The FDA sent a warning letter to Duchesnay Inc. in response to an Instagram post by celebrity Kim Kardashian endorsing the morning sickness drug Diclegis, calling the post misleading because the post did not include any risk information for the drug.
Brendan Carroll, attorney in Alston & Bird’s Food, Drug & Device/FDA Group, noted that the enforcement letter is unique because it “focuses on a personal Facebook, Twitter and Instagram account, as opposed to a drug company’s website.”
“While the FDA warning letter may be unique, it is not surprising,” Carroll said. “One of the bedrock principles of FDA regulatory oversight, and one that extends beyond social media, is that a company is generally responsible and accountable for any website, social media or other product promotion that it maintains and over which it has control. This includes any content generated by an employee or agent who is acting on behalf of the company to promote the firm’s product.”
Carroll noted that although the content appeared on Kardashian’s personal account, the post clearly discloses that she “is partnering with Duchesnay USA to raise awareness about treating morning sickness such that the company is exerting influence or control over the content,” making Kardashian an acting agent.
“Although the warning letter does not describe the ‘partnership,’ if Duchesnay is paying Kim Kardashian, the FDA views that as establishing sufficient control over the content,” Carroll said, adding that even though the social media guidance released by the FDA last year “provided clearer direction for the use of social media, many companies have continued to tread carefully since there are several ways to overstep the bounds of these guidances.
“Partnering with one of the highest profile celebrities on social media, without ensuring that the firm-controlled content abides by the appropriate rules and regulations, is a sure-fire way to overstep those bounds,” Carroll continued. “Improper celebrity endorsements rarely lead to repercussions for the celebrity; it is the companies that must deal with the aftermath.”
Brendan Carroll, attorney in Alston & Bird’s Food, Drug & Device/FDA Group, noted that the enforcement letter is unique because it “focuses on a personal Facebook, Twitter and Instagram account, as opposed to a drug company’s website.”
“While the FDA warning letter may be unique, it is not surprising,” Carroll said. “One of the bedrock principles of FDA regulatory oversight, and one that extends beyond social media, is that a company is generally responsible and accountable for any website, social media or other product promotion that it maintains and over which it has control. This includes any content generated by an employee or agent who is acting on behalf of the company to promote the firm’s product.”
Carroll noted that although the content appeared on Kardashian’s personal account, the post clearly discloses that she “is partnering with Duchesnay USA to raise awareness about treating morning sickness such that the company is exerting influence or control over the content,” making Kardashian an acting agent.
“Although the warning letter does not describe the ‘partnership,’ if Duchesnay is paying Kim Kardashian, the FDA views that as establishing sufficient control over the content,” Carroll said, adding that even though the social media guidance released by the FDA last year “provided clearer direction for the use of social media, many companies have continued to tread carefully since there are several ways to overstep the bounds of these guidances.
“Partnering with one of the highest profile celebrities on social media, without ensuring that the firm-controlled content abides by the appropriate rules and regulations, is a sure-fire way to overstep those bounds,” Carroll continued. “Improper celebrity endorsements rarely lead to repercussions for the celebrity; it is the companies that must deal with the aftermath.”