Warning Letter (To General Mills from the FDA regarding Cheerios)

FDA ^ | 05/05/2009 | W. Charles Becoat

[ontap]

Well! I will finally come out of this deep depression I've been in since reading that first Cheerios box. I am very much at ease knowing the FDA has been on top of this dastardly deed.

[Ironfocus]

Here we go, no more tea parties, from now on it will be Cheerio parties. What a bizarre parallel between the two.

[Ultra Sonic 007]

Scientific studies seem to have fallen on the spectrum of ‘it does’ to ‘not as much as advertised’.

[Hodar]

When researchers pooled the results of the studies, they found people who ate whole-grain oatmeal had lower total cholesterol and LDL cholesterol levels compared with those who ate refined grain foods. The average reduction in total cholesterol levels was 7.7 mg/dL and the average reduction in LDL cholesterol levels was 7 mg/dL. link

Doesn't sound like BS to me.

[TheOldLady]

Dear Ms. Wisecup:
Please F Off.
Respectfully With all due respect,

There, fixed it.

[Jeff Head]

Official FDA Letter to General Mills CEO

To Ken Powell Chairman of the Board and CEO from W. Charles Becoat, Director, Minneapolis District FDA.

[jurroppi1]

I believe the warning letter is legit. Most likely the beef they have is that the claim made by General Mills is that it will reduce your cholesterol level by a certain amount when taken (consumed) as prescribed (labeled). If they merely stated it MAY help when eaten in conjunction with a healthy diet containing fruits, grains and nuts, etc... as the CFR states, then they could get away with it.

I believe the claim used to be worded that way, but they (General Mills) decided to be more aggressive in their advertising and that’s when things went awry.

Looks like other similar warning letters I’ve seen. I work in the implantable medical device industry, so I’ve seen my share of warning letters both to the company I work for and to our competitors.

[clee1]

All of them.

[Mrs. Ranger]

“Your response should include any documentation necessary to show that correction has been achieved”

Change the box. Change the website. Send the bill for said changes to Mr. Becoat as requested above. ;P

[rightwingintelligentsia]

I understand he plans to relent if they rename the cereal “Obama-os”.

[Freedom56v2]

Cereal killers!
————————————————————\
Really!!

I am picturing the CheeriOs box with the “Obama O” on the box.

I am not good at photo-shopping stuff into posts, but anyone out there, feel free!

[kb2614]

At least I know what I’ll do after President Unicorn destroys the economy. I’ll be an illicit Cheerios dealer!! With my not yet made Cheerios bong, you can now smoke it!! I’ll even expand my market. Need to freebase some Count Chocula?? A speedball made out of Cheerios and Capt. Crunch?? The money will be rolling in!!

[Seruzawa]

Actual drug companies make continuous false and misleading claims on TV all the time. Maybe General Mills needs to offer some double-dip stay-at-home retirement jobs to FDA officials.

Works for El Lily.

[mvpel]

If it’s a bullshit claim (and let’s face it, it probably is), then it shouldn’t be on the box or in their commrecials.

It's not a BS claim. It's been clinically proven and substantiated.

---

Oat products and lipid lowering. A meta-analysis - C. M. Ripsin, J. M. Keenan, D. R. Jacobs Jr, P. J. Elmer, R. R. Welch, L. Van Horn, K. Liu, W. H. Turnbull, F. W. Thye, M. Kestin and al. et

Department of Family Practice and Community Health, University of Minnesota, Minneapolis 55414.

Twenty trials were identified. Using the methods of DerSimonian and Laird, a summary effect size for change in blood total cholesterol level of -0.13 mmol/L (-5.9 mg/dL) (95% confidence interval [CI], -0.19 to -0.017 mmol/L [-8.4 to -3.3 mg/dL]) was calculated for the 10 trials meeting the inclusion criteria. The summary effect size for trials using wheat control groups was -0.11 mmol/L (-4.4 mg/dL) (95% CI, -0.21 to -0.01 mmol/L [-8.3 to -0.38 mg/dL]). Calculation of Keys scores demonstrated that substituting carbohydrates for dietary fats and cholesterol did not account for the majority of blood cholesterol reduction. Larger reductions were seen in trials in which subjects had initially higher blood cholesterol levels (greater than or equal to 5.9 mmol/L [greater than or equal to 229 mg/dL]), particularly when a dose of 3 g or more of soluble fiber was employed. CONCLUSION--This analysis supports the hypothesis that incorporating oat products into the diet causes a modest reduction in blood cholesterol level.

[Sloth]

If it’s a bullshit claim (and let’s face it, it probably is), then it shouldn’t be on the box or in their commrecials.

I didn't read the whole thing, but I don't think FDA is saying the claim is false... just that Cheerios shouldn't be making the claim even if it's true.

[RC2]

I know......it’s time to take our government back. Now they are looking at hiring 250K more people. Guess who is going to pay for that.

[thefactor]

I see a difference between “Cheerios lowers cholesteral!” and “Some ingredients in Cheerios have been shown to lower cholesteral.”

[madinmadtown]

Based on the first three and a half months of the current administration’s overreaching and rampant disregard for rule of law and the Constitution, I believe that we should be wary of all warnings coming from Washington. If anything, recent history would suggest that we haven’t been agitated enough.

[adm5]

They can have my Cheerios when they pry them from my cold, dead cereal bowl.

+1

[bboop]

I think Cheerios should just add the words — “May not be true”— at the top. Or maybe, “Use at your own risk.” I like what Bill Handel does at the end of his show (Talk Radio) — “We apologize to xxx, xxx, xx and anyone else who might be offended.”) It could be similar.