Food Politics

While we are on the subject of European decisions on health claims, Kellogg has just petitioned the European Food Safety Authority to be allowed to put claims for weight loss on its breakfast cereals: “Ready-to-eat breakfast cereal can help to reduce body weight, can help to reduce body fat, can help to reduce waist circumference.”

Do you think they mean Froot Loops?

Kellogg is always way ahead of the curve on health claims.  What is especially creative about this one is that the company is filing the claim through “article 13.5,” which means that the “science still remains proprietary and does not require disclosure through this process.  A Kellogg official explained:

As we understand article 13.5, five years after approval of the health claim, the wording can then can be used by other cereal manufacturers but our scientific data does not have to be made public.

EFSA, I hope, will turn this one down flat.  I want to see the science before believing that breakfast cereals are diet products.  Sure they are, if you eat just one serving for breakfast, use one more to substitute for a meal, and then eat a small meal.  That would work.  But so would chocolate bars.

Thanks to Anita Laser Reutersward in Sweden for forwarding the most recent decisions of the European Food Safety Authority (EFSA) on  petitions for health claims.

Health claims are vitally important to food marketers.  Evidence: they have filed 44,000 petitions with EFSA to date.  EFSA consolidated these into 4,185 claims.  It is dealing with them in batches.

EFSA did not approve many of the 416 petitions in this latest batch :

Experts issued unfavourable opinions on most of the claims in the second series due to the poor quality of the information provided to EFSA including:

• Lack of information to identify the substance on which the claim is based, e.g. “probiotics”
• Lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of the functions of the body (e.g. food with “antioxidant properties”)
• Lack of human studies with reliable measures of the claimed health benefit

Its decisions about antioxidants are especially interesting in light of claims on products in American supermarkets.  Under EFSA rules, this Kellogg package would not be allowed.

In its decision, EFSA said:

“On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) evaluated in this opinion and (1) a beneficial physiological effect related to antioxidant activity, antioxidant content, or antioxidant properties, and (2) the protection of body cells and molecules such as DNA, proteins and lipids from oxidative damage.”

My translation: EFSA panels took a good hard look at the science and could not find evidence for benefits at the physiological or molecular levels from taking antioxidant supplements or eating foods with antioxidants.

I can’t wait to see how food manufacturers respond.

March 1 update: here come the comments.  According to FoodNavigator.com, EFSA rejected health claims for:

vitamin D, probiotics, green tea, black tea, lutein, beta glucans, meso-zeaxanthin, alpha-lipoic acid, melatonin, peptides, xanthan gum, sugar-free gum, guar gum, gamma-linolenic acid (GLA), fermented whey and linoleic acid.

These decisions “came as a massive blow to the European and international functional foods and nutraceuticals industries, especially the herbal antioxidant and probiotic sectors, which have yet to see a positive NDA opinion.”

I went to the reception last week for Diet Coke’s red dress event,:

Diet Coke and the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health have joined forces to raise awareness about women’s risk of heart disease — in support of NHLBI’s The Heart Truth campaign — with a multi-faceted program that will reach consumers across the nation.

To celebrate American Heart Month in February, Diet Coke’s Red Dress Program will take center stage at high-profile events, including sponsorship of The Heart Truth’s, Red Dress Collection fashion show at Fashion Week 2008. Diet Coke will also unveil new packaging and programs featuring The Heart Truth and Red Dress logos and messages on heart health.

The Center for Science in the Public Interest points out that Coca-Cola, whose products are not exactly heart healthy, is a strange partner for the NHLBI.  The agency should reconsider.  It wrote NHLBI to say so.

New York Times reporter Tara Parker-Pope asks: “Should Coke talk about heart health?”

I don’t know how long Diet Coke and NHLBI have been engaged in this partnership but it is surely more than five years.  From NHLBI’s point of view, the partnership publicizes the risk of heart disease to women.  For Coca-Cola, the benefits are obvious.

Are such partnerships a benign win-win?  History suggests otherwise.  In 1984, Kellogg cooked up a partnership with the National Cancer Institute to put health claims for fiber on the boxes of All-Bran cereals (I discuss this incident in Food Politics).  In doing so, Kellogg (and NCI) went around the FDA and undermined that agency’s control over health claims on food packages.  This let to the current mess over health claims, which the FDA is now trying to clean up.

Update March 3: The Public Health Advocacy Institute at Northeastern University has filed a petition to NHLBI to give up the partnership.

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!

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

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.

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.

I 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?

Earlier this week, I received a phone call from Dr. Celeste Clark, Kellogg’s senior vice president for global nutrition, corporate affairs and chief sustainability officer.

She had seen my previous blog post on the Smart Choices program, and wanted me to know that Froot Loops has been reformulated to contain 3 grams of fiber, not less than 1 gram, as I had posted, and that  in all fairness, I ought to post the new version.  Sure.  Happy to.  Here it is.

