Currently browsing posts about: Health-claims

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.

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.

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?

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?

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.

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.

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:

• Front-of-package labeling information
• Copies of the warning letters
• The letter from Dr. Hamburg to the industry
• Q and A, and
• Link to terms with strict, regulatory definitions

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).

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.