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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?

Mead Johnson announced yesterday that it was withdrawing its Enfagrow Chocolate Toddler Formula–just the Chocolate version–from the market:

Like all our Enfagrow Premium products, the recently introduced chocolate-flavored version has a superior nutritional profile to many other beverages typically consumed by toddlers — including apple juice, grape juice, and similarly flavored dairy drinks. Unfortunately, there has been some misunderstanding and mischaracterization regarding the intended consumer for this product and the proper role it can play in a child’s balanced diet. The resulting debate has distracted attention from the overall benefits of the brand, so we have decided to discontinue production of Enfagrow Premium chocolate toddler drink and phase it out over the coming weeks.

I can’t resist quoting the Chicago Tribune’s explanation of the origin of the debate caused by “misunderstanding and mischaracterization:”

Introduced in February, the chocolate-flavored formula was widely criticized in the blogosphere after Marion Nestle, professor of nutrition, food studies and public health at New York University, wrote that the drink would lead children to crave sugary beverages on her influential blog, www.foodpolitics.com.

Influential?  Maybe, but it seems that my comments on this formula did not go nearly far enough.  Mead-Johnson may be withdrawing the Chocolate version, but it is keeping the Vanilla (as explained by Susan James on ABCNews.com, which also quotes me).

What’s the difference?  The Vanilla has exactly one gram less sugar than the Chocolate, 18 grams per 6-ounce serving, rather than 19 grams.  In contrast, the milk in my refrigerator has 9 grams of sugar (natural, not added) in 6 ounces.

Clearly, Mead-Johnson doesn’t get that it’s the sugars, stupid.

Why do I think this is a PR stunt?  Three reasons:

• The Vanilla doubles the sugars in regular milk.
• The Vanilla has the same health claims as the Chocolate: growth, brain development, and immunity.
• Mead-Johnson’s stock went up after the announcement.

One more time: Where are the FDA and FTC on this product?  This Immunity claim is no different from the one on Kellogg’s Krispies cereals that the FTC went after a couple of days ago.

Tomorrow: Some speculation on why the FDA is reluctant to take on things like this.

Addition, June 11: Here is Melanie Warner’s take on this on her BNet Food Industry blog site (she quotes my post).

If you don’t have a small baby, or your baby is breastfed(and see note at end) you no doubt are missing the furor over “functional” ingredients that companies have been adding to infant formulas.

DHA (an omega-3 fatty acid) came first.  As I discuss in my book, What to Eat, infant formula companies could not wait to add it.  They knew they could market it on the basis of preliminary evidence associating DHA with visual and cognitive benefits in young infants.    Although evidence for long term benefits is scanty, the companies also knew that they could charge higher prices formulas containing DHA.

The FDA approved the use of DHA in infant formulas on the grounds that it is safe, but did not require the companies to establish that DHA makes any difference to infant health after the first year.  Because of its marketing advantage, virtually all infant formulas now contain DHA.  Surprise!  They also cost more.

Companies now want to add other ingredients, such as prebiotics, probiotics, lutein, lycopene, and betacarotene, which also can be marketed as healthier and at higher prices.

In response, the Center for Budget and Policy Priorities (CBPP), has issued a report on the lack of evidence for the benefits of functional ingredients and the substantial harm they will cause to the economic viability of the WIC program, the USDA’s assistance program for low-income mothers and children.

WIC buys about half the infant formula sold in the United States each year.  WIC is not an entitlement program, meaning that the number of participants is limited by available funding (a GAO report explains how this works).

The CBPP report says:

As pressure mounts to limit federal discretionary spending, it is critical to ensure that WIC not spend funds on foods with functional ingredients that do not deliver clinically significant benefits. WIC spent approximately $850 million on infant formula last year, and a recent USDA study found that more than ten percent of that spending ($91 million annually) is attributable to higher-priced formulas with functional ingredients.  Under current law, the additional cost to WIC of providing foods with these ingredients is likely to grow substantially as such foods proliferate.

As the report explains, formula companies do not have to demonstrate that the added–and more expensive–ingredients do any good:

There is no mechanism within the national WIC program that requires USDA to review the research evidence on the claimed benefits of these functional ingredients or to base decisions about whether to offer foods containing such ingredients on their benefits and the specific needs of WIC participants. Currently, instead, infant formula manufacturers themselves decide whether WIC offers infant formulas with new functional ingredients, while state WIC programs decide whether WIC should offer other foods with such ingredients.

As I keep saying, functional foods (and ingredients) are about marketing, not health.  If companies are going to add functional ingredients–and charge higher prices–they need to have some convincing scientific evidence to back up their claims.

Postscript: Laurie True of the California WIC program writes:

Congressman George Miller, Chair of the House Education and Labor Committee, is writing the bill that reauthorizes the WIC Program this week. He should include a provision requiring independent scientific review of the efficacy of these “functional ingredients” before USDA allows them in WIC foods and infant formula.

Note:  Lori Dorfman sends a Berkeley Media Studies Group issue paper on how to advocate for hospitals and workplaces to make it easier for moms to breastfeed.

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?

Today’s New York Times has an op-ed, “Crying over raw milk“, about the political fights over raw milk in Wisconsin.  The Wisconsin legislature has introduced a bill allowing dairy farmers to sell raw milk directly to consumers.  The conventional dairy industry is not happy about that.

The author of the piece, Michael Feldman, is dubious about the purported health benefits of raw milk but is quite clear about its economic benefits: “you can’t get $6 a gallon for pasteurized milk.”

