Currently browsing posts about: Health-claims

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.

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.

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!

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.

Kellogg has had a bad year on the truth-in-advertising front.

First, It took the brunt of the furor over the late and unlamented Smart Choices fiasco, when the program’s first logo turned up on Froot Loops of all things and was attacked by the Connecticut attorney general.

Next, the IMMUNITY banner on Cocoa Krispies drew fire from the San Francisco city attorney’s office.

Both boxes are now collectors’ items.

Now, FoodNavigator-USA reports that Kellogg has taken another expensive beating, this time on its health claim for Mini-Wheats.

In 2009, Frosted Mini-Wheat boxes sported this health claim:  “Clinically shown to improve children’s attentiveness by nearly 20%.”

Of course this cereal can do that, especially when kids eating it are compared to kids who don’t eat any breakfast at all—which is what this study did.

But that’s not what the adorable television advertisements imply, as shown in exhibits A and B in the summary of the class-action decision.

Last April, Kellogg settled a dispute with the FTC over this claim.  The FTC did not argue that the claim was inherently absurd because of the lack of an appropriate control group for the study.  Instead, it took the study at face value and charged Kellogg with exaggerating the results because hardly any children—only 11%—improved attentiveness by 20% or more.

Kellogg has just settled a class-action suit over this claim that will cost the company $2.75 million in order to pay customers between $5 and $15 each in compensation.  The company also will give $5.5 million to charities.

Because of city and state attorneys and the FTC, the most egregious health claims are slowly disappearing from cereal boxes.     But lawsuits do not constitute policy.  What goes on the front of food packages is FDA territory.

FDA: Get to work!

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!

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.