FDA FInally Acts

[jburns]

But the target is Cheerios, for the same reason they are about to ban E-cigs. You can not make any health claims in your advertising without it being declared a drug by the FDA.





WASHINGTON (AFP) – Popular US breakfast cereal Cheerios is a drug, at least if the claims made on the label by its manufacturer General Mills are anything to go by, the US Food and Drug Administration (FDA) has said.
"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," the FDA said in a letter to General Mills which was posted on the federal agency's website Tuesday.
Cheerios labels claim that eating the cereal can help lower bad cholesterol, a risk factor for coronary heart disease, by four percent in six weeks.
Citing a clinical study, the product labels also claim that eating two servings a day of Cheerios helps to reduce bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol, the FDA letter says.
Those claims indicate that Cheerios -- said by General Mills to be the best-selling cereal in the United States -- is intended to be used to lower cholesterol and prevent, lessen or treat the disease hypercholesterolemia, and to treat and prevent coronary heart disease.
"Because of these intended uses, the product is a drug," the FDA concluded in its letter.
Not only that, but Cheerios is a new drug because it has not been "recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease," the FDA said.
That means General Mills may not legally market Cheerios unless it applies for approval as a new drug or changes the way it labels the small, doughnut-shaped cereal, the FDA said.
General Mills defended the claims on Cheerios packaging, saying in a statement that Cheerios' soluble fiber heart health claim has been FDA-approved for 12 years, and that its "lower your cholesterol four percent in six weeks" message has been featured on the box for more than two years.
​

 

[Vicks Vap-oh-Yeah]

That means General Mills may not legally market Cheerios unless it applies for approval as a new drug or changes the way it labels the small, doughnut-shaped cereal, the FDA said.

General Mills defended the claims on Cheerios packaging, saying in a statement that Cheerios' soluble fiber heart health claim has been FDA-approved for 12 years, and that its "lower your cholesterol four percent in six weeks" message has been featured on the box for more than two years.
​

The emphasis is mine.......and I'll say it again......CHANGES THE WAY IT LABELS.............


Soooooo, if they can offer this alternative to Cheerio's, they have to offer it to all.......fair's fair, right?

Stop the health claims, market the PV as a novelty device for adult smokers, and we win, right?
Yes, I know this is simplistic, but it might be an arguement we can use, or the ECA is getting at in self-regulation.....

Hmmmmmm food for thought? I'm gonna have a bowl of my new drugs, now...

 

[OldBiker]

Amazing how hard the government works to protect us isn't it.

 

[DarthVaper]

Wow. Whats next? oatmeal? Cheerios purchasable at pharmacies for $100 dollars a box? Cheerios has the research to backup their statements. But somehow the FDA always has to "approve" everything. I wonder how much poptarts paid them to look into this. And how much Phillip Morris and RJ reynolds are investing to ban e cigs.

 

[ccure]

Amazing how hard the government works to protect us isn't it.

LOL, yes, It is amazing.

Vicks-Vap, changing the way it is labeling may work for Cheerios; they do not have Nicotine!

I think the nicotine on our liquid is also a problem for the FDA. And the Big tobacco and Big Pharma!

 

[twolostminds]

Amazing how hard the government works to protect us isn't it.

Our tax dollars at work. lol

 

[Kate51]

Honestly, I just heard this on Hannity, could not believe it.
What is the FDA doing, have they got their wires crossed or what!!!
A food product cannot be advertised as "heart healthy" because they have
not been designated as a drug??? These people are drug nuts.
Speaking of nuts, has anyone heard the all-clear on PECANS, really would like some.
Guess the PEANUTS are ok too, don't know. Course, those aren't drugs, either, so what the heck is going on NOW!!!!!!!
FED UP WITH 'EM ALL

 

[jburns]

Honestly, I just heard this on
A food product cannot be advertised as "heart healthy" because they have
not been designated as a drug???

Actually "heart healthy" would be fine. Here is the problem statement:

"Cheerios labels claim that eating the cereal can help lower bad cholesterol, a risk factor for coronary heart disease, by four percent in six weeks."

That statement is much to specific. There apparently is not enough research available to back up the 4% in 6 weeks claim. The FDA is basically saying, "prove it", change the label or stop selling the product.

