Jun 6, 2009

Recent FDA actions

A couple of questionable moves by the FDA have made the press recently.

FDA cracks down on Cheerios health claims and sends them a warning letter:

According to a letter from the FDA General Mills' advertising violates the federal Food, Drug and Cosmetic Act. The agency said claims that Cheerios ingredients can lower cholesterol within a certain amount of time, all while providing cancer-fighting and heart-healthy benefits, essentially makes Cheerios "a drug" by their definition. And no drug in this country can be legally marketed without an approved new drug application.
The company claims what they say is the truth, you just can't say it because Cheerios isn't classified as a drug, which the FDA considers misbranding. I'll save my criticism because you can run through it just as easily in your head as reading it here.

And Megan McArdle criticizes the FDA over the new asthma inhalers:
And testing these things on only mild-to-moderate asthmatics for short periods of time, which is all the FDA did before phasing them out, seems borderline criminal.
This claim doesn't sound like a sound practice by the FDA, you test extreme cases, not the easy ones. That is the whole point of verification and validation.

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