by Marion Nestle

Currently browsing posts about: Health-claims

Sep 28 2010

FTC says no to POM Wonderful advertising claims

The newly alive Federal Trade Commission (FTC) says POM Wonderful must stop making unscientific claims for the health benefits of pomegranate juice.  POM juice, the FTC says, has not been shown to prevent or treat heart disease, prostate cancer, or erectile dysfunction, as the company claims:

  • “SUPER HEALTH POWERS! … 100% PURE POMEGRANATE JUICE. … Backed by $25 million in medical research.  Proven to fight for cardiovascular, prostate and erectile health.”
  • “NEW RESEARCH OFFERS FURTHER PROOF OF THE HEART-HEALTHY BENEFITS OF POM WONDERFUL JUICE.  30% DECREASE IN ARTERIAL PLAQUE … 17% IMPROVED BLOOD FLOW … PROMOTES HEALTHY BLOOD VESSELS … ”
  • “Prostate health…You have to be on pomegranate juice.  You have a 50 percent chance of getting [prostate cancer].  Listen to me.  It is the one thing that will keep your PSA normal.  You have to drink pomegranate juice.  There is nothing else we know of that will keep your PSA in check. … It’s also 40 percent as effective as Viagra.”
  • Clinical studies prove that POM Juice prevents, reduces the risk of, and treats, erectile dysfunction.

The complaint cites advertisements in the Washington Post and Fitness magazine, as well as this ad:

According to the New York Times account, the POM Wonderful folks are not taking this lightly.  They have spent a reported $34 million on research to “prove” that POM has antioxidant activity.

But I could have told them that before they spent a dime!  All fruits and vegetables have antioxidant activity.

I love using POM research as an example of how easy it is to design studies to give you the answer you want.  POM research demonstrates that pomegranate juice has antioxidant activity and acts as an antioxidant in the body.  Of course it does.

But so does every other fruit and vegetable and what this research does not do is compare the effects of pomegranate juice to those of orange juice, for example.     That’s the issue I talked about in my November 19, 2007 post titled “The (silly) battle of the antioxidants.”

Which fruit has the most antioxidants? The latest report says blueberries, followed by cranberries, apples, red grapes, and finally green grapes. What? Pomegranates don’t even make the top five? In this case, who knows? The investigators were testing a new assay method and those were the only fruits they examined.

And then there is the troubling matter of whether antioxidants make a demonstrable difference to health.  The European Food Standards Agency has been turning down health claims for antioxidants like mad.  As I discussed on April 16, 2009:

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.

If only that pesky science weren’t so inconvenient, marketers could do as they please.  The New York Times reports that the POM folks are not taking this lightly.  They are suing the FTC—not because they are claiming they have science on their side, but because they think their health claims, believable or not, are protected by the First Amendment.

Did our founding fathers really introduce the First Amendment to protect the right of marketers to make unsubstantiated health claims?  Do our judges really believe this?  Is this a good case for taking on this question.  Lawyers: get to work!

Aug 2 2010

Why the FDA must act on health claims

On July 30, Center for Science in the Public Interest (CSPI)—in collaboration with representatives of a long list of distinguished health and consumer organizations (see below)–wrote Martha Coven of the Domestic Policy Council and Ezekiel Emanuel of the Office of Management and Budget urging them to encourage the FDA to take more vigorous enforcement action against misleading health claims on food packages.

Their petition responds to comments by the FDA’s Michael Taylor (discussed in a previous post) in a July 19 article for the Atlantic Food Channel, titled “How the FDA is picking its food battles.”   In explaining why the FDA is backing off from doing anything about unsubstantiated health claims on food products, Taylor said:

FDA must pick its battles—and set its priorities—in a way that will best benefit the public health….We have no pre-market review authority over such claims, and, under prevailing legal doctrines concerning “commercial free speech,” the evidentiary requirements placed on FDA to prove that such claims are misleading are significant and costly to meet. Moreover, meeting them requires tapping the same team of nutritionists, labeling experts, and lawyers who are working on our other nutrition initiatives.

