FDA Spotlights Products “Fraudulently Marketed for Serious Diseases”

November 6, 2015

By Ricardo Carvajal

FDA has established a web page that “alerts consumers to companies fraudulently marketing products for the treatment or prevention of serious diseases.”  If a company receives a warning letter challenging such claims and fails to correct its marketing practices within 30 days, it can expect to find itself on the list.  The underlying warning letters contain the following language: “After 30 days of the date of this letter, if your website(s), labeling, or other promotional materials for the products listed above continue to recommend or suggest the use of the products to treat, cure, mitigate, or prevent diseases, your firm and these products will be listed on the FDA webpage for products illegally marketed for serious diseases.”  There is no indication either in the warning letters or on the web page of how a company can seek removal from the list once the company corrects its marketing practices.

Although the new web page appears intended to alert consumers, it is likely to also be of interest to state attorneys general and the plaintiffs’ bar – especially given that FDA characterizes the challenged marketing practices as fraudulent.  Notably, the underlying warning letters do not use the term “fraud,” nor do they address any purported lack of substantiation.  Thus far, the list names only four companies, all of which purport to market dietary supplements.  It’s not clear whether companies marketing other types of FDA-regulated products can expect to be placed on the list if they also fail to timely respond to a warning letter alleging similar violations.

Categories: Enforcement