by Marion Nestle

Currently browsing posts about: Health-claims

May 12 2010

IOM wants just as rigorous science for food claims as for drugs

Buried in an Institute of Medicine report released today on, of all things, “biomarkers and surrogate endpoints in chronic disease” are some truly astonishing recommendations:

Rec. 3: The FDA should use the same degree of scientific rigor for evaluation of biomarkers across regulatory areas, whether they’re proposed for use in the arenas of drugs, medical devices, biologics, or foods and dietary supplements.

Rec. 4: The FDA should take into account a nutrient’s or food’s source as well as any modifying effects of the food or supplement that serves as the delivery vehicle and the dietary patterns associated with consumption of the nutrient or food when reviewing health-related label claims and the safety of food and supplements.

Translation: The FDA should require the same level of scientific substantiation for health claims as for pharmaceutical drugs, and not assume that a supplement has the same health effect as a food or diet.

As the press release states:

The FDA should apply the same rigor to evaluating the science behind claims of foods’ and nutritional supplements’ health benefits as it devotes to assessing medication and medical technology approvals…There are no scientific grounds for using different standards of evidence when evaluating the health benefits of food ingredients and drugs given that both can have significant impacts on people’s well-being.

The committee set out to recommend scientific criteria for evaluating the types of scientific data that companies use to convince the FDA to allow health and safety claims.  Food claims got tossed into the mix. 

The impact of these recommendations could be considerable.  The IOM is saying that health claims need to have rigorous science to back them up, not least because the kinds of claims now used to market foods do not come close to meeting those criteria.

Here’s what the Wall Street Journal has to say about this report (it quotes me).

How right they are, as witnessed by the health claims on chocolate-flavored, sugar-sweetened Enfagrow.

Mar 16 2010

Cargill thinks beta-glucan is the new oat bran

In 2008, in response to a petition by Cargill, the FDA authorized a health claim for beta-glucan extracted from barley.  Beta-glucan is a form of soluble fiber similar to that from oats, psyllium, and other grains or from the cell walls of yeast.  It can help lower blood cholesterol levels and, therefore, the risk of coronary heart disease.

Cargill must think that beta-glucan will create another oat bran craze such as the one that occurred in the late 1980s.  Or at least that’s the impression given by the latest news from the U.K.: “Cargill says EFSA health claim will transform beverage fibre fortunes.”

The deal with beta-glucan is that it can be added to drinks (presumably sugary).  If so, the drinks can carry the claim:

3 grams per day of barley beta-glucan, as part of a diet low in saturated fat, and a healthy lifestyle, can help manage normal blood cholesterol (my emphasis).

Beta-glucan is a “functional” ingredient, meaning that it is something added to a food ostensibly to boost its health value.  But the entire point of functional ingredients is to be able to make health claims for them.  Health claims sell food products when nobody bothers to read the fine print.

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.