by Marion Nestle

Currently browsing posts about: Health-claims

Nov 30 2011

Report from the EU: functional foods, supplements, health claims


Sebastián Romero Melchor writing in Food Chemical News (subscription required, alas) a few days ago points out that the market for functional foods in the European Union is growing.  He advises U.S. firms who want to take advantage of  its €40 billion (equal to roughly $54 billion USD) market to pay attention to some important facts:

  • Novel ingredients: Ingredients that were not consumed to a significant extent in the EU before May 15, 1997 must undergo a costly and lengthy authorization procedure so dreadful that most companies give up and choose not to include them.
  • Supplements: The European Commission has no problem with vitamins and minerals, but marketing of food supplements and fortified foods remains subject to each European country’s separate national laws.  Products legally marketed and/or manufactured in a member-state can be legally marketed throughout the EU, provided that they are (a) safe, (b) not novel, and (3) not medicinal.
  • Health claims: The European Food Safety Authority (EFSA) has issued opinions on health claims for most substances.  It has evaluted about 2,750 petitions for health claims but only approved about 600.

If only the FDA would take as rigorous a stance.

Jun 28 2011

Health claims on alcoholic beverages, exposed!

The California-based Marin Institute, “the alcohol industry watchdog,” has issued an enlightening new report: Questionable Health Claims by Alcohol Companies: From Protein Vodka to Weight-Loss Beer.

According to the Institute’s press release, “Major alcohol companies are exploiting ineffective or non-existent regulatory oversight with deceptive marketing and potentially dangerous products.

Some examples described in the report:

  • Devotion Vodka (“Infused with Casein”)
  • Fragoli strawberry liqueur (promoted with antioxidants)
  • Absolut, Skyy, and Finlandia vodkas (“infused with natural flavors”)
  • Michelob Ultra, and MGD 64 beer (promoted as fitness and weight-loss aids)

Or how about vodka advertised as “no sugar, gluten free, low calorie?”  The Marin Institute points out that terms like these are “promoted as logical compliments to a healthy, fitness-oriented lifestyle, without a hint of irony.”

Irony?  Check the illustrations!

As the report concludes, such marketing messages when applied to alcoholic beverages are “legally tenuous, morally unsound, and potentially dangerous.”

But don’t blame the FDA for this one.  Alcoholic beverages are regulated by the Treasury Department because they are a lucrative source of revenue.  Health claims sell products.

Treasury benefits more when companies sell more.  This sounds to me like a clear conflict of interest.  You?

 

 

May 27 2011

Why I think health claims are about marketing, not health? Gerber’s whey claim

Yesterday’s New York Times displayed a full-page advertisement for Gerber baby food (owned by Nestlé, no relation):

Gerber is taking more than baby steps to reduce the risk of certain allergies

.…The FDA concludes that current scientific evidence is appropriate for consideration of a claim regarding the relationship between the consumption of 100% whey-protein partially hydrolyzed infant formula and reduced risk of atopic dermatitis.

….We’re proud to say that Gerber Good Start is the first and only formula brand made from 100% whey-protein partially hydrolyzed.  In contrast, most other routine milk-based formulas are made with intact cow’s milk protein.

Translation: Some infants are allergic to the proteins (whey) in cow’s milk.  Treating the proteins so they are split apart into smaller fragments (partial hydrolysis) apparently destroys some of their ability to elicit allergic immune reactions in the skin.

But here’s where the ad gets totally weird:

The FDA has concluded that the relationship between 100% whey-protein partially hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is little scientific evidence for the relationship.  Partially hydrolyzed formulas should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms.

Huh?

Blame Congress for this one.  It insists that the FDA allow “qualified” health claims” for which scientific evidence is uncertain.

If you want to know why the FDA can’t seem to get anything done, take a look at what it’s staff had to do to respond to the Gerber petition.  Graduate students take note: this is an exhaustive review of scientific studies on the relationship between hydrolyzed whey protein and infant skin allergies.

Here is the FDA’s conclusion, written in FDA-speak, about Gerber’s petition for a health claim:

In light of the above considerations, FDA intends to consider the exercise of its enforcement discretion for the following qualified health claims (my emphasis):

1. “Very little scientific evidence suggests that, for healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow’s milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life and up to 3 years of age.”

2. “Little scientific evidence suggests that, for healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow’s milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life.”

3. “For healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow’s milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life and up to 3 years of age. FDA has concluded that the relationship between 100% Whey-Protein Partially Hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is very little scientific evidence for the relationship.”

4. “For healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow’s milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life. FDA has concluded that the relationship between 100% Whey-Protein Partially Hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is little scientific evidence for the relationship.”

Why would Gerber’s place a hugely expensive full-page ad in national newspapers to celebrate a decision like this?  Because it knows that any health claim, no matter how poorly substantiated by science, gives it a competitive advantage.