We’re also conscious of the cleverness of marketing folks, who, once we prove today’s claim is misleading, can readily come up with another one tomorrow. Going after them one-by-one with the legal and resource restraints we work under is a little like playing Whac-a-Mole, with one hand tied behind your back.

So, we must make choices….especially considering the other high-priority nutrition and food safety initiatives that compete for FDA’s finite resources. We’ll consider all possibilities, but, in the meantime, we call on the food industry to exercise restraint, and we welcome the scrutiny CSPI and the media give to this issue.

Clearly, I was not the only one dismayed by this statement, which appears to be an open invitation to food companies to do whatever they like with health claims.  Indeed, Taylor’s statement reminded me of the Bush Administration’s FDA which, in 2003, announced that it had lost so many first amendment  health claims cases in court that it no longer intended to fight them.

But Taylor’s statement is also an open invitation to food advocates to get busy, as CSPI and the other signers of this letter have now done. The letter, dated July 30, 2010, is a follow up to a June 11 meeting on FDA/USDA Food Labeling Reform Efforts:

At Zeke’s suggestion, we are attaching a Priority List/Timetable Chart that provides an overview of the recommendations we made at our meeting and delineates how those recommendations intersect. As we discussed:

• We commend the Food and Drug Administration (FDA) for increasing the number of enforcement actions it has taken against misleading food labeling, and we urge the agency to increase those efforts. We also commend the FDA’s initiative to develop a system for disclosing key nutrition information on the fronts of food labels. However, we emphasize that the existing Nutrition Facts panel must also be modernized. In particular, nutrition information must be based on up-to-date serving sizes, a Daily Value for added sugars must be established and added to the existing Nutrition Facts panel, and “Calories per serving” must be displayed more prominently. Revisions to the Nutrition Facts panel and the development of a front-of-pack disclosure system are closely intertwined and should be developed concurrently.

• We urge the Domestic Policy Council to ask the FDA to ensure that any front-of-pack labeling scheme is not undercut by deceptive health-related claims on the fronts of food packages. Such claims, if unabated, will divert attention from any front-of-pack scheme the FDA develops. Since our meeting, the Federal Trade Commission (FTC) issued a consent order prohibiting claims that a food product could strengthen immunity because the claim lacked sufficient clinical evidence. Such claims are called “structure/function” claims by the FDA. The FDA should take a consistent position regarding the use of those claims. In addition, the FDA should address claims exaggerating the presence of healthy ingredients stressed in the U.S. Dietary Guidelines such as whole grains, fruits, and vegetables. For example, failure to remedy claims such as “Made with real fruit” on products that contain little fruit will detract from a declaration of sugar content that the FDA may specify in a front-of-pack labeling scheme, thus frustrating the Administration’s attempts to reduce childhood obesity.

• One way to remedy exaggerated claims for healthy ingredients (other than prohibiting them completely) is for the FDA to revise the ingredient list to require that the percentage of key ingredients such as fruit be disclosed in a clear, easily readable manner. FDA could also require that ingredient lists group all sources of added sugars to provide consumers with a clearer indication of the amount of added sugar in a product. The First Lady has recognized that ingredient labeling reform is an integral part of the Administration’s broader efforts to combat childhood obesity. The U.S. Department of Agriculture (USDA) is already working on new formats for ingredient labeling. We support those efforts and request the Council to encourage the FDA to follow USDA’s approach.

• In regard to a timetable, the recommendations we have made are closely intertwined with efforts already ongoing at the FDA. In some cases, they are necessary to ensure that those ongoing efforts by FDA succeed. We, therefore, urge the Council to recommend that the FDA expand its food labeling reform initiatives to include these additional issues and address them concurrently. Additional efforts that complement existing FDA labeling reform initiatives should commence as soon as the first set of initiatives is published in the Federal Register. All initiatives should be finalized by October 2012. This request is based on the fact that the FDA implemented the Nutrition Labeling and Education Act of 1990 in two years. The reform efforts we request are more limited than the requirements of the 1990 Act, and the FDA should be able to accomplish them by 2012 based on the agency’s previous performance on such matters.

