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Cheerios an Untested New Drug

From the Food and Drug Administration:

Based on claims made on your product’s label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease. Specifically, your Cheerios® product bears the following claims ort its label: “you can Lower Your Cholesterol 4% in 6 weeks” […]

Working in the industry, I know a fair amount about these regulations, and the FDA is technically correct in its ruling.  But if this isn’t an example of the government being out of control, I don’t know what is.

13 Responses to “Cheerios an Untested New Drug”

  1. M Gallo says:

    Stellar; cGMP production of breakfast cereals is on the way, citizens!

  2. BadIdeaGuy says:

    You mean to tell me the 8 servings of cheerios per day I’m eating aren’t reducing my cholesterol 32%?

    I’d agree that technically they’re making a medical claim, but that anyone using it as a medicine is insane.

    Plus, with alll the laws that go unenforced, to pick this to enforce fully is bizarre.

  3. Graumagus says:

    I’ve been chopping up Cheerios and snorting them off a mirror for years…

    Speaking of which, I need to call my dealer and score another 8-ball of Honey-Nut.

  4. Ian Argent says:

    Wonder if General Mills is going to have to comply with 21 CFR 11? (My personal exposure to which was a letter from our customer that said the ticketing system we were using was not covered by 21 CFR 11 so we could keep being sloppy; but my wife has done work for Merck that was, and a friend of mine is in Pharma robotics).

  5. Aaron says:

    I can see the spam now: “GENERIC CHEERIOS CHEAP ONLINE NO PRESCRIPTION!”

  6. BobG says:

    Sounds like a bunch of bureaucrats at the FDA don’t have enough work to keep busy.

  7. Ian Argent says:

    +1 to aaron

  8. Sennin says:

    “… promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease.”

    Does that mean that the water I drink, which is intended to prevent, mitigate, and treat dehydration, now falls under FDA control as a drug? Do I need a prescription?

  9. comatus says:

    Sennin, are you referring to dihydrogen monoxide?
    For God’s sake, don’t snort that stuff.

  10. Sebastian says:

    Water is GRAS. I’m not kidding either.

  11. Ian Argent says:

    GRAS? Not familiar with the acronym in this context

  12. Sebastian says:

    Generally Regarded as Safe. Lots of drugs, when the current FDA regime was implemented, were declared GRAS, like asprin and tylenol, which if they were to go through the process today wouldn’t make it as drugs. Asprin causes severe gastrointestinal side effects, and tylenol can fry your liver at not much higher than the recommended dose. But they are GRAS, because they were regarded as safe before all this crap was implemented.

  13. Ian Argent says:

    Thanks for the reminder. I’ve known for a while that aspirin and tylenol would be unlikely to be approved under the current guidelines (IIRC, Paracetomol (generic tylenol there) is *not* an OTC drug in Britain because of the side effects).

    It’s a shame the system is set up such that the career-safest route for drugs is to be slow to approve and rapid to de-approve. (see Vioxx)

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