Cheerios Warned about Health Claims

[quarky]

It seems that the health claims need to offer an 'instead of' addition. If you eat cheerios, instead of Lucky Charms, for instance. Cheerios is sort of a crappy food, anyway.

 

[Skeptic Ginger]

You're asking general questions about the regulatory environment, and the answers need to be nation-specific. Since you're asking in context of FDA, I'll assume you're talking about the US.

Basically, all products are covered by the Trade Act. Claims need to be truthful, regardless of the product.
....

Adding to what blutoski is saying here, the FDA has had a weak performance enforcing medicinal claims about food supplements during the Bush years. Typically product marketers push the envelope until they get scolded. They know that by the time the FDA or FTC rule against them, the message will have sunk into the public consciousness.

This kind of product lying has gone since products have been sold. Some of the more famous US cases have been Geritol (claims sounded like iron was going to give you energy), and Listerine, one of my pet peeve products. Listerine was one of the only products a retraction commercial was ever ordered made. They had to publicly retract the claims they'd been making that Listerine "prevented colds and flu."

Lot of good it did. People still think Listerine really does kill germs that matter. If you read the label, you'll find the 'germ killing alcohol' listed as an INACTIVE ingredient. They buried that fact by not printing "inactive" as a new paragraph. Clever bastards. And after losing a lawsuit filed by the dental floss association for falsely claiming Listerine "fights plaque", they added fluoride to the ingredients and got permission to keep making the claim.

What you typically see to get around the law are implied claims. Apparently if you say, "apply it to the forehead when you have a headache" but never say it actually relieves a headache, that falls under free speech rather than a false claim. "Lysol kills germs" implies it prevents disease. It doesn't prevent any more disease than cleaning does. "Airborne was invented by a school teacher that was exposed to kids' germs." That implies it has some related purpose. Guess what? Not actually claimed on the label that Airborne treats or prevents infection.

So it's in the wording rather than the claim that gets the FDA's attention. Perhaps other oat bran products are making more indirect claims.


This Cheerios ruling is a good sign the non-enforcement policy against false medical claims on food products might be reversed under the Obama administration.

 

[Skeptic Ginger]

No question active yogurt is effective for intestinal fauna - you could also just swallow acidophelous.

Adding an effective ingredient gives you a pass to make the claim the product itself is effective. You don't have to disclose that the product does nothing to enhance the active ingredient. That's exactly what the makers of Listerine did so they didn't have to quit saying their product was effective against tooth decay. And as I mentioned above, they've hidden the inactive ingredient list within the active ingredient paragraph to imply the inactive ingredients are actually important.

I highly recommend skeptics look at that tricky Listerine label for themselves.

 

[Skeptic Ginger]

It seems that the health claims need to offer an 'instead of' addition. If you eat cheerios, instead of Lucky Charms, for instance. Cheerios is sort of a crappy food, anyway.

The FDA rule is, to advertise a medical benefit, you have to provide evidence to the FDA that your product is effective for the medical claim you are making. There's a bit of a gray area with claims like "feel great", but decreasing heart disease or lowering cholesterol is not so gray.

The Cheerios claim stems from a single oat bran study that showed a very modest decrease in cholesterol if you ate oat bran. Oat bran became synonymous with "must be healthy" overnight thanks to the food marketing industry. I haven't looked at the FDA ruling yet, but it will be interesting to see what they have to say, if anything, about oat bran claims.

 

[Skeptic Ginger]

...
Kellog's was nailed last month for claims associated with Frosted Mini Wheats.

Apparently this one was from the FTC regarding turning your kid into baby Einstein.

Kellogg to settle FTC charges of false advertising

A proposed consent agreement would bar Kellogg from making misleading claims for its breakfast and snack foods and from misrepresenting studies, the FTC said.

Kellogg's national TV ads asserted that attentiveness improved nearly 20 percent in children who ate the cereal, compared with those who skipped breakfast, the FTC said. But the study the ads refer to found a benefit from eating Frosted Mini-Wheats in only half the children studied, and only 11 percent of the children's attention improved 20 percent, according to the FTC.

A settlement? They agreed to stop making the claim.

 

[blutoski]

From their website:



On the up side, they seem to place quite an emphasis on clinical trials and peer review.

They're vulnerable, although they may be able to argue that the bracketing with 'as part of a healthy diet and lifestyle' passage dilutes their claim as they're not saying their product actually makes a difference.

The same way all children's breakfast cereals claim they can be part of a complete breakfast. The reserve the fact that if you remove the cereal, it's still a complete breakfast, since the cereal contributes no nutrition itself. Pocket lint and brass tacks with juice, toast, and milk is a complete breakfast.


The other thing is that the FDA responds to complaints. There are billions of products, and they do not police on a product-by-product basis. Somebody will have to complain about Activia's claims before they are really required to respond.

 

[Skeptic Ginger]

Here's the actual FDA 'warning letter'. Like I said, a scolding, nothing that actually discourages envelope pushing.

May 5,2009; WARNING LETTER

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" "
• "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is ... clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol."

These claims indicate that Cheerios® is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia. Additionally, the claims indicate that Cheerios® is intended for use in the treatment, mitigation, and prevention of coronary heart disease through, lowering total and "bad" (LDL) cholesterol. Elevated levels of total and LDL cholesterol are a risk factor for coronary heart disease and can be a sign of coronary heart disease. Because of these intended uses, the product is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321 (g)P)(B)]. The product is also a new drug under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease. Therefore,under section 505(a) of the Act [21 U.S.C. § 355(a)], it may not be legally marketed with the above claims in the United States without an approved new drug application.

Further information indicating an "approved" health claim vs how the Cheerios' claim is worded:

In addition to the health claim authorized by regulation in 21 CFR 101.76, a health claim linking the consumption of whole grain foods to a reduced risk of certain cancers has been authorized through the notification procedure in section 403(r)(3)(C) of the Act. The authorized claim is: "Diets rich in whole grain foods and other plant foods ... may help reduce the risk of... certain cancers."2 Although the claim on your website also concerns whole grains and reduced risk of some cancers, it is different from the authorized claim in significant ways. For example, the authorized claim states that diets rich in whole grain foods and "other plant foods" may help reduce the risk for certain cancers. However,the claim on your website does not mention "other plant foods." Also, by using the language "especially cancers of the stomach and colon" the claim on your website emphasizes the relationship between whole grain foods and stomach and colon cancers as compared to other cancers, suggesting a greater degree of risk reduction or stronger evidence for the relationship between whole grain foods and risk of those two cancers. The claim authorized through the notification procedure does not emphasize the relationship between whole grain foods and stomach and colon cancer as compared to other cancers.

 

[jasonpatterson]

It's not very common. What medical claim is Danon making? eg: what illness are they specifying their product treats?

From their website:

Activia with Bifidus Regularis is scientifically proven to help with slow intestinal transit when eaten daily for two weeks, as part of a balanced diet and healthy lifestyle.

On the up side, they seem to place quite an emphasis on clinical trials and peer review.

On the down side, they fail to mention that someone just eating yogurt with active cultures for the very first time often gets awful diarrhea... I see kids do this all the time when they decide to go 'all natural' in their diet. They'll try eating this stuff (or related products) and wind up spending the next two days in the bathroom. My poor 3 year old had the same problem when she snuck a bite of my homemade yogurt. I wonder why that's not mentioned in Activia's advertising...

ETA: I guess their claim is correct though, it definitely speeds up the biological delivery service.