Jul 29, 2013

Warning letters issued by the US Food and Drug administration this year suggests that medical device companies should ensure their online information such as keyword search and other metadata strategies do not deviate from their products’ therapeutic claims on file with regulators.

In late January 2013, the FDA sent a warning letter to a nutritional supplement manufacturer, Medical Doctors Research, citing marketing claims the company made for some if its products in violation of the US Federal Food, Drug and Cosmetic Act. US regulators took issue not only with marketing claims the manufacturer made explicitly in some of its online descriptions, but also (and more interestingly) keyword terms including “cancer” and “diabetes” the firm incorporated in its product search field. Search results, according to the FDA warning, implied that some of the company’s products treat or prevent such diseases.

A second dietary supplement maker, Nature’s Health Supply, received a similar warning letter from the FDA in July 2013. The letter contends that several metatags used for search engine optimization (SEO) on the company’s websites—terms such as “cancer,” “diabetes” and “cholesterol”—imply that the firm’s products are intended for use to treat such diseases and conditions, even though those products have not been reviewed for such uses by the FDA.

Although these particular circumstances do not directly involve medical devices, the FDA’s warnings have broader implications for how medical device manufacturers should manage their online marketing and product claims. All aspects of a medical device manufacturer’s online marketing, even those as seemingly innocuous as metatagging and SEO strategy, should align closely with the indications for use and therapeutic claims statements associated with the firm’s valid Premarket Approval (PMA). Clearly, US regulators consider online activities as fair game for monitoring.

Stewart Eisenhart


  • Stewart Eisenhart