 

[taz3cat]

Darn my cheeros just went bad, from food to drugs in the blink of the eye. None of us ever knew what drug addicts, we were till the FDA really got on the ball.

I told my hubby he could not eat oatmeal any more because was going to be the next drug.

I bet they get Tony the Tiger on Frosted Flakes on the hit list too. I hope they don't put him in jail, for the children's sake. It will break thier hearts.

 

[TropicalBob]

And that's an entirely proper action by the FDA (referring to JBurns last post, since Taz jumped in seconds before I posted).

Make no claims you can't prove -- and all will be fine. But what's done is done, and e-smoking has had some really unprovable claims made in order to sell products.

 

[antok]

You know, a more important thing that nobody seems to have noticed that's even more worrisome than just the label issue is the confirmation of something I had read a while back. According to the FDA, if you use or market ANY substance for the purpose of treating an illness, injury or disease, it MUST be considered a drug. Makes no difference if it's man-made, appears in nature, etc. Makes no difference if there's boatloads of proof even backing up a claim of effectiveness to prevent or cure an illness. I honestly thought it was simply an out-there hypothetical that if Dole or whoever put on their box "Oranges, naturally high in Vitamin C, can help prevent or alleviate scurvy (an almost unheard-of condition in the US resulting from a lack of vitamin c in the diet)," then not only would they be busted out by the FDA for making such a claim, but that orange juice would be considered a "drug".

That letter's statement "Because of these intended uses, the product is a drug," is the real cause for worry. Sad but true that the FDA has the magical powers to appoint something a "drug" simply because of it's "intended use."

If they had their way (and it looks like they're starting to be more bold in getting it,) they would push for more and more stringent control over every little thing. Power move all the way? I'm not a conspiracy theorist (much), but I can see "food" being declared a "drug" because someone makes the claim that it prevents the "medical condition" of malnourishment. They slap the term medical condition or even better "disease" on something, then the ONLY thing that can claim to have any effect on it's treatment, prevention, etc. is by definition a drug and under their purview. Regardless of how ludicrous or obvious it is.

This disturbs me even more than the ludicrous attempt to ban e-cigs "for our own good."

 

[Smokin'Sandy]

>snip<
I'm not a conspiracy theorist (much), but I can see "food" being declared a "drug" because someone makes the claim that it prevents the "medical condition" of malnourishment.

For some reason that struck me as horrifically funny! 8-o

Really, where is the line they have created and when are they crossing it? How can anyone tell? I think they are coming close when they have reached an area of pure idiocy.

 

[youfillintheblank]

If they did hit Frosted flakes, and sold it at prescription drug prices, Tony the Tiger would be on the box saying "They're fffffffff*cking expensive!"

Darn my cheeros just went bad, from food to drugs in the blink of the eye. None of us ever knew what drug addicts, we were till the FDA really got on the ball.

I told my hubby he could not eat oatmeal any more because was going to be the next drug.

I bet they get Tony the Tiger on Frosted Flakes on the hit list too. I hope they don't put him in jail, for the children's sake. It will break thier hearts.

 

[Vicks Vap-oh-Yeah]

If they had their way (and it looks like they're starting to be more bold in getting it,) they would push for more and more stringent control over every little thing. Power move all the way?

The corralary here isn't that the FDA is getting bolder, its that Americans are classifying more and more "conditions" as medically treatable....

30 years ago, children that were hyper in school were just that: hyper.....take 'em off the sugar, push 'em outside to run off the excess energy, and voila - kid ready to work again... Now we pump these kids full of Ritalin and label them as ADD.

Heartburn used to be treatable with a dose of milk or other calcium diritive, or the sufferer learned not to eat certain foods....now the little purple pill (that you need to take every day for the rest of your life!!!) is the answer...

Need I go on?

 

[funkyness]

Wow. Whats next? oatmeal? Cheerios purchasable at pharmacies for $100 dollars a box? Cheerios has the research to backup their statements. But somehow the FDA always has to "approve" everything. I wonder how much poptarts paid them to look into this. And how much Phillip Morris and RJ reynolds are investing to ban e cigs.

HAHAH great comment!!! The FDA is being ridiculous, seriously!!! I understand the need for food and drug safety, and even the need to test ecigs (although i feel it will end up with an unwarranted ban) but CHEERIOS!!!!! they are heart healthy, im sure they've paid good money for the research behind it too. Poor Cheerios thought they got the green light 12 years ago to make certain claims, now this?

