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FDA Cracks Down on Online Claims

The FDA is cracking down.

It’s been a tough year on the advertising front, at least for food and drug companies.  As part of an Obama-backed, pro-active approach to regulation enforcement, the Food and Drug Administration has been cracking down on product information and claims. As a result, a number of companies have received warning letters indicating that certain of their marketing claims on their websites are not compliant with the FD&C Act, particularly section 403(r)(1)(A).

Presumably, everyone supports the idea of advertising with integrity and honesty — but regulators and marketers often have differing views about what language is permissible.  What do the companies themselves say?  Many companies will probably object to the FDA’s statements. And that’s where PageFreezer comes in.

Not because we are lawyers (we aren’t), and not because we have any authority over the rules and regs of marketing claims (we don’t) — but because PageFreezer can provide defensible, accurate records that verify the exact online activity of any of our clients on any given day. This eliminates one man’s word against another and ensures that our clients have easily-accessible archives that can be viewed as if they were live.

Think it won’t happen to you?

In a modern claims-skeptical environment, many businesses will have to answer challenges about their marketing vocabulary, as was recently noted on a health news website. The same article quotes Ivan Wasserman, a Washington DC-based advertising and labeling attorney at Manatt Phelps & Phillips:

Even for companies working diligently to accurately communicate the health benefits of their products, it seems like it is becoming almost inevitable that if you have success in the market at some point you will find yourself defending a class action.

We have the tools you need.

PageFreezer is proud to offer an innovative solution to the pressing issue of regulation-compliant website archiving. We provide a digital timestamp and digital signature to each archived page, as required by the FDA’s 21 CFR Part 11 guidelines. So our clients have the security of defensible evidence when it comes to the contents of their websites.

The FDA and the marketing departments may disagree on the definition of acceptable advertising.  And no one can agree as to the motivations behind the endless litigation.  But everyone can agree on the benefit of reliable website record-keeping — brought to you by PageFreezer.

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