Regulatory Focus™ > News Articles > FDA Website Knockoff Markets Non-FDA-Approved Products

FDA Website Knockoff Markets Non-FDA-Approved Products

Posted 28 April 2014 | By Alexander Gaffney, RAC

In the mid-1990s, when "The Internet" was still in its infancy and government institutions were just beginning to develop an online presence, the world got perhaps its most notable look at how some purveyors will seek to profit off of website confusion. Twenty years later, though, it's still a problem, including for US healthcare product regulators.

Background

The problem then, as now, is that many people aren't always sure about which domain name suffix- .com, .org, .gov, etc-they should use to access a website. For example, the correct address for the US White House is www.WhiteHouse.gov -not.com or .org.

But as it turns out, many people will simply enter whichever suffix seems to make the most sense. And in 1997, the ubiquitous suffix of choice was .com. But when well-intentioned people looking to access the White House website went to WhiteHouse.com, they stumbled upon not a web property of the office of the president, but instead a website peddling pornography.

Why are we Writing About This? Glad You Asked…

Even today, government institutions like the US Food and Drug Administration (FDA) deal with similar suffix-based problems.

Take for example FDA.org, a website which could at first glance appear to be a poorly designed government website. Calling itself the "Center for Health and Wellness," it features links to information on FDA regulation, clinical trials, compliance and recalls.

But also included on the website are links to more than a dozen treatments which purport to help weight loss, support smoking cessation efforts, treat menopause, and clear one's skin of acne. None of the purported treatments have obtained FDA approval despite some using claims restricted to approved medicinal products.

Acne, for example, is a medical condition. Therefore, under 21 USC 321, any product purporting to treat it would, by definition, be a drug or device subject to FDA regulation.

While the website is unlikely to fool many people, its lack of prominent disclaimers on its main page may result in some consumers, and in particular older consumers who may not be as familiar with the Internet, becoming confused.


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