Crass economics is behind much of the politics of raw milk these days.  The conventional dairy industry is in trouble: too many cows, too much milk, and not nearly enough regulation of supply.  In contrast, raw milk has passionate advocates willing to pay premium prices.

Not fair, says the dairy industry, which wants raw milk to be regulated:

In a letter to two senior members the Senate Committee on Health, Education, Labor and Pensions, the dairy groups called for a measure obliging all facilities producing raw or unpasteurized milk products for direct human consumption to “register with FDA and adhere to the tried-and-true food safety requirements that are followed by all other facilities producing milk products”.

As for the safety of raw milk, it is useful to take a look at Seattle attorney Bill Marler’s website: “Real Raw Milk Facts.”   There, he summarizes recent cases of illness caused by toxic E. coli and Salmonella contaminants in raw milk.  These constitute a full employment act for attorneys like Marler who represent victims of foodborne illness.

My position on raw milk has long been that people have a right to drink it but it had better be produced safely.  I believe that all foods–no exceptions–should be produced under well designed and carefully followed HACCP plans (or their equivalent) with pathogen testing at intervals commensurate with the level of risk.

But food safety experts tell me that raw milk can never be tested frequently enough to be confident it is safe.

Raw milk carries a greater risk of bacterial contamination than pasteurized milk and people who buy it should know what those risks are.  The risk may be small, but it is finite.  Putting a child at risk of hemolytic uremic syndrome from toxic E. coli just doesn’t make sense to me.

Like Michael Feldman, I’m dubious about the claims made for the health benefits of raw milk.  No question, it tastes better and that may be reason enough to want it.  But until I can be sure that the producer is scrupulous about safety, my personal choice favors pasteurization.

But that’s just me.  You?

My latest San Francisco Chronicle column is about calorie labeling going national and what the FDA is going to have to do to write regulations that make it work effectively.

While we are waiting for all that, how about what Burgerville is doing.  Burgerville, a fast-food chain in the Pacific Northwest, now does personalized calorie counts.  When you get your food, your receipt displays the calories for each item you ordered.  It also makes suggestions for ordering lower calorie items: “if you like the blueberry shake, you might consider getting a blueberry smoothie next time.”

Will doing something after-the-fact like this affect future food choices?  Researchers: get busy!

My newly updated book, Safe Food: The Politics of Food Safety, is just out from University of California Press.  Half the book is about the politics of genetically modified (GM) foods.  Politics explains these latest developments:

1.  FDA awards GRAS status to Monsanto’s Vistive Gold soybeans:  These beans have been genetically modified to be lower in linolenic acid and, therefore, more stable to oxidation.  Does this refer to alpha-linolenic acid (ALA)?  If so, this is an omega-3 fatty acid that gets converted in the body to the longer chain omega-3s, EPA and DHA.  Don’t we want more linolenic acid in our foods, not less? Or am I missing something here?

2.  Friends of organics in Congress want USDA to continue the ban on Roundup Ready (RR) alfalfa: The courts ruled that this alfalfa cannot be planted until USDA completes and Environmental Impact Statement (EIS), is is required by law.  According to the USDA’s preliminary assessment of the impact, RR alfalfa will not adversely affect the environment. But more than 20,000 people wrote to say that they disagreed with the USDA’s benign view.

The letter to USDA Secretary Vilsack points out that alfalfa is a major forage for dairy cows.  If USDA allows GM alfalfa to be grown, it will contaminate conventional alfalfa grown organically (through pollen drift).  If organic dairy producers cannot get uncontaminated organic alfalfa to feed their cows, they will not be able to get their milk certified as organic.

3.  USDA says it will do an EIS for GM sugar beets: Last year, a judge ruled that GM sugar beets, which now comprise 90% or more of sugar beet plantings, could not be planted again until the USDA did an EIS.  Oops.  Somehow, the USDA forgot to do an EIS in 2005 when it allowed GM beets to be planted.

What are GM sugar beet producers supposed to do now? Apparently, a hearing to decide the main issues of a lawsuit (Center for Food Safety v. Schafer) has been scheduled for July 9.  At that hearing, the court is supposed to decide whether RR sugar beets should be banned until USDA does the EIS.  This is awkward because the EIS is expected to take 2 or 3 years.  Why?  Because it must consider:

• Management practices for organic sugar beets, conventional sugar beets, and glyphosate-tolerant (Roundup Ready) sugar beets
• Potential impacts on food and feed
• Occurrence of common and serious weeds found in sugar beet systems and practices for controlling them
• Potential for gene flow from Roundup resistant sugar beet to other plant species
• Economic and social impacts on organic and conventional sugar beets, Swiss chard, and table beet farmers
• Potential health impacts

4.  Most American consumers will accept GM wheat if it is produced sustainably, at least according to the results of a survey done by the International Food Information Council, a food industry group:

Although commercially available genetically modified (GM) wheat crops are likely to be at least a decade away, 80 percent of survey respondents said they would be likely to purchase bread, crackers, cookies, cereal, or pasta products containing GM wheat “if they were produced using sustainable practices to feed more people using fewer resources such as land and pesticides.” And consistent with the 2008 survey, 77 percent of respondents said they would buy foods produced through biotechnology if they helped cut pesticide use.

Now, if only they would!

I don’t know how Michele Simon finds these things but she has just sent me this link to the latest video advertisement for Kraft’s Lunchables on YouTube’s Kids’ Channel.

As Melanie Warner points out,  Kraft has promised not to advertise its junk foods to kids under the age of 12.

Or maybe Kraft just means this to be advertising its “better-for-you” Lunchables?  The ones that are slightly lower in saturated fat, salt, and sugars?

What do you suppose an ad like this costs?