Popular Cheerios cereal is a 'drug': U.S. FDA

[China]

Popular Cheerios cereal is a 'drug': U.S. FDA

WASHINGTON — Popular U.S. 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 U.S. 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 per cent in six weeks.

Click on the link for the full article

[ACW]

:doh:

How about going after the hucksters (Kevin Trudeau, Klee Irwin, Donald Barrett, etc)?

[No_Pressure]

The FDA needs to devote all of it's time and resources to the question of whether or not a breakfast cereal is a drug because it has alleged health benefits. This is the thing that's important. Cheerios. Yes.

[frostyj]

You can't take Cheerios to school anymore with the zero tolerance rule!!

"Wanna buy an oz of O's?"

[Stophovr6]

Way to go, don't worry about any of the legal speed being pedaled in this country, and marketed towards youth. Concentrate on Cheerios.

[SkinsHokieFan]

:doh:

Well I guess I better pick another ceral

[Larry]

So, a product that claims that, if taken, it will produce a medical benefit is . . . ?

[wysknz1]

I hope at least 30 days goes by till our next random..

[CrypticVillain]

Damn. Gotta go by my nephew a "Wizzinator." He can't stop eating them, he is hooked.

[Larry]

Good thing they didn't say anything about Honey Nut Cheerios.

I think that's the Official Cereal of Tailgate.

[Cooked Crack]

Cheerios can go change their boxes. Easy solution.

Good thing they didn't say anything about Honey Nut Cheerios.

I think that's the Official Cereal of Tailgate.

Don't even understand how people eat plain Cheerios.

[jpillian]

So I take it they'll be going after all the pro-biotic yogurts next? (off the top of my head, they make similar claims -- restore digestive health). Milk also is marketed for its ability to promote growth in children and slow osteoporosis. If a food making a health claim (eg. claiming medical benefit) from its consumption is the key criteria to the FDA treating it as a drug, they're going to busy.

Sounds more like someone at General Mills ticked someone off on Capitol Hill.

[Zguy28]

:doh:

How about going after the hucksters (Kevin Trudeau, Klee Irwin, Donald Barrett, etc)?

Actually, this is one (and probably only) thing that Kevin Trudeau is right about.

He says that in his book. Anything that makes a claim to cause a positive medical benefit is a drug in the FDA's eyes. That's why herbs have the words "may" in their labels.

We are such a messed up country.

[twist]

So I take it they'll be going after all the pro-biotic yogurts next? (off the top of my head, they make similar claims -- restore digestive health). Milk also is marketed for its ability to promote growth in children and slow osteoporosis. If a food making a health claim (eg. claiming medical benefit) from its consumption is the key criteria to the FDA treating it as a drug, they're going to busy.

Sounds more like someone at General Mills ticked someone off on Capitol Hill.

The food a person eats can have major effects on health, but claiming such doesn’t make food a drug.

Claims advertized on food products should be true. Is the claim made by the Cheerios box true? What standards were used when making such a claim?

[Corcaigh]

Cheerios can go change their boxes. Easy solution.

True. The FDA has even approved general statements for use, something along the lines of "soluble oat fiber is proven to lower LDL ... and can improve cardiovascular health ... etc"

Don't even understand how people eat plain Cheerios.

My kids love the Honey Nut variety. So dad out picking up some items at Giant at the weekend sees Cheerios on a big sale and buys two boxes ... of the plain type. Kids are disgusted. Dad finds they're very tasty if you ... pour actual honey on them.

[Hubbs]

I've heard that, if I eat a lot of fruits and veggies, that can lower my cholesterol, too.

Thus, fruits and veggies = drugs.

[jpillian]

The food a person eats can have major effects on health, but claiming such doesn’t make food a drug.

Claims advertized on food products should be true. Is the claim made by the Cheerios box true? What standards were used when making such a claim?

I think it will be interesting to see how the FDA explains this:

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 per cent in six weeks" message has been featured on the box for more than two years.

The first claim has been FDA-approved for 12 years. The second claim seems to be backed by at least some sort of clinical study, and has been on store shelves for more than two years.

Perhaps the FDA and General Mills have been tussling over the results of the study for the past two years and this is just the first public recognition of that squabble? :whoknows:

[Corcaigh]

I've heard that, if I eat a lot of fruits and veggies, that can lower my cholesterol, too.

Thus, fruits and veggies = drugs.

A long but excellent article by Michael Pollan, author of In Defense of Food, is here:

http://www.nytimes.com/2007/01/28/magazine/28nutritionism.t.html?_r=3&ei=5087&em=&en=ce28063f61d4a925&ex=1170219600&pagewanted=all&oref=slogin&oref=slogin

"Of course it’s also a lot easier to slap a health claim on a box of sugary cereal than on a potato or carrot, with the perverse result that the most healthful foods in the supermarket sit there quietly in the produce section, silent as stroke victims, while a few aisles over, the Cocoa Puffs and Lucky Charms are screaming about their newfound whole-grain goodness."

[ixcuincle]

Yeah, interesting how much fraudulent advertising is on those products which hasn't been backed up. It's just appealing to a growing number of "health-conscious" consumers, and I use the quotes because the buzzwords such as LOWER CHOLESTEROL are there, so consumers can pick it up. People should investigate further into what they consume, check the nutrition labels, or use common sense (like stay away from processed foods, the salt-laden chain restaurants, etc)

[ixcuincle]

A long but excellent article by Michael Pollan, author of In Defense of Food, is here:

http://www.nytimes.com/2007/01/28/magazine/28nutritionism.t.html?_r=3&ei=5087&em=&en=ce28063f61d4a925&ex=1170219600&pagewanted=all&oref=slogin&oref=slogin

"Of course it’s also a lot easier to slap a health claim on a box of sugary cereal than on a potato or carrot, with the perverse result that the most healthful foods in the supermarket sit there quietly in the produce section, silent as stroke victims, while a few aisles over, the Cocoa Puffs and Lucky Charms are screaming about their newfound whole-grain goodness."