This higher fiber product, of course, gets us into the philosophical question:  Is a somewhat-better-for-you, highly processed food really a good choice?  Does the additional 2.5 grams of fiber convert this product to a health food?  Whether Froot Loops really is a better choice than a doughnut as the Smart Choices program contends, seems debatable.

If I read the Nutrition Facts and ingredient list correctly, Froot Loops cereal contains:

• No fruit
• Sugar as the first ingredient (meaning the highest in weight–41%)
• Sugar as 44% of the calories
• Partially hydrogenated vegetable oil and, therefore, trans fat (although less than half a gram per serving so the label can read zero)

But with an implied endorsement from the American Society of Nutrition, which is managing the Smart Choices program, I guess none of that matters.  Or maybe the added fiber cancels all that out?

I pointed out to Dr. Clark that I had just bought the fiberless Froot Loops at a grocery store in midtown Manhattan, which means the old packages must still be on the market.

I discussed this and other such products with William Neuman of the New York Times whose reporting on the Smart Choices program appears on the front page of today’s business section under the title, “For your health, Froot Loops.  Industry-backed label calls sugary cereal a ‘Smart Choice.’”

According to his well reported account, Kellogg’s and other participating companies pay up to $100,000 for that seal.  No wonder the American Society of Nutrition and everyone else involved in the program want to set nutrition standards so loosely that they can encompass as many products as possible.   The more products that qualify for the Smart Choices logo, the more money the program gets.  I’d call that a clear conflict of interest.

Neuman managed to find nutritionists who defend the program.  I am not one of them.

Update September 6: CBS did a story on Smart Choices (I’m interviewed in it)

Update September 9: The American Society of Nutrition must be getting a bit defensive about the negative publicity, as well it should be.  It has issued an explanation to members.

Functional foods, you may recall, are those to which nutrients are added beyond those already in the foods.  The latest example from Unilever: calcium-enriched ice cream!  The philosophy: “better-for-you” foods will improve health.  Maybe, but is functional ice cream a good choice?

Functional foods differ from fortified foods, in which nutrients lost during processing are replaced.  The addition of iron to white flour, for example, replaces the iron lost during the milling of whole wheat.  Its replacement helps prevent iron-deficiency anemia.

So I suppose you can consider Kellogg’s new fiber-enriched cereals to be a form of fortification.  The PR people tell me  that adding fiber “is another example of our continued commitment to improving the nutrition credentials of our products to meet consumers’ needs and preferences.”  Their press release explains that Kellogg is doing this as a public service to improve kids’ nutrition: it is starting with Froot Loops.

What kind of fiber and how much?  Kellogg is a bit vague on these points, but says the fiber will be a combination of whole grain corn and oat flours and fibers.  Metamucil anyone?  And why don’t they just make whole grain cereals in the first place?

That’s why I keep thinking that functional foods are about marketing, not health.

I was interviewed for 5 seconds on ABC News last night about the peanut butter recalls (look for Saturday, January 25, “Salmonella outbreak worsens”).  So far, nearly 500 people have become ill and there may be as many as 11 deaths.  ABC reporters were right on top of what’s happening, mainly because they participated in the FDA’s teleconference on January 21.  The transcripts of these sessions make interesting reading.  Here’s the take-home:

1.  How did Salmonella get into the peanut butter? They don’t know yet, and it’s a puzzle.  Investigators found traces of Salmonella in the plant, but  not the particular strain found in the peanut butter.

2.  Shouldn’t peanut butter be free of bacteria? Yes, in theory, because the peanuts are roasted (this should be a kill step) and bacteria do not grow well in foods that don’t have much water.  This plant roasted its own peanuts, but it also used peanuts that arrived already roasted.  These could have arrived contaminated or the contamination could have occurred at the plant.

3.  Why are so many products affected? The plant shipped two different kinds of peanut butter: the bulk kind that goes to institutions and a peanut butter ingredient that goes to factories to be turned into other products.  Both contained the particular toxic strain of Salmonella.

4.  Which products  have been found with this toxic strain? The bulk kind and Austin Sandwich Crackers made by Kellogg.  But give Kellogg credit for admirable behavior.  The company recalled its products the minute it heard about the potential problem.  By the time the FDA’s tests came back positive, Kellogg had already recalled the products.  The Kellogg website provides full disclosure.

At the request (and expense) of Kellogg’s, the Life Science Research Organization convened an expert panel to evaluate studies linking consumption of whole grains – as defined by FDA – to reduced risk of cardiovascular disease and diabetes.  Using the FDA’s definition, the panel judged the studies insufficient to support a claim that whole grains reduce the risk of cardiovascular disease or diabetes.  The FDA defines whole grains as whole: grains that are ground, cracked, or flaked but include all the parts in their original proportions.  When the panel expanded the definition of whole grains to include supplements of bran, germ, or fiber, the results came out better.   Supplements work better than the real thing!  Kellogg’s must be pleased with the results of its investment.