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FDA to General Mills: Your Marketing Has Made Cheerios Into A Drug

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Do you want to know something about Cheerios that, until recently, General Mills didn't know? Of course you do. Cheerios is a drug. No, really. The WSJ Health Blog says that General Mills made a slight, um, let's call it a "miscalculation" when they were drafting their marketing speech and by claiming that Cheerios is "clinically proven to lower cholesterol," they inadvertently "cause[d] it to be a drug." Whoopsies!

The FDA says, in a letter to General Mills:

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.

The letter continues on to say that Cheerios "may not be legally marketed with the above claims in the United States without an approved new drug application."

Is it wrong that we desperately want to read such an application?

FDA Warns General Mills: Cheerios Is a Drug [WSJ]
(Photo:Superchou)

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104
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I'm not sure if I should comment on General Mills here for their absurd marketing claims, or th FDA for their absurd demands.

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This is awesome. I really do wish that the FDA would similarly-snarky smack-downs onto other companies who market things that are "clinically proven". As someone who was a clinician, I can tell you that "clinically proven" doesn't mean much unless you're dealing with hundreds of trials.

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..."would lay similarly-snark smack-downs". I forgot to get laid. :(

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Great. Now can the FDA please do the same for probiotic yogurt, antioxidant tea, antioxidant juice, vitamin water, and high fiber V8?

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Kids, in every box you'll get a prize...one of 10 Authentic Drug Reactions and Site Effects Data Sheets! Approved by the FDA! COLLECT THEM ALL!

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Side effects include: inability to stop slurping and the urge to do this: [cuteoverload.files.wordpress.com]

Also, you may experience some asthma, chest pains, and sudden lack of breathing.

Cheerio!

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Could this be that "new drug" that Huey Lewis sang about all those years ago??

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I completely understand the FDA's reasoning for this. But I wonder if the FDA acknowledges that the regular consumption of whole grain oats is a natural cholesterol eradicator (but, of course is not a substitute for regular medical screening)? If so, I don't see a problem with Cheerios' claim - except you will always have those few ding-dongs who will try and eat Cheerios once a day instead of taking their cholesterol-lowering Rx.

I eat a packet of instant oatmeal everyday for breakfast (and have a habit of eating Walmart-brand honey nut Cheerios as a snack at home) and my cholesterol is so low it's barely even on the chart at all. My doc is really happy about that.

Then again, I'm 25 and not 49 like my old man.

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Hrm. I think that if they just put on the box that they're cheerios and one of the most delicious cereals to eat dry, that would be enough. I know it's enough for me.

If I was worried about my health, I wouldn't be eating boxed cereal anyway.

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But they probably should remove the words "clinically proven" and say something about oats in general being proven to naturally lower cholesterol.

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I'm glad to see this. Usually I'm not for the govt stepping in and telling us what we can and can't do and such... But lately companies have just been going overboard with their advertising and I think the govt needs to step in and tame this crap down.


You have this example right here, and I personally think food places should be held for their advertising as well.

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Yeah, I got the money.


Show me the Cheerios first.

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@djanes1: And, for the love of god, "Male Enhancement" pills?!?

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Hahahahahahaaa!

Oh, I have no other immediate response than giddy laughter.

FDA + FTC, heart you.

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I always figured it was "proven to lower cholesterol" when it is used to replace the bacon and eggs and Jimmy Deans sositch you would ordinarily be eating for breakfast.

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@Vanilla5: The FDA DOES allow foods to make (true and substantiated) health-related claims, but those claims are EXTREMELY strictly regulated (language you can use, where on the box it can appear, etc.). Cheerios claims simply went over the line; Cheerios has been pointing out its health benefits for years, well in line with FDA regulations. This latest round went too far and put them outside the rules for "healthy food" and into the rules for "drug."

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Here's a handy chart of FDA-allowed health-related claims about food that manufacturers can make:

[www.cfsan.fda.gov]

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Great. Now teenagers across the country are going to be swiping Cheerios from their parents' pantry.

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@litrock: Yeah, seems to me Cheerios pretty much sell themselves, especially when you consider that they're the first solid food many of us eat. In my mind they're synonymous with healthy, universal-appeal cereal (whether or not that's actually true).

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@Coles_Law: Snorting Cheerios will become the next big thing at parties. (Hit 'Enter" instead of 'preview')

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@pete7919: The demand seems pretty reasonable, if only a bit snarky.

