The FDA tells Purell to stop claiming it can prevent Ebola | Hacker News Reader

The FDA tells Purell to stop claiming it can prevent Ebola

washingtonpost.com

35 pointsoropolo8 comments

What a colossal failure of regulation. A strongly worded letter, ha! Outright lies in medical advertising ought to cause the parent company's entire product line to be pulled from shelves for 6 months.

This is a pretty ignorant statement for a lot of reasons.

If you look up the term "FDA warning letter" you'll find out that it's not just a communication... it's a step in the process that may result in sanctions, fines, or even the ultimate punishment of being ordered to exit business.

How often do these things get beyond the first step? Large companies can make unsubstantiated claims with relative impunity. Remember when Cheerios got away with claiming they lower cholesterol? They changed the wording slightly.

> Our delicious O’s are made from whole grain oats which contain beta-glucan, a soluble fiber that can help lower cholesterol as part of a heart healthy diet

Vodka, combined with a healthy diet, can help lower cholesterol. Their latest scandal, BTW, is that the cereal contains glyphosate.

I've had it with this crap. The government shouldn't be this toothless. Enforcement actions for certain transgressions should start with being ordered to exit business, not end there.

A vodka would not be able to claim that. The FDA allows the “part of a heart healthy diet” language only if the food could actually be part of that diet and the claim can be supported. Cheerios meets that qualification but alcohol does not.

I recommend reading about how the FDA operates.

You're assuming that this "first step" has no impact. It does, and a company that receives one of these letters must undertake measures to correct the problem ($$$) or else face worse sanctions.

Getting a warning letter can also hit a company's stock price, cause a reshuffling of management, and other results.

You may not be aware of this but the FDA has armed agents (OCI) and the stories I've heard about when they show up are pretty scary. This "letter" is an early step of an escalating process.

Everywhere I've worked in the life sciences has bent over backwards to follow the rules. And as far as I can tell the Agency has a lot of antibodies against attempts to game the system, which is common, but if you follow the rules they are pretty helpful.

(I've also heard that nothing I said above applies to the ""F" -- "food" -- side of the FDA, but that's hearsay).

FDA sent a similar warning to 23&Me and later shut down their operations (and Anne Wojicicki later admitted she didn't take the warning seriously enough). These are not trivial.

I got once a notice, not even a warning letter but just a request for a missing sheet of paper in a 1600+ page submission. I mentioned it in the next board meeting and my board wanted to know how many minutes it had taken us to respond to the FDA's fax.

When 23andMe got their warnings there was much outcry in the Valley (and on HN) that the FDA was "not receptive to new technologies". But 23andMe took weeks to respond and when they would they often didn't even address the issues raised. The FDA bent over backwards for them because they were a new kind of technology -- those of us making real drugs got no such leeway.

BTW they weren't shut down but were prohibited from making unsubstantiated claims. If you want to print "use of this product will not cause you to grow a third arm" you would have to design a trial to support that claim even if the product is a tongue depressor. FDA will actually let you claim anything as long as you have demonstrated it to their satisfaction.

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