This is reason enough to promote breastfeeding.

 

May 23 2011

POM Wonderful vs. the FTC: what this is about

On May 24, an administrative law judge will deal with the matter of the Federal Trade Commission’s (FTC) complaints that health claims made for POM Wonderful pomegranate juice are unsubstantiated by science.

To review:  last September, the FTC complained that the company was advertising its juice with unsubstantiated claims like these:

  • Clinical studies prove that POM Juice and POMx prevent, reduce the risk of, and treat heart disease, including by decreasing arterial plaque, lowering blood pressure, and improving blood flow to the heart;
  • Clinical studies prove that POM Juice and POMx prevent, reduce the risk of, and treat prostate cancer, including by prolonging prostate-specific antigen doubling time;
  • Clinical studies prove that POM Juice prevents, reduces the risk of, and treats, erectile dysfunction.

The FTC argues that these claims are false because POM Wonderful’s studies do not prove what the company claims.  The FTC particularly takes exceptions to the company’s advertisements:

If you want to follow the legalities, the FTC provides a handy summary.

According to FoodNavigator.com, this company must be supporting armies of lawyers:

POM is currently embroiled in a complex web of litigation, having itself launched legal action against the FTC alleging it had exceeded its statutory authority by establishing a two-clinical trial standard to back claims.

It has also filed actions against Coca-Cola Minute Maid, PepsiCo Tropicana and Ocean Spray alleging misleading claims about the contents of their pomegranate-containing juice products.

Separately, POM is itself accused of misleading consumers in a class action lodged in a Florida state court.

Leaving this particular company’s legal strategies aside, at issue is whether food health claims need to be backed up by science.   POM says it has the science.   The FTC says it doesn’t.   I will have more to say about that issue in subsequent posts.

In the meantime, it will be interesting to see what happens at the hearing.  Stay tuned.

May 15 2011

Foods with benefits? Oh, please.

Sunday’s New York Times has not one but two articles about “functional foods,” those with something added over and above what’s in the food in the first place.

A front-page story, “Dessert, laid-back and legal,” describes brownies.  No, not brownies laced with marijuana.  This time they contain the sleep-inducing drug melatonin.

The brownies, according to the Times, contain just as much melatonin as are found in drug pills but are cheaper and can be purchased with food stamps (another reason for taking a look at the whole question of SNAP benefits?).

Since melatonin is a drug and not an approved food additive, the makers of these products are trying to get around the annoying FDA restrictions by marketing the brownies as “dietary supplements.”  Supplements, by order of Congress when it passed the Dietary Supplement Health and Education Act (DSHEA) of 1994, do not have to meet FDA’s rigorous scientific criteria for safety or efficacy.

DSHEA applied to supplements, not foods, but the FDA has chosen to regulate foods containing such additives by the weaker rules applying to supplements and to deal with them as a regulatory gray area.   Is melatonin a drug, a supplement, or in brownie from a food?  The FDA is going to have to decide this, and fast.

A much longer story in the business section, “Foods with benefits, or so they say” (in which I am quoted) focuses on the entire point of functional foods: the ability to put something in a product that allows you to market it using health and wellness claims.  Health claims sell food products.  People like buying products with a “health aura,” no matter how poorly the health claim is supported by science.  Science is irrelevant here.  Marketing is what’s relevant.

As I discuss in my book, Food Politics, until the early 1990s, the FDA did not allow health claims on food products.  Claiming a specific health benefit for a food, said the FDA, meant that the food was being marketed as a drug.  If a food was being marketed as a drug, it needed to prove safety and efficacy, something no food maker wanted to do.

When Congress passed the Nutrition Labeling and Education Act in 1990, it struck a deal with the food industry.  The industry was objecting that because Nutrition Facts labels required them to say what was bad about their products, they ought to be allowed to say what was good about them.  Congress agreed, and forced the FDA to review the science linking certain food ingredients to health benefits as a basis for permitting health claims.

The FDA approved some claims but rejected others.  The rejected companies took the FDA to court, and the courts mostly ruled in favor of the companies on the grounds of the First Amendment.  The FDA stopped trying to control unsupported health claims and only recently has taken then on again.

But as sales soar, federal regulators worry that some packaged foods that scream healthy on their labels are in fact no healthier than many ordinary brands. Federal Trade Commission officials have been cracking down on products that, in their view, make dubious or exaggerated claims. Overwhelmed regulators concede that they are struggling to police this booming market, despite recent settlements with makers of brands like Kellogg’s Rice Krispies and Dannon’s Activia, which the authorities say oversold their health benefits.