These novel products of food science often come in packages festooned with health claims, which brings me to a related rule of thumb: if you’re concerned about your health, you should probably avoid food products that make health claims. Why? Because a health claim on a food product is a good indication that it’s not really food, and food is what you want to eat.

I just got In Defense of Food today and I'll be reading this to see what wisdom this intellectual has regarding food.

[SnyderShrugged]

The FDA is yet another bloated, useless department with a massive budget that rarely accomplishes its goals (which I think were worthy at its inception, btw)

[China]

Here's an interesting perspective from an e-mail I received:

OJ and Cheerios: A Good Start?

By Cole Werble

Orange juice and Cheerios are an archetypal American breakfast: a great way to start the day. And also, perhaps, a great way for a new leadership team at the Food & Drug Administration to start its tenure.

It is one of the ironies of leadership at FDA that the more the public views the head of the agency as a tough, anti-industry regulator, the more ambitious the agency can be in taking on initiatives that benefit the regulated industries.

Just as a generation ago (18 years being a good regulatory generation), a new young FDA commissioner, David Kessler, used an attack on orange juice labeling to establish the tone for his tenure in the public’s mind, the new Obama Administration FDA leadership – headed in the interim until Margaret Hamburg’s pending confirmation by Deputy Commissioner Josh Sharfstein -- is going after another iconic breakfast food to flex its muscle.

FDA’s warning letter to General Mills attacking Cheerios’ cholesterol claims can be read as a message to all food and dietary supplement manufacturers that make any type of health claims on their products: hew tightly to FDA’s claims regulations and approved language, or else. FDA claims that the reference to specific percentage cholesterol lowering claims push Cheerios labeling in the realm of new drug claims.

But the agency gets more from the action against a product like Cheerios than just a message to the food industry.

Because of the almost universal brand recognition for Cheerios, any action by FDA against the product is certain to stimulate broad public comment – from amusement to agreement. It is a great way to get FDA talked about, in terms of taking an action instead of reacting to an event. The publicity can re-establish FDA in the public’s eye as a force that is willing to take on big commercial products.

This is the new FDA leadership’s clearest message that things are going to work a little differently in the regulated industries than they have over the previous eight years. The warning letter could very well be the product of staff work that had been underway before Sharfstein arrived on the scene. Even in that case, the issuance of the letter shows how the staff interprets the priorities of the new FDA leadership.

General Mills uses a soluble fiber claim the agency approved years ago, but the agency says certain variations in the Cheerios labeling move it over the line. This is just a warning letter compared to a very large seizure action against the orange juice. But even FDA is not likely to try to take Cheerios out of the hands of toddlers for a labeling issue. That would risk way too much backlash from parents.

Tough on Orange Juice; Efficient on Drugs

Observers who followed FDA in the 1990’s are having flashbacks to the tenure of former commissioner Kessler, who used a major action against Procter & Gamble’s Citrus Hill brand of orange juice to announce that the agency would not tolerate claims that juice made from concentrate was “fresh.” In that case, the agency actually went as far as to seize a huge quantity of Citrus Hill.

At the time of the Citrus Hill affair, some former FDA officials expressed disbelief that Kessler and FDA would pick a time-consuming fight with P&G. To the skeptics, Kessler’s action was a worthless display of FDA’s power with little public benefit.

There are still people who feel similarly. To the suggestion in a recent blog post by RPM on the Cheerios action, one reader was skeptical and dismissive of any indirect, positive effects. “I can't believe how you could even kind of think this action resembles anything close to ‘good,’” the blog commenter wrote. “The FDA is not standing up for any righteous principle whatsoever. This is absolutely asinine. Our taxpayer dollars spent on this type of action. Ridiculous.”

The orange juice crusade did, however, set the tenor for Kessler’s term and gave him a platform and reputation of decisive regulator from which to undertake a range of initiatives at FDA – including getting user fees for drug approvals and speeding approvals of AIDS drugs.

As FDA says in its official biography of Kessler:

“Early in his tenure, he took action to protect consumers from misleading uses of the term ‘fresh’ in conjunction with processed or partially processed orange juice and tomato products, gaining himself the nickname ‘Elliot Knessler.’”

That nickname led to parodies of FDA inspectors breaking down warehouse doors to seize common products. But it also led to a solid position with the public which allowed FDA to make a political deal with industry to raise funds for drug reviews, gave Kessler a platform for creating an expedited approval process for AIDS medications, and put the agency in position to achieve its best drug approval records during the final years of Kessler’s term at the agency.

From outside the agency, Kessler is currently urging the new leadership to work on creating a new accelerated process for reviewing cancer drugs based on changes in the understanding of tumor identification.

There could be a silver lining to drug development from the FDA attack on Cheerios.

It’s a good time to enjoy your bowl of cereal tomorrow and reflect: the agency’s attack on an American icon may mark the start of something good for other FDA regulated industries.

[Thiebear]

Cheerios gave me 20/17 vision, cured my GBS and regenerated cartilage in my shoulder.

[Mickalino]

Cheerios gave me 20/17 vision, cured my GBS and regenerated cartilage in my shoulder.

I overdosed on Cheerios last night......I spent 3 hours in the ER, having the Doctors pump those oat grains out of my stomach.

[-Scar-]

Way to go, don't worry about any of the legal speed being pedaled in this country, and marketed towards youth. Concentrate on Cheerios.

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