• Rep. DeLauro, Chair of the House Agriculture Appropriations Subcommittee, asked the FDA how many FTEs the agency would need to issue regulations to revise the Nutrition Facts panel, increase the prominence of calories per serving, require caffeine labeling, and establish a daily value for added sugars, as well as other issues. The FDA stated that approximately “10-12” additional FTE’s would be necessary to address such concerns. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2005: Hearings Before a Subcomm. of the House Comm. on Appropriations, 108th Cong. 2d Sess. 323 (2004). While the FDA’s response at the time involved some issues not covered by our current requests, we believe that the FDA’s estimate is still reasonable, and we urge the Council and the Office of Management and Budget to work with the FDA to ensure that the FDA devotes additional resources to this effort.

We welcome the opportunity to assist the Administration and look forward to continuing our dialogue.

The letter is signed by Bruce Silverglade, Director of Legal Affairs, CSPI and representatives of Consumers Union, American Public Health Association, American Medical Association,  American Cancer Society Cancer Action Network, American Heart Association,  American Society of Bariatric Physicians, American Diabetes Association,  American Dietetic Association, Alliance for Retired Americans, Society for Nutrition Education, American Institute for Cancer Research, and Directors of Health Promotion and Education.

Let’s hope the FDA pays attention and gets busy on these issues.

Jul 20 2010

UK Food Standards Agency stripped of responsibilities

Britain has, as threatened, split up its Food Standards Agency (roughly equivalent to our FDA).  The split only applied to FSA in England.  Its role in Scotland, Northern Ireland and Wales remains the same for the moment.

As I mentioned in a previous post, the precipitating cause of the new government’s distress about the FSA was—incredible as it seems—the agency’s support of traffic-light front-of-package labeling. 

In its new configuration, FSA keeps its food safety functions.  Its nutrition and labeling functions go to the Department of Health.  Its country-of-origin and other non-labeling policies go to the Department for Environment, Food and Rural Affairs (Defra).

Surprise!  The UK Food and Drink Federation thinks this is a terrific move.

As the voice of the UK food and drink manufacturing sector, we believe it is important to maintain an independent food safety regulator and fully support today’s decision by the Government to retain the Food Standards Agency…We also support the decision to move responsibility for nutrition, and other food policy issues, back into Government departments…This should lead to clearer and more consistent policy making, while avoiding unnecessary duplication of effort across Whitehall.

FSA may be keeping its food safety responsibilities, but Food Safety News reports that the agency hasn’t been doing such a great job with them.  FSA’s most recent  Annual Report says that it did not achieve its target for reduction of Campylobacter infections.  It also failed to reach targets for reductions in salt and saturated fat.

Under the new division of responsibility, salt and fat are no longer FSA’s problem.  The Health Department will be dealing with them—or not.

Given the industry-friendly bent of the new new health minister, expect considerable backing off from previous FSA policies. 

England is not setting a good example for our FDA, alas.

As for what FDA can and cannot do, see Michael Taylor’s post on the Atlantic Food Channel.  In discussing why the FDA isn’t taking a more vigorous enforcement stance against unsubstantiated health claims on food products, Taylor says:

We have no pre-market review authority over such claims, and, under prevailing legal doctrines concerning “commercial free speech,” the evidentiary requirements placed on FDA to prove that such claims are misleading are significant and costly to meet. Moreover, meeting them requires tapping the same team of nutritionists, labeling experts, and lawyers who are working on our other nutrition initiatives.

If they go after health claims, he says, it’s a losing proposition:

We’re also conscious of the cleverness of marketing folks, who, once we prove today’s claim is misleading, can readily come up with another one tomorrow. Going after them one-by-one with the legal and resource restraints we work under is a little like playing Whac-a-Mole, with one hand tied behind your back.

