Robert Durkin

Robert Durkin

Arnall Golden Gregory LLP

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I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Business Divorces in the Food and Supplements Space [Audio]

In this episode, Michael E. Burke, partner and co-chair of the Pharmaceutical & Biotechnology industry team is joined by Robert Durkin, an attorney in our Dietary Supplements team, as they discuss issues around business...more

9/27/2021  /  Business Disputes , Business Divorce , Business Strategies , Dietary Supplements , Distributors , Food Manufacturers , Risk Mitigation

I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - FDA Regulated Natural Products: Leveraging IP and Regulatory... [Audio]

AGG Dietary Supplements team leader Kevin M. Bell and team member Robert Durkin discuss some of the more interesting issues and challenges they have encountered when working with clients to ensure they maximized opportunities...more

12/22/2020  /  Dietary Supplements , Food and Drug Administration (FDA) , IP Portfolio , Natural Products , Regulatory Requirements , ROI

Amazon Issues New Requirements for Dietary Supplements Sold on Its Site – At Least One Will Be Problematic

In a move that some in the natural product space have been asking for, Amazon has begun the process of implementing new requirements for selling dietary supplements on its online platform....more

12/21/2020  /  Amazon , Dietary Supplements , Labeling , Marketing , Online Platforms , Product Labels

Be Careful to Not Beat Yourself in the Race To Market and Wind Up Excluding Your Own Ingredient From Being Allowed in Food or...

We are often approached by clients interested in conducting studies relating to an article that qualifies as a dietary substance or ingredient. Some of these clients are interested in studies intended to provide insight into...more

11/20/2020  /  Animal Food , Biotechnology , Dietary Supplements , Food and Drug Administration (FDA) , Manufacturers , Product Labels

AGG Food & Drug Newsletter - October 2020

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more

10/30/2020  /  Dietary Supplements , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Food Labeling , Imports , Manufacturers , Medical Devices , Nutrition Facts Labels , Pharmaceutical Industry , Prescription Drugs

Required Revisions to Nutrition and Supplement Facts Labels are to be Fully Implemented by January 1, 2021

The Food and Drug Administration issued new regulations requiring changes to the nutrition and supplements facts labels of conventional food and dietary supplements, respectively, on May 27, 2016....more

10/29/2020  /  Dietary Supplements , Food and Drug Administration (FDA) , Food Labeling , Manufacturers , Nutrition Facts Labels , Nutritional Supplements , Product Labels

Another Piece to the CBD Puzzle? FDA Submits Report on CBD Sampling Study to Congress

On July 8th, the Food and Drug Administration (FDA) submitted a report to the House and Senate Committees on Appropriations detailing the results of a sampling study of the current cannabidiol (CBD) marketplace....more

7/24/2020  /  Animal Food , Cannabidiol (CBD) oil , Cannabis Products , Dietary Supplements , Food and Drug Administration (FDA) , Marijuana-Infused Edibles , Product Labels

AGG Food & Drug Newsletter - June 2020

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more

7/6/2020  /  Coronavirus/COVID-19 , Dietary Supplements , Medical Devices , Medical Supplies , Pharmaceutical Industry , Prescription Drugs , Price-Fixing

FSVP: Basics for Importers of Dietary Supplements and Their Components

Importing dietary supplements and dietary supplement components can present many challenges. Not the least of which are those required to stay in compliance with aspects of the Food Safety and Modernization Act (FSMA)....more

6/29/2020  /  Dietary Supplements , Food and Drug Administration (FDA) , Food Safety , Foreign Suppliers , FSMA , FSVP , Imports , Manufacturers

Legal Update on the Coronavirus and Dietary Supplement Industry

The novel Coronavirus and the response by federal and state government agencies has been unprecedented in its nature and scope. This is certainly true for the manufacture and sale of dietary supplement products. ...more

5/14/2020  /  Coronavirus/COVID-19 , Dietary Supplements , Food and Drug Administration (FDA)

With One Warning Letter, FDA Demonstrates Many of the Ways It Can Establish the Intended Use of a Product Labeled as a Dietary...

On March 31, 2020, the Food and Drug Administration issued a Warning Letter to a dietary supplement firm for making claims about its products that establish the products are unapproved new drugs, in violation of Federal Food,...more

5/1/2020  /  Dietary Supplements , FDA Warning Letters , Food and Drug Administration (FDA) , Product Labels , Social Media

Is It a Conventional Food, a Dietary Supplement, or a Drug?

When clients seek out legal assistance about regulatory issues concerning one of their products, frequently, the first task is to determine exactly what the product “is.” Most would assume that this determination is made by...more

11/27/2019  /  Dietary Supplements , Food and Drug Administration (FDA) , Pharmaceutical Industry
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