Food Politics

I think not nearly well enough, but you would never know it from listening to food manufacturers. 

Let’s start with Europe.  Health claims are a big deal there these days, as the agency dealing with them, EFSA (European Food Safety Authority), copes with thousands of petitions.

In June,  EFSA representatives complained that the “scientific” evidence submitted by food companies to support their petitions included—get this—”excerpts from the Old Testament, Wikipedia, a Tea Association press release, a Royal Air Force report and the American Heritage Dictionary.”

The NDA panel, which is responsible for assessing the mountain of health claims applications submitted under the Regulation, said that along with the expected references to clinical studies published in peer-reviewed academic journals, it had also been presented with references from Wikipedia, press releases, dictionaries, the Bible and even an RAF report.

Trying to make sense of translations of references from other languages into English had presented additional difficulties, while ‘clarifications’ provided by some applicants in response to requests for further information had been confusing or inadequate, further delaying the process.

The quality of this evidence, says EFSA, is ‘far from optimal.”  Indeed.

From the food industry point of view, however, scientific substantiation of health claims presents pesky barriers.  Moving on to the United States, a food industry commentator asks:

We’re talking about the biggest food companies in the world being told the claims that help sell some of their foods are deceptive and misleading….And them agreeing to change or withdraw the claims…Er sorry… but why go along with it if you stand by the science?…Is the science there or not? Do these products (a probiotic drink and an antioxidant-boosted cereal) work or not?…Does the problem lie with the nutrition science itself (not enough clinically backed, human intervention trial-demonstrated, positive associations), or the way the science is being interpreted by regulators and companies that wish to express some of that science in their marketing materials?

Good questions.  As I read the literature, the more carefully done studies of functional ingredients tend to show the least benefit. 

As I keep saying, functional foods are about marketing, not health.

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.”

As readers of this blog know, I am not a fan of health claims on food packages or supplements.  I think they are inherently misleading.   It’s hard for me to believe that eating any one food product or supplement will have a significant effect on disease risk.

It is one thing to say that a nutrient is required for good health.  It is quite another to say that products containing that nutrient are going to have the same effect.  We would all be better off eating foods rather than food products.

That’s why health claims are really about marketing, not health.

Food marketers work hard to get approval for health claims.  America is well ahead of Europe in allowing them.  European regulatory agencies are still trying to hold health claims to reasonable scientific standards.

The European Food Safety Authority (EFSA) has been turning down requests for health claims right and left, but recently broke down and  approved one for iron, requested by the Association de la Transformation Laitière Française, a trade association of French dairy cooperatives.  Iron, of course, is an essential nutrient.

EFSA said the association could say: “Iron contributes to normal cognitive development of children.” But EFSA said the association could not say: “Iron is necessary for the cognitive development of children.”

I don’t think dairy products should say either, but that’s just me.

As for supplements:  In December, Food Chemical News reported that supplement firms in the European Union are considering filing a case with the World Trade Organization over EFSA’s refusal of so many of their proposed claims.   They consider the rejections a barrier to trade.  The firms are looking for a non-European Union country to make their case.

Never underestimate the self-interest of makers of food products and supplements in the struggles over health claims.

The FTC Forum last week got everyone going about food labels.  Here are the latest items to hit my inbox:

Traffic light front-of-package labels may do some good after all: As I explained in a previous post, British investigators did a study showing that the green-yellow-red traffic light dots on food packages do not necessarily help people make healthier choices.  Now, another British scientist argues that the study showed no such thing; at best, it showed that more research is needed to see how consumers interpret and act on those signals.

European Food Safety Authority (EFSA) approves some (weak) omega-3 claims: Under great pressure from food companies desperate to make claims for omega-3 fatty acids, EFSA is allowing three, if somewhat grudgingly:

• DHA intake can contribute to normal brain development of the foetus, infant and young children
• DHA intake can contribute to normal development of the eye of the foetus, infant and young children
• DHA intake can contribute to the visual development of the infant

“Can,” I suppose, is a bit less conditional than “may,” but these are not strong claims.  And they say nothing at all about making kids smarter.  Under these rules, that  “brain development” claim on Nestlé’s omega-3-fortified Juicy Juice drink (the one I find so absurd), would be OK.  But anything more specific, the EFSA committee said, would have to be backed by further science.

FDA food labeling rules: if after all the fuss about serving sizes at the FTC Forum, you want to know what FDA really says about them,  you can find the details on the FDA food labeling website.  On that site, click on Label Formats/Graphics to find the current rules on serving sizes.  Good luck making sense of them.

That’s more than enough about food labels for the moment.  It’s the holidays and time to talk about something cheerier.  Stay tuned.

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!