To the distress of international food marketers, the U.S. currently has much looser regulations about health claims than are available in Europe.  The European Food Safety Authority has been reviewing thousands of petitions for health claims on food products and turning most of them down as scientifically unsubstantiated.  That doesn’t stop American food makers from loading on the claims.

From the ivory tower in which I sit, the remedy is easy: don’t allow health claims on processed foods at all.  The claims are all inherently misleading, as would be obvious if you gave it a minute’s thought.

But if they aren’t worth much to you, they are worth plenty to the marketers of processed foods.  And that’s what this is really about.

Jan 20 2011

What are we to think about Walmart’s healthy food initiatives?

In a press conference attended by Michelle Obama, Walmart today said it will do five things:

  • Work with processed food suppliers to reduce sodium, sugars, and trans fat in hundreds of foods by 2015
  • Develop its own front-of-package seal to identify healthier products
  • Make healthier processed foods more affordable
  • Put a new, different kind of Walmart store in low-income “food deserts”
  • Increase charitable support for nutrition programs

I’ve been on the phone all day with interviewers, most of them totally focused on the first two.  Walmart has established its own nutrition criteria for judging its own products.  These seem generous and not particularly challenging, and this is just what Pepsi, Kraft, and other companies have been doing.  These criteria are only slightly better.

The idea that Walmart is going to do its own front-of-package label to identify those products is particularly annoying.  They are doing this just when the Institute of Medicine and FDA are trying to establish research-based criteria for front-of-package labels.  So here is one more company trying to preempt FDA regulations.

When I asked Walmart representatives about this, they told me that the FDA moves slowly and the public needs this information now.  Sorry.  I don’t buy that.

The next two initiatives are much more interesting and have much greater potential to do some good.  Walmart says it will price better-for-you processed foods lower than the regular versions and will develop its own supply chain as a means to reduce the price of fruits and vegetables.  This sounds good, but what about the downside?  Will this hurt small farmers?   Walmart didn’t provide many details and we will have to see how this one plays out.

And then there is the one about putting smaller Walmart stores into inner cities in order to solve the problem of “food deserts.”  This also sounds good—and it’s about time groceries moved into inner cities—but is this just a ploy to get Walmart stores into places where they haven’t been wanted?  Will the new stores drive mom-and-pop stores out of business?  Here too, Walmart is short on details.

None of the reporters seems to be connecting these initiatives with Walmart’s dismal history of low wages and poor working conditions.  Will these change for the better?

Walmart is not a social service agency.  It is a business and a hugely successful one.  It outsells the largest grocery chains in America by a factor of two.   Today’s New York Times says that 16% of U.S. sales of Kraft products are at Walmart stores.  PepsiCo admits to 10%.   These are huge numbers.

Walmart can get whatever it wants from suppliers—and even get Mrs. Obama to endorse its actions.  That’s power.

Whether these initiatives will do anything for health remains to be seen.  They will certainly put pressure on other suppliers and stores to tweak their products. I don’t think that’s good enough.

I’ll say it again: a better-for-you processed food is not necessarily a good choice.

That’s why I think the most important of these initiatives is the one to reduce the price of fruits and vegetables.  That could make a real difference.

Jan 18 2011

GAO takes on health claims. Yes!

Let’s hear it for the Government Accountability Office, the congressional watchdog agency that has still managed to remain independent of the more corrupt aspects of Washington food politics.  In its most recent investigation, the GAO took a tough look at the inability of the FDA to hold health claims on food packages to reasonable scientific standards.

The new GAO report, Food Labeling: FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims, appeared on January 14.

The report reviews the history of health claims on food labels.  By law, these must be supported by “significant scientific agreement,” but court decisions in 2002 led the FDA to allow “qualified health claims.”  These claims have less—and, sometimes, no—scientific support.

Parke Wilde, who writes the U.S. Food Policy Blog, brilliantly parses the categories of health claims now allowed by the FDA:

  • Health claims — aka REAL health claims — which must have evidence that meets a standard called “significant scientific agreement”
  • Qualified health claims — aka WISHFUL health claims — which can meet a weaker standard of evidence, so long as the company admits the weaker evidence on the label.
  • Structure / function claims — aka STEALTHY health claims — which purport not to be health claims (for example, a high-fiber product that “keeps your bowels moving” without explicitly claiming to “treat constipation”; or a high-calcium product that “builds strong bones” without explicitly claiming to “prevent osteoporosis”)

The GAO reviews evidence that consumers can’t tell the difference between one kind of health claim and another (I could have told them that).

Food companies take advantage of this confusion and increasingly use the stealth structure/function claims, which the FDA pretty much ignores.

The FDA has to ignore them.  It doesn’t have much choice.  The FDA has no authority to require companies to submit evidence of scientific substantiation.  The FDA is permitted to ask for the information, but it has no legal authority to force companies to provide it.