 

[Jim Davis]

And that's an entirely proper action by the FDA (referring to JBurns last post, since Taz jumped in seconds before I posted).

Make no claims you can't prove -- and all will be fine. But what's done is done, and e-smoking has had some really unprovable claims made in order to sell products.

Hey Bob.

I got an extra unused bag of 36mg Cheerios, I'll swap for a bag of 36mg Fruit Loops. (Coco Puffs will be considered.) (The starter kit contains a spork)

 

[Txrider]

You know, a more important thing that nobody seems to have noticed that's even more worrisome than just the label issue is the confirmation of something I had read a while back. According to the FDA, if you use or market ANY substance for the purpose of treating an illness, injury or disease, it MUST be considered a drug. Makes no difference if it's man-made, appears in nature, etc. Makes no difference if there's boatloads of proof even backing up a claim of effectiveness to prevent or cure an illness. I honestly thought it was simply an out-there hypothetical that if Dole or whoever put on their box "Oranges, naturally high in Vitamin C, can help prevent or alleviate scurvy (an almost unheard-of condition in the US resulting from a lack of vitamin c in the diet)," then not only would they be busted out by the FDA for making such a claim, but that orange juice would be considered a "drug".

That letter's statement "Because of these intended uses, the product is a drug," is the real cause for worry. Sad but true that the FDA has the magical powers to appoint something a "drug" simply because of it's "intended use."

If they had their way (and it looks like they're starting to be more bold in getting it,) they would push for more and more stringent control over every little thing. Power move all the way? I'm not a conspiracy theorist (much), but I can see "food" being declared a "drug" because someone makes the claim that it prevents the "medical condition" of malnourishment. They slap the term medical condition or even better "disease" on something, then the ONLY thing that can claim to have any effect on it's treatment, prevention, etc. is by definition a drug and under their purview. Regardless of how ludicrous or obvious it is.

This disturbs me even more than the ludicrous attempt to ban e-cigs "for our own good."

ROFL...

How about water...

Water, a liquid used to prevent dehydration and related conditions including death.

I can see the FDA's point, but they have a lot more dangerous issues to deal with that they are not doing such as chemicals in imported food and inspection of food and drug plants etc. to be wasting time on cheerios.

 

[antok]

The corralary here isn't that the FDA is getting bolder, its that Americans are classifying more and more "conditions" as medically treatable....

30 years ago, children that were hyper in school were just that: hyper.....take 'em off the sugar, push 'em outside to run off the excess energy, and voila - kid ready to work again... Now we pump these kids full of Ritalin and label them as ADD.

Heartburn used to be treatable with a dose of milk or other calcium diritive, or the sufferer learned not to eat certain foods....now the little purple pill (that you need to take every day for the rest of your life!!!) is the answer...

Need I go on?

About that first statement, it's not the American people who have the power to declare something a medical condition or disease. That power rests with the FDA. The FDA, which is financed, supported, and influenced largely by the pharmaceutical industry (feel free to do your own reading on that one) is tasked with declaring as many things as it can to be medical conditions or diseases, because once they do, the ONLY thing that can make ANY claim with respect to it's treatment or alleviation is by definition a drug. And guess who makes and makes money on the drugs?

Good examples are your mentioning the proliferation of drugs for "hyperactivity" and ADD. Good money-makers, those.

True, too, about the condition formerly known as heartburn. Now "acid reflux disease" has it's own drugs and God forbid you claim something else works on it. Best solution I know of for heartburn is still a half-teaspoon of baking soda dissolved in water. 30 seconds and one burp later, heartburn's gone. Wonder if Arm & Hammer still mentions that on the box.

 

[antok]

For some reason that struck me as horrifically funny! 8-o

Really, where is the line they have created and when are they crossing it? How can anyone tell? I think they are coming close when they have reached an area of pure idiocy.

Heh, true. It would be nice if those who have the power spent more of their time on common sense rather than dollars and cents. Or that common sense was more common?

 

[rav]

Damn....I forgot to pick up a prescription for my cheerios this weekend...what will I eat now??? Do you think my doctor would consider that an emergency so I can call his cell phone?