In what the functional food industry refers to as a “bad day at the office,” the European Food Standards Agency (EFSA) rejected hundreds of health claims, particularly those for probiotics.  More recently, it rejected a claim that glucosamine prevents cartilege degeneration.  Hard as it may be for the food and supplement industries to believe, EFSA just can’t find scientific evidence to support those claims.

A representative of the company that applied for the glucosamine claims says his company now anticipates a loss in product sales, and complains that it had “invested quite heavily in this submission, in terms of effort and financial outlay.”

Too bad.

Why can’t they come up with the science to support those claims? For one thing, who would want to do the research?  Danone and Yakult have just announced two $50,000 grants to study probiotics.  This won’t go far and the sponsorship is an almost certain guarantee that the results will be just what the companies paid for.

Independent research is much more complicated.  Consider folic acid, for example.  The latest clinical trial of folic acid and colon cancer went to a lot of trouble to prove that folic acid supplements are harmless.  In most people, they have no effect on colon cancer, neither benefit nor risk.  Among the few people who had unusually low levels of the vitamin in their blood, the supplements appeared to have some protective effect.  You can interpret results like this either as evidence for no benefit or as evidence that folic acid supplements might benefit some people under some circumstances.

And that brings us to supplements again.  A trade association for supplement manufacturers says:

While it cannot be denied the food and supplement industry has entertained its fair share of cowboys, our concern is that the [EFSA] regulation goes so far as to throw the baby out with the bathwater. At the very point in time when consumers need most information to help them make the right food and supplement choices to help them offset largely preventable chronic diseases, we see the industry being gagged.

“Cowboys” are indeed a problem, and one well known to the American supplement industry. Says the head of the Council for Responsible Nutrition, the euphemistically named supplement trade association:

Fifteen years ago, our biggest threat was an over-reaching FDA….More recently, the problem has been an FDA that’s under funded and lacks the political will to do what it needs to do. And as a result today, many of the problems that burden the dietary supplement industry are ones that come from within the industry itself from that lack of oversight….Companies… intentionally – or inadvertently – put prescription drugs or anabolic steroids into their products and call them dietary supplements; products that just don’t do what they claim.  Also some companies practice economically motivated adulteration, passing off shoddy products as something more than they are … and ignore the new GMP requirements in hopes that they will fall under the radar screen.

Perhaps in response, the Boston Globe says we should repeal the 1994 law that deregulated dietary supplements and give the FDA some regulatory teeth.  Good idea.

Please forgive my endless repetition of this mantra: health claims are about marketing, not health.

The European Food Safety Authority (EFSA) has just rejected a proposal from Merck to allow it to use a health claim stating that omega-3 supplements promote  eye and brain health in infants.  Merck wants moms to take omega-3 supplements during pregnancy and give such supplements to their infants.  EFSA reviewed nearly 90 studies on this topic and concluded that the study results were not “informative.”    In other words, they showed no benefit.  Imagine.  The EFSA demands scientific substantiation of health claims.  I wish we could do that.

Here’s another example from the pomegranate folks.  They do brilliant advertising, but this time the British are complaining that these marketers went too far when they posted billboards stating that pomegranate (“antioxidant powerhouse”) juice will help you cheat death.  The British advertising standards agency balked.  Here too, pesky science gets in the way.  Studies not only fail to support a benefit of antioxidants but sometimes show harm.

Our Congress, however, forces FDA to permit health claims, no matter how absurd.  Try the FDA-allowed “qualified” health claim for omega-3′s: “supportive but not conclusive evidence  shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease” [my emphasis].  The FDA allows omega-3′s to be added to infant formulas, but here’s what it says about them:  “The scientific evidence is mixed…There are no currently available published reports from clinical studies that address whether any long-term beneficial effects exist.”

The EFSA interprets all this as unworthy of a health claim.

What can the FDA do?  If it says there isn’t enough evidence, it gets sued and loses.  The courts tend to rule that food companies can say whatever they like about health benefits on the grounds of free speech and the First Amendment.

In January, the FDA published “guidance” for industry about how it plans to evaluate the scientific basis of health claims.     Guidance is just that.  It is non-binding.

Hello new administration.  How about taking a fresh look at the health claims situation and paying close attention to what regulators in Europe are doing.  How about considering just saying no to health claims.

A report just out from the European Union explains why food companies so strongly oppose traffic light systems for labeling food products.  Consumers interpret red lights as meaning “don’t eat me.”  Here is how the U.K. Food Safety Authority is using traffic lights.  Compare this to the check mark system preferred by the food industry.

More cheery regulatory news.  To the consternation of food companies, the European Food Safety Authority has turned down 8 of 9 petitions for approval of health claims on food labels, largely because of lack of evidence.  For a while, at least,  Europeans won’t be confronted with food packages promising them that they will lose weight if they eat dairy foods.  FDA take notice!