 7, 2018 was met with mixed reactions from industry. While the National Association of...more

7/20/2017 / Food and Drug Administration (FDA) , Food Labeling , Grocery Stores , Menu-Labeling , Nutrition Facts Labels , Restaurant Industry , Retail Market

Trump Administration Delays Yet Another Food Rule: Revised Nutrition Facts Label Paused Indefinitely

On June 13, 2017, the U.S. Food and Drug Administration (FDA or the Agency) delayed indefinitely the Nutrition Facts and Supplement Facts Label and Serving Size rules (the Rules), which were set to go live on July 26, 2018...more

6/16/2017 / Food and Drug Administration (FDA) , Nutrition Facts Labels , Trump Administration

FDA Update: Menu Labeling Delay Suit, Research Oversight Change, UDI Compliance Date Delays, and Inspection Staff Reorganization

Within the past few weeks, the U.S. Food and Drug Administration (FDA or the Agency) has taken a number of actions that could impact nearly all of the industries it regulates, but in particular, companies in the medical...more

6/9/2017 / Food and Drug Administration (FDA) , Institutional Review Board (IRB) , Menu-Labeling , Restaurant Industry , Unique Device Identifiers

Jonathan Havens

Saul Ewing LLP

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