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!

Alas, Congress did not pass food safety legislation by Thanksgiving, and I’m getting lots of requests to comment on it.  For example, Johannes G writes: “Marion, I’m usually spot on with you about a lot of things you talk about, but your final comment truly irritates me. We don’t need more regulatory policy, we need a food policy that makes sense.”

Actually, I think we need both.  No question, a better food safety regulatory policy is high on my priority list.  Why?  Because the food industry will never produce safe food voluntarily.  It’s time to give regulation a try, and now is the time.  While the window of opportunity is open, we need to convince Congress to act.

Current legislative proposals

To recap where we are on this: the House passed H.R. 2749, the Food Safety Enhancement Act last July. The Senate is currently considering S. 510, the FDA Food Safety Act.  Some version of these bills seems likely to pass, although it is not at all clear by when.

Although food safety advocates generally agree that we need a single food safety agency that integrates the activities of USDA and FDA, these bills are designed to fix the FDA alone, not the overall food safety system. For a quick take on the provisions of some of the bills under consideration, see the summary chart produced by the Center for Science in the Public Interest.

The bills require science-based (HACCP-type) processes for producing food, starting on the farm. And at long last they authorize the FDA to order recalls or detain foods deemed unsafe. No, the FDA does not already have these basic tools.  It needs them.

One more time on HACCP: It means Hazard Analysis Critical Control Point with Pathogen Reduction.  Translation: identify where in the production process contamination might occur, take steps to prevent contamination from occurring at those points, document that the steps were taken, monitor and inspect periodically to make sure the documentation is accurate, and test to make sure no contamination has occurred.

Without much chance of getting a single food safety agency, fixing the FDA is a good thing to do.  We can hope that once the FDA bill is passed, Congress will work on legislation to reconcile the inconsistencies in FDA’s and USDA’s food safety rules.  But that cannot happen unless the FDA first has the ability to require science-based food production and can authorize recalls and detentions.

The “scale” problem

This brings us to the problem of small farmers, or what regulatory agencies refer to as the “scale” (translation: size) problem. Steve Gilman, the policy coordinator for the Interstate Council of the Northeast Organic Farming Association (NOFA) sent me a copy of a letter to Senators signed by 70 or so members of the National Sustainable Agriculture Coalition.

This group is deeply worried about the bill’s “unintended negative impact on family farms, value-added agricultural development, conservation and the environment, organic farming, and emerging local and regional food systems.”

The Coalition wants the Senate to consider, among other things:

• A two-track regulatory system based on the size, type, and diversity of a farm’s production.
• Rules based on level of risk (“fresh cut, ready-to-eat packaged fruits and vegetables pose a far greater risk than whole produce”).
• Exemptions for traceability requirements.
• Scale-appropriate food safety training as outlined in additional legislation (introduced as S. 2758, The Growing Safe Food Act).

I greatly favor support of small farmers.  But I think all farmers – no exceptions – should be producing safe food. Thinking through a food safety plan is not that hard to do and farmers of any size operations should be carefully designing and diligently following HACCP-type plans appropriate to their specific situations.

Farmers who produce foods unlikely to be cooked before eating — raw vegetables, raw milk, raw oysters, for example – should be testing for contaminants on some kind of regular basis at time intervals that depend on the level of risk.

I think testing is so badly needed that I would add support of testing facilities to the Coalition’s legislative wish list.

The scale issues are important and I hope the Senate will consider them seriously, incorporate them into the final legislation, and look for ways to support the food values outlined by the Coalition.   But the fix-the-FDA legislation should not be held hostage to the scale problem.  The FDA needs better methods for protecting the public from the hazards of industrial production methods.  While making sure the FDA gets food safety authority, we need to work hard to get scale-appropriate rules or enforcement for smaller farmers who want to opt out of industrial food production, grow diverse crops, and produce them sustainably.

It’s post-Thanksgiving so I suppose I must say something about overeating.  Fad diets contribute to obesity, says the president of the British Society of Gastroenterology.  He singles out Atkins, Raw, Hallelujah (fruits and seeds mentioned in the Book of Genesis), and Grapefruit diets for particular scorn.  Why?  He doesn’t say.  His otherwise sensible conclusion: “The problem facing society is not the content of our diet but it’s the quantity we are consuming and the consequential impact of obesity.”

Ah yes, quantity.  Probably best not to mention it this week.  Enjoy the weekend!

The British Medical Journal has a new meta-analysis of 13 studies of the health effects of high salt intake.  Its conclusion:

High salt intake is associated with significantly increased risk of stroke and total cardiovascular disease. Because of imprecision in measurement of salt intake, these effect sizes are likely to be underestimated. These results support the role of a substantial population reduction in salt intake for the prevention of cardiovascular disease.

In commentary, the authors insist that regulation is needed.  The effects of salt are large:

a 5 g reduction in salt intake at the population is associated with a 23 per cent difference in stroke rates, and a 17 per cent difference in total cardiovascular disease….eating less salt could avert 1.25 million deaths from stroke and almost 3m deaths from cardiovascular disease – and these projections are…conservative because of imprecision in assessing salt intake.

Why regulation?  Because nearly 80% of salt enters the diet through processed and pre-prepared foods.  The rest is about equally divided between naturally occurring salt in foods and salt added at the table.   To reduce salt, food manufacturers and restaurants need to cut down, and all of them have to do it.

This is because the taste for salt depends on how much is eaten.  On a low salt diet, even lightly salted foods taste salty.  But if you are used to eating a lot of salt, it takes even more to taste salty.  So the object needs to be to reduce salt in the diet across the board.

