FDA Regulatory Compliance: Can You Prove What Your Website Said?

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Hanzo

If you’re marketing any pharmaceutical or medical device, the Food and Drug Administration (FDA) has its eye on you. More accurately, the FDA has its eye on your website and social media, checking to see what you’re claiming about the efficacy of your product and evaluating whether your claims are backed up with adequate evidence.

Should a regulatory agency challenge something currently on your website, it’s at least reasonably easy to prove or disprove that allegation. You can go to the live site, explain how it functions, and demonstrate where you have disclaimers and evidentiary support. But what if you’ve changed your site and you no longer have the contested content on it, or no longer have it in that format? Will you be able to point to functional, interactive website archives to prove that your former content was, in fact, in compliance with regulations?

Here’s what you’re up against.

The FDA Is Actively Investigating Websites and Social Media Accounts

The onset of the COVID-19 pandemic unleashed a flood of false claims involving supposed treatments, cures, and preventatives. Even now, the FDA continues to monitor both social media and company websites in search of advertisements about products that claim to prevent or resolve COVID-19. Of the 166 warning letters, the FDA issued and posted in the first quarter of 2021, 28 of those letters related to supposed COVID-19 treatments. Given the spread of disinformation about the virus, the agency is also encouraging citizens to directly report any unauthorized treatments they see advertised and is listing companies that it has warned on a website of fraudulent COVID-19 products

To take just one example from earlier this year—and a particularly colorful one at that—the FDA recently warned Everything Health LLC that its “CoronaBox” was an unapproved and misbranded product that claimed to prevent and treat COVID-19. In that letter, the FDA noted that it had reviewed the company’s website as well as its Facebook, Instagram, Twitter, and YouTube accounts, all of which “direct consumers to your website … to purchase your products.” Among the claims the FDA objected to were the statements “The Corona box is all you need to kick that nasty virus!” and “I am reversing corona by using GODS [SIC] MEDICINE CABINET.”

While that example is an egregious misrepresentation of a product’s efficacy, it’s not hard to see how the door is open for individuals to complain about advertisements—and how companies might be hard-pressed to prove that their online content complied with the FDA’s regulations. 

Regulatory Compliance Is Only as Good as Proof of Compliance

We often say that an organization’s compliance with regulations is only as good as its ability to prove compliance. Here’s how that could play out right now.

With the FDA encouraging people to report their concerns directly, a competitor or disgruntled former employee could easily take a screenshot of your website or social media and misrepresent your content in one of at least two ways. First, suppose that you provide all required disclaimers and evidentiary support for your claims, but you do so in an interactive text element. Perhaps you have to scroll down on the screen for a popup to appear, or maybe you have essential language in mouse-over text. However you access that content, it’s definitely there, it’s clear, and your customers can’t miss it—but a carefully chosen screenshot could. Alternatively, suppose we’re assuming a more nefarious actor. In that case, anyone could edit a screenshot or still image to make it appear as if you did not include warnings about your products or evidence for your claims, even though you clearly did. 

If you don’t have an interactive, fully functional archive of your website, how will you be able to prove—one or two or six months later, when the FDA gets in touch—that the required language was there?

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