"Stop marketing it as curing heart disease, or file an application to classify it as a heart disease cure, IE a drug."

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@Eyebrows McGee (popping ~May 29): That's what I was figuring with the whole "clinically proven" business.

Let any company tell it, everything is "clinically proven" by their "rigorous studies" - that the marketing department conducted in the mall and on napkins at the bar.

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@EarlNowak: Why is Enzyte still advertising on TV? I thought they were shut down?

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The FDA does the same thing to vitamins. They cannot claim that vitamins do a dang thing to help your body otherwise it's a drug and cannot be sold without the FDA's all knowledgeable involvement.

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@Coles_Law:

- "These Cheerios yours, son? Your mother said she found this box in your closet. Where did you get it? Answer me! Who taught you how to do this stuff?"

- "YOU alright!? I learned to eat Cheerios by watching you!!!"

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I love Cheerios. The cereal has been around for so long that every grocery store I go to has their own dirt- cheap generic version. I wish Wheaties would finally surrender to the generic world; Raisin Bran, Wheat Chex and Rice Crispies have.

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@Darrone: Imagine if they did that. See the big pharmacy machines dispensing "perscriptions" of thousands of cheerios.


I'm guessing it's fine if they just drop the "clinically" part though.

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@Coles_Law: Now all the bowls at the pharming parties will need is a splash o' milk.

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I'm glad to see the FDA going after these compaines, now go after "Smilling Bob" and his magic man pills.

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Does this mean I'll have to show my ID when picking up a couple boxes.

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I'd like to know the lethal dose of Cheerios...

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What would be funny (and never happen) is if General Mills took the FDA to the mat and filed the application!

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I grind that shit up and snort it. But it didn't work so well, so now I just get high on Life.

*rimshot*

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Cheerios is a gateway drug. Pretty soon, you'll be jonsing for a nickle bag of Kix, and it's all downhill from there. Anyone want to do a line of Frosted Miniwheat scrapings?

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@wheresmymind: That's why I drench mine in honey before I put the milk on. Too much health makes my head spin.

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I figured there was something addictive about them by the way my 2 year old snarfs them down.

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The FDA did not need to throw this onto General Mills. The only reason the FDA would have even consented to categorize Cheerios As a Drug is IF GM went to them for FDA Approval. If they did and were denied the disclaimer would read: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." Substantiation will be needed from GM to provide the FDA if it really through at least 2 clinical studies that prove it can "lower cholesterol".


Trust me... I do BS&P for a living ladies and gentlemen.

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@djanes1: The yogurt, tea, juice, etc. folks are allowed to make vague (but substantiated) claims as long as no specific condition is mentioned. If you want to mention a specific condition, it has to be on an FDA-approved list and worded in an FDA-approved way.

Good: Promotes digestive health (probiotic yogurt)
Bad: Reduces constipation

Good: Contains anti-oxidants for a healthy lifestyle.
Bad: Prevents cancer.

You get the idea...

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With all of the fake scam diet products on the market, FDA is going after Cheerios??? I'm speechless. Seriously, completely befuddled. Wow.

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Nothing like a confluence of idiots!

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@pete7919: They don't actually expect General Mills to fill out an NDA, even though it is technically an option.

All Cheerios failed to do was word the claim properly so folks did not try and substitute them for their statins.

SirWired

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@m4ximusprim3: Or drown them in spoonfulls of brown sugar.

Mmm, it tastes so good.

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@sirwired: Great News! This surely means I can claim my kids' Cheerios on my Medical Flex Account -- Woohoo!, pre-TAX Cheerios!

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I just started eating it since its one of the few cereals out there that doesn't have HFCS..

Gotta go back to the basics to get the cereals that don't have HFCS. There are a few others however most cereals labeled as "healthy" contain HFCS...

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The FDA is understaffed and underfunded. I suspect therefore that this was a follow up on a complaint from a competitor.

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@babyruthless: But didn't ya know?? Skim milk is "clinically proven" to counteract osteoporosis.


Two drugs in one meal?? THAT'S ECONOMIC.

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@sirwired: Yeah, the claims have to be vague and only allude to medical claims. There are tons of silver-ion antimicrobial additive products that over-claim, saying they protect users from cross-infections and other such BS (truthfully you can't protect a user from infection with an antibacterial toilet, you only lower the risk that the toilet is going to let bacteria live there). Too bad the FDA hasn't cracked down on all of them yet.