by Marion Nestle

Currently browsing posts about: Health-claims

Mar 3 2010

Cheers to FDA: health claim warnings!

Here are some excerpts from today’s FDA press release, “FDA Calls on Food Companies to Correct Labeling Violations; FDA Commissioner Issues an Open Letter to the Industry.”

The U.S. Food and Drug Administration has notified 17 food manufacturers that the labeling for 22 of their food products violates the Federal Food, Drug, and Cosmetic Act…In an open letter to Industry dated March 3, 2010, Dr. Hamburg underscored the importance of providing nutrition information that consumers could rely on.

…The violations cited in the warning letters include unauthorized health claims, unauthorized nutrient content claims, and the unauthorized use of terms such as “healthy,” and others that have strict, regulatory definitions.  Companies that received warning letters have 15 business days to inform the FDA of the steps they will take to correct their labeling.

Take a look at what the FDA is saying, starting with a handy chart of the affected companies, their products, and the ways their claims violate FDA regulations.  Some of my favorite examples are on this chart (for example, Juicy Juice!).

The FDA also provides:

What’s behind all this?  Take a look at Center for Science in the Public Interest’s extraordinary report on violations of FDA regulations on food package labels, Food Labeling Chaos.  No way can the FDA – or anyone else – ignore this report.

Cheers to the FDA for taking this on!

Update March 4:  The New York Times was able to reach some of the affected companies. They all say the same thing (my translation): we are shocked, shocked.  We would never tell a lie.  We will do everything we can to cooperate (make sure the FDA backs down on this).

Mar 2 2010

Kellogg seeks weight-loss health claim for cereals

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.

Feb 28 2010

European decisions on health claims: Vitamins, yes. Antioxidants, no.

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.”

Feb 17 2010

Should our national heart agency partner with Coke?

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.

Feb 16 2010

European companies’ ongoing struggle for food and supplement health claims

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.

Dec 27 2009

FDA warns Nestlé: Juicy Juice misbranded!

I’ve been fretting about the immunity and brain claims on Nestlé’s Juicy Juice for quite some time now, but completely missed the FDA’s December 4 warning letter about them.  Thanks to Hemi Weingarten at Fooducate for keeping track of such things.

JuicyJuice

If you give these products a moment’s thought, you can quickly figure out that feeding DHA- or antioxidant-fortified juice drinks to kids is unlikely to have much effect on how smart they are or whether they can resist colds or swine flu.  But never underestimate the power of food marketers.   Adding a little DHA or a few antioxidants to juices sells products.  Health claims, as I keep pointing out, are about marketing, not health.

In warning the company to cease and desist, however, The FDA did not take on the health issues.  Instead, it invoked labeling regulations:

The Food and Drug Administration (FDA) has reviewed the labeling for several Nestlé Juicy Juice products…Based on our review, we have concluded that these products are misbranded…. because [their] labeling includes unauthorized nutrient content claims. Except for statements that describe the percentage of a vitamin or mineral in relation to a Reference Daily Intake (RDI), a nutrient content claim cannot be made for a food intended for use by infants and children less than 2 years of age….On October 30, 2009. we also reviewed your website….The labeling found on your website makes an additional unauthorized nutrient content claim, which further misbrands the product. The website claims that Juicy Juice Brain Development Fruit Juice Beverage is “naturally lower in sugar”…[but] no nutrient content claims can be made for a food intended specifically for use by infants and children less than 2 years of age unless specifically permitted by FDA regulations.

Additionally, we have reviewed the labeling of your Nestle Juicy Juice All Natural 100% Juice Orange Tangerine and Nestle Juicy Juice All Natural 100% Juice Grape products. These products are misbranded…because their labels are misleading. The label of the Orange Tangerine product is designed to imply that the product is 100% orange/tangerine juice, and the label of the Grape product is designed to imply that product is 100% grape juice…neither orange/tangerine juice nor grape juice is the predominant juice in the products….

Nestlé (alas, no relation) is the largest food company in the world with $102 billion in sales last year.  It should know better.

Just for the record, the misbranded products are still displayed on the Juicy Juice website.

The FDA also warned Nestlé that its Boost Kids Essentials products are misbranded. Why?  Because their labeling does not follow the rules for medical foods, those aimed at alleviating specific conditions – in this case “failure to thrive.”   Oops.  The Boost Kids Essentials website is now under revision.

Dec 4 2009

Food agencies at work (or not): FDA

Front-of-Package Labels: The FDA is hard at work trying to do something about public understanding of food labels.  What with the fuss about the Smart Choices program (now withdrawn), FDA wants to get the front-of-package labeling under control.  It is considering various formats for giving a quick overview of the nutritional quality of food products.  FDA is asking for public comment on the various formats (see Federal Register notice).

The FDA chose five versions (plus variations) for comment:

  1. A mini Nutrition Facts version called Nutrition Tips
  2. A UK traffic lights version
  3. A version like Hannaford’s Guiding Stars
  4. A version like the discontinued Smart Choices
  5. One that just highlights calories/servings

I rather like this one, a variation of #1 (colorful, easy to understand, not too cluttered, and makes calories clear).

Scan10266

The Nutrition Facts Panel: The FDA also is taking another look at the Nutrition Facts panel on the back of food packages.  It is seeking public comment on  a plan for consumer research to test understanding of elements on the Nutrition Facts panel.  Here’s the Federal Register notice with all the information about what’s going on and where to file comments.

What’s interesting about this is that the FDA has great social science researchers on staff.  They’ve been kept under wraps the last eight years and apparently are being let loose again.  Even so, they don’t get to just go out and do studies like we academics do (with human subjects approval, of course).  Oh no.  First, they have to announce that they plan to do the studies (which they did some time ago) and get comments on the idea.  Then they do the research plan and have to ask for further comments on the research design.  That’s what this notice is about.  Once they deal with these comments, they can finally get to work.    It’s a miracle if they do anything at all.  Keep them busy: send comments!

Agency Transparency: The Association of Health Care Journalists (ACHJ) and ten other journalism organizations have filed a complaint.  The FDA, they say, is still requiring journalists to obtain permission from an agency official in order to conduct interviews with staff members.  This is a leftover from the Bush administration.  Time to get rid of it.

Blogging: It is especially time to open up to reporters because Michael Taylor, who is now senior advisor to the FDA commissioner, is now blogging on the Atlantic Food Channel (which also reprints my posts).  If he can blog, FDA staff can talk to reporters.

Addendum: Beverages pretending to be dietary supplements: The FDA has just issued guidance to the beverage industry to stop putting herbal supplements into beverages and calling them dietary supplements so they can get around food rules on health claims.  If a beverage is consumed as a food, it should be labeled as a food.  Guidance, of course, is non-binding but I see this as a warning that the FDA is going to be enforcing its own rules.  Good show!

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!