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.

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 >