The U.S. Food and Drug Administration (FDA) issued a warning letter to Duchesnay, Inc after a social media endorsement posted by U.S. celebrity Kim Kardashian was reported through FDA’s Bad Ad program. Kardashian published a lengthy post on her Instagram describing her successful experience with Duchesnay Inc’s product DICLEGIS, a prescription morning sickness medicine. “It’s been studied and there was no increased risk to the baby,” Kardashian said in her post.
FDA has strict regulations regarding the promotion of prescription drugs. Advertisements of drug products may only include information supported by strong evidence and must provide risk information in equal proportion to any benefit information. A referral to risk and safety information in another location, such as a website, does not fulfill this requirement.
“The social media post is false or misleading in that it presents efficacy claims for DICLEGIS, but fails to communicate any risk information associated with its use and it omits material facts,” FDA said in the warning letter. FDA said Kardashian’s post “suggest[s] that DICLEGIS is safer than has been demonstrated” and therefore misbrands the drug product. FDA requested that Duchesnay Inc either cease misbranding DICLEGIS (remove Kardashian’s endorsements) or stop distributing DICLEGIS in the United States, as distributing misbranded drugs in the U.S. is a prohibited act.
Registrar Corp is a U.S. FDA consulting firm that helps drug establishments navigate FDA regulations. Registrar Corp offers website and advertisement reviews through which Regulatory Specialists review the text of a drug establishment’s website and advertisements line by line and alert drug establishments of any non-compliance.
For questions or assistance with FDA regulations for advertising drug products or other FDA requirements for drug establishments, contact Registrar Corp at +1-757-224-0177. Live help is available 24-hours a day at https://www.registrarcorp.com/livehelp.