What he doesn’t point out nearly strongly enough, in my opinion, is that doing something about health claims rests with Congress.  Congress passes laws.  The FDA’s job is to enforce them.  Congress needs to give the FDA the tools it needs to protect the public and promote public health. 

And that, of course, brings us back to the food safety bill that has been sitting in the Senate for the last 11 months.  If Congress can’t even get that passed, it’s hard to be optimistic about its doing anything reasonable about misleading health claims.

Jul 19 2010

Does science support food health claims?

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.

Jun 11 2010

Health claims: Should the First Amendment protect bad science?

I keep complaining about the health claims on Enfagrow toddler formula, a sugary product aimed at children from ages one to three:

These claims, for the uninitiated, are a special kind called structure-function.  Congress authorized such claims when it passed the Dietary Supplement Health and Education Act (DSHEA) in 1994.

Structure-function claims do not say that the product can prevent or treat disease. They merely suggest that the product can help in some unspecified way with some structure or function of the body.

When Congress passed DSHEA, it meant the claims to apply to dietary supplements, not foods. Enfagrow is marketed as a food, not a supplement.  It displays a Nutrition Facts label, not a Supplement Facts label.

Over the years, the FDA has issued cease-and-desist warnings about foods that bear structure-function claims.  In recent years, it has simply stated that manufacturers are responsible for ensuring that the claims are “truthful and not misleading.”

One reason for the shift is what the Courts have ruled.  The Courts say that structure-function claims are protected by First Amendment guarantees of free speech.  The most recent case is Alliance for Natural Health USA v. Sebelius. As described in Food Chemical News (June 7), a D.C. District Court judge ruled that the FDA cannot deny health claims that link selenium supplements to reduced risk of several diseases, or require those claims to be qualified, just because the claims lack adequate scientific substantiation.

In other words, supplement makers can say anything they want to about the benefits of their products—on the grounds of free commercial speech—whether or not science backs up the claim.

Recently, the FDA issued a warning letter to Nestlé, the maker of a Juicy Juice product aimed at toddlers, which displays a claim that its content of added omega-3 DHA improves brain development.  The FDA did not take on the claim, even though research seems unlikely to find that such drinks have any special benefits for brain development.  Instead, the FDA focused on a technicality:

The product makes claims such as “no sugar added,” which are not allowed on products intended for children under 2 yrs of age because appropriate dietary levels have not been established for children in this age range.

I’m guessing—this is speculation—that the FDA is reluctant to take on Enfagrow’s brain or immunity claims because Mead-Johnson has deep pockets and might well be willing to fight this one in court as a First Amendment case.

I am not a lawyer but I thought that intent mattered in legal cases.  Surely, the intent of the founding fathers in creating the First Amendment was to protect the right of individual citizens to speak freely about their political and religious beliefs.  Surely, their intent had nothing to do with protecting the rights of supplement, food, and drug corporations to claim benefits for unproven remedies, or to promote sales of sugary foods to babies.

I think it is time to give these First Amendment issues some serious thought.  How about:

  • FDA: Fire those lawyers and hire some who will protect the FDA’s ability to use science in its decisions.
  • FTC: Take a look a the immunity claim on the Enfagrow Vanilla toddler formula, now that the Chocolate is off the market.
  • Legal scholars: Surely there are ways to protect real First Amendment rights while restricting unsubstantiated health claims?

Other ideas are most welcome.  Your thoughts?

Jun 8 2010

FTC goes after Kellogg’s Immunity claim, but why?

The FTC has imposed new advertising restrictions on Kellogg because of the Immunity claim on Rice Krispies.  The company is not to make claims about “any health benefit of any food  unless the claims are backed by scientific evidence and not misleading.”

Under a previous order dealing with Frosted Mini-Wheats, Kellogg was not supposed to make claims about benefits to cognition on any of its cereals or snack foods unless the company could prove that the claims were backed by real science. This new decision extends that ruling to include any claim at all.