I’m hearing a lot these days about how federal agencies are getting interested in the salt issue.  Stay tuned on this one.

And have a safe, healthy, delicious, and lightly salted thanksgiving!

Remember last year’s scandal about the 300,000 Chinese infants who developed kidney disease after being fed infant formula laced with melamine?  That anyone would put melamine into infant formula was shocking on its own (although the previous year’s scandal over melamine in pet food ought to have been fair warning, as I explained in my book, Pet Food Politics).

Even more shocking is that the Sanlu infant formula company knew about problems with its milk long before it issued a recall, in part because it did not want to embarrass the country just prior to the start of the Olympic games in Beijing.

Now, Chinese authorities have executed two men deemed responsible for adding melamine to the milk powder sold to Sanlu.  The Sanlu manager was given a life jail sentence, and 18 others involved with the Sanlu company also have been jailed for up to 15 years.

One can always debate whether the punishment fits the crime but a BBC press account quotes a lawyer who laid the blame on

an inadequate regulatory system…It’s hard to understand why these people are give such harsh punishment because generally speaking… there is a lack of monitoring and regulation…It’s the food supervision and inspection authorities that are responsible for this.

Congress, take notice: pass that food safety bill now!

What, you may well ask, is cupuaçu?  I confess never having heard of it but thank heavens for Wikipedia, which explains in somewhat limited detail that it is a chocolate-like tree with a sweet fruit.  Botanically, it is a Theobroma in the chocolate family.

Mintel, the market research firm, identifies it as the newest antioxidant-rich fruit craze.  It says this fruit is not only rich in antioxidants, but also in vitamins, essential fatty acids and amino acids.  Well, yes, but so are all fruits to a greater or lesser extent.  But never mind.  Anything this exotic has to be a marketers’ dream “superfruit,” no?

Can’t wait to taste it.  If you know anything about this, do say, especially about how it might taste.

Mintel has six other predictions for upcoming hot trends:  sweet potato, cardamom, rose water, hibiscus, and Latin spices. Yum.  Aren’t you happy to be the first to know?

European food manufacturers continue to file thousands of petitions for approval of health claims for their products.  The European Food Safety Authority (EFSA) takes a dim view of most of them, arguing that the claims are poorly substantiated by scientific evidence, if at all.

Now EFSA is attempting to clarify what manufacturers have to do to gain approval for their claims.  I say “attempting” because EFSA’s statements often are models of bureaucrat-speak.

EFSA, for example, says it is willing to consider evidence for claims based on studies performed in people with a particular disease:

For studies in groups (e.g. subjects with a disease) other than the target group (e.g. general population) for a claim EFSA considers whether scientific conclusions can be drawn for the substantiation of the claim on a case by case basis…For example, for claims on reducing gastro-intestinal discomfort (in the general population) evidence in patients with irritable bowel syndrome may be accepted.

OK.  I get that.  Then it offers further clarification:

For claims on maintenance of normal joints (in the general population, evidence in osteoarthritis patients is not accepted as osteoarthritis patients are not considered to be representative of the general population with regard to the status of the joint tissues.  In its evaluation, EFSA considers that where a health claim relates to a function that may be associated with a disease, subjects with the disease are not the target for the claim.

EFSA explains its overall philosophy for deciding which claims to approve.  It does not use a pre-established formula for the type or number of studies.  Instead, it weighs:

All the evidence from the pertinent studies (i.e, studies from which scientific conclusions can be drawn for substantiation of the claim)…with respect to its overall strength, consistency and biological plausibility, taking into account the quality of individual studies and with particular regard to the population group for which the claim is intended and the conditions of use proposed for the claimed effect.

As with all scientific evaluations, EFSA’s judgments are subjective.  It considers animal studies, but grants more weight to studies in humans.  These, it says, are “central for the substantiation of the claim.”

Food manufacturers also view the evidence subjectively, but tend to be less scientifically rigorous in their interpretation of benefit, especially when their own products are involved.   Hence: conflict.

At the moment, EFSA is holding a hard line on health claims.  FDA: take notice!

The supplement industry has its hands full these days trying to keep up with negative publicity about taking vitamins.    Its latest damage-control efforts are aimed at some Norwegian studies published in this week’s Journal of the American Medical Association (JAMA).  Norway does not fortify foods with folic acid and investigators evidently wanted to know if the vitamin was safe.  They gave various combinations of vitamin supplements to heart disease patients.  Oops.   Patients taking folic acid and vitamin B12 had higher death rates than those taking no supplements or vitamin B6.  The excess deaths were generally from cancer, mostly of the lung.

Implications?  Like all such studies, this one requires interpretation.  The supplement industry has one interpretation.  Others are likely to follow.

But maybe it’s time to think more carefully about adding folic acid to the food supply?  We add folic acid to flour in the U.S. in an effort to reduce prenatal risks for neural tube disease (NTD).  Rates of NTD have decreased with folic acid fortification, but they might have done so anyway.  Maybe taking single vitamins is not such a good idea?  Maybe we need a whole lot more research on mechanisms of action?  Do vitamins promote the growth of cancer cells, for example?  Are people with heart disease especially susceptible to excessive vitamin intake?  And maybe we need stronger regulation of dietary supplements?  What a concept!

For the supplement industry, these kinds of studies mean bad news.  Nutrition Business Journal worries about how such research will affect sales.  Watch the industry spin on this one.