Dec 1 2009

San Francisco attorney vs. Kellogg’s immunity claim

My latest column in the San Francisco Chronicle deals with the immunity health claim on boxes of Kellogg Cocoa Krispies (see previous posts).  I’ve been writing the column for the last year at irregular intervals of about once every three weeks.  Beginning in January 2010, it has its own slot and will appear on the first Sunday of the month.  Here’s this one:

Q: It’s great that San Francisco City Attorney Dennis Herrera put a stop to the absurd “immunity” claim on Kellogg’s Cocoa Krispies, but how do companies get away with this?

A: I confess; I’m a health-claims junkie. I snatched up the immunity-claiming box of Cocoa Krispies the minute I saw it in a supermarket last August. I consider it a treasure: “Now helps support your child’s IMMUNITY.”

How does Cocoa Krispies perform this miracle? The cereal contains 25 percent of the daily value of antioxidant vitamins A, B, C and E per serving instead of the old 10 percent. Vitamins, Kellogg points out, play an important role in immunity.

Of course they do. All nutrients are involved in immune function. But is it remotely possible that Cocoa Krispies might protect your child against colds or swine flu? I wish.

Antioxidants present an unparalleled marketing opportunity. Kellogg does not have to prove that its cereals are protective. Immunity claims fall into a Food and Drug Administration regulatory gray area. “Supports immunity” is a “structure-function” claim, so called because it promises to support a structure or function of the human body. However you might interpret such claims, they do not really promise to prevent, treat or cure disease.

Congress expressly authorized structure-function claims when it deregulated dietary supplements in 1994. But that law did not apply to foods. Food companies wanted to use these claims, too. At first the FDA balked. When faced with further legislation and court overturns, the FDA gave up. Now it merely says that structure-function claims on supplements must be truthful and not misleading. The FDA says nothing about structure-function claims on food products. It mostly looks away when they appear.

“Misleading” is inevitably in the eye of the beholder. Herrera turns out to be a skeptic.

“The Immunity claims,” he said, “may falsely suggest to parents that cereals like Cocoa Krispies are more healthy for their children than other breakfast foods … [and] mislead parents into believing that serving this sugary cereal will actually boost their child’s immunity.” Kellogg, he said, must produce the evidence or have the claim subject to “immediate termination or modification.”

Faced with this threat and with ridicule in the press, Kellogg wisely decided to phase out the immunity-labeled Cocoa Krispies packages. Consider them collectors’ items.

Much is at stake. Ready-to-eat cereals produce more than $8 billion a year in sales. Kellogg spent about $32 million in 2008 to promote Rice Krispies cereals, and $4 million of that amount went to advertise Cocoa Krispies alone.

Shoppers care about health. If cereals can be advertised with special health benefits, more boxes will fly off the shelves. Food companies consider health claims essential for marketing their products.

This explains why so many companies are adding omega-3 fats, probiotics and antioxidants to so many foods. These ingredients make foods “functional,” meaning that the foods contain something beyond their usual nutritional value. Although little evidence shows that functional foods make healthy people healthier, companies can use functional ingredients to make health claims, no matter how far-fetched. These days, functional foods are about the only processed foods with increasing sales.

Kellogg has plenty of company with functional ingredients and health claims. See, for example, the claims on Nestlé (no relation) Juicy Juice products targeted to toddlers. One product adds antioxidants to “help support immunity.” The other adds omega-3s to “aid brain development.”

Think about it: Will feeding your toddler a sugary juice product really make her smarter? Face it. You are not supposed to think about it. You are supposed to buy – and feel good about doing so.

Absent the FDA, Herrera stepped into the breach. He does not care whether the claims are on Kellogg cereals or Juicy Juice cartons. If companies make such claims, he insists that they produce the evidence for them.

This will not be easy to do. It is one thing to find evidence that specific nutrients are involved in immune function. It is quite another to show that people who eat sweetened cereals or juices containing such nutrients are healthier than those who do not.

That is why the European Food Standards Agency denied hundreds of company petitions for health claims. The agency cannot find much evidence for the health benefits of foods with added functional ingredients. Its decisions have put European food marketers into crisis. How are they supposed to sell products without health claims?

As I keep saying, health claims are about marketing, not health. If it were up to me, I would remove all health claims from food packages. Foods are not drugs. Health claims cannot help but mislead.

So let’s congratulate Herrera for filling a regulatory gap. His colleagues – and the press – are doing their job on this one. FDA: Get to work!

Nov 5 2009

Kellogg’s withdraws IMMUNITY claim!

Kellogg’s says it will phase out boxes of Cocoa and other Rice Krispies cereals with the IMMUNITY claim on them.

Withdrawn, November 4, 2009

Withdrawn, November 4, 2009

The Immunity claim falls into an FDA regulatory grey area.  It is a structure-function claim, meaning that the product is supposed to support a structure or function of the human body – not treat or cure a disease. If Cocoa Krispies were a dietary supplement, the claim would be completely legal because Congress authorized structure-function claims for supplements when it passed the Dietary Supplement Health and Education Act of 1994.

Over the years, food makers complained that if supplements could use such claims, they could too.  At first, the FDA issued warning letters to food companies using structure-function claims.  It stopped after the courts ruled that food companies could make claims for the health benefits of their products on First Amendment grounds.

Now FDA says structure-function claims are OK to use as long as they are truthful and not misleading.  Misleading, of course, is in the eye of the beholder.  Evidently, the San Francisco city attorney thought this claim was misleading and demanded the evidence to back it up.  USA Today wrote about this on the front page (I’m quoted in it).