OK, but I’m confused about several aspects of this decision:

  • How come the FTC is doing this and not the FDA?  At some point years ago, regulatory responsibility was split between FDA and FTC.  Since then, the FDA regulates claims on food package labels, whereas the FTC regulates advertising claims.  I realize that food labels are a form of advertising, but it’s unusual and surprising for the FTC to get involved in FDA-regulated matters.
  • As FoodNavigator also wonders, why didn’t the FTC fine the company and, instead, write a harsh letter? [see update below]
  • Why is the FTC doing this?  Kellogg agreed months ago to withdraw its Immunity claim ( see my November 5 post about the withdrawal).  The Immunity boxes gradually disappeared from supermarket shelves and I haven’t seen one for a long time.

So what’s going on here?  Is the FTC getting serious about regulation (and about time, too)?  Or is FDA sitting back and letting the FTC do its enforcement work?

Could this be why the FDA hasn’t sent a warning letter to Mead-Johnson, the maker of the chocolate toddler formula with three health claims aimed at kids ages 1 to 3.  I posted about this product on April 26, but haven’t heard whether the FDA is doing anything about it.  Can the FTC be on this case but waiting for investigations to be completed before taking action?

Kellogg, it seems, is under fire on all fronts.  CSPI’s Margo Wootan sent me the recent decision by the Children’s Advertising Review Unit of the Better Business Bureau that Kellogg must stop advertising Pop-Tarts to kids:

CARU was concerned that the product packaging, which features berries and states “Made with Real Fruit” for several of Kellogg’s Pop-Tarts®  products that have fruit in their names, impliedly represents to children that the products contain substantial amounts of fruit.

In fact, according to CARU, Pop-Tarts contain less than 6% fruit and less than 2% of the fruit shown in the advertising. Kellogg claimed that its marketing was not aimed at kids, but lost that one.

It’s great that regulatory agencies like FTC and FDA (and voluntary agencies like CARU) are regulating but it’s hard to keep track of who is doing what.   Nothing to do but wait and see what happens next.  Stay tuned.

Update, June 8: CSPI’s Margo Wootan writes that FTC can’t impose fines because it does not have the authority to issue civil penalties.  Ted Mermin of Public Good Law concurs.  He says:

Companies fight hard to make FTC (and similar) orders as narrow as possible, in large part to avoid precisely the situation in which they are held responsible for violating an existing injunction/order.  Since (in the Commission’s view, at least) Kellogg hadn’t violated an existing order, the FTC did not have the authority to fine them without first going to the US Department of Justice to get DOJ to take the case (a matter of a 45 day delay, if DOJ takes it at all).  The burden of that delay (and of needing to get authority from DOJ in the first place) is precisely what is driving the congressional charge for enhanced FTC authority as part of the financial reform legislation.

If the House version of financial reform legislation had been in effect, the FTC would have had the authority to seek civil penalties (i.e., fines) and the outcome here might have been different.  As it was, the fact that Kellogg had stopped the practice…kept the Commission (at least the three commissioners in the “majority”) from focusing on any remedy other than injunctive relief–that is, a broadening of the existing order from the Mini-Wheats case, with the threat of that $16,000 per violation (and an expanded area of prohibited activity) running into the future.

Update, June 11: In an editorial titled “Snake oil for breakfast,” the New York Times explains why health claims matter so much.  If you can’t believe health claims, what part of the food label can you believe?:

Businesses have been making dubious claims about their products at least since the 17th century, when the British clergyman Anthony Daffy sold Daffy’s Elixir as a cure for scurvy as well as agues, gout, rheumatism, rickets, worms and other ailments. Hucksterism — no matter how implausible the claim — lives on…[for example] POM Wonderful claimed its pomegranate juice helps treat, prevent or cure hypertension, diabetes and cancer.  This might be par for the course for an era of swift-boating political ads and a torrent of television commercials plumping for myriad wonder drugs (sudden death may result). It leaves the consumer in a quandary: what part of the label can be believed?

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.