GAO says this situation does not sufficiently protect the public from unscrupulous marketers.  It says the FDA should:

  • Ask Congress to grant it the authority to access companies’ evidence for the scientific support of potentially false or misleading structure/function claims on foods.
  • Provide guidance to industry on the evidence it needs to support such claims.
  • Provide direction to FDA inspectors to help identify claims for further review.

FDA: Do this, please, and right away.  Congress: Pay attention and act.

Imagine: health claims on food packages that actually have some science behind them.  What a concept!


Jan 1 2011

Predictions: national nutrition issues for 2011

My first San Francisco Chronicle “Food Matters” column for the new year deals with some predictions:

Q: Whatever you used as a crystal ball last year turned out to be a pretty good predictor of the most prominent food issues of 2010. How about trying again: What food matters will we be hearing about in 2011?

A: It doesn’t take a crystal ball to figure out what’s coming up with food issues. I’m happy to make predictions, especially since most seem fairly safe.

Dietary guidelines will be released this month. By law, they were due last year and are already late. What will they say? The 2010 guidelines advisory committee recommended eating more fruits, vegetables and whole grains, but introduced a new euphemism – SOFAs, or Solid Fats and Added Sugars – for the “eat less” advice. SOFAs really mean “cut down on fatty meat and dairy products” and “avoid sugary sodas.”

Will government agencies have the nerve to say so? Let’s hope.

The U.S. Department of Agriculture will issue a new food guide. The 2005 pyramid’s rainbow stripes proved impossible to teach and useless to anyone without a computer. I’ve heard a rumor that I will love the new design. I’m skeptical. I liked the original 1992 pyramid. It showed that bottom-of-the-pyramid foods were healthiest, making it unpopular with companies selling top-of-the-pyramid products. But it is healthier to eat some foods than others (see: dietary guidelines).

Will the USDA improve on the 1992 design? We will soon find out.

The fights over food safety will continue. At the last possible moment, Congress passed the food safety bill by a large majority. Now the fights really begin.

Funding will be most contentious, with the actual regulations not far behind. The Congressional Budget Office absurdly considered the bill’s provisions to be “budget neutral.” They are anything but.

The bill’s provisions require the Food and Drug Administration to hire more inspectors just at a time when Republican lawmakers have sworn to cut domestic spending. The FDA also must translate the bill’s requirements and exemptions for small farmers into regulations.

Rule-making is a lengthy process subject to public comment and, therefore, political maneuvering. Watch the lobbying efforts ratchet up as food producers, large and small, attempt to head off safety rules they think they won’t like.

Expect more lawsuits over the scientific basis of health claims. The Federal Trade Commission just settled a $21 million claim against Dannon for advertising that yogurt protects against the flu. The agency also has gone after scientifically unsubstantiated claims that omega-3s in kiddie supplements promote brain development and that pomegranate juice protects against prostate problems. POM Wonderful has already countersued the FTC on grounds that the First Amendment protects commercial speech. I’ll be watching this case carefully.

The FDA will issue new front-of-package label regulations. The FDA has promised to propose an at-a-glance symbol to indicate the overall nutritional value of food products. Food companies like the Guideline Daily Amount spots they are using in the upper corners of food packages because the symbols are factual but nonjudgmental. The FDA, however, is considering red, yellow and green traffic-light symbols that do convey judgments. Food companies say they will not voluntarily use a symbol that tells people to eat less of their products.

Will the FDA have the courage to make traffic lights mandatory? It will need courage. The new British government dealt with the traffic-light idea by summarily dismantling the food agency that suggested it.

Corporations will seek new ways to co-opt critics. Under the guise of corporate social responsibility, food companies have been making large donations to organizations that might otherwise criticize their products. The most recent example is the decision by Save the Children, formerly a staunch advocate of soda taxes, to drop that cause coincidentally at a time when its executives were negotiating funding from Coca-Cola.

Such strategies remind me of how the Philip Morris cigarette company distributed grants to leading arts groups. Expect food companies to use generosity to neutralize critics and buy silence.

School meals will make front-page news. Congress passed the Healthy, Hunger-Free Kids Act last month. Now the USDA must implement it by setting nutrition standards, adding fresh fruits and vegetables (some locally grown) and expanding eligibility.

President Obama has promised to restore the $4.5 billion “borrowed” from the SNAP (food stamp) program to fund this act. The scrambling over the regulations and financing should make excellent spectator sport.

Farm bill advocates will be mobilizing. You might think it too early to be worrying about the 2012 Farm Bill, but I’ve already gotten position papers analyzing commodity and food-assistance issues from groups gearing up to lobby Congress to bring agricultural policy in line with nutrition and public health policy.

I have a personal interest in such papers. I will be teaching a course on the Farm Bill at New York University next fall. Please get busy and write more of them!

Happy new year, and let’s see how my guesses play out.

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