Wisely, Kellogg’s is going to find another design for its Rice Krispies packages.  Consider this particular box a collector’s item.

The lesson: In the absence of FDA action, food marketing is allowed to run rampant, and city and state attorneys are doing the FDA’s job.  Good for them.  And let’s hear cheers for the power of the press.

Oct 28 2009

San Francisco takes on Cocoa Krispies!

Now that the Smart Choices program is on hold, it’s time to take a look at what else is on food packages these days.  My current favorite example is the huge IMMUNITY banner across Kellogg’s Cocoa Krispies.

ImmunityI don’t know how you interpret this but my mind boggles at the very idea that eating Cocoa Krispies might protect kids against swine flu.

Apparently, the minds of the San Francisco attorney general’s staff are equally boggled.  They just sent a warning letter to Kellog:

“Specifically, the Immunity Claims may falsely suggest to parents that cereals like Cocoa Krispies are more healthy for their children than other breakfast foods that are not high in sugar and not highly processed.  The Immunity Claims  may also mislead parents into believing that serving this sugary cereal will actually boost their child’s immunity, leaving parents less likely to take more productive steps to protect their children’s health.”

The city attorneys are asking Kellogg to provide copies of all of the consumer and scientific research the company used to establish this claim, or else.  If they don’t get these documents, they will “seek an immediate termination or modification of the advertising claim….”

Good idea.  I can’t wait to see how Kellogg’s – ever at the leading edge of advertising claims – will respond.

But wait!  Shouldn’t the FDA be taking this on?

Sep 29 2009

Health claims for yogurt? Really?

I like yogurt.  But do probiotics – those “friendly” bacteria in yogurt and  increasingly added to other foods – do anything for you beyond making yogurt taste good?  I wrote about probiotics in What to Eat at some length.  Tara Parker-Pope has a quick summary of the state of the research in today’s New York Times.

The quick answer is mixed.  It includes a lot of  “maybe” or “probably,” always a sign that whatever probiotics might do isn’t going to be much.  The answer is probably yes for infant diarrhea and, maybe, irritable bowel syndrome, and maybe or no for just about everything else.

In the absence of FDA action to regulate misleading health claims, lawyers have jumped into the breach.  They have just won a large class-action settlement – $35 million – against Dannon for claiming that Activia yogurt promotes immunity.   According to one news account, Dannon spent $100 million marketing the immunity-promoting effects of Activia ignoring the results of its own company-sponsored research which inconveniently showed few benefits.  (Did they not pay enough for the research?).

Dannon is working hard to get an approved health claim from the European Standards Agency which annoyingly wants to see some science behind health claims before approving them.  Dannon has now added a tomato extract to its yogurts with the idea that this substance, which appears to help deal with diarrhea, will strengthen its bid for a health claim.

Probiotics are another reason why the FDA needs to set better standards for health claims.  If it were up to me, food packages would have no claims on them: none at all.  Foods are not drugs.

cocoa Krispies

And here’s another reason why:

Will Cocoa Krispies  be the next target of those pesky lawyers?

FDA: get to work!

Jan 1 2008

The first topic in 2008: food scoring systems

My first question in the new year is from “fretful reader” who asks: “Esteemed Wise Woman Whose Writing Lights A Fire Under Me: …today’s [San Francisco] Chronicle has a story about the ONQI(overall nutritional quality index)…which purports to ‘make nutrition easy’. My college education (about 30 yrs old, damn near antiquated) is
inadequate to the task of combining “positive nutrients” , “negative nutrients”, dividing them, and why didn’t they remember to subtract the number of ingredients on the list altogether…as a way of penalizing the ‘foods’ that have those scary long lists in a designed to be unreadable, vertical typeface? Does it sound like I’m irritable? Probably.”

Dear irritable, fretful: Me too. I’m not much for scoring systems of any kind on food. I don’t think you need a score to know whether you are eating a junk food or not and is a slightly better junk food better for you? I can’t remember who started these things but PepsiCo has its Smart Spots and Kraft has its Sensible Solutions and companies like those can set up their own criteria for what is and is not “healthier.” It’s a lot of fun to go to supermarkets and look to see which products qualify. Kraft’s Lunchables are a good place to start. See if you can tell the difference between products that do and do not qualify. Hannaford supermarkets got some independent nutrition researchers to develop criteria for awarding one , two, or three stars to healthier products and guess what: less than one quarter of nearly 30,000 products qualified for even one star, and most of those were fruits and vegetables in the produce section. So when the criteria are tough, hardly anything qualifies. So now Dr. David Katz at Yale has gotten a committee together to develop his own set. You have to have a degree in mathematics to understand it but that doesn’t really matter. Do you really need a scoring system to tell you that General Mills’ Wheaties (score: 246.2403) is better than Barbara’s Puffins Peanut Butter (9.937892) or Kellogg’s Cocoa Krispies (0.476746)? Never mind the apparent but misleading precision of the 4 to 6 decimal places. All of these are low scores. The problem with these systems is that the criteria are arbitrary and make some highly processed foods look better than others. This is a great marketing tool but will it help people eat more healthfully? I doubt it. I take an extreme position on all such systems. They should not be allowed. If we must have them, the FDA needs to step in and set up one set of criteria. And I don’t envy the committee that has to do that. So I am adding one more item to my list of “rules” for supermarket shopping in What to Eat. If it has a self-endorsement of nutritional quality, don’t buy it; such things are about marketing, not health.