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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

A Drug Company Finds Itself With a Headache and Over Its Head With Unlawful Promotional Messaging
By: Alan G. Minsk & Genevieve M. Razick 

In keeping with family tradition, another Kardashian made headlines again in our food and drug world for the wrong reasons. And the Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) was not likely amused to issue its third letter in 2021 – its first Untitled Letter this year — for unlawful promotion. In this case, OPDP took exception to a direct-to-consumer video of an interview with Khloe Kardashian, a paid spokesperson for a pharmaceutical company that marketed a prescription drug product for acute treatment of migraine with or without aura in adults. More >

FDA Is (Once Again) Keeping Up With the Kardashians: A Cautionary Tale Involving Endorsements, Testimonials and Influencer Marketing
By: Matthew V. Wilson

In March, Khloe Kardashian unwittingly joined her sister, Kim Kardashian, as the subject of a Food and Drug Administration (FDA) Warning Letter relating to the reality star’s influencer-marketing activities. Khloe’s more recent reprimand emanates from a guest appearance on The View, where she lauded Biohaven Pharmaceuticals’ product, Nurtec ODT. Although Kardashian is properly identified in the piece as an official spokesperson of Biohaven, the star refers to the drug as a “game-changer,” insisting that “it works in 15 minutes,” and states that “other medications would give me rebound headaches, and this one doesn’t.” More >

Not Worth the Paper It’s Printed On: FDA Calls Companies to Stop Issuing Misleading Medical Device Establishment Registration Certificates
By: Carolina M. Wirth

At the beginning of the COVID-19 pandemic, we saw what seemed to be a surplus of “FDA Registration Certificates” being presented by Chinese manufacturers of face masks and other personal protective equipment (PPE) as evidence that the products and companies were properly listed and registered with the Food and Drug Administration (FDA). These registration certificates may have created a false sense of security for companies seeking to import PPE products from China. In many cases, the product listings were not legitimate, but more of a way for companies to try to get their products through U.S. Customs and Border Protection. More >

Times They Are A-Changin’… and Your Website Terms and Policies Should Too
By: Kevin L. Coy & Matthew V. Wilson

It is a good time to review your website and its accompanying terms and conditions and privacy policies. From year to year, the legal landscape evolves with changes being driven by technological advancements, shifting business models, regulatory activity, legislative attention, and judicial rulings. As such, website operators must be aware of the changes that impact their existing policies and practices and any resulting liability risks. This alert provides a brief summary of issues and recent legal events that may affect your website and governing policies. More >


AGG Food & Drug Podcast Episode 6

Data Privacy Issues Life Sciences Companies May Encounter

In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and co-chair of AGG's Data Privacy practice, Kevin L. Coy, discuss U.S. and international privacy and data security law issues life sciences companies may encounter, such as privacy policies, the patchwork of federal and state privacy and data security laws in the U.S., international data protection laws, such as GDPR, and related international data transfer issues. To listen to the episode, please click here.
Upcoming Webinars
Building Quality (Agreement) into Your Product: Part 2

On April 29, 2021, from 1:00 PM – 2:00 PM EDT, AGG’s Food & Drug team leader, Alan G. Minsk, and co-chair of AGG’s Pharmaceuticals & Biotechnology industry team, Michael E. Burke, will present a webinar as a continuation of their 2017 webinar on drafting quality agreements with third-party companies; as well as, FDA enforcement. They will cover FDA expectations; explore common areas of potential dispute between contract manufacturers and the sponsoring companies, including practical tips to address these issues; evaluate ways to minimize regulatory risk and business conflicts; and to minimize conflicts between quality- and related-agreements. To register for the webinar, please click here.


Employment Law Update: What Did the First Quarter of the Biden Administration Bring for Employers? 

On April 1, 2021, from 1:00 PM - 2:00 PM EDT, AGG’s Employment attorneys, Ashley S. Kelly, Henry M. Perlowski, Megan P. Mitchell, and Edward P. Cadagin, will present a webinar to discuss how the first months of the Biden Administration have impacted employers. They will cover the employment provisions of the new stimulus package, including voluntary continuation of federal emergency paid sick leave; changing agency priorities and positions, including at the DOL, EEOC and OSHA; and the increased availability of and guidance regarding the COVID vaccine. To register for the webinar, please click here.

Industry Activities and Recognition

Mergermarket Named AGG’s Jeff R. Friedman and Matthew M. Brohm in Global and U.S. M&A League Tables

AGG earned notable rankings in Mergermarket's (an M&A intelligence service company) first-ever individual league tables for M&A lawyers. AGG partner Jeff R. Friedman ranked fifth in the world on Mergermarket’s Global league table for closed transactions and tied for first by deal count on the U.S. league table with 31 deals and a disclosed value of $141 million. AGG partner Matthew M. Brohm ranked twelfth in the world on the Global league table for closed transactions and sixth on the U.S. league table with 25 deals and a disclosed value of $98 million. For more information, please click here.


Kevin M. Bell Quoted in Nutritional Outlook Article

AGG partner and leader of Dietary Supplements industry team, Kevin M. Bell, was quoted in a Nutritional Outlook article titled “Why One FDA Import Alert on Higenamine Could Increase NDI Compliance Industry-Wide for All Dietary Supplements,” on March 18. To read the full article, please click here.


Kevin M. Bell and Robert Durkin Quoted in Natural Products Insider Article

AGG Dietary Supplements industry team attorneys, Kevin M. Bell and Robert Durkin, provide comments on the 2021 priorities of the FDA and ODSP, as well as the current leadership of ODSP in a Natural Products Insider article titled “ODSP Outlines Priorities for 2021,” on March 17. To read the full article, please click here.


Robert Durkin Quoted in FoodNavigator Article

AGG of counsel and former FDA deputy director of the Office of Dietary Supplement Programs (ODSP), Robert Durkin, was quoted in a FoodNavigator article titled “Baby Food Companies Now Facing At Least 43 Lawsuits Over Heavy Metals,” on March 15. Durkin suggests that parents should do more research before throwing out packaged infant foods currently in their household. For more information, please click here.

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This newsletter is published by Arnall Golden Gregory’s Food & Drug and Government Affairs & 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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