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Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from colleagues in other related life science disciplines. We are thinking of all of you in these difficult times, and hope that you and your loved ones are healthy and safe. 

In This Issue

Industry Insights

Meet the New Boss, Same as the Old Boss: OPDP Issues Its First Letter of 2021
By: Alan G. Minsk 

New Year. Same types of issues. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued its first Warning Letter of 2021, and it identified many of the same types of unlawful promotional deficiencies that OPDP cited other companies for in the past (and which we have noted in previous Bulletins). More >

A Year in Review: FDA Enforcement in the Prescription Drug Advertising and Promotion World
By: Alan G. Minsk and Genevieve M. Razick

Good riddance to 2020 for so many reasons. But, as the "AGG Year in Review" of the Food and Drug Administration’s enforcement of prescription drug advertising and promotion has become an annual ritual, let’s take a quick peek back and review some themes and trends. More >

Life Sciences Investigations – 2020 Year in Review and 2021 Outlook
By: Aaron M. Danzig and Sara M. Lord

On February 11, 2020, AGG’s Government Investigations team leaders, Aaron M. Danzig and Sara M. Lord, conducted a webinar, titled “Life Sciences Investigations and Enforcement Actions: 2020 Year in Review and 2021 Expectations.” The presenters highlighted the government’s 2020 cases and investigations involving life sciences companies under the False Claims Act (FCA) and Anti-Kickback Statute (AKS), recent antitrust prosecutions, and the ever-expanding number of actions related to opioid enforcement. The webinar focused, in particular, on aspects of the cases that demonstrated new and continuing priorities in enforcement, as well as whether to expect changes or shifts in these areas under the new administration. More >

OTC Monograph Reform – Takeaways from FDA’s Webinar on Expedited Administrative Orders
By: Carolina M. Wirth

On January 27, 2021, the Food and Drug Administration held its second webinar since the enactment of the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) in March 2020, to further discuss over-the-counter (OTC) Monograph Reform and provide guidance on the Administrative Order process, with a particular emphasis on “safety orders.” Prior to the CARES Act, FDA had to engage in a multi-step public rulemaking process in order to establish or revise an OTC drug monograph. This process was not only burdensome but, more important, it made it challenging for the agency to be able to quickly implement changes to an OTC drug monograph to address safety issues. More >


AGG Food & Drug Podcast Episode 5: 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends

FDA Regulation of Rx Drug and Medical Device Advertising and Promotion: 2020 Year in Review

In this episode, AGG’s Food & Drug team leader, Alan G. Minsk and team member, Genevieve M. Razick give an overview of FDA’s Office of Prescription Drug Promotion's (OPDP) enforcement of unlawful advertising in 2020. To listen to the episode, please click here.
Upcoming Events

Alan Minsk to Speak at the 2021 International Good Manufacturing Practices Conference

AGG’s Food & Drug team leader, Alan G. Minsk will present at the 2021 International Good Manufacturing Practices (GMP) Conference on Quality Agreements on March 11, 2021, at 1:45 p.m. ET. The International GMP Conference gathers all distinguished industry leaders in FDA and pharmaceuticals to discuss and present important and timely issues in drug compliance and quality. The conference is widely recognized as the oldest and the top international GMP meeting in the world. For more information or to register, please click here.

Robert Durkin to Speak at FDLI’s Food and DS Safety Conference

Robert Durkin, AGG of counsel and former acting Director and Deputy Director of the Office of Dietary Supplement Programs (ODSP), will moderate “Dietary Supplements: Regulatory Challenges and Litigation Risks” at the Food and Dietary Supplement Safety and Regulation Conference on March 25, 2021, at 1:00 p.m. ET. For more information or to register, please click here.

Industry Activities and Recognition

Kevin Bell Quoted in Nutritional Outlook on 2021 Dietary Supplement Industry Outlook

AGG Dietary Supplements team leader Kevin M. Bell was quoted in a Nutritional Outlook article titled “2021 Dietary Supplement and Natural Product Industry Outlook: Insights from Nutritional Outlook’s Editorial Advisory Board,” on February 4, 2021. Nutritional Outlook’s Editorial Advisory Board consists of a distinguished group of thought leaders in dietary supplements, nutrition, and natural products. To read the full article, please click here.


Kevin Bell and Robert Durkin Quoted in Food Navigator on Presence of Heavy Metals in Baby Foods and the Possibility of Lawsuit

AGG Dietary Supplements attorneys Kevin M. Bell and Robert Durkin were quoted in a Food Navigator article titled “Baby Food Brands Defend Protocols as Congressional Report Alleges ‘Highly Dangerous’ Levels of Heavy Metals in Infant Foods; Expect Lawsuits, Says Attorney,” on February 5, 2021. To read the full article, please click here.


Richard Oparil and Robert Durkin Quoted in Nutritional Outlook on Retailer-Devised Standards for Dietary Supplements

AGG Dietary Supplements attorneys Richard J. Oparil and Robert Durkin were quoted in a Nutritional Outlook article titled “Patchwork of New Retailer-Driven Dietary Supplement Standards Alarms Some Industry Members,” on February 9, 2021. To read the full article, please click here.

Robert Durkin Questions Baby Food Brands’ Knowledge of Heavy Metal Found in Baby Food Products in Food Quality and Safety

AGG Dietary Supplements attorney Robert Durkin was quoted in a Food Quality & Safety article titled “Some Baby Food Contains High Levels of Heavy Metals, Says Congressional Report,” on February 11, 2021. To read the full article, please click here.


AGG Food & Drug Attorneys Co-Authored Chapter in FDLI’s Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment

AGG attorneys Alan G. Minsk, Carolina M. Wirth, and Genevieve M. Razick co-authored a book chapter, entitled “Postmarket Considerations,” which was published in the Food and Drug Law Institute (FDLI)'s Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment. For more information, please click here.
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This newsletter is published by Arnall Golden Gregory’s Food & Drug & Government Affairs and Public Policy practices. This information presented provides a general summary of recent legal and regulatory developments. It is not intended to be, and should not be relied upon, as legal advice. For more information on the Food & Drug practice, please contact Alan